Brain Mechanisms of Mindfulness Based Cognitive Therapy in Women at High Risk for Depressive Relapse ("The Women's Wellness Study")
Phase: NA
Conditions: Recurrent Major Depression
Sponsor: University of Colorado, Boulder

 
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TITLE:  Neural effects of wellness classes in women with vulnerability to depression (“The Women’s 
Wellness Study”) 
 
PROTOCOL VERSION DATE: 5 December 2016 
VERSION:  3 
PRINCIPAL INVESTIGATOR (PI):  
Name: Marina Lopez-Sola, Ph.D. 
Email: marina.lopezsola@colorado.edu 
Address: University of Colorado, Boulder 345 UCB Muenzinger, D154 Boulder, CO 80309-0345 
Telephone: 303-817-2410 
 
Name: Jessica Andrews-Hanna, Ph.D. 
Address: University of Colorado, Boulder 345 UCB Muenzinger, D154 Boulder, CO 80309-0345 
Telephone: 617-276-4562 
Email:  Jessica.Andrews-Hanna@colorado.edu  
 
Name: Sona Dimidjian, Ph.D. 
Address: University of Colorado, Boulder 345 UCB Muenzinger, D314 Boulder, CO 80309-0345 
Telephone: 303-492-3485 
Email: sona.dimidjian@colorado.edu 
KEY PERSONNEL 
Name:  Marina Lopez-Sola, Ph.D. 
Role in project: Co- Principal Investigator. 
 
Name: Jessica Andrews-Hanna, Ph.D.  
Role in project: Co- Principal Investigator. 
 
Name: Sona Dimidjian, Ph.D. 
Role in project: Co-Principal Investigator. 
 
Name:  Tor Wager, Ph.D. 
Role in project: Co-Investigator. 
 
Name: June Gruber, Ph.D. 
Role in project: Co-investigator. 

 
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Name: Yoni Ashar. 
Role in project: Graduate Research Assistant. 
 
Name: Natasha Hansen 
Role in project: Graduate Research Assistant. 
 
Name: Christina Ann Metcalf.  
Role in project: Graduate Research Assistant. 
 
Name: Sarah Louise Hagerty  
Role in project: Graduate Research Assistant. 
 
 
Volunteer RAs in the Wagerlab, the Dimidjian Lab or the Gruber Lab, who are registered through CU 
Boulder, with completed CITI and background checks, may also be added to the study staff.  
I. 
OBJECTIVES 
This project aims to characterize the psychological, physiological, and neural mechanisms underlying 
symptoms of depression as well as the neural and psychological effects of an eight-week mindfulness 
based cognitive therapy (MBCT) intervention in preventing depression among women with past history 
of major depression. We also aim to develop informative brain biomarkers able to accurately predict 
future remission/relapse 6 months following the interventions.  
 
II. 
BACKGROUND AND SIGNIFICANCE  
Major depression is estimated to be the fourth leading contributor to disease and suffering world-wide 
(Murray and Lopes, 1998), showing prevalence rates between 2.9% and 12.6% (Kessler et al. 1994; JAMA, 
2003). It is also characterized by a markedly chronic nature (Judd, 1997); patients experience on average 
4.3 major depressive episodes (Perris, 1992), with each additional episode significantly increasing the 
future probability of relapse (APA, 2000; Bhagwagar and Cowen, 2008). Therefore, addressing MDD 
prophylaxis and understanding the pathogenic mechanisms involved in depressive relapse are essential 
to guide tailored selection of preventive interventions on an informed basis. 
  
Compelling evidence suggests that Mindfulness Based Cognitive Therapy (MBCT) has beneficial effects in 
preventing depressive relapses when compared to treatment as usual, placebo or psycho-education 
interventions8-15, and similar effects when compared with antidepressant pharmacotherapy9. Initial 
evidence points out that reductions in residual symptomatology after MBCT seem to be mediated by a 
reduction in worry and rumination, together with increases in mindfulness skills and self-compassion13-15. 
One recent study15 showed that MBCT is able to disrupt the relationship between cognitive reactivity –
ruminative thought- after sad mood induction and symptoms of depression in remitted patients. With the 
exception of such scarce literature on the subjective effects of MBCT, there are no previous studies 
addressing the behavioral and, more specifically, the neural underpinnings of the beneficial effects of 
MBCT on relapse prevention in remitted patients with previous recurrent history of depression. 

 
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Given this context, efforts to prevent depression hold obvious appeal. Mindfulness-based cognitive 
therapy (MBCT) represents one of the most important recent developments in the effort to prevent 
recurrent depression (Segal, Williams, & Teasdale, 2001). Explicitly designed to modify core underlying 
vulnerability factors among recovered individuals with histories of depression, MBCT may have high 
applicability to the prevention of MDD.  
 
MBCT is based on Mindfulness-Based Stress Reduction (MBSR), combining principles of cognitive therapy 
(CT) with those of mindfulness meditation to prevent depression relapse. Both MBSR1 and MBCT use 
contemplative practices, including sitting meditation, body scan and walking meditation, as core methods 
to teach awareness of negative thoughts and emotions with the aim of disengaging from pervasive 
patterns of ruminative self-centered mentation. Compelling evidence suggests that MBCT has significantly 
greater beneficial effects in preventing depressive relapse than placebo or psychoeducation 
interventions3-10 and comparable effects as maintenance antidepressant pharmacotherapy11.  
There is an emerging body of literature12,13 on the specific mechanisms of action of MBSR suggesting (i) 
increased non-judgmental awareness of the contents of consciousness and their transitory nature,2,14 (ii) 
reduced ruminative thinking15-17 and emotional reactivity18-21 with augmented self-compassion2,19,27,  and 
(iii) increased capacities in the domains of attention, working-memory and cognitive flexibility22-27.  In 
contrast to this compelling evidence, there is a scarcity of empirical support as to the psychological and 
neural mechanisms underlying the beneficial effects of MBCT in preventing depression relapse. Only 
recent preliminary data, relying predominantly on self-report questionnaire methods, suggest that 
reductions in residual symptomatology after MBCT is mediated by a reduction in worry and rumination, 
with concurrent increases in self perceived mindfulness, sleep improvements and self-compassion28-32.  
Recent imaging studies of MBSR33-37 suggest that mindfulness meditation promotes a shift from more 
“narrative” to “experiential” forms of self-related awareness. Narrative self-focus refers to a concept of 
self that is extended in time, including past memories and intentions for the future, together with abstract 
self representations in relation to socio-emotional values. In contrast, the “experiential self-focus” refers 
to a more immediate self experience and is associated with greater awareness of external stimuli and 
internal somatic-visceral bodily states. MBSR has been shown to increase brain activity in regions relevant 
for conferring “experiential” self-focus (insula-opercula, dorsal anterior cingulate/supplementary motor 
area), while decreasing responses in rostral-medial, lateral frontal and hippocampal regions that support 
the “narrative” mode of self-focus. Such changes in brain activity are associated with increased well-
being35-37,12,13. 
The extension of these findings to the practice of MBCT is particularly important given the central role of 
mindfulness meditation and the specific vulnerabilities associated with recurrent depression. Research 
suggests that among individuals with histories of depression, episodes of stress increase dysphoria and 
activate analytical ruminative thinking about past events with strong “narrative” self-focus, which is 
congruent with their easy access to negative self-relevant material (e.g. self-criticism, dissatisfaction and 
blameworthiness)38,39. Rumination then intensifies the dysphoric state and increases relapse risk38-39. 
These ideas and some of the observations grounded the development of MBCT as a prophylactic 
intervention for recurrent depression1,43. 
 
Brain imaging studies have provided parallel information on the neural underpinnings of increased 
vulnerability for depression44-53. These studies suggest that structural, functional and biochemical 
alteration in specific elements within two major functionally-connected brain networks, the “default 

 
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mode” (DMN) and the “insular-paralimbic” (PLN) networks, are involved in the generation and 
maintenance of depressive episodes. Importantly, activity and connectivity balances within and between 
these two brain networks have shown to be responsible for either greater “narrative” or “experiential” 
self-focus33-37. Interestingly, neural activities in these two brain systems are strongly negatively 
correlated54. It has repeatedly been shown that ruminative self-related tendencies, depressive symptom 
severity and augmented fear are associated with enhanced activity within DMN components33-35,55-58. On 
the other hand, augmented perception of visceral autonomic and somatic information, such as attention 
focused on heart-beating or breathing, enhance activity within the PLN59-62.  
 
In summary, a wealth of evidence suggests that (i) Women that have experienced at least one past episode 
of depression are at high risk of relapse and there is need for new psychosocial prophylactic interventions 
guided to prevent depression relapse in such populations, (ii) MBCT interventions effectively reduce risk 
for depressive relapse in chronic depressive patients, (iii) enhanced narrative (vs experiential) self-focus 
and negative rumination are associated with high risk for depression relapse, (iv) neural systems 
conferring vulnerability for depression highly overlap with those responsible for different forms of self-
referential focus (“narrative” and “experiential”) and (iv) MBSR promotes the transition from more 
“narrative” to more “experiential” modes of self-focus, which is associated with enhanced subjective well-
being and reduced stress-related responses. Despite this growing body of research, the specific 
psychological and neurobiological mechanisms underlying the positive effects of MBCT as a prophylactic 
intervention for depression remains unknown.  
III. 
RESEARCH STUDY DESIGN AND PROCEDURES 
Overall, this study aims to characterize the neural and psychological effects of an eight-week mindfulness 
based cognitive therapy (MBCT) intervention (online group class) in preventing depressive relapse in 
women with past history of major depression when exposed to different forms of self-relevant and 
context-specific emotional challenge. We also aim to establish psychological and neural mechanisms 
contributing to depressive symptoms prior to intervention and develop informative brain biomarkers able 
to accurately predict future remission/relapse 6 months following the interventions. A key objective of 
the study is to assess baseline markers of depressive symptoms and possible change resulting from the 
MBCT intervention from interdisciplinary perspectives, including the psychological perspective (i.e. 
measured with computer-based tasks, self-report ratings, questionnaires, etc.), the physiological 
perspective (i.e. heart rate, skin conductance, and respiratory response upon viewing emotional and non-
emotional material), and the neural perspective (neural activity measured with functional MRI).  We aim 
to uncover how differences in emotional well-being across individuals manifest both in the lab and in daily 
life.   
 
Overview of Design and Procedures: 
 
We aim to enroll two groups of participants in this study. Extensive behavioral and clinical measurements 
will be collected at baseline for both groups.  
 
Group 1: Group 1 (healthy control participants) will comprise women with no prior history of depression 
or other mental health disorders.  Participants in group 1 will be asked to:  
• 
Undergo a clinical interview and a series of behavioral tasks (session 1) 
• 
Answer several self-report questionnaires administered online (at home session) 

 
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• 
Answer questions about their daily mood and thoughts over a period of approximately 10 
days (at home) 
• 
Return to the laboratory for an MRI session and additional behavioral tasks (session 2) 
• 
Return to the laboratory for a second MRI/behavioral session after 8 weeks (an equivalent 
duration as the intervention administered to Group 2). 
 
Group 2: Group 2 will comprise women with a prior history of depression who lack other exclusion criteria 
(see below).  Participants in group 2 will be asked to undergo the same procedures requested of group 1 
participants, as well as to complete an 8-week intervention and 6-month follow-up assessments.  Thus, 
group 2 participants will be asked to: 
 
• 
Undergo a clinical interview and a series of behavioral tasks (session 1) 
• 
Answer several self-report questionnaires administered online (at home session) 
• 
Answer questions about daily mood and thought content over a period of approximately 
10 days (at home). Right after this assessment, we may include a baseline period of up to 
4 weeks, in which we would ask the patient to complete a subset of the questionnaires 
including the PHQ-9 to assess the stability of the symptoms (to have a measure of changes 
in symptomatology due to natural history/regression to the mean).  
• 
Return to the laboratory for an MRI session and additional behavioral tasks (session 2) 
• 
Complete an 8-week at home MBCT intervention (see below) and answer weekly 
questionnaires about mood and thoughts over the course of the intervention 
• 
Return to the laboratory for a post-intervention MRI session and the same behavioral 
tasks as completed prior to the intervention 
• 
Complete the same set of self-report questionnaires as completed prior to the 
intervention (at home session) 
• 
Answer questions about daily mood and thought content over a period of approximately 
10 days (at home) 
• 
Undergo a clinical assessment approximately 6 months post-intervention and complete 
self-report questionnaires 
 
 
The 8-week online MBCT intervention 
 
Participants in group 2 will be asked to complete an 8-week online MBCT intervention following session 
2. MBCT will be delivered in 8 ‘online group sessions’, featuring an initial orientation and including guided 
mindfulness and yoga practices, cognitive-behavioral strategies, and psychoeducation procedures, 
consistent with standard MBCT. The following table outlines the topic and targets of each session (Table 
1).   
 
Table 1. Description of MBCT sequence of session topics and targets.  
#  
Topic 
Targets 
1 
Orientation to 
MBCT 
Rationale for daily practice not tied to symptom presence, facing difficulties, 
patience and persistence; enhancement of motivation. 
2 
Automatic pilot 
Recognizing cognitive, behavioral, and affective automatic patterns and how 
such automaticity can be associated with increased risk of relapse/recurrence 
during periods of sad mood; committing to mindfulness practice as a means of 
stepping out of automatic pilot 

 
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3 
Dealing with 
barriers 
Practicing moving attention to specific foci to learn that attention can be 
intentional as opposed to automatic; identifying barriers to mindfulness 
practice that arise, with specific focus on automatic cognitive patterns  
4 
Mindfulness of 
breathing 
Increasing awareness of how often the mind is busy/scattered; introducing key 
formal practices including mindfulness of breathing, walking, and yoga 
5 
Staying present 
Increasing awareness of the ways avoidance or clinging to particular 
experiences can be associated with depression; practicing a new mode of 
responding that stays present and attentive in the face of difficulty; identifying 
symptoms and cognitions characteristic of depression as early warning signs 
6 
Allowing and 
Letting be 
Increasing use of mindful attention at the first step in responding effectively to 
difficulties, including difficult internal experience such as sadness; decreasing 
judgmental thoughts and avoidant responses to difficulties 
7 
Thoughts are 
not facts 
Decreasing affective reactivity to thoughts previously associated with 
depression; learning to “de-center” from difficult thoughts, realizing that 
thoughts are merely thoughts; recognizing patterns of recurring thoughts 
8 
How can I best 
take care of 
myself? 
Identifying unique warning signs of relapse (“relapse signature”); identifying 
activities that improve or deteriorate mood; developing action plans to 
implement during periods of high risk; using mindfulness practice explicitly to 
guide action plan steps  
 
As in previous studies, before interviewing the potential participants, we will ask them to complete an 
online screening form (see Attachment_6, Attachment_7 and Attachment_8 in Table 3) using CU’s secure 
survey system provider, i.e., RedCap (for a detailed description see Recruitment Methods). Before the 
formal intervention begins, we will address subjects’ possible reluctance to devote time to self-care during 
a period of symptom quiescence. We will present information about MBCT in the orientation session 
within a broader motivational context aimed at enhancing subjects’ intrinsic motivation to practice 
mindfulness (or homework exercises) by exploring and resolving possible ambivalence.  
 
As part of the intervention, participants will be encouraged to engage in the intervention modules and 
complete supplementary “homework” 6 days per week, measured using a daily practice record online.  
 
Weekly phone coaching based on the modified telecoach manual developed by Mohr and colleagues 
(Duffecy et al. 2010) will be provided by clinical graduate students, under the supervision of Dr. Dimidjian, 
and Dr. Segal. Phone coaching will include two initial engagement sessions that will last ~30 minutes, and 
follow up calls are anciticapted to last 5-10 minutes (after sessions 1 and 2). The coach and participant 
collaboratively decide whether to continue phone calls or transition to weekly email support after the 
second session. Participants also are reminded that they can always resume phone calls if they prefer 
them to the email support. 
 
In the following sections we will provide a detailed explanation of the (a) clinical interviews and cognitive 
functioning battery, (b) psychological scales and questionnaires, (c) specific cognitive-emotional 
experimental tasks, and (d) naturalistic thought sampling that will be measured before and after the 
interventions. We also provide a summary of the timeline of the study. 
 
 
 
 

 
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• 
(A) CLINICAL INTERVIEWS AND COGNITIVE FUNCTIONING BATTERY 
 
All subjects will have an introductory session where they will receive all relevant information about 
the study. The same day they will be asked to carefully read, ask about and sign the written informed 
consent. Demographic and clinical information will be registered for every subject. The Structured 
Clinical Interview for the DSM-V-RV, Research Version will be administered. The SCID-V-RV (First, 
Spitzer, Gibbon, &Williams, 1996; see Attachment_9 in Table 3) is a semi-structured psychiatric 
interview designed to yield judgments with respect to all five axes in the DSM-V.  The SCID-V-RV is 
widely used for diagnostic purposes in clinical and research settings, and will be given by research staff 
who are trained in implementing and coding the interview.  The SCID-V-RV is modular in format, with 
each DSM-V disorder investigated separately. The research interviewer begins each module with 
screening questions, and depending upon the participant’s report, may continue to query for more 
information regarding symptoms or may skip to the next module.  Furthermore, the SCID allows for 
assessment of both current and history of clinical disorders, and the Global Assessment of Functioning 
Scale (GAF; Luborsky, 1962) to assesses overall psychological, social, and occupational functioning on a 
scale from 1 (lowest level of functioning) to 100 (highest level of functioning). We will audio-record the 
clinical interview for a subset of the patients only for research purposes (which will not include the 
participant's name, address, or date of birth) in order to determine inter-judgement reliability 
assessments. As we discuss in detail below, all of the participants' information will be kept strictly 
confidential and will be only used for research purposes. We will store the clinical audio-recording 
files (identified only by participants’ study ID) in an external hard drive designated for the study, 
located in a locked file cabinet within a locked room within Sona Dimidjian's CREST lab. Audio data 
will be retained indefinitely on encrypted, password protected, and firewalled servers in the Department 
of Psychology and Neuroscience.  
 
At post-intervention and at 6 months follow-up post-intervention, we will use the Longitudinal Interval 
Follow-up Evaluation (LIFE, please see Attachment_10 in Table 3) to ascertain subsequent diagnostic 
status, again according to DSM-V diagnostic criteria. The LIFE provides a retrospective assessment of 
relapse and recurrence based on a semi-structured interview.  
 
 
 
• 
(B) PSYCHOLOGICAL MEASURES (SCALES AND QUESTIONNAIRES) 
 
For both groups, several psychological constructs will be measured pre-intervention, post-intervention 
and, for a subset of questionnaires, 6 months after the end of the intervention. Note that for Group 1, this 
will occur 8 weeks after the session 2, and 6 months after that. We summarize the main constructs of 
interest below. 
 
1. Depression and anxiety. 
We will use the 21-item Beck Depression Inventory II (BDI; Beck, Steer, & Brown, 1996; please see 
Attachment_11 in Table 3), which is the most widely used measure of depression in intervention studies, 
and the Patient Health Questionnaire (PHQ-9, Kroenke et al. 2001, please see Attachment_12 in Table 3). 
We have added the section entitled ‘Management of Potential Clinical Deterioration and Suicidal 
Ideation’, please see page 14, in order to explain how these measures will be used for ongoing safety 
monitoring.  
 

 
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To assess generalized anxiety symptoms we will administer the GAD-7 (Spitzer et al. 2006, Attachment_13 
in Table 3).  
 
2. Rumination and cognitive reactivity. 
The 22-item Ruminative Response Scale (RRS; Nolen-Hoeksema 1987, 1999; please see Attachment_14 in 
Table 3) will be used to assess the degree to which people tend to ruminate when they are feeling down, 
sad, or depressed. The scale consists of a list of possible things that people could do, in general, when 
they are feeling down or sad. Example items include: "Think about how alone you feel" and "Go someplace 
alone to think about your feelings." Items are answered on a 4-point scale (1=almost never and 4=almost 
always). 
 
To measure excessive and uncontrollable worry, we will administer the 16-item Penn State Worry 
Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990; please see Attachment_15 in Table 3). 
This questionnaire measures people’s tendency to worry about things in general and does not ask about 
whether people worry about any specific types of situation or events, and therefore allows a 
measurement of worry that is distinctively different from the constructs of either depression or anxiety.   
Example items include: “Many situations make me worry,” “I never worry about anything,” and “Once I 
start worrying, I can’t stop.” Items are answered on a 5-point scale (1 = Not at all typical and 5 = Very 
typical).  Lastly, we will include the Leiden Index of Depression Sensitivity (LEIDS-R, Van Der Does, 2002; 
Attachment_16 in Table 3). 
 
We are also including a validated measure of self-concept (Twenty Statements Test, Kuhn and McPartland, 
1954; Attachment_53 in Table 3) and of Cognitive Behavioral Avoidance (Ottenbreit and Dobson, 2002; 
Attachment_54 in Table 3). 
 
3. Perceived Stress. 
The 14-item Perceived Stress Scale (PSS) is a measure of the degree to which situations in one’s life are 
appraised as stressful (Cohen, S., Kamarck, T. & Mermelstein, R., 1983; please see Attachment_17 in Table 
3). The PSS has been validated in both clinical and community samples, and shows high reliability with 
alpha = .84 to .86.  The scale was additionally found to correlate positively with number of life events, 
impact of life events, and to be a better predictor of health and health-related outcomes than simple life-
event scales. Items are rated on a five-point scale indicating how often they have experienced specific 
feelings and thoughts in the past month.  
 
4. Positive and Negative Affect and Empathy.  
The 20-item Positive and Negative Affect Scale (PANAS; Watson & Clark, 1994; please see documents 
Attachment_18 and Attachment_19 in Table 3) is the gold standard assessment of affect used in clinical 
research.  Both subscales of positive and negative affect are found to have high internal consistency 
(Cronbach’s alpha of .83 to .91) for clinical and community samples. Separate questionnaires encourage 
participants to rate each item based on the extent to which they feel that way currently (in the moment), 
or in general.  Example items include: “interested” and “distressed.”  Items are rated on a five-point scale.   
 
To specifically assess positive affect and beliefs about positive emotions and affective states, which are 
susceptible to change following the intervention, we will include the following measures: Affect Valuation 
Index (Tsai et al. 2006, Attachment_20 in Table 3), Emotion Beliefs Scale (Rimes et al. 2010, 
Attachment_21 in Table 3), Happiness Beliefs Scale (Gruber et al. 2014, Attachment_22 in Table 3), the 
Emotion Regulation Valuation Index (Attachment_23 in Table 3). Lastly, we will include the Hypomanic 
Personality Scale (HPS-24, Attachment_24 in Table 3). We are also including the Positive Empathy Scale 

 
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(Morelli, 2012; Attachment_56 in Table 3) and the Interpersonal Reactivity Scale including Empathic 
Concern subscale (Davis, 1980; Attachment_57 in Table 3). 
 
5. Mindfulness. 
The 39-item Five-factor Mindfulness Scale (FFMQ; Baer, Smith, Hopkins, Krietemeyer & Toney, 2006; 
please see document Attachment_25 in Table 3) assesses five domains of mindfulness, including acting 
with awareness, non-reactivity, observing, describing, and non-judging. This measure is widely used to 
capture individual differences in mindfulness strategies.  Items are rated on a five-point scale. 
 
The 20-item Experiences Questionnaire (EQ) has a 2-factor structure that evaluates rumination and 
decentering (Fresco, Moore, Dulmen, Segal, Ma, Teasdale, & Williams, 2007; please see document 
Attachment_26 in Table 3). The decentering scale of the EQ shows significant negative relationships with 
concurrent levels of depression and anxiety symptoms and theoretically meaningful associations with 
constructs including depressive rumination, experiential avoidance, and emotion regulation (Fresco et al., 
2007, p. 244). Items are rated on a 5-point scale ranging from 1 “never” to 5 “all the time.” 
 
We will include the Imaginal Process Inventory, specifically the mind wandering and thought fluency 
subscales (IPI, Singer et al., 1963;Mason et al., 2007; please see Attachment_27 and Attachment_28 in 
Table 3). 
 
6. Psychological and physical well-being. 
The 54-item RYFF (Ryff, 1989; please see document Attachment_29 in Table 3) measures 6 dimensions of 
psychological well-being: autonomy, environmental mastery, personal growth, positive relations with 
others, purpose in life, and self-acceptance. These dimension scales (9-items each) have high internal 
consistency ranging from 0.83 to 0.91. The items are rated on a scale of 1 (strongly disagree) to 6 (strongly 
agree). We will also include the SF-12 (Attachment_30 in Table 3; Ware, 2006) which is a brief self-report 
measure of mental and physical functioning and overall health-related-quality of life and a few more 
demographical and health related questions (Attachment_31 in Table 3). Sleep quality (Attachment_32 in 
Table 3; Buysse et al. 1989), and physical activity (Attachment_33 in Table 3; Hagströmer et al. 2006) will 
also be assessed. 
 
7. Self-compassion.  
Self-compassion involves “being open to and moved by one's own suffering, experiencing feelings of 
caring and kindness toward oneself, taking an understanding, nonjudgmental attitude toward one's 
inadequacies and failures, and recognizing that one's experience is part of the common human 
experience”. The Self-Compassion Scale (SCS: Neff, 2003; please see Attachment_36 in Table 3) measures 
how individuals typically act and react towards themselves in difficult times. It particularly addresses the 
ability to treat oneself with kindness when things go badly. It specifically measures self-kindness, self-
Judgment, common humanity, isolation and mindfulness.  
 
8. Social Support. 
We will assess social support with the Social Support Questionnaire, short form (please see 
Attachment_37), which yields measurements of the size of the social support network and the satisfaction 
with available supports. It has excellent construct and discriminant validity as well as strong internal 
consistency and test-retest reliability.  
 
 
 

 
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9. Bodily Pain and Fatigue. 
Considering the relationship between pain complaints and depression (Launtenbacher et al. 1993; 1994; 
Gieseche et al, 2005), we will assess clinical pain complaints pre and post intervention using the Brief Pain 
Inventory-short form (please see Attachment_38 in Table 3). We may also use the Pain Catastrophizing 
Scale (PCS, Sullivan et al. 1995-2009, Attachment_39 in Table 3). In order to measure fatigue in our sample, 
we are including the Multidimensional Fatigue Inventory (Smets et al. 1995; Attachment_55 in Table 3). 
 
10. Expectations about treatment outcome and client satisfaction. 
To 
measure 
the 
effects 
of 
expectations 
on 
intervention 
outcomes, 
will 
administer 
the 
Credibility/Expectancy Questionnaire (CEQ, Devilly, G. J., & Borkovec, T. D. 2000, Attachment_40 in Table 
3) and a modified version of the BDI and PHQ-9 questionnaires (see Attachment_41 and Attachment_42 
in Table 3) in which the questions refer to participants’ expectation of improvement in each clinical 
domain (e.g., sadness) after receiving the intervention. To measure client satisfaction, we will administer 
the Client Satisfaction Questionnaire (CSQ, Attkisson & Greenfield, 2009; Attachment_43 in Table 3). 
 
 
The following Table 3 provides a summary of all data collection instruments/measures/attachments to be 
completed in this study, including additional validated questionnaires not summarized above.  
 
Table 3. Summary of all attachments (i.e. instruments, scales, letters of support, etc.) to be completed in 
the WWS study.  
#  
Topic 
content 
0 
Protocol 
Protocol 
1 
Attachment 1 
Consent Form Group 1 
2 
Attachment 2 
Consent Form Group 2 
3 
Attachment 3 
Empty attachment. Removed. 
4 
Attachment 4 
Flyer 1 for control women 
5 
Attachment 5 
Flyer 2 for women at risk  
6 
Attachment 6  
Pre-screening online consent form 
7 
Attachment 7 
Screening questions, old OnlForm_mod document 
8 
Attachment 8 
Screening PDSQ, i.e., Psychiatric Diagnostic Screening Questionnaire 
9 
Attachment 9 
SCID. Structured Clinical Interview DSM-V-RV, Research Version 
10 
Attachment 10 
LIFE-Rift. Longitudinal Interval Follow-up Evaluation  
11 
Attachment 11 
BDI-II. Beck Depression Inventory II 
12 
Attachment 12 
PHQ-9. Patient Health Questionnaire 
13 
Attachment 13 
GAD-7. Generalized Anxiety Disorder symptoms 
14 
Attachment 14  
RRS. Ruminative Response Scale 
15 
Attachment 15 
PSWQ. Penn State Worry Questionnaire 
16 
Attachment 16 
LEIDS-R. Leiden Index of Depression Sensitivity 
17 
Attachment 17 
PSS. Perceived Stress Scale  
18 
Attachment 18 
PANAS.  Positive and Negative Affect Scale, last week. 
19 
Attachment 19 
PANAS-NOW. Positive and Negative Affect Scale, right now. 
20 
Attachment 20 
AVI. Affect Valuation Index 
21 
Attachment 21 
EBS. Emotion Beliefs Scale 
22 
Attachment 22 
HBS. Happiness Beliefs Scale 
23 
Attachment 23 
ERVI. Emotion Regulation Valuation Index 
24 
Attachment 24 
HPS-20. Hypomanic Personality Scale 

 
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25 
Attachment 25 
FFMQ. Five-factor Mindfulness Scale 
26 
Attachment 26 
EQ. Experiences Questionnaire 
27 
Attachment 27 
IPI-MW. Imaginal Process Inventory- Mind Wandering 
28 
Attachment 28 
IPI-TF. Imaginal Process Inventory- Thought Frequency 
29 
Attachment 29 
Ryff Scales. Psychological well-being scales 
30 
Attachment 30 
SF-12. Mental and physical functioning 
31 
Attachment 31 
Demog_Health_Medit_ShortForm Questionnaire 
32 
Attachment 32 
PSQI. Pittsburgh Sleep Quality Index  
33 
Attachment 33 
IPAQ. International Physical Activity Questionnaire 
34 
Attachment 34 
Empty attachment. Removed. 
35 
Attachment 35 
Empty attachment. Removed. 
36 
Attachment 36 
SCS. Self-Compassion Scale 
37 
Attachment 37 
SSQ. Social Support Questionnaire 
38 
Attachment 38 
BPI. Brief Pain Inventory-short form 
39 
Attachment 39 
PCS. Pain Catastrophizing Scale 
40 
Attachment 40 
CEQ. Credibility/Expectancy Questionnaire 
41 
Attachment 41 
BDI-II Expected Improvement 
42 
Attachment 42 
PHQ-9 Expected Improvement 
43 
Attachment 43 
CSQ. Client Satisfaction Questionnaire 
44 
Attachment 44 
Safety.  
45 
Attachment 45 
Autobiographical Memory Interview 
46 
Attachment 46 
Phone Screening Patients WWS 
47 
Attachment 47 
Phone Screening Controls WWS 
48 
Attachment 48 
Letter Collab. Dr. Zindel Segal 
49 
Attachment 49 
Letter Collab. Dr. Norman Farb 
50 
Attachment 50 
Mini-Mental State Exam, MMSE. 
51 
Attachment 51 
Empty attachment. Removed. 
52 
Attachment 52 
List of referral options in case excluded during screening for diagnosis 
53 
Attachment 53 
Twenty Statements Test (TST) 
54 
Attachment 54 
Cognitive Behavioral Avoidance Scale (CBAS) 
55 
Attachment 55 
Multidimensional Fatigue Inventory 
56 
Attachment 56 
Positive Empathy Scale 
57 
Attachment 57 
IRI Interpersonal Reactivity Index (a measure of negative empathy) 
58 
Attachment 58 
Naturalistic Thought Sampling Questionnaire 
59 
Attachment 59 
Document to track Medication Use 
60 
Attachment 60 
Flyer 1b generic flyer for control women and women at risk 
61 
Attachment 61 
fMRI Release Form 
62 
Attachment 62 
Experience Sampling Weekly questionnaire ES_Weekly 
63 
Attachment 63 
Mind Wandering Questionnaire 
64 
Attachment 64 
NAART35_10-12-07 questionnaire  
65 
Attachment 65 
NAART35_WORD.LIST Word list for previous questionnaire 
66 
Attachment 66 
Psychotherapy form. To assess concurrent psychotherapies 
67 
Attachment 67 
Spontaneous deliberate mind wandering questionnaire, to assess everyday 
mind wandering  
 
Management of Potential Clinical Deterioration and Suicidal Ideation 

 
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Participants will be asked to complete the PHQ9 at evaluation contact and weekly throughout the 
duration of the intervention phase of study for Group 2. Each time a participant completes the PHQ9 on 
Qualtrics, an email trigger containing the de-identified response data will be sent to the study coordinator.  
This allows for ongoing monitoring of depression symptom severity. If participants report any suicidal 
ideation on online questionnaires, we will not provide additional assessment to determine level of 
risk, but will provide all subjects who report any suicidality with national and local mental health 
referral information. Thus, if a participant endorses suicidal ideation, branching logic in the 
questionnaire will display the statement: 
 
“Thank you for being willing to take a few minutes to answer questions 
about how you are doing. The study staff may not immediately review your 
responses to these questions and will not be responding to thoughts about 
death or hurting yourself. Thoughts about death or hurting yourself are 
serious, but not uncommon. Because you indicated that you may be having 
these thoughts, we want to be sure you know how to access support from the 
National Suicide Prevention Lifeline (available 24/7) at 1-800-273-8255. 
There are also a number of local and regional resources including:  
- The Colorado Crisis Services at 844-493-8255 
- The Colorado Mental Wellness Network at 720-842-9222 
- The Mental Health Center of Denver at 303-504-6500 
 
If you think you are in danger of hurting yourself, call 911 or go to the 
nearest emergency room.” 
 
Decisions about continuation in the study protocols will be made on a case-by-case basis by 
Dr. Dimidjian. Generally, we intend to continue all participants in the study unless doing so would 
present complication for another treatment modality that is deemed to be more appropriate for the 
participant’s care.  
 
All participants will be provided with a study information sheet that explains these general 
procedures (Attachment_44 in Table 3). 
 
• 
(C) EXPERIMENTAL TASKS 
 
The following experimental tasks will be split across sessions 1 & 2, and will be repeated during session 3 
to assess intervention effects on a number of well-established psychological measurements related to 
cognitive and emotional function at several time points along the study progression. 
 
(C1) EXPERIMENTAL TASKS IN THE BEHAVIORAL LABORATORY 
 
Breath counting task 
This task has been validated as an objective behavioral measure of mindfulness in four independent 
experiments with more than 400 participants. This measure is reliable and significantly correlated with 
self-reported mindfulness (Levinson et al. 2014). As in the previous study (Levinson et al. 2014), 
participants will be instructed to be aware of the movement of their breath and count their breaths from 
1 to 9 repeatedly. With breaths 1–8 they will press one button, and on the nine breath they will press 

 
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another, measuring counting accuracy. Every ∼90 s (60–120s range) experience sampling will probe state 
mind wandering and meta–awareness, respectively, with two 6-point Likert scales, “just now, where was 
your attention? (completely on-task/off-task)” and “how aware were you of where your attention was? 
(completely aware/unaware).” Participants will then be probed for their count.  
 
Dot-probe Task 
Using the Dot-Probe task we are going to measure negative emotion attentional bias. After presentation 
of a fixation cross in the center of the screen, participants are presented with 2 words from two categories 
(here: depression and neutral words). The position of the words is randomly chosen to be either above or 
below the location of the fixation cross. After a short duration, the two words disappear and a probe 
stimulus (here: < or >) appears in the location of one of the words. Participants are asked to press one key 
if the probe is < and another if the probe is >. 
 
 
Autobiographical Memory Interview (Attachment_45 in Table 3) 
In this task participants will be prompted with various words and will be asked to recall a specific event 
(lasting no more than one day) that happened in their past (within a timeframe of 6 months – 3 years 
before the date of the interview) related to each word, and verbally describe the event to the researcher. 
Then, each participant will be asked to rate each memory on a variety of dimensions (i.e., temporal 
distance, valence, personal significance, vividness, emotional intensity, approach vs. avoidance-related 
behaviors such as anxiety, motivation/difficulty engaging and unpleasant feelings while recalling. Lastly 
we will ask for the level of perceived controllability/uncontrollability regarding the ability to stop thinking 
about that memory when desired). Participants will be video recorded while reporting their memories. 
This task will serve as a means to quantify the nature of participants’ autobiographical memory recall in 
an ecologically-valid manner, and will be later used during the MRI assessment.  
 
Thought Fluency task/Free-association semantic task  
In this task, subjects are given a cue and required to state the first word that comes to mind in response 
to the cue and repeat this process every 3s until a target number of response is reaches. Cues vary in level 
of self-reference, valence, type of thought elicited (i.e. FAILURE, FUTURE, etc.). In verbal fluency trials, the 
subject must list as many words as possible that fall within particular categories (e.g. begin with the letter 
“F”).   Participants will be video recorded while completing this task.   
 
 
Emotional movies task 
We will use short emotional movies (total task duration 20 min) to assess moment-by-moment ratings of 
positive and negative emotions in the participants. We will specifically assess emotional reactivity; time 
to reach peak response and ability to recover the baseline emotional state. Specifically, the participants 
will be told that they will be viewing a positive and negative brief film clips lasting between 2-5 minutes 
in length, and answering questions at the end of the film clip. Film clips have been established as a valid 
and safe elicitor of emotion in laboratory settings and previously used by the P.I. (Gruber et al., 2008; 
2011; Rottenberg, Ray & Gross, 2007). Positive film stimuli includes a variety of video clips and slides 
meant to induce particular positive emotions, such as compassion, pride, happiness, amusement, and 
enthusiasm.  Examples of the video stimuli include the US Open tennis tournament depicting Andy 
Roddick winning the tournament, the figure skating Olympics depicting Sarah Hughes’ gold medal victory, 
a clip about a boy named Trevor who helps homeless people in Philadelphia, a clip depicting heroism from 
the movie Rudy. The negative film stimuli include a variety of video clips and slides meant to induce 
particular negative emotions, such as sadness (clips from Steel Magnolias, Dead Poets Society, Rocky, The 
Champ, and 21 Grams) and fear (clips from Taxi Driver and Trainspotting). There will be a 60 second 
baseline before each film clip and a 60 second recovery period at the end of each film clip. At the end of 

 
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the film clip, participants will also self-report their emotions using the Affect Valuation Index 
(Attachment_20 in Table 3). 
 
 
(C2) EXPERIMENTAL TASKS TO BE CONDUCTED IN THE MRI SCANNER 
 
Rest task 
In the rest task, participants will simply be asked to quietly relax for a period of approximately 6 minutes, 
and afterwards will be given a questionnaire to indicate the nature of their thoughts during this 
unconstrained task by allocating the approximate percentage of time they thought about various 
categories of thoughts (i.e. past-positive, past-negative, etc.). 
 
 
“Narrative” vs “Experiential” task during autobiographical memory recall  
Subjects will be exposed to a word probe signaling them to recall a specific autobiographical memory (that 
will have been previously assessed by the Autobiographical Memory Test). The participant will be asked 
to engage either: (i) A Narrative Focus mode, reflecting on what the memory means regarding their sense 
of self and their value as a person, allowing themselves to enter a train of thoughts or (ii) An Experiential 
Focus mode, monitoring their moment-to-moment experience in response to the memory being recalled 
(observing and monitoring their body response to the memories, thoughts and feelings that appear while 
trying to maintain an observers perspective in a non-judgmental, curious attitude without being trapped 
by the flow of thought). After each memory recall period subjects will be asked to complete a working 
memory task, a form of the n-back (1-back), in order to measure their ability to focus attention on an 
externally demanding task right after recalling self-related memories, which will make high-risk for 
depression participants more prone to enter a ruminative state. 
 
Mood-induction task (administered during the acquisition of the anatomical scan) 
Subjects will be asked to listen to a sad piece of music and to try and recall a time in their lives when they 
felt sad. The participants will be asked to experience as intensely as possible the feelings of the music and 
their memories for approximately 3-4 min. Similar music pieces as in Segal et al. 1999, Segal et al. 2006 
and Joorman and Gotlib, 2008, will be used. This type of provocation (combining elements of music 
associated with sad mood and autobiographical recall) has been found to be effective in bringing on 
transient dysphoric mood states (Martin, 1990).  
 
 
Self-Syllable Judgment Task 
This task will be administered both pre- and post- mood induction. Participants will see self-directed 
statements about personality traits that vary in terms of valence (negative, e.g., ‘ugly’, ‘unintelligent’ vs. 
positive, e.g., ‘pretty’, ‘intelligent’) and they have to rate how much that adjective trait applies to 
themselves. As a control condition for this task, subjects will be asked to report the number of syllables 
of each personality trait word.  
 
 
Post-scanning memory assessment 
Right after the imaging session we will perform a memory test to assess whether participants can recall 
the information presented during the Self-syllable Judgment task. Subjects will also judge the emotional 
valence of each stimulus. This will allow us to measure selective memory biases for negative information, 
particularly during the “self” condition.  
 
 

 
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• 
(D) NATURALISTIC THOUGHT SAMPLING (Attachment_58 in Table 3) 
 
     These daily surveys will be administered 5x per day for 7-10 days immediately following session 1 and 
8 weeks following session 2.  The naturalistic thought sampling surveys are designed to estimate several 
factors characterizing the occurrence of spontaneous thoughts in real-world settings. In particular, we will 
estimate the frequency with which participants engage in spontaneous thoughts, the nature of the 
participants’ ongoing activity and environmental context, and the nature of the content underlying one’s 
thoughts. To assess these factors, the participant will receive a text message on five randomly-determined 
occasions between 10am and 10pm until they respond to 35 thought sampling probes (a minimum of 7 
days, maximum of 10 days. Participants will have the opportunity to either ignore the text message or 
continue onto questions assessing various objective and phenomenological questions regarding their 
experiences immediately before the alarm sounded by clicking on the link to a questionnaire on the 
Qualtrics survey website, where participants will enter a unique, non-identifying subject ID each time. 
While response options for some questions will be discrete, other questions will be answered using a 
Likert scale (from strongly disagree to strongly agree) to gain more precision. Participants will be asked to 
complete the spontaneous thought task prior to and following their intervention period and intermittently 
throughout the intervention. During these daily thought samples, we will also ask participants, if 
convenient, to speak their current thoughts out loud for 60 seconds and record this using the Voice 
Memos 
app 
(or 
equivalent) 
on 
their 
phone.  They 
will 
then 
send 
this 
recording 
to 
our womens.wellness@Colorado.EDU email account.  These recordings are so that we can transcribe 
participants’ thoughts and analyze thought content as another between-group outcome variable in the 
study. 
 
The instruments comprising the test battery will be programmed into a laptop or desktop computer.  
Participants will read and respond to all tasks and questionnaires directly on the computer in individual 
testing sessions with a trained researcher. The researcher will closely monitor the participant’s progress, 
reading aloud the instructions as each new experimental task is presented and providing assistance as 
needed.   
 
• 
(E) Physiological measurements and visual eye tracking  
 
We will passively record a number of physiological variables during subjects performance of some 
behavioral (breath counting task, emotional movies and probabilistic reward task) and all MRI tasks. These 
measures include (a) heart rate, (b) skin conductance, (c) pupil diameter, (d) eye gaze, and (e) respiration. 
These recordings will be entirely passive and non-invasive, and will not require any additional effort on 
the part of the participants (except for having sensors attached to one’s hand for physiological recording).  
Physiological data will be recorded using the BioPac Acquisition system and the Siemens Physiological 
Monitor system.  Visual eye tracking and pupillometry will be conducted using an integrated SR Research 
Eyelink eye-tracker. The eye-tracker does not record video of the participants. We include a more detailed 
description of the specific equipment and measures: 
 
Eye tracking system: We will use an EyeLink 1000 system for use in MRI environments (SR Research Ltd., 
Kanata, Canada). This system uses a non-ferromagnetic optimized design, with a fiber optic camera affixed 
to the bottom of the MRI head-side projector screen. It provides a 1000 Hz binocular sampling rate, 0.01  
RMS spatial resolution, and a 32 x 25  tracking range. Multiple data types can be output for statistical 
analysis, including: fixation, saccade, interest area (overlay on presented stimuli), and trial-based reports. 
In addition, eye gaze to pre-defined areas of the stimulus display can be used as task responses. 
 

 
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Physiological recording system: We will record physiological measures including ECG monitoring, 
respiration, pulse oximetry and electrodermal activity using the BIOPAC integrated system (BIOPAC 
Systems Inc., Camino Goleta, CA). All components are specially designed for use in the MRI environment. 
Pulse can be measured via photo plethysmographic methods sensitive to Blood Volume Pulse (BVP). The 
transducer is non-invasively taped to the participant’s finger or toe and records continuous pulse and 
pulse rate data. Respiration can be measured via a respiratory effort transducer, which measures changes 
in thoracic or abdominal circumference that occur as the participant breathes. The transducer has an 
adjustable Velcro strap to comfortably fit a wide range of participants, and records continuous respiration 
rate and amplitude data. Electrocardiogram and electrodermal data can be measured via radiotranslucent 
leads and disposable electrodes non-invasively attached to the participant’s chest and palm or foot, 
respectively. The MRI Smart Amplifier removes MRI artifact from the source physiological data, allowing 
continuous recording during fMRI acquisition. AcKnowledge software from Biopac is used for physiological 
data analysis. 
 
• 
(F) Summary of the study timeline: 
Phone screening: After reviewing the information acquired using the online screening form (see 
Recruitment Methods for an entire description of this step), potential participants will receive a phone 
call during their preferred hours with screening purposes to further to further determine eligibility (see 
Recruitment Methods for further details on this procedure). 
Session 1 – Clinical Interview & Behavioral Tasks (Groups 1 and 2): The first laboratory visit will last 
approximately ~3-4 hours. The first laboratory visit will consist of a diagnostic clinical interview and, if 
deemed eligible following the clinical interview, behavioral tasks completed on a computer.  
 
Online Questionnaires & Naturalistic Thought Sampling (Groups 1 and 2): Participants will then 
continue at home to perform online assessments for an additional hour, and complete the daily 
naturalistic thought sampling surveys. 
 
Session 2 – Behavioral Tasks & MRI (Groups 1 and 2): Eligible participants will be asked to return to the 
laboratory to complete additional tasks and assessments. This portion of the study will last approximately 
~3 hours. The visit will consist of tasks completed on a computer designed to measure cognitive and 
emotional processing, and an MRI assessment. The MRI assessment will last for approximately 1 hour. 
During the MRI assessment, the subjects will be performing a number of cognitive- emotional tasks inside 
the scanner while we assess their brain activity in response to these tasks. After the MRI session, 
participants will be sent a link to a ~5-10 minute online questionnaire in which they will be asked to make 
subjective valence ratings for each word they generated in the Free-association semantic task.  In this 
questionnaire, participants will rate a total of 140 words using a sliding scale from very negative to very 
positive.  Because these words are unique to each participant in that they are generated by the participant 
during the experimental session, we cannot provide a copy of the questionnaire here.    
 
8-session MBCT intervention (Group 2):  If subjects are assigned to Group 2, they will be asked to 
complete the 8-session intervention. The participant will be asked to complete 8 class sessions that will 
be administered online. The completion of the class modules will take approximately 2 hours per week 
and the participant will need to do basic homework exercises that may take approximately 15-30 
minutes per day. Participants also will have access to a coach who will support their participation by 
phone and email contact to promote engagement in the online interventions and to troubleshoot any 
challenges. As outlined above, we will also ask the patient participants to answer a brief set of 

 
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questionnaires each week, representing a subset of those completed before the intervention (see Table 
3: 
attachment_18 
PANAS, 
attachment_25 
FFMQ, 
attachment_26 
EQ, 
attachment_36 
SCS, 
attachment_38 
BPI, 
attachement_42, 
PHQ9, 
attachment_58 
naturalistic 
thought 
sampling 
questionnaire).  This will allow us to assess the evolution in their symptoms and their mindfulness skills 
along the course of the intervention.  
 
Session 3 – Behavioral Tasks & MRI (Groups 1 and 2): After the end of the intervention (or 8 weeks after 
Session 2 for Group 1), the participant will be asked to complete Session 3, which will take about ~5 hours. 
The visit will consist of the same laboratory tasks as in Sessions 1 and 2 completed on a computer, and an 
MRI assessment. The MRI assessment will last for approximately 1 hour.  
 
Online Questionnaires & Naturalistic Thought Sampling (Groups 1 and 2): Participants will then 
continue at home to perform online assessments for an additional hour, and complete the daily 
naturalistic thought sampling surveys. 
 
6-month followup phone Interview and/or questionnaires (for Group 2 only: LIFE and questionnaires): 
Following the MBCT intervention, participants in group 2 will complete the Longitudinal Interval Follow-
up Evaluation (LIFE, please see Attachment_10 in Table 3) via a phone interview to ascertain subsequent 
diagnostic status, again according to DSM-V diagnostic criteria. The LIFE provides a retrospective 
assessment of relapse and recurrence based on a semi-structured interview.  Participants from groups 1 
and 2 will be sent a link to a subset of questionnaires. Participants in group 1 will not undergo any follow 
up assessments.   
Once every two weeks during the 6-month follow up period, we will ask the participants to answer a very 
brief questionnaire (attachement_42, PHQ9) to assess the evolution of clinical symptoms during this 
period.  
 
 
IV. 
ABOUT THE SUBJECTS  
 
For this examination, we will recruit a sample of 30 healthy control participants and 30 women with a 
previous history of MDD. Participants will be recruited from the patient population accessible to Prof. 
Dimidjian through the Clinical Research Evaluation Services and Training clinic (CREST) center that she 
directs at the University of Colorado, Boulder and by advertising in online local forums/bulletins 
associated with the Boulder/Denver Community Mental Health Center. In order to have greater access to 
potential participants, as in previous studies in our Labs, we will access Craigslist, the Buff Mail, local 
mental health centers and clinical service settings, libraries, cafeterias, bus stops, local transit and, 
eventually, newspapers, email distributions lists, and online posting. (See following section, Recruitment 
Methods, for further details). 
 
Eligibility criteria for Group 2 (women with a past history of MDD) include the following INCLUSION 
criteria: (1) women who are not currently pregnant, (2) meeting criteria for prior depression (at least two 
episodes) and showing residual symptoms of depression (PHQ-9 score of 5-12), (3) not meeting criteria 
for a current active depressive episode (SCID criteria) (4) having access to internet and a smartphone with 
data plan, (5) ages 18-55 and (6) receiving no antidepressant/anxiolytic medication or under a stable 
regime of antidepressants/anxiolytics. 

 
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Eligibility criteria for healthy participants include the following INCLUSION criteria: (1) women that are not 
currently pregnant (2) do not meet criteria for prior or current depression (3) having access to internet 
and a smartphone with data plan and (3) ages 18-55.   
 
 
Exclusion criteria for all participants include:  
 
• 
Current diagnoses of: psychosis, bipolar disorder/maniac episodes, OCD, persistent antisocial 
behavior, severe developmental delay, or persistent self-injury needing clinical management or 
therapy, organic brain injury, substance misuse.  
 
• 
Past diagnoses of psychosis, bipolar disorder/mania episodes or OCD.  
• 
Use of marijuana equal or more than 4 days per week. 
 
Additional exclusion criteria related to Magnetic Resonance Imaging safety requirements:  
We will exclude participants who have metal or electrical equipment including:  
 
• Non-removable metal piercing 
• Tattoos on head or neck, an older tattoo with metal-containing inks, and/or permanent makeup 
(eyeliner). 
• An implanted (internal) defibrillator or pacemaker 
• Cochlear (ear) implant 
• Some type of clips used on brain aneurysms 
• An intrauterine device (IUD) that is not compatible with the MRI scanner 
• An implanted infusion pump device like an insulin pump 
• Implanted nerve stimulators 
• Magnetic dental appliances or fillings 
• Metal plates, screws, staples, joint replacement, and prosthetics.  
 
Additional exclusion criteria for all participants include the following: 
•  Clear claustrophobic symptoms. 
• Abnormal capability of performing the experimental tasks as they are designed and implemented (e.g., 
unable to read, unable to cooperate during fMRI examination, showing visual processing impairments 
that cannot be corrected using lenses or any significant impairments in the processing of auditory 
stimulation).  
 
All subjects will be asked to read carefully the experiment procedure and give their written informed 
consent to participate in the study.  
 
Several members of the key personnel involved in the current study have extensive experience with fMRI 
scanning procedures, as all of them have been involved in a large number of fMRI experiments in the past. 
All researchers and assistants involved in the MRI study are also asked to complete a quiz about safety 
precautions in the MRI environment. The full-time scanner technician employed at the Intermountain 
Neuroimaging Consortium (Center for Innovation and Creativity, Boulder, CO) has extensive experience 
and training with MRI research protocols involving procedures that are very similar to the ones described 
in this protocol.  

 
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V. 
VULNERABLE POPULATIONS 
Our study does not involve vulnerable populations.  
VI. 
RECRUITMENT METHODS 
Only the principal investigators, co-investigators, or experienced researchers in Prof. Dimidjian and 
Prof. Wager’s research laboratories will invite subjects to participate in the study. Investigators López-Solà 
and Andrews-Hanna are Research Associates in the Department of Psychology and Neuroscience (CU 
Boulder) and/or Institute of Cognitive Science. June Gruber is an Assistant Professor at the Department of 
Psychology and Neuroscience. Yoni Ashar, Sarah Hagerty and Natasha Hansen are graduate students in 
clinical psychology with experience in research and clinical work with depressed individuals. 
 
Participants will be recruited from the local area, including Boulder and Denver metro areas, through 
referrals from community mental health centers, clinical settings, and local advertisements. Recruitment 
will be conducted primarily through the Clinical Research Evaluation Services and Training clinic (CREST) 
center, directed by Dr. Dimidjian. We plan to recruit participants by phoning a group of participants who 
have agreed to be contacted for future studies, and flyering in the CREST center and other area research 
and clinical centers. Additionally, participants will be recruited from announcement via electronic posting 
including, but not limited to, Craigslist, Buff Mail, and via flyers posted at local medical settings in which 
participants may be identified for prior depression. We may post flyers at local libraries, cafeterias, bus 
stops, local transit and, eventually, newspapers. Interested participants will be invited to write an e-mail 
to the research team. We may post flyers in local schools of the Boulder area to attract potential mothers 
of children and adolescents attending the schools. Schools have already given permission for this action 
to Dr. Nicole K. Speer, the operations director at the Intermountain Neuroimaging Consortium. We will 
also be putting recruitment blurbs in the Intermountain Neuroimaging Consortium (INC) recruitment 
handout and on the INC website as well as sending out recruitment blurbs to INC-related list servers. This 
will give us access to church and community group newsletters, which might be an important source of 
recruitment.  
 
After receiving the e-mail from the potential participants, the research team will send them via e-mail the 
link to the brief online screening form (see Attachment_6 and Attachment_7 in Table 3, which include a 
complete but summarized description of the study and specific consent to participate. Also, as part of the 
screening procedure we will add the PDSQ questionnaire, Attachment_7 in Table 3, PDSQ, i.e., Psychiatric 
Diagnostic Screening Questionnaire, to ensure that patients are not currently showing symptoms of any 
mental health disorder) using CU’s secure survey system provider, i.e., RedCap. The potential participants 
are explained the nature of the study, the potential risks, benefits, entirely voluntary participation and 
option of withdrawal at all times, and are asked to sign a consent form. Then, they answer a few screening 
questions and provide initial demographic and basic health-related information. The research team will 
then call potential participants over the phone to further determine eligibility. The phone call will involve 
a detailed assessment of the screening questions (see phone screening scripts for the high-risk women 
and healthy control women, Attachment_46 and Attachment_47 in Table 3) to confirm the existence of 
at least one previous depressive episode and absence of a current clinical episode. Please see the Data 
Management section below for a detailed explanation of the procedures applied to screening data 
collected using the brief online screening form. 
 
At the beginning of the phone screening, participants will be informed of the nature of the questions, told 
how long the call is expected to take, and asked whether there might be a better time to answer the 

 
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questions. Participants will be informed that the questions will be used to further determine eligibility. If 
appropriate, participants who are not eligible based on the prescreening will be provided a list of local 
mental health referrals. Participants who are eligible based on the prescreening will be scheduled for an 
intake appointment at the Department of Psychology to complete consenting and further screening.  
VII. 
COMPENSATION  
Participants will be compensated for participation using a fixed schedule (calculated using a rate of 
$10/hour for behavioral tasks and $25/hour for MRI sessions). Specifically, during Session 1, participants 
will be compensated $10 for completing the SCID and $20 for the behavioral tasks. Participants will earn 
$40 for completing Session 2.  We will provide an Amazon Gift Card for value of $25 to participants in 
Group 2 half-way through the intervention to provide a reward for their sustained efforts and to further 
motivate the participants to continue. For session 3, we will compensate all participants (Group 1 and 2) 
$50. After completing the set of at home questionnaires, all participants (Groups 1 and 2) will receive $55 
($20 for at home questionnaires + a $35 bonus for completion of the study). This compensation ($55) 
could take the form of a mailed check or a gift card or by scheduling an appointment at our Laboratory, 
depending on the preference of the participant.  Participants in group 2 will receive a $25 Amazon Gift 
Card for completing the 6-month followup interview and questionnaires.  In total, participants in group 
1 can earn up to $175 and participants in group 2 can earn up to $225. A detailed description of the 
payment schedule is provided in the Consent Form for each group.  
VIII. 
CONSENT PROCESS 
Participants who pass the initial screening questions and agree to continue will be scheduled for an 
appointment to come to our clinical CREST center, where they will undergo a verbal consenting procedure 
explaining the study in much greater detail, as well as the details of the written consent (which they will 
also sign) regarding potential risks, benefits, study compensation, data management and confidentiality. 
Also all participants will be given a verbal explanation of the purpose and procedures that will be used, 
and will be reminded that their participation is entirely voluntary.   Importantly, participants will also be 
informed that they can choose to omit any responses or withdraw from the study at any time. Participants 
will be asked to initial each page to signify understanding the materials and procedures. All of them will 
be given a chance to read the consent form and ask any questions. They will be reminded that there is no 
penalty for choosing not to participate, or from withdrawing their participation at any time. A description 
of the MRI procedures is included in the consent form, and all participants will be given a verbal 
description of the MRI screening and pregnancy forms. 
IX. 
PROCESS TO DOCUMENT CONSENT IN WRITING 
The consent will be documented (see attached consent forms). We are including 2 different consent forms 
for groups 1 and 2, respectively.  
X. 
SPECIMEN MANAGEMENT 
N/A 

 
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XI. 
DATA MANAGEMENT 
 
Data obtained using the brief online screening form, acquired after the participant provides written 
consent to participate, will be stored in a database and will be treated following the same security 
procedures that will apply to the rest of data collected in the study (see below). The screening data will 
be stored in restricted-access servers, which will only be accessible to the graduate students involved in 
the study (listed above) and the principal investigators.  
After conducting and receiving informed consent in person at the 1st laboratory session, the researcher 
will enter the subject’s unique ID code onto all subsequent questionnaires and stimulus presentation 
programs. The user ID is linked to participant identity only through a master list stored in restricted-access 
servers and/or in locked filing cabinets in a locked room, to which only the investigators have access. The 
internet site which may be used for at-home tasks will require participants to log-in with this unique ID.  
The hard copies of participant data/questionnaires will be stored in locked filing cabinets in a locked room, 
to which only the investigators have access. Furthermore, all electronic data will be stored on a private, 
password-protected hard drive or secure university-hosted online server accessible only to the PI or 
trained researchers in the lab.  
Audio-recorded interviews and videos of "responses" will be temporarily stored on an encrypted hard 
drive and identified by subject ID.  A written and de-identified transcript of the audio files and videos will 
be created and electronically stored with the other subject data (tasks and questionnaire data). Then, the 
audio-recordings and videos will be erased. 
These procedures will minimize the risk of personal information being divulged to individuals who are not 
members of the research team.  
 
We plan on retaining all the collected data indefinitely. We will ask the participants to give us permission 
to contact them in future studies from our Laboratory (see Participant Online Brief consent form, 
Attachment_6 and Attachment_7 in Table 3), which will involve retaining their identifier information.  
 
The MBCT intervention website will be hosted at Noggin Labs for the study’s duration, and will be secured 
using a firewall and password access, with a 128-bit level of SSL encryption. User passwords will be 
distributed to participants via email by the research team.  The research team will store a file linking the 
passwords to participants' identity on a password-protected computer inside a locked laboratory in the 
Department of Psychology & Neuroscience. NogginLabs will not collect any identifying information from 
participants and will only require access to their numeric device ID.  Passwords and their associated web 
access will be deleted from the study registry by the research staff at the close of this study or at the 
patient’s termination or completion of the study, whichever is earlier. The study team will have 
administrative 
access 
to 
the 
website 
to 
monitor 
activity.  Noggin 
Labs 
is 
experienced 
in 
managing confidential data using encryption and passwords. 
 
Regarding one of the experimental tasks mentioned above, the Dot Probe task, we plan on releasing de-
identified data (subjects performance of this task) to another institution, The University of Toronto, where 
two collaborators (Dr. Normal Farb and Dr. Zindel Segal) will analyze it (please see the two attached 
letters, in which our collaborators declare the agreement as to the characteristics of their collaboration, 
Attachment_48 and Attachment_49 in Table 3). 
 

 
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XII. 
WITHDRAWAL OF PARTICIPANTS 
Research subjects may withdraw from participation at any time. Should a research subject choose to 
withdraw from either research session, she may do so immediately and without penalty.  The participant 
will be compensated in the amount reflecting her time. Subjects will indicate at the time of consent 
whether or not they give permission for researchers to retain their data if they choose to withdraw.  
In case that the participant feels uncomfortable due to claustrophobic symptoms or any other MRI-related 
environment issue, or in case she is not able to maintain a still position, she will be withdrawn from the 
MRI part of the study, considering both ethical and quality of brain data, but will continue to undergo the 
intervention procedure and the behavioral experimental tasks outside the scanner. 
 
Importantly, during the scanning session the participant will always be able to communicate with the 
technician and the researchers via a microphone system and a squeezable pneumatic device that will be 
provided at the beginning of the MRI session. The participant will be instructed to press the device if she 
feels uncomfortable, which will signal to the technician to stop the scanning procedure and take her out 
immediately. 
XIII. 
RISKS TO PARTICIPANTS AND MANAGEMENT OF RISKS 
The potential risks associated with participating in this research are minimal.   
Every member of the research team will be trained in standard regulations governing the conduct of 
human subjects research. Specific additional training regarding phone screening, clinical interviewing, and 
task assessments will also be implemented to ensure the safety and confidentiality of all research 
participants.  
 
In addition to these important safeguards, we describe additional procedures we will use to minimize each 
of the identified potential risks described above. 
 
 
Physical Risks 
 
 
Depending on the individual’s capacity there may be physical risks associated with the mindfulness or 
yoga practices in the MBCT sessions. We will ensure that patients stop any exercise or practice they think 
will be harmful to their health or well-being and not to engage in any practice at home that they think 
may cause harm. 
 
Psychological, social, economic, and legal risks 
 
There may be some psychological discomfort with (1) the knowledge that study personnel are reviewing 
participants’ survey scores, health information, or other personal materials, and/or (2) the insight that 
may be gained from completing surveys and the group sessions. Study personnel will assure that 
participants understand the confidentiality measures taken in this study to protect them and their 
information. Participants will be invited at any time to share their concerns with the study co-
investigators. Every precaution will be taken to protect personally identifiable information and avoid 
disclosure. In order to minimize psychological risk of harm, we will include detailed information about 
possible risks in the informed consent form and process. Participants will also be instructed that they are 

 
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free to not answer any questions they do not wish to answer on the questionnaires and during interviews, 
and that they may abort participation in the study at any time. 
 
We have designed the assessment procedures to minimize burden on participants. We have ensured that 
there is no redundancy in measurement tools, with the exception of depression outcomes that are 
assessed both by self-report and clinical interview, which is standard in clinical research of this type. We 
also include a number of different assessment days to avoid exhaustion or boredom. Assessment 
appointments will be scheduled at times that are most convenient for participants.  
 
MRI environment-related risks 
The magnetic field of the MRI environment has the potential to cause burns or bodily injury if ferrous 
metal objects are implanted in the body, or if personal articles containing ferrous material are brought 
into the MR environment. Because we are excluding participants with contraindications for MR studies 
(e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded 
in the body) using a standard screening form, the risk of damage due to implanted metal is low. 
Investigators and personnel of the MRI unit have extensive experience with standard safety precautions, 
including safety screening on paper and verbally by a trained technologist. These considerations minimize 
the risk of accident or injury in the MR environment. Although the risk of MRI to pregnant women is 
currently unknown (and is widely thought to be nonexistent), pregnancy is a standard exclusion criterion 
for MRI scanning. We will offer all participants in the fMRI study a free pregnancy test. Participants who 
decline this request will be asked to sign a document to acknowledge this. 
 
Incidental and MRI findings 
Each image will be reviewed by the technician and/or Co-Investigators for anomalies. We expect to 
observe at least one incidental finding in 42.9% of the scans, with 2.2% requiring further clinical action 
(Orme et al, 2010). 
 
In the case of an anomalous finding in a brain image, the following procedure is followed: 
1. 
The technologist and/or research personnel flag potential abnormalities. 
2. 
The MRI technologist notifies the INC Director of Operations, the MRN Director of Research and 
Clinical Operations, and the P.I.  
3. 
The scan gets queued to the radiologist worklist in COINS.  All cases of suspected incidental 
findings are sent for formal neuroradiologic review at MRN. 
4. 
Radiology reviews will be completed within 30 days. 
5. 
The radiology review contains a written summary of the findings and classifies the referral status 
into one of these categories: 
• 
No referral: The finding is not medically relevant and there is no need for follow-up with a 
physician.       
• 
Referral: The finding shows something that needs to be brought to the attention of the 
participant’s doctor.   
6. 
INC staff, the MRN Director of Research and Clinical Operations and the PI will get an electronic 
copy of the radiology review (coded via URSI) as soon as the review is completed.  
7. 
If a referral is recommended, the MRI technologist will contact the participant and explain that 
an unusual feature was observed in their scan and it was reviewed by a radiologist, leading to 
either a referral or a no referral recommendation. In the case of a referral, the technologist will 

 
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provide contact information for the MRN Medical Director in case the participant has questions 
prior to contacting his or her physician.  
 
All cases reviewed will generate a formal radiology report, which is printed on letterhead and a copy of 
which is mailed to the participant.  
 
Risks to privacy and confidentiality 
Identifying documents will be de-identified and coded with a unique study ID number. Information will be 
stored confidentially in a locked file cabinet and in computer files protected by passwords and located in 
a secure facility. Access to information will be restricted on a “need to know” basis for this study. No 
information will be disclosed to others without written permission from the participant, except: 1) if 
necessary to protect the patient’s rights or welfare; or 2) if required by law. Only aggregate, de-identified 
data will be reported. Data will be housed at CINC (Center for Innovation and Creativity, University of 
Colorado, Boulder) and archived for seven years and then destroyed by shredding or electronically.  
 
Participating in this study will involve access to the REDCap websites – where the online surveys will be 
completed.  The self-report surveys will be hosted by REDCap and will be secured using a firewall. All 
participants enter their responses to instruments using a study assigned ID, so that identifying data is 
never recorded at this stage. All data are accessed only by the study team who must provide a user ID and 
a password.  
 
All information that directly identifies the subjects will be kept in a locked file cabinet, and separate from 
the research data, which will contain only the unique subject number.  Because the UCB research co-
Investigators may need to contact participants during the study, their phone number and email address 
will be stored in a locked file cabinet in Dr. Dimidjian’s research office at CU Boulder.  Only de-identified 
data will be used in publications.  
 
 
 
XIV. 
POTENTIAL BENEFITS  
All remitted patients will be receiving online MBCT (an empirically validated program) classes that may be 
beneficial for their mental/physical health. They will receive coaching support by a trained clinical 
graduate research assistant. Those assigned to the MBCT class may benefit from receiving an empirically 
validated program to prevent depression relapse. More generally, the information obtained from their 
participation in this study may help in the development of new therapies to prevent relapse following 
recovery and benefit others looking to help themselves in this way. 
 
Additionally, participants will also have the option to receive a copy of their MRI brain scan (structural 
MRI only) on a DVD.  Doing so will require signing an additional MRI release form (attachment 61) in which 
they agree to take ownership of this scan for personal use only  
 
 
 
XV. 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS  

 
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We do not anticipate that participation in this study will have an impact on participants’ privacy interests. 
Community member recruitment is open to participants with a range of mood and psychiatric 
experiences. Research participants will be undergoing the study at the Center for Innovation and 
Creativity (CINC, CU Boulder), where both the MRI scanner and the CREST clinic are housed. Participants 
entering the CINC are unlikely to be stigmatized, as this building also contains a variety of other services 
and laboratories. 
XVI. 
MEDICAL CARE AND COMPENSATION FOR INJURY 
This research investigation involves minimal risk. There are no provisions for medical care or 
compensation to research participants. 
XVII. 
COST TO PARTICIPANTS 
Community members will visit the CINC on several instances along the study progression.  Parking is free 
at these locations, however the participant is responsible for his/her own transportation fees. The 
payment for participation is intended to help compensate for such fees. Also, a number of buses would 
allow participants to reach these centers easily.  
XVIII. 
DRUG ADMINISTRATION 
No drugs will be administered as part of this protocol. 
XIX. 
INVESTIGATIONAL DEVICES 
No investigational devices will be used in this protocol. 
XX. 
MULTI-SITE STUDIES 
N/A 
XXI. 
SHARING OF RESULTS WITH PARTICIPANTS 
Research results will not be shared with participants. 
XXII. 
DISCLOSURE OF INVESTIGATORS 
Dr. Dimidjian is on the advisory board Mindful Noggins, which is part of NogginLabs, a private company 
specializing in customized web based learning.