Optimizing Psychotherapy for Older Veterans With Chronic Pain
Phase: NA
Conditions: Musculoskeletal Pain
Sponsor: VA Office of Research and Development

 
 
 
Optimizing Psychotherapy for Older Veterans with Chronic Pain 
Study Protocol 
Funding Agency: CSR&D Career Development Award 
Principal Investigator: Brandon C. Yarns, MD, MS 
Version 5: February 28, 2020 
NCT03918642 

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Abstract: 
The overarching goal of the proposed research is to learn how to optimize psychotherapy for 
those Veterans most in need and most likely to benefit from psychotherapy, older Veterans with 
chronic musculoskeletal pain. Chronic pain is a critical healthcare challenge, as the condition 
affects 50% of all Veterans and affects older Veterans most commonly, severely, and 
persistently. For years, chronic pain treatment has been notoriously difficult at VA and 
elsewhere, especially in light of the recent “opioid crisis,” in which opioid analgesics, previously 
a mainstay of chronic pain treatment, have come under increased scrutiny. In response, CDC, 
VA/DoD, and some experts have called for enhancing and expanding psychosocial treatment 
options for chronic pain, such as psychotherapy, which are low risk for older Veterans who 
frequently have multiple medical comorbidities and are taking multiple medications.  
Yet standard VA psychotherapy approaches, such as Cognitive Behavior Therapy (CBT), have 
shown modest benefits for Veterans on pain and other related outcomes, such as mood, 
anxiety, and sleep. In contrast, a novel psychotherapy approach, Emotional Awareness and 
Expression Therapy (EAET), has shown medium to large benefits for some chronic pain 
patients. Whereas CBT improves pain and negative emotion by teaching patients cognitive and 
behavioral coping skills, affecting brain regions that enhance “cognitive control” of pain, EAET 
operates primarily through emotion regulation, which is thought to influence brain regions and 
circuits that modulate both physical pain and emotion—a mechanism absent from existing 
approaches. The literature and our pilot data indicate that patients who express emotional 
distress at baseline, such as high anxiety and depressive symptoms, may be particularly likely 
to benefit from EAET’s emotion regulation approach, whereas patients who express less 
emotional distress may derive more benefit from an approach like CBT, which does not require 
ready access to emotions.  
The proposed randomized clinical trial tests the hypothesis that EAET is superior to CBT on 
reduction in mean pain severity and other outcomes derived from IMMPACT. To examine which 
patients are most likely to benefit, this research also tests whether greater baseline emotional 
distress (using measures of anxiety and depression) predicts stronger benefits from EAET and 
whether lower baseline emotional distress predicts stronger benefits from CBT. Finally, this 
research explores whether the benefits of EAET are mediated by improved emotion regulation 
the benefits of CBT are mediated by improved cognitive and behavioral coping, and whether the 
benefits of both are mediated by a stronger working alliance. We plan to enroll 160 multi-
ethnic/multi-racial older Veterans (age 60-95 years) with chronic musculoskeletal pain at the 
West Los Angeles VA Medical Center.  
This research can introduce an additional, potentially more effective format of psychotherapy at 
VA so that more Veterans with chronic pain can respond. In addition, this research can lead to 
better treatment targeting and enhance our understanding of how psychotherapy treatments 
work. Finally, this research can facilitate the development of critical skills for the PI in 
psychotherapy research and pain management and enhance his ability to effect positive change 
for older Veterans.

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List of Abbreviations: 
AAGP – American Association for Geriatric Psychiatry  
APA – American Psychoanalytic Association 
APS – American Psychosomatic Society 
ACOS/R – Associate Chief of Staff for Research 
ACT – Acceptance and Commitment Therapy 
BPI – Brief Pain Inventory 
CBT – Cognitive Behavior Therapy 
CBT-CP – Cognitive Behavior Therapy for Chronic Pain 
CDA – Career Development Award 
CDC – Centers for Disease Control and Prevention 
CSR&D – Clinical Science Research and Development 
DoD – Department of Defense 
EAET – Emotional Awareness and Expression Therapy  
EBP – Evidence-Based Psychotherapy 
ECT – Electroconvulsive Therapy 
EMG – Electromyography  
fMRI – Functional Magnetic Resonance Imaging  
GLMM – General Linear Mixed Model  
GPOP – Geriatric Psychiatry Outpatient Program 
HIPAA – Health Insurance Portability and Accountability Act 
IBM – International Business Machines Corporation 
IMMPACT – Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials 
IEDTA – International Experiential Dynamic Therapy Association 
IPA – International Psychoanalytical Association 
IRB – Institutional Review Board 
ISTDP – Intensive Short-Term Dynamic Psychotherapy  
ITT – Intent to Treat 
LGBT – Lesbian, Gay, Bisexual, and Transgender 
MAR – Missing at Random 
MCAR – Missing Completely at Random 
MMSE – Mini-Mental State Examination 
MoCA – Montreal Cognitive Assessment  
NIH – National Institutes of Health 
OBSSR – Office of Behavioral and Social Sciences Research 
OPTIMUM – Optimizing Outcomes of Treatment-Resistant Depression in Older Adults 
PAST-FM – Pain and Stress Treatment for Fibromyalgia 
PCO – Patient-Centered Outcomes 
PCORI – Patient Centered Outcomes Research Institute 
PGY – Post Graduate Year 
PI – Principal Investigator  
PROMIS – Patient Reported Outcomes Measurement Information System 
PSS – Post-Traumatic Stress Disorder Symptom Scale 
PTSD – Post-Traumatic Stress Disorder 
RCT – Randomized Clinical Trial 
SBCC – Statistical/Biomathematical Consulting Clinic 
SD – Standard Deviation  
SO – Sheryl Osato, PhD (Lead CBT Interventionist) 
SPSS – Statistical Package for the Social Sciences 
STTS-R – Satisfaction with Therapy and Therapist Scale—Revised  

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UCLA – University of California, Los Angeles  
UNM – University of New Mexico 
VA – Veterans Affairs 
VAGLAHS – VA Greater Los Angeles Healthcare System 
WLA – West Los Angeles VA Medical Center

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Contents 
 
 
Protocol Title:  Optimizing Psychotherapy for Older Veterans with Chronic Pain ......................... 6 
1.0 
Study Personnel ................................................................................................................. 6 
2.0 
Introduction ........................................................................................................................ 6 
3.0 
Objectives ........................................................................................................................ 10 
4.0 
Resources and Personnel ................................................................................................ 11 
5.0 
Study Procedures ............................................................................................................. 11 
5.1 Study Design ..................................................................................................................... 11 
5.2 Recruitment Methods ........................................................................................................ 12 
5.3 Informed Consent Procedures .......................................................................................... 13 
5.4 Inclusion/Exclusion Criteria ............................................................................................... 13 
5.5 Study Evaluations .............................................................................................................. 14 
5.6 Interventions and Interventionists ...................................................................................... 16 
5.7 Data Analysis .................................................................................................................... 19 
5.8 Withdrawal of Subjects ...................................................................................................... 21 
6.0 
Reporting/Risks/Safety ..................................................................................................... 22 
7.0 
Privacy and Confidentiality ............................................................................................... 23 
8.0 
Communication Plan ........................................................................................................ 24 
9.0 
References ....................................................................................................................... 26 
 

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Protocol Title:  Optimizing Psychotherapy for Older Veterans with Chronic Pain 
 
1.0 
Study Personnel 
 
Principal Investigator: Brandon C. Yarns, MD, MS; Staff Psychiatrist, West Los Angeles VA 
Medical Center, 11301 Wilshire Blvd., Bldg. 401, Rm. A236; Ph: 424-279-8439; Email: 
brandon.yarns@va.gov 
Co-Investigator: David L. Sultzer, MD; Staff Psychiatrist, West Los Angeles VA Medical 
Center, 11301 Wilshire Blvd., Bldg. 158, Rm. 166, Los Angeles, CA, 90073; Ph: 310-268-3708; 
Email: david.sultzer@va.gov 
2.0 
Introduction 
Scientific Background and Rationale: 
The proposed Career Development Award research is a randomized clinical trial 
comparing Emotional Awareness and Expression Therapy (EAET) with Cognitive 
Behavior Therapy (CBT) on pain severity and other outcomes. It also proposes to test 
differences in emotion regulation as predictors of differential treatment response and 
explore mediators of response to each treatment. Chronic pain affects as many as 50% 
of male Veterans and 75% of female Veterans and is one of the costliest disorders 
treated in Veterans Affairs (VA) settings (1-3). Older male and female Veterans are most 
commonly and severely affected by chronic pain, with 80% of Vietnam-era Veterans 
reporting chronic pain (4).  
For years, the treatment of chronic pain has been notoriously difficult at VA and 
elsewhere, with opioid analgesics, previously a mainstay of chronic pain treatment, 
coming under increasing scrutiny, especially in light of the burgeoning “opioid crisis” (5-
7). In fact, opioid use disorders are almost 7-fold higher in the VA population compared 
to commercial health plans (8), and although younger Veterans have higher rates of 
opioid use disorders, older adults with these disorders are at significantly higher risk of 
all-cause mortality (9). Elders who use high-dose opioids also have an annual fracture 
risk approaching 10% (10). 
Scientists and policy leaders advocate psychotherapy as a crucial tool to help combat 
chronic pain and the opioid crisis at VA (6, 11). In the past year, the CDC, VA, and DoD 
all recommended psychotherapy as a first-line treatment for chronic pain (11, 12). 
Cognitive Behavior Therapy (CBT) is the most widespread psychotherapy approach 
currently in use for chronic pain at VA (6). VA has implemented CBT nationally as part of 
the VA Evidence-Based Psychotherapy (EBP) Training Program, which trains 
psychologists, psychiatrists, and other mental health professionals to perform this 
evidence-based approach (6, 13).  

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Current Gaps in Knowledge of How to Treat Chronic Pain with Psychotherapy and 
a New Way Forward: 
Although a VA study indicated overall statistically significant reductions in pain severity 
and associated patient-centered outcomes (PCO) using VA’s CBT for chronic pain 
manual, average improvement in 7-day worst pain was only -0.34 points, baseline to 
post-treatment, on an 11-point (0-10) scale (6). In addition, two meta-analyses 
investigating CBT for chronic pain found only modest short-term reductions in pain 
severity, disability, depression, and catastrophic thinking in trials that compared CBT to 
no treatment, and small positive effects on disability and catastrophizing, but not on pain 
or mood, when comparing CBT to active controls (14). Among chronic pain patients with 
the common comorbidities of depression or a trauma history—especially common 
among Veterans with chronic pain—CBT may be particularly ineffective (15). 
Acceptance and mindfulness-based approaches to chronic pain have also been of 
recent interest at VA (16, 17). These approaches comprise a broad category that 
includes acceptance and commitment therapy (ACT) and other mindfulness approaches 
such as mindfulness-based stress reduction (18). VA has implemented ACT for 
depression as part of the EBP Training Program but not for chronic pain (19). Similar to 
CBT, acceptance and mindfulness-based approaches are effective beyond no treatment 
or usual care, and may have positive effects on mood and functioning, but still have little 
impact on pain severity (17, 20-22).   
In contrast, promising research on an innovative psychological treatment, Emotional 
Awareness and Expression Therapy (EAET), has shown that some chronic pain patients 
who receive psychotherapy can achieve medium-to-large benefits on pain severity and 
other outcomes (23-25). EAET is grounded in exposure-based, experiential, and 
psychodynamic theories and uses innovative emotion-focused techniques to reduce 
stress and alter central nervous system processes to reduce or eliminate pain (26). A 
recent large study, PAST-FM, showed significantly greater rates of 50% pain reduction 
at both post-treatment and 6-month follow-up for EAET compared to either CBT or 
education control for adult outpatient non-Veterans with fibromyalgia, a disorder of 
widespread musculoskeletal pain (27). Additionally, in a series of 72 adult patients with 
chronic musculoskeletal pain conditions who received EAET, two-thirds of patients 
achieved at least 30% pain reduction and one-third of patients had at least 70% pain 
reduction—rates of success that are almost never found with CBT (23). Finally, in our 
pilot project at VA Greater Los Angeles, older Veterans with chronic musculoskeletal 
pain who received EAET had a reduction in mean pain severity nearly three times 
greater than those who received CBT: -1.44 versus -0.39. 
Rationale for the Population Chosen: 
In order to begin the process of optimizing the psychosocial treatment of chronic pain at 
VA, the proposed research uses a sample of Veterans likely to respond to 
psychotherapy, older Veterans. First, according to theory, developmentally older adults 
are at a phase of life in which they often desire to reflect and process issues, such as is 
the case in psychotherapy (31). Second, group cognitive behavioral and psychodynamic 
psychotherapy treatments have been found to be beneficial in depressed older adult 
Veterans and depressed caregivers in two separate trials at the Palo Alto VA (32, 33). 
Finally, psychotherapy is suited to older adult Veterans because older adults have been 
shown to overwhelmingly prefer psychosocial treatments of any modality to 
pharmacologic treatments (34, 35). 

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Individual Differences in Response to Cognitive/Behavioral and Emotional 
Interventions and Proposed Moderators: 
Chronic pain is frequently accompanied by many comorbid psychiatric symptoms, 
including depression and anxiety (36-38). Although individual difference research in 
chronic pain is in its infancy, it is important—and in keeping with recent calls for 
“personalized medicine” (e.g., (39))—to investigate what factors predict response to 
different psychosocial treatments. In the literature, higher baseline depression scores 
predicted greater pain reduction among adults with chronic musculoskeletal pain who 
completed EAET (23). In addition, in our pilot work, higher baseline anxiety was also 
associated with greater pain reduction for EAET patients. One possible explanation for 
these findings is that patients who report higher anxiety or depression, or patients who 
express greater emotional distress, may be more able to readily access and work with 
the affective components of pain, which provides the substrate that is amenable to this 
emotion-focused therapeutic modality.  
In contrast, some data suggest that patients with high emotional distress, using 
measurements of anxiety and depressive symptoms, may have less likelihood of benefit 
from CBT for chronic pain (15). Theoretically, this may be explained because patients in 
less emotional distress may be more amenable to learning cognitive and behavioral 
coping skills in CBT and less capable of working with a treatment such as EAET, which 
requires ready access to emotions. Thus, this research will investigate these theoretical 
and empirical findings in our population by examining whether patients with higher 
emotional distress at baseline—depression or anxiety—have stronger benefits from 
EAET on primary and secondary outcomes, and Veterans who express lower baseline 
emotional distress have stronger benefits from CBT.  
The measurement of emotional distress commonly uses assessments of depression and 
anxiety as proxies for distress, such as in the Patient-Reported Outcomes Measurement 
Information System (PROMIS), which relied on comprehensive literature searches and 
qualitative item analysis to define item banks for depression and anxiety to, in part, 
represent emotional distress (40). 
Two Interventions with Largely Distinct Mechanisms of Action to Influence the 
Central Nervous System Aspects of Chronic Musculoskeletal Pain: 
Although they may share some similarities, such as the importance of a positive working 
alliance, CBT and EAET are hypothesized to operate through largely distinct 
mechanisms of action, which this research aims to explore. 
EAET is hypothesized to achieve reduction of pain and related symptoms through the 
mechanism of improving emotion regulation. Emotion regulation includes at least two 
processes and is thought to be impaired following stressful or traumatic life experiences 
(41). The first process, emotional awareness, involves the ability to attend to, 
differentiate among, and label feelings. An example of impaired emotional awareness is 
the case of alexithymia, which has been linked to a variety of negative health outcomes, 
including worse pain (42). More specifically, an inability to differentiate among feelings 
has been linked to more stress and pain in several small experiments (43). The second 
component of emotion regulation is healthy emotional expression, which involves an 
ability to disclose and express one’s feelings verbally and behaviorally in adaptive ways. 
Substantial evidence shows that secrecy and decreased expression of emotions has 
negative health effects (44-48). For example, elegant studies by Burns demonstrate that 
impaired healthy expression of anger, in particular, increases subjective and behavioral 
pain as well as the activity of the relevant muscles (49-51). Emotion regulation is thought 

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to operate primarily through brain structures involved in processing both the affective 
component of pain and other emotions. These structures include the insula, dorsal 
anterior cingulate cortex, thalamus, and secondary somatosensory cortex (52). 
Some research suggests that interventions can improve pain through the mechanism of 
improving emotion regulation (i.e., emotional awareness and expression). There were 
early reports of substantial success of approaches that encourage pain patients to 
acknowledge psychological conflicts and emotions (53, 54), but the reliability of these 
findings is limited by patient selection bias and lack of controls. More recent studies with 
greater methodological rigor suggest that experiencing rather than avoiding one’s 
negative emotional experience has benefits for pain. One approach, including writing 
repeatedly about one’s private stressful experiences and avoided emotions (i.e. written 
emotional disclosure) has shown benefits in controlled studies for a range of populations 
and outcomes (55, 56). Specifically, emotional disclosure has led to improvements in 
chronic pelvic pain (57), several specific chronic pain conditions (58), and fibromyalgia, a 
disorder of widespread chronic musculoskeletal pain (59). In addition, there are positive 
trials of EAET specifically in adults with chronic musculoskeletal pain (23) and 
fibromyalgia (24). Finally, as described below in the Preliminary Studies section, our pilot 
data has demonstrated even greater benefits of EAET compared to CBT in older 
Veterans with chronic musculoskeletal pain. The proposed research tests whether EAET 
actually works through the hypothesized mechanism of improving emotion regulation, 
using measures of ambivalence (hypothesized to decrease) and emotional approach 
coping (hypothesized to increase). 
In contrast, CBT for chronic pain is hypothesized to achieve improvement in pain, 
dysfunction, and distress through the mechanism of enhancing patients’ cognitive and 
behavioral coping (60, 61). Techniques to improve cognitive coping include cognitive 
control (e.g., distraction), reframing of cognitions, and logical problem solving, whereas 
techniques to improve behavioral coping include arousal reduction (e.g., relaxation) and 
increasing positive experiences. The proposed research tests whether CBT actually 
works through the mechanism of improving cognitive coping skills (using measurement 
of pain catastrophizing) and behavioral pain coping (using measurement of adaptive 
coping). Basic science research indicates that CBT primarily acts through improving the 
volume and functioning of prefrontal brain regions, rather than brain regions that are 
involved in emotional processing, as in EAET (62, 63). 
In spite of these distinct hypothesized mechanisms of action, both CBT and EAET are 
proposed to share some mechanistic qualities. For instance, both psychodynamic 
treatments and CBT are hypothesized to operate, in part, through the strength of the 
working alliance (64, 65). Thus, the proposed research also tests whether response to 
both treatments is mediated by a positive working alliance. 
Significance of the Proposed Research: 
Given the limited efficacy of available psychosocial treatments for chronic pain and the 
recent opioid crisis, it is vital that novel approaches be developed and tested. There is 
substantial evidence that emotional avoidance resulting from failure to process stressful 
experiences and their accompanying emotions contribute to the pain and symptoms of 
many individuals with chronic pain, suggesting the need for a treatment such as EAET 
that largely targets these processes. Thus, the proposed research holds substantial 
promise to advance clinical practice and treatment outcomes, as well as theory and 
future research.  

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As suggested by theory, empirical research, and our pilot data, an EAET approach has 
great potential to improve the health of older Veterans with chronic musculoskeletal pain, 
thus filling a gap in current pharmacologic, physical, and cognitive-behavioral 
approaches. This research can make available an innovative, empirically-supported 
therapy, including a written protocol, for use in treating these Veterans. Comparing 
EAET to a standard intervention is key to determining whether the innovative EAET 
approach is superior to what is currently available, and also whether different subsets of 
older Veterans, such as those with different levels of emotional distress, respond to 
these two different interventions. If these aims are supported, then our ability to tailor 
interventions for specific patients, or match Veterans to optimal treatments, will be 
greatly enhanced. Furthermore, the strong recruitment of racial/ethnic minorities in our 
pilot work is a further strength of this research, which will focus on a multi-ethnic/multi-
racial Veteran population and the importance of understanding and improving treatment 
approaches across Veterans of all races and ethnicities. 
With respect to theory, this research will advance our understanding of the distinct and 
shared mechanisms of EAET and CBT and the role played by emotional factors in 
chronic pain. Indeed, whether stress and emotional avoidance contribute to chronic 
pain—as suggested by correlational data—needs to be tested experimentally, such as 
with this clinical trial. This research will examine hypothesized mediators of both EAET 
and CBT, thus providing an optimal test of whether each intervention operates as 
theoretically specified, or whether these interventions change more general processes 
(e.g., working alliance). In addition, this research will enhance our understanding of 
individual differences in emotional regulation and how such differences map onto 
emotional and cognitive-behavioral interventions. 
This work will also inform and direct future research. For example, a subsequent study 
during the Merit Review period can focus more on therapist factors by examining 
whether typical patients will accept and benefit from this intervention when it is 
presented by therapists with little or no prior experience with emotional interventions. 
Future research may also focus on how best to implement EAET in VA, whether through 
the Evidence-Based Psychotherapy Training Program or elsewhere. In addition, future 
studies can test whether EAET is effective for other populations of Veterans with chronic 
pain and Veterans with other syndromes involving elevated stress and emotional 
dysregulation, such as irritable bowel syndrome and chronic fatigue. Future research 
can also test alternative EAET formats such as self-help, telepsychiatry, and internet-
based delivery methods. Given current movements toward integration, ultimately one 
should develop a unified or integrative protocol that combines cognitive-behavioral and 
emotional components along with pharmacologic therapies in an effort to have the 
greatest coverage for the greatest number of patients. Indeed, empirically-based 
treatment integration has the potential to give new direction to a field that has been 
marked by isolated theories and narrow treatments, and the proposed research can 
contribute to that integration. 
3.0 
Objectives 
The Specific Aims for this study are:  
Aim 1: Main Effects. Test the hypothesis that EAET is superior to VA standard treatment (CBT) 
in 160 older Veterans (age 60-95 years) with chronic musculoskeletal pain on the following 
PCO:  
 
a. Primary outcome: change in mean pain severity baseline to post-treatment. 

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b. Secondary outcomes: change in pain interference, mood, anxiety, PTSD symptoms, 
meaning/purpose, sleep disturbance, fatigue, patient global impression of change, and 
patient satisfaction baseline to post-treatment and baseline to 6-month follow-up and 
change in mean pain severity baseline to 6-month follow-up.  
 
Aim 2: Moderation of the Interventions. Test the hypothesis that EAET will have stronger 
benefits for patients who express more baseline emotional distress (using greater depression 
and anxiety as proxies for emotional distress), whereas CBT will have stronger benefits for 
patients who express less baseline emotional distress (using greater depression and anxiety as 
proxies). 
 
Aim 3: Mediation of the Interventions. Explore hypotheses that the benefits of EAET are 
mediated by improved emotion regulation (as reflected in several measures of emotion 
regulation), the benefits of CBT are mediated by improved cognitive and behavioral coping (as 
reflected in several measures of coping), and both interventions are mediated by a positive 
working alliance. 
4.0 
Resources and Personnel 
All study procedures will take place at the West Los Angeles VA Medical Center. The PI 
will oversee all aspects of the research, including recruitment/screening, informed 
consent, performance of study interventions, and data collection and analysis. Study 
coordinators will conduct procedures involving recruitment/screening, informed consent, 
data collection and analysis. Interventionists will conduct study interventions, as 
described below in Section 5.6. The Co-Investigator, Dr. Sultzer, will assist the PI in 
overseeing all aspects of the research.  
5.0 
Study Procedures 
5.1 Study Design 
 
The project is a randomized superiority trial that compares change in mean pain severity and 
other outcomes in older Veterans (age 60-95 years) with chronic musculoskeletal pain who 
receive either Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior 
Therapy (CBT). The study includes 160 total participants, 80 randomly assigned to EAET and 
80 to CBT. Each participant receives one 90-minute individual session and eight 90-minute 
group sessions based on the treatment condition (EAET or CBT) to which he/she is randomly 
assigned. Each EAET group at a time runs concurrently with one CBT group throughout the 
study. Group sessions consist of small groups of eight Veterans. All participants complete self-
report questionnaires on pain, physical and psychiatric symptoms, and emotional well-being at 
baseline, post-treatment, and 6-month follow-up. Participants also complete self-report 
questionnaires on emotional approach coping, ambivalence over emotional expression, pain 
catastrophizing, and adaptive pain coping skills at baseline, post-treatment, and 6-month follow-
up. Participants complete a working alliance questionnaire at post-treatment. The data are used 
to assess the superiority of EAET compared to CBT on change in mean pain severity scores 
from baseline to post-treatment (primary outcome) and 6-month follow-up and change in other 
patient-centered outcomes (PCO) from baseline to post-treatment and 6 month-follow-up 
(secondary outcomes). In addition, the data are used to test mediation of EAET by improved 
emotion regulation (greater emotional approach coping and decreased ambivalence over 

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emotional expression), mediation of CBT by improved cognitive and behavioral coping 
(decreased catastrophizing and increased pain coping skills), and mediation of both treatments 
by strength of the working alliance. Finally, the data are used to test whether higher baseline 
depression and anxiety predict response to EAET and lower baseline depression and anxiety 
predict response to CBT. 
 
5.2 Recruitment Methods 
Participants: 
The study includes 160 Veterans age 60-95 years (2 treatment conditions x 10 groups x 
8 Veterans = 160) with chronic musculoskeletal pain. Veterans are recruited from 
outpatient clinical sites at West Los Angeles Veterans Affairs Medical Center (WLA), the 
largest VA Medical Center on the West Coast. We have already partnered with several 
clinical sites, including Geriatric Psychiatry, Geriatrics, Chronic Pain, Interventional Pain, 
Women’s, and Primary Care Clinics, for our pilot, and plan to use these sites for this 
project as well. In our pilot, we were able to recruit 48 participants from our clinical sites 
in 30 weeks. For the proposed trial we have a similar recruitment schedule of 
approximately 1-2 Veterans per week, in order to complete all treatments and 6-month 
follow-ups by the end of Year 4, leaving Year 5 for data clean-up and analysis. The 
schedule in Table 1 indicates recruitment goals for the duration of the study. 
Table 1: Enrollment for Each Year 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Screening, Baseline Assessments, EAET, Post-Treatment 
and 6-month Follow-Up Assessments  
24 
 
24 
 
16 
16 
- 
Screening, Baseline Assessments, CBT, Post-Treatment and 
6-month Follow-Up Assessments 
24 
24 
16 
16 
- 
Recruitment and Screening Procedures: 
Approved clinician and patient flyers are distributed to clinic staff in participating 
programs (see attached). Before clinic, a medical chart review is performed to determine 
whether potential Veteran participants meet basic inclusion/exclusion criteria. Clinicians 
not associated with the study will passively recruit patients by handing them a flyer and 
referring them to the research team. No Veteran is approached by research staff without 
having previously agreed to such contact with his/her clinician.  
In addition, we will screen additional medical charts using a VA Data Warehouse 
generated list of veterans aged 60 and older, who carry a diagnosis of low back pain, 
and are actively receiving care from a VA PCP. Patients identified as eligible this way 
will be mailed a letter and a flyer about the study. Only patients who reach out to the 
research team will be considered for enrollment in the study and will not be contacted 
otherwise. 
Finally, we post flyers on VA bulletin boards and at identified locations in the 
aforementioned clinics, and prospective Veterans are self-referred to research staff 
through these flyers. A waiver for consent and documentation of consent for 
recruitment/screening only is being sought from the IRB. Patients who are unable to give 
informed consent or have a legal conservator are not included in the study. Only in 
cases in which a patient’s capacity to provide informed consent is questionable 
(according to the clinician’s best judgement) will they be required to complete the UCLA 
Capacity for Consent Form to determine whether they may be included in the study. 
Patients who have assigned payees are compensated accordingly. 

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Payments: 
After completing the baseline visit (baseline questionnaires), participants will receive 
$50. After completing posttreatment questionnaires (Week 9), participants will receive 
$50. After completing 6-month follow-up questionnaires (Week 39), participants will 
receive $50. Participants receive a check, which is mailed within three weeks of 
completing the aforementioned study procedures. 
Proposed payments are provided for participant time, inconvenience, and transportation 
to complete research procedures (i.e., questionnaires). Substantial time is needed in 
order to complete the battery of questionnaires. In addition, driving in Los Angeles can 
be challenging, with many participants driving a considerable distance. Thus, payments 
are modest. Participants are not reimbursed for attendance at psychotherapy sessions. 
5.3 Informed Consent Procedures 
After a Veteran has expressed interest in the study, the PI or other research team 
member discusses the details of the study, including study procedures, risks, and 
benefits, with the Veteran by phone or in person. There is an opportunity to ask 
questions, to have information clarified, and for potential participants to discuss the study 
with other family members. Standardized demographics and medical history are 
obtained, as well as psychiatric diagnoses and substance use disorder status. All 
patients complete the MMSE for screening purposes. If the potential participant meets 
screening criteria, he/she is invited to enroll as a primary research participant. Those 
who fail to meet the inclusion/exclusion requirements are thanked for their time. 
Interested participants come to meet in person with the PI or another research team 
member to enroll in the study. Consent and HIPAA forms are reviewed with the 
participant prior to the start of the study. As the need arises, decision-making capacity is 
assessed by a member of the research team who is a psychiatrist or licensed 
psychologist. The UCLA Capacity to Consent Form will be used for this purpose. 
Baseline assessments are then completed. Finally, the Veteran is randomized and 
scheduled for an individual preparatory session based on treatment assignment 
(described below). 
5.4 Inclusion/Exclusion Criteria 
 
Inclusion Criteria: 
Eligible Veterans are age 60 to 95 years old and have had at least 3 months of musculoskeletal 
pain, including the following conditions most likely to benefit from psychosocial intervention 
based on previous research (28):  
• 
regional pain syndromes (e.g., low back, neck, leg, or pelvic pain, or temporomandibular 
joint disorders);  
• 
widespread pain syndromes (e.g., fibromyalgia);  
• 
whiplash; 
• 
tension headaches; or 
• 
any combination of these disorders. 
 
 
Exclusion Criteria: 
We exclude the following conditions:  
• 
Confirmed hip or knee osteoarthritis without other musculoskeletal pain complaints; 

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• 
Leg pain greater than back pain only without other musculoskeletal pain complaints (to 
exclude radiculopathy in isolation); 
• 
EMG-confirmed “tunnel” syndromes (e.g., carpal or tarsal tunnel syndrome) only without 
other musculoskeletal pain complaints; 
• 
Autoimmune disease that typically generates pain (e.g., systemic lupus erythematosus, 
rheumatoid arthritis, inflammatory bowel disease, ankylosing spondylitis);  
• 
Cancer pain, sickle cell disease, neuralgias (e.g., trigeminal neuralgia), burn pain, 
infection associated with pain (e.g., vertebral infection), cauda equina syndrome, gout, 
migraine or cluster headaches without additional musculoskeletal pain complaints; 
• 
Uncontrolled severe psychiatric disorder including current psychotic disorder or severe 
mood disorder not controlled with medications (e.g., schizophrenia or bipolar I disorder), 
dissociative identity disorder, or active suicide/violence risk in the past 6 months; 
• 
Substantial cognitive impairment or dementia (Mini-Mental State Exam (78) score ≤ 24); 
• 
Active severe alcohol or substance use disorder that inhibits the participant’s ability to 
attend session or participate in homework; 
• 
Currently with pain-related litigation or applying for pain-related compensation or 
compensation increase, or undergoing compensation re-evaluation (e.g., applying for VA 
service connection or service connection increase for pain); 
• 
Patients who are currently receiving CBT or EAET psychotherapy treatment for pain; 
• 
Patients who have received CBT for pain in the past 3 months;  
• 
Unable to fluently read/converse in English; 
• 
Planning to move from the area in the next 6 months.  
 
Medications/Other Treatments: 
Consistent with other trials of psychosocial interventions for chronic pain (23, 24), participants 
will not be excluded due to using any medications at any dose, or for pursuing other non-
psychotherapy treatment options for chronic pain (e.g., trigger point injections, physical 
therapy), or for participating in psychotherapy for another condition (e.g., depression, insomnia). 
However, current medications and dosages, other treatments, and presence of psychotherapy 
for other conditions are recorded at baseline, post-treatment, and follow-up visits for monitoring 
purposes and possible post-hoc analyses.  
 
5.5 Study Evaluations 
 
Data are collected from participant self-report before, after, and at 6-month follow-up from 
interventions. Descriptive measures collected at baseline include demographics (age, sex, 
race/ethnicity, marital status, education) and clinical characteristics (medical comorbidities, 
medications, psychiatric diagnoses, substance use). Mini-Mental State Examination is collected 
at screening.  
 
Primary Outcome: The primary outcome is change in mean pain severity scores on the Brief 
Pain Inventory (BPI) (70) from baseline to post-treatment. The BPI is a short, self-administered 
questionnaire that was developed for use in cancer patients but is now one of the most widely 
used tools for assessing a variety of pain conditions in clinical and research settings (71, 72). 
The BPI contains four items rated 0-10 assessing worst and least pain during the last seven 
days, as well as average pain and current pain. The mean of these four items is determined to 
assess mean pain severity. This metric is referred to alternately in the literature as “mean pain 
severity” and the “pain severity index” (24). 
 

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Secondary Outcomes: Consistent with recommendations from IMMPACT (73) and our pilot 
data, we examine pain interference, physical symptoms (sleep disturbance, fatigue), emotional 
symptoms (anxiety, depression, PTSD symptoms), purpose and meaning, patient-reported 
global impression of change, and satisfaction with treatment as secondary outcomes. PROMIS 
and NIH Toolbox measures are used, where available, because of their long-term potential to 
improve standardization of patient-reported outcomes (79). 
 
Potential Moderators: Based on previous literature and our pilot work, we examine whether 
greater baseline anxiety or depression predict greater response to EAET on primary and 
secondary outcomes post-treatment and at follow-up, and lower baseline anxiety or depression 
predict greater response to CBT on primary and secondary outcomes post-treatment and at 
follow-up. We use the same PROMIS measure to evaluate baseline anxiety and depression as 
used for secondary outcomes. 
  
Potential Mediators: Potential mediators are assessed using standardized assessments which 
have been validated in the chronic pain population. Emotional approach coping, ambivalence 
over emotional expression, emotion differentiation, self-conscious affect, anger discomfort, and 
emotional associations are assessed at baseline, post-treatment, and 6-month follow-up to 
represent emotion regulation, the proposed distinct mediator for EAET. Pain catastrophizing and 
coping skills are assessed at baseline, post-treatment, and 6-month follow-up to representing 
cognitive and behavioral coping, the proposed distinct mediators for CBT. Change on these 
measures baseline to post-treatment and 6-month-follow-up will be compared to changes in 
outcomes from baseline to post-treatment and 6-month follow-up. In addition, working alliance, 
pain beliefs, pain attitudes, and pain control are assessed to mediate response to both 
treatments. Working alliance will be compared to treatment response at post-treatment and 6-
month follow-up. Patients will also be given the opportunity to answer a few open-ended 
questions at 6-month follow up to assess for mediators that may be worth exploring in future 
research. 
 
All study variables and their associated measurement instruments are shown in Table 2.  
 
Table 2: Study Assessments  
Base- 
line 
Post- 
treat. 
6-
mo. 
f/u 
Expect. 
Direct. 
of 
Change 
Primary Outcome 
Variable 
Measurement Instrument 
Cognition 
Mini-Mental State Examination 
Screening 
only 
 
 
 
Pain Severity  
Mean of 4 Brief 
Pain Inventory 
(BPI) (70) Items:  
Current Pain 
√ 
√ 
√ 
↓ 
Average Pain 
Worst Pain – 7 days 
Least Pain – 7 days 
Secondary 
Outcomes 
Pain Interference 
PROMIS-Pain Interference Short Form 
(80, 81) 
√ 
√ 
√ 
↓ 
Pain Behavior 
PROMIS-Pain Behavior Short Form (80,  
√ 
√ 
√ 
↓ 
Depression 
PROMIS-Depression Short Form (40) 
√ 
√ 
√ 
↓ 
Anxiety 
PROMIS-Anxiety Short Form (40) 
√ 
√ 
√ 
↓ 
PTSD Symptoms 
PTSD Symptom Scale (82) 
√ 
√ 
√ 
↓ 
PTSD Symptoms 
PCL-5 with LEC-5 and Criterion A (94) 
√ 
√ 
√ 
↓ 
Purpose and 
NIH Toolbox-Purpose and Meaning Short 
√ 
√ 
√ 
↑ 

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5.6 Interventions and Interventionists 
 
Interventions: 
Emotional Awareness and Exposure Therapy (EAET) includes one individual preparatory 
session plus 8 weekly group therapy sessions for small groups of 8 Veterans. The conceptual 
model of EAET is based on 1) neurobiological research indicating the importance of the central 
nervous system in chronic pain disorders; 2) neurobiological evidence showing structural and 
functional relationships between emotional brain circuits (e.g., anxiety) and brain circuits dealing 
with pain; 3) experiential and psychodynamic theories and particularly the relationship between 
life stress, emotional coping, and symptoms (pain); 4) epidemiological evidence relating 
trauma/life stress to pain; and 5) research relating alexithymia, emotional expression, and 
emotional awareness to pain and other somatic disorders. We will use the most updated version 
of the EAET treatment manual and accompanying patient handouts (26). The sessions include: 
• 
Individual preparatory session. Following screening and consent, each participant 
receives a psychodiagnostic interview (90) and pain history (26). These components 
focus on stressful events, how the patient unconsciously avoids emotional experiences, 
Meaning 
Form (83) 
Life Satisfaction 
NIH Toolbox-Life Satisfaction Short Form 
√ 
√ 
√ 
↑ 
Positive Affect 
NIH Toolbox-Positive Affect Short Form 
√ 
√ 
√ 
↑ 
Sleep Disturbance 
PROMIS-Sleep Disturbance Short Form 
(84) 
√ 
√ 
√ 
↓ 
Fatigue 
PROMIS-Fatigue Short Form (85) 
√ 
√ 
√ 
↓ 
Global Improvement 
Patient Global Impression of Change 
(PGIC) (86) 
 
√ 
√ 
↑ 
Patient Satisfaction 
Satisfaction with Therapy and Therapist 
Scale—Revised (74) 
 
√ 
 
 
Mediators 
Ambivalence 
Ambivalence over Emotional Expression 
Questionnaire (AEQ) (46) 
√ 
√ 
√ 
↓ 
Emotional Approach 
Emotional Approach Coping Scales (EAC) 
(77) 
√ 
√ 
√ 
↑ 
Emotion 
Differentiation 
PANAS Emotion Differentiation (95) 
√ 
√ 
√ 
↑ 
Self-Conscious 
Affect 
Test of Self-Conscious Affect 3 - short 
version (TOSCA-3) (96) 
√ 
√ 
√ 
↓ 
Anger Discomfort  
Anger Discomfort Scale (97) 
√ 
√ 
√ 
↓ 
Emotional 
Associations 
Property Association Task (98) 
√ 
√ 
√ 
↑ 
Catastrophizing 
Pain Catastrophizing Scale (PCS) (87) 
√ 
√ 
√ 
↓ 
Pain Coping 
Coping Strategies Questionnaire (CSQ) 
(88) 
√ 
√ 
√ 
↑ 
Pain Beliefs 
Pain Beliefs and Perceptions Inventory 
(PBAPI) 
√ 
√ 
√ 
↓ 
Pain Control 
Beliefs in Pain Control Questionnaire 
(BPCQ) 
√ 
√ 
√ 
↑ 
Pain Attitudes 
Survey of Pain Attitudes (SOPA) 
√ 
√ 
√ 
↑ 
Working Alliance 
Working Alliance Inventory (WAI) (89) 
 
√ 
 
 
 
Future Mediators 
Open-Ended Questions 
 
 
√ 
N/A 

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and how this avoidance is linked to the onset and maintenance of pain and associated 
symptoms (e.g., depression, anxiety, fatigue). 
• 
Group Session 1: Rationale; Model of Stress, Emotions, and Pain; Identifying Stress-
Symptom Connections. The therapist presents the intervention and rationale, including 
the links between life stress, emotional avoidance, and pain, and the role of altered pain 
pathways in the central nervous system. The therapist presents the task of therapy, 
which involves attenuating pain through directly addressing stress and experiencing 
previously avoided emotions. Home exercises throughout will include increasing 
activities, reading, and completing worksheets on avoidance, stress, and disclosure of 
emotions. 
• 
Group Session 2: Triangle Model of Stress and Symptoms; Experiencing and 
Expressing Anger and Closeness. This session focuses on the Triangle Model, which 
represents how people function internally, including their emotions, avoidance 
techniques, and anxiety/symptoms. In-session experiential exercises are introduced to 
focus on overcoming avoidance techniques and fully experiencing and expressing 
avoided emotions, starting with anger and emotions related to closeness with others. An 
avoidance log is introduced for patients to keep track of avoided emotional experiences.  
• 
Group Session 3: Avoidance in Daily Life; Conflicted Relationships; and Experiencing, 
Expressing, and Releasing 1. Conflicted relationships that lead to emotional avoidance 
are discussed, and imaginal exercises which focus on experiencing, expressing, and 
releasing difficult feelings during the session are practiced.  
• 
Group Session 4: Reversing Self-Blame and Guilt with Self-Compassion and Self-
Forgiveness; Experiencing, Expressing, and Releasing 2. This session focuses on the 
difference between healthy guilt when one has done wrong and self-blame which is 
unhealthy and contributes to symptoms. In session exercises focus on reversing self-
blame with assertion and building forgiveness and compassion toward oneself.  
• 
Group Session 5: Forgiving Others or Letting Go; Experiencing, Expressing, and 
Releasing 3. This session focuses on experiences of being violated, hurt, or neglected 
and releasing emotions that come from these experiences. Further in-session exercises 
on experiencing, expressing, and releasing emotions are practiced.  
• 
Group Session 6: Shame, Intimacy, and Private Experiences or Secrets. Shame is 
defined as a sense of self that is bad and discussed as always unhealthy. Experiential 
exercises focus on intimacy and sharing secrets of which patients are ashamed.  
• 
Group Session 7: Healthy Communication in Relationships. The two parts of healthy 
communication, connection to others and assertiveness, are discussed and practiced in 
session. This is distinguished from the intense emotional expression we have practiced 
thus far.  
• 
Group Session 8: Review and Planning. The final session reviews all exercises and 
progress made. Participants describe optimal emotional and interpersonal functioning, 
which serves as a goal for their continued work, and they develop a written plan for 
continued exercises to perform to meet that goal. 
 
Cognitive Behavior Therapy (CBT) also includes one individual preparatory session and 8 
group therapy sessions for groups of 8 Veterans. The conceptual model for CBT for chronic 
pain is that pain is enduring and requires ongoing coping to control or manage it. Patients are 
taught skills to modify their behaviors and cognitions, which is thought to reduce pain, 
dysfunction, and distress. Our treatment manual and patient handouts for group CBT are from 
the VA CBT for Chronic Pain (CBT-CP) Evidence-Based Psychotherapy manual. Sheryl Osato, 
PhD, (SO) our chief CBT interventionist, adjusted the timing of CBT-CP sessions in order to 

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match the EAET intervention with respect to the number of sessions, length of sessions, timing 
of sessions, and amount of homework. SO’s adjustments are described here: 
• 
Individual preparatory session (CBT-CP Manual Session 1). This session reviews the 
participant’s pain and health history; including medical, behavioral, and other 
approaches the participant has tried to manage pain. Therapist and patient discuss the 
outcomes of those efforts and prepare for cognitive and behavioral skills training.  
• 
Group Session 1: Treatment Orientation (CBT-CP Manual Sessions 2-3). The therapist 
presents the rationale for CBT pain coping skills, which shows that pain is a complex 
experience influenced by thoughts, feelings, and behaviors.  
• 
Group Session 2: Relaxation Training (CBT-CP Manual Session 5). This session 
presents relaxation training and demonstrates that relaxation can reduce pain by having 
patients engage in a moderate pain-eliciting activity both before and after relaxation. 
Difficulties with relaxation are examined.  
• 
Group Session 3:  Applied Relaxation (CBT-CP Manual Session 4). This session 
focuses on teaching and implementing applied relaxation (brief relaxation used in the 
natural environment). The ability to integrate relaxation exercises into one’s daily routine 
is of paramount importance and will be addressed here.  
• 
Group Session 4: Pleasant Activity Scheduling (CBT-CP Manual Sessions 6-7). This 
session encourages pleasant activities, which can combat negative mood. Activity 
pacing (identifying activities in which patients overexert themselves and then dividing 
activities into periods of activity and rest) is taught to avoid pain flares.  
• 
Group Sessions 5-6: Cognitive Coping and Distraction (CBT-CP Manual Sessions 8-9). 
These sessions focus on changing cognitions underlying pain, particularly 
catastrophizing. Cognitive techniques are taught to help patients recognize relationships 
among thoughts, feelings, and behaviors and replace maladaptive thoughts with 
alternative, rational coping thoughts. Relaxation through distraction techniques are also 
taught.  
• 
Group Session 7: Sleep (CBT-CP Manual Session 10). This session addresses the 
importance of sleep as it relates to chronic pain. Sleep hygiene will be reviewed with 
patients, and exercises will be completed to improve sleep hygiene.    
• 
Group Session 8 (CBT-CP Manual Session 11). Review and Planning. This session 
focuses on planning for maintenance by having each participant develop a written plan 
that lists coping skills to deal with setbacks.  
 
Interventionists: 
Experienced interventionists will be primarily responsible for the administration of both EAET 
and CBT, in keeping with the primary efficacy aim of this research. Hannah Roggenkamp, MD, 
will conduct EAET sessions, and Sheryl Osato, PhD, will conduct CBT interventions.  
 
As they become available, trainees are recruited to assist the primary interventionists with 
administration of EAET and CBT. Trainee interventionists are psychologists with at least a 
master’s degree in clinical psychology (licensed psychologists, psychology interns, or 
psychology residents), psychiatrists or psychiatry residents who have completed at least two 
years of post-graduate training, licensed marriage and family therapists, or social workers. Each 
interventionist conducts only one of the two conditions to preserve fidelity by assuring there is 
no overlap or blending of treatments or allegiance effects. 
 
All interventionists receive a detailed outline of the protocol and participate in exercises, 
activities and group management skills taught through didactic instruction, taped illustrations 
from model cases, and role-plays of common scenarios prior to assisting with interventions. 

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Trainee interventionists shadow and assist the primary interventionists for up to eight sessions 
before conducting interventions independently. Supervision occurs weekly for trainee 
interventionists working independently, in which video recordings of sessions are reviewed, and 
it is verified that the skills and content are being faithfully presented according to protocol. 
Primary interventionists make ratings of adherence to the protocols to assess trainees. 
Numerical protocol adherence criteria are developed for each session, with satisfactory 
adherence defined as ≥90% of the maximum possible score on the adherence rating scale. 
Training is reinitiated when adherence is found to decrease below 90% (91). In addition, 
independent fidelity monitoring occurs for a randomly selected 25% of all sessions (see section 
below).    
 
Fidelity Monitoring: 
Both EAET and CBT therapy sessions are video recorded for the purposes of fidelity monitoring. 
Video recording is essential for EAET, given the importance of observing participants’ nonverbal 
behavior for this intervention. An independent fidelity monitor, who is a geriatric psychiatrist with 
research experience, reviews the video recording of one early and one late session from each 
course of group EAET or CBT (2 out of every 8 sessions = 25%). In addition, the fidelity monitor 
reviews 2 out of every 8 = 25% individual psychotherapy sessions for both EAET and CBT. The 
fidelity monitor completes a standardized checklist to ensure that the session covered targeted 
topics (based on therapy model) but did not contain non-targeted topics (e.g., CBT concepts 
during EAET treatment). Participants consent to the production of video recording at the time of 
informed consent for the study by completing HIPAA authorization, in compliance with IRB 
policy. Videos are produced on a VA-approved laptop, and video files are immediately 
transferred to our encrypted VA research server.  
 
5.7 Data Analysis 
Statistical Plan: 
The experimental design for this study is a 2-group randomized superiority trial, with 
assessments at baseline, post-treatment (primary endpoint), and 6-month follow-up. The 
aims correspond to comparisons of the effects of two active treatments to each other 
(Aim 1), moderation of the interventions (Aim 2), and mediation of the interventions (Aim 
3).  
Prior to performing the primary analyses, descriptive statistics and graphical summaries 
are obtained for all outcomes to check for missing data, outliers, and the need for 
transformations or non-parametric methods.  
To assess the success of randomization, continuous baseline covariate statistics will be 
reported and compared with p-values computed using the t-test or the nonparametric 
analog (Wilcoxon rank sum test). The p-values for comparing categorical baseline 
covariates will be computed using chi-square tests or the nonparametric analog (Fisher’s 
exact test). We will compare primary pain and secondary outcomes, demographic (age, 
race/ethnicity, marital status, education) and clinical (number of medical conditions, 
presence of psychiatric disorder, presence of substance use, presence of opioid 
medications) characteristics. While will do not anticipate imbalance in a randomized trial, 
baseline factors that are clinically and statistically significant and are thought or shown to 
have a nontrivial effect on the pain change or other outcomes will be considered as 
adjustment factors. If adjustments are needed, both unadjusted and adjusted results will 
be reported.  

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Aim 1: Treatment Group Comparisons: The general linear mixed model (GLMM) will be 
used to compare BPI mean pain severity changes from baseline and other secondary 
continuous outcomes between the two groups (EAET, CBT) over time in order to 
account for correlations induced by repeated measures within subjects and allow for 
both fixed and time-varying covariates. For ease of interpretation, change from baseline 
is used as the outcome instead of modeling post-treatment pain with baseline pain as an 
additional predictor. The GLMM produces consistent estimates when there are missing 
data if the data are missing at random (MAR). Group, time, and the group x time 
interaction will be evaluated accounting for correlations via random person effects. 
Analyses will be carried out via intent to treat (ITT). The primary analyses will use all 
data.  
If an adjusted analysis is needed, we will use logistic regression of treatment group 
versus the selected covariates to create a propensity score. This score will then be used 
as an added covariate in the GLMM or will be used to create adjustment strata if the 
association of pain change with the propensity score is nonlinear or not easily modelled.   
Aim 2: Moderation of the Interventions. We hypothesize that patients with higher 
baseline depression and anxiety will experience greater pain reduction from EAET 
relative to CBT, whereas those with lower baseline depression and anxiety will benefit 
more from CBT relative to EAET. To test moderation of condition effects by these 
baseline characteristics, we will use the PROCESS macro developed by Hayes (92). 
This approach, which is based on the most current statistical considerations for model 
testing, involves bootstrapped analyses and estimates of various prespecified models, 
including tests of both moderators and mediators (92). We will examine depression and 
anxiety separately to test our hypotheses, but we will also explore, using principal 
components analysis, whether depression and anxiety should be combined into a 
composite. Significant interactions will be plotted for post-hoc probing, and high and low 
values (e.g., ± 1 SD from the sample mean) will be plotted. We also will examine cut-
scores on the moderators to classify participants into subgroups that are responsive or 
amenable to each intervention—an approach that can facilitate later tailoring or 
treatment matching. For exploratory purposes, we will carry out the same analyses for 
the secondary outcome measures as well. 
Aim 3 (Exploratory): Mediation of the Interventions. This aim pertains to the potential 
mediating effects of ambivalence over emotional expression and emotional approach 
coping on the effects of EAET, of pain coping and catastrophizing on CBT, and working 
alliance on both EAET and CBT. For primary and secondary outcomes at post-
treatment, we will test the potential mediators that are assessed concurrently. For the 6-
month follow-up evaluation, we will test both the post-treatment and the 6-month follow-
up (concurrent) mediators. We will examine the mediators separately, but we also will 
use multivariate methods (principle component scoring algorithm) to explore whether the 
potential mediators for each intervention should be combined into composites. We will 
assess mediation by also using the PROCESS macro developed by Hayes (92, 93).  
Sample Size and Power Considerations: 
Aim 1: Data from our first two pilot groups showed a mean 1.13-point improvement in 
BPI mean pain severity under EAET compared to a 0.33-point mean improvement of BPI 
mean pain severity under CBT, a mean difference of 1.13 – 0.33 = 0.80 points. Using a 
sample size of n = 60 per group and assuming the same SDs, there is 80% power to 
confirm mean differences as small as 0.70 points using the usual two-sided α = 0.05 
significance level. In our pilot, only six of 32 participants were lost to follow-up after 

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completing baseline assessments and randomization. We estimate at least this dropout 
rate for the proposed study and possibly up to 25% of participants (based on previous 
studies, e.g., (16)). We therefore will need to enroll at least 60/0.75 = 80 participants per 
group or 160 participants total.     
Aim 2: A sample size of n = 60 has 80% power (α=0.05) for confirming correlations as 
small as r = 0.35 (in absolute value) using the usual α = 0.05 significance level. Our pilot 
data shows that the correlation between anxiety and pain change in the EAET group 
was r = -0.40, and the correlation between anxiety and pain change in the CBT group 
was r = 0.53, both well within this margin. Based on the findings of Burger, et al. (23), we 
anticipate a possibly larger correlation between depression and reduction in pain than 
found in our pilot groups. We believe that correlations between pain severity change and 
depression and anxiety also may be even larger, given the large variation in the pilot 
sample. 
 
 
Dropouts: 
While we anticipate few dropouts, we will use a logistic or Cox proportional hazard 
regression model to assess the association between baseline covariates including the 
demographic and clinical covariates, versus dropping out or time to drop out. If the 
dropouts are missing completely at random (MCAR), there should be no association 
between any of the baseline covariates and dropping out. If the dropouts are MCAR, 
they are MAR. If the dropouts are not MCAR, we will carry out secondary subanalyses 
for baseline and post-treatment using only the subset that completed both and 
secondary subanalyses for baseline, post treatment and six-month follow up using only 
those who completed all three. Based on comparing this to the primary analysis using all 
data, we will consider sensitivity analyses to try to quantify the amount of possible bias.   
Personnel and Location for Analyses: 
Statistical analyses will be conducted primarily by the PI in his office in Bldg. 401, Rm. 
A236 or in the Brain, Behavior, and Aging Research Center in Bldg. 158 Rms. 154-169 
on VA computers with statistical software including STATA and SPSS. 
5.8 Withdrawal of Subjects 
Although extremely unlikely, it is possible that a participant’s participation in the study 
might be terminated by the investigator without regard to their consent. Instances in 
which termination could occur include excessive absences (>4) from psychotherapy 
sessions or extreme disruptiveness in sessions. The participant would be notified of 
termination in advance and in writing.  
No adverse effects of termination from this study would be anticipated. However, the 
participant would not be likely to receive the benefits of full participation described 
above.  
If you a participant is withdrawn from the study, no additional follow-up would be 
required. However, any data already collected prior to withdrawal from the study may be 
used by the investigators. No further information will be collected after a participant’s 
withdrawal from the study. 

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6.0 
Reporting/Risks/Safety 
Reporting: 
In the event of an unanticipated problem, serious adverse event, or protocol deviation, 
this information will be reported immediately to the IRB according to IRB policy by 
submitting a Form 5.  
In addition, data and safety monitoring for this study will be provided by the Clinical 
Science Research & Development (CSR&D) centralized Data Monitoring Committee 
(DMC).  The DMC is provided by CSR&D to ensure independent oversight of the safety 
and integrity of the project. The DMC is an independent multidisciplinary group, whose 
members have collectively – through research, education, training, experience, and 
expertise – the requisite knowledge pertinent to the subject areas to be reviewed.  
Membership details are available on the CSRD website.  The DMC will provide an 
ongoing independent evaluation of this study focused on safety and feasibility, including 
participant accrual and retention, adverse events monitoring, and data analyses.  
Meetings will be held three times per year at which recommendations will be made to the 
Director of CSR&D for endorsement. These recommendations will range from approval 
to continue (unconditionally or with conditions to be addressed) to probation or possibly 
termination, if there are problems with enrollment or safety concerns. 
 
Risks and Risk Minimization:  
 
Clinical interview, psychotherapy interventions, and questionnaires: no major risks. Minor risks 
include inconvenience, frustration with questions, sadness or distress with discussing emotional 
experiences, and potential embarrassment if the confidentiality of research records is breached. 
We minimize breach of confidentiality by keeping all participant data in a locked cabinet. 
Regarding psychotherapy specifically, participants may feel discomfort disclosing personal 
information to the therapist and other group members. Participants are also at risk for 
nonresponse or limited response to treatment but are always free to end participation in the 
study and pursue alternate treatment if they so choose.  
We will be monitoring for safety of participants throughout the study. At the beginning of 
each therapy session, there will be a verbal check-in period in which patients can 
discuss any worsening of symptoms, or any suicidal ideation. In addition, in case of 
worsening of symptoms between sessions, the participant will be provided with the PI’s 
direct telephone number (424-279-8439), in addition to the telephone number for his/her 
therapist and other study personnel, and the participant will be encouraged to call.  
On check-in or upon receiving a phone call from the participant, if the participant is found 
to have worsening of physical medical symptoms (e.g., pain), the patient’s primary care 
provider will be contacted, and a close follow-up appointment will be obtained for the 
participant. In the event of worsening psychiatric symptoms (e.g., depression, anxiety), 
the patient may be referred to their mental health provider, or a referral may be placed to 
the Geriatric Psychiatry Outpatient Program in the even the participant does not have a 
primary mental health provider. In the event of suicidal or violent ideation, the participant 
will be referred immediately to the emergency department or to 911, as outlined in our 
suicide safety plan below. 
In the event of worsening physical or medical symptoms, study procedures (i.e., 
psychotherapy) will be suspended after a conversation with the participant, if that is the 

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participant’s preference. In the event of suicidal or violent ideation, study procedures 
(i.e., psychotherapy) will be suspended immediately.  
 
Suicide Safety Plan:  
 
We do not expect any study participants to develop suicidal ideation in this treatment study for 
chronic pain. However, it is known that chronic pain patients have twice the rate of suicide of 
those without chronic pain. Therefore, we have a suicide safety plan in place. Research 
physicians and the research psychologist are clinicians in geriatric psychiatry, and each session 
will begin with a verbal check-in period, and assessments will be completed periodically to 
monitor for depression. If researchers feel that the participant is at risk for suicide and/or a 
threat to others while he/she is present at WLA either undergoing clinical interview, completion 
of assessments, therapy sessions, or other study procedures, he/she will be evaluated by a 
trained research physician or psychologist who is a study team member and brought to the WLA 
ER if psychiatric hospitalization is thought to be required. All Veterans will have the PI’s direct 
telephone number (424-279-8439) to call in the event of worsening symptoms and will also be 
instructed to dial 911 or report to the nearest ER if a psychiatric emergency, such as suicidal or 
violent ideation, occurs during the study but while the Veteran is not present at WLA. If a 
Veteran participant is noted to have significant depression but is not suicidal, the research team 
will discuss the benefits of treatment and provide contact information for the GLA Geriatric 
Psychiatry Outpatient Program. 
 
Potential Benefits:  
The study will be of direct relevance and benefit to older Veterans who suffer from chronic pain. 
All study participants will receive a psychological intervention, either standard treatment (CBT) 
or a promising experimental treatment (EAET). We anticipate this could be of benefit for 
participants on pain and related outcomes, such as mood, anxiety, sleep, and fatigue. Results 
from the study will inform future research on psychological interventions for chronic pain and 
contribute to understanding the psychological change processes involved in improvements in 
chronic pain.  
Risk/Benefit Ratio:  
 
The risks of this study are small. We will be gaining valuable information to help improve our 
understanding of the psychological processes involved in improvement in chronic pain and help 
inform research aimed at using alternate psychological treatment strategies for older adults with 
chronic pain. 
 
Alternatives to Participation:  
 
The patient may receive ongoing medical care in their respective clinics, including in primary 
care, pain clinic, Women’s Clinic, etc. for pain whether or not s/he participates in the study. This 
includes medications and interventional pain approaches (e.g. injections, ketamine). The VA 
also offers a chronic pain rehabilitation program, cognitive behavior therapy for chronic pain, 
and physical and occupational therapy for chronic pain. Mindfulness classes, acupuncture, and 
other complementary/integrated medicine approaches are also offered. The patient may elect to 
not participate, and this will not adversely affect any ongoing care at the VA. 
7.0 
Privacy and Confidentiality 

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Taking part in this study will involve collecting private information about participants, 
including name, diagnoses, medications, responses to study questionnaires, and video 
recordings. All information will be labeled with an alphanumeric code to protect 
participant confidentiality. Study records will be stored in a locked cabinet in Bldg. 401, 
Rm. A236 or Bldg. 158 Rm. 154-169. See below for further information on data security.  
Information about participants will be combined, publications and presentations about 
the combined data we have gathered will be created. Any talks or papers about this 
study will not identify individual participants.   
In addition, a description of this clinical trial will be available on 
http://www.ClinicalTrials.gov as required by U.S. Law. This website will not include PHI 
for study participants. At most, the website will include a summary of the results.  
We will not share participant records or identify participants unless we are legally 
required.  Participants will be notified that the following government agencies may have 
access to their records: Office of Human Research Protections, the Government 
Accountability Office, the Office of the Inspector General, the VA Office of Research 
Oversight, the VA Greater Los Angeles IRB, our local Research and Development 
Committee, the sponsor (VA Clinical Science Research and Development – CSR&D), 
and the CSR&D Data Monitoring Committee.  
By law, information can still be released if we find or suspect child abuse, elder abuse, 
an by a participant intent to harm him/herself or others, or if a participant has an 
infectious disease that State or Federal law requires us to report.   
Participants are permitted to release data about themselves or involvement in the study. 
8.0 
Communication Plan 
Data Security Plan: 
At the time of a patient’s enrollment, appropriate informed consent is obtained, and all 
prior identifying information obtained during screening is destroyed. Each participant has 
a hardcopy of the original signed consent form. A study folder for each participant is 
created with an alphanumeric code that does not include portions of the participant’s 
social security number. These folders contain completed questionnaires and data sheets 
with corresponding labeling by alphanumeric code. The decoding algorithm is stored in a 
password protected encrypted electronic file. Hardcopy study folders are stored in a 
locked filing cabinet in the locked office of the PI (WLA, Bldg. 401, Rm. A236). The PI 
has primary access to the key to the filing cabinet where hardcopy records are kept. 
Other project staff (Study Coordinator, investigators, and assistants) have access to the 
hardcopy records only through the PI. 
For video files of psychotherapy sessions, a customized VA intranet-based data system 
is created. Data are collected and processed on a separate VA laptop computer, and the 
files are extracted and uploaded into the primary database. The system is housed on the 
VAGLAHS Geriatric Psychiatry research server. An alphanumeric code is generated for 
all video files. All files are encrypted, and the systems and tools are protected by 128-bit 
SSL, the secure socket layer technology used for sensitive transactions on the web. The 
system is accessible only via the VA intranet and employs a hierarchical system of 
password protected logins, allowing differential access to project team members as 
appropriate to their roles. Data are accessed only through the system, not transported. 
Dr. Sultzer (Co-Investigator) and his team have extensive experience conducting and 

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supporting studies ranging from small pilot studies to large multisite centers, which have 
required creating data systems such as this for neuroimaging data and other types of 
encrypted electronic files. 
Data Banking/Future Use: 
 
Participants will be invited to have their data (interviews, questionnaires, and video recordings of 
psychotherapy sessions) stored in a new repository after study closure for future research 
involving psychotherapy, aging, psychological processes, and chronic pain; this will be optional 
for participants. Prior to study closure, an application for the creation of a new data repository 
will be submitted to the local IRB. Information will be labeled with a code that does not contain 
participants name or other ways that identify them. Any future research will be done for research 
purposes only; participants’ doctors will not be notified about the results of the research. 
 
Privacy Breaches:  
In the event of a privacy breach, the IRB and involved participants will be notified immediately, 
in accordance with IRB policy.  

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