Clinical trial NCT04719780: An Attachment Based Approach for Anxiety and Depression
Official title: A Randomized Controlled Trial of an Attachment Based Approach for Anxiety and Depression, Emotionally Focused Individual Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Keywords: Randomized control trial
Emotionally focused therapy
Depression
Anxiety
Lead sponsor: Saint Paul University
Sponsor class: OTHER
Collaborators: name: International Centre for Excellence in Emotionally Focused Therapy
First posted: 2021-01-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a randomized controlled trial (RCT) carried out across three study sites (Ottawa, Denver, Victoria). We will have two study groups, treatment (n=44) and wait-list control (n=44). The wait-list control will be given an online transdiagnostic cognitive-behavioural treatment for depression and anxiety that has been empirically validated. The treatment condition group will be provided 12-15 sessions of Emotionally Focused Therapy for Individuals. Approximately 22 experienced EFT therapists will be given training in EFIT and will provide treatment to 2-3 clients each. Therapy will be carried out in person and/or online.
Primary purpose: TREATMENT

Brief summary: The purpose of the current study is to examine the efficacy of Emotionally Focused Therapy for Individuals (EFIT) as a treatment for depression and anxiety. It is formulated as a trans-diagnostic treatment in line with the call for more transdiagnostic approaches to treat depression and anxiety given the many similarities in the underlying psychological and emotional factors of these disorders, the high levels of co-morbidity, and the preliminary success of transdiagnostic treatment approaches. EFIT has been formulated as an attachment-based alternative to current cognitive transdiagnostic approaches. The strong evidence for insecure attachment as an underlying factor in psychopathology, especially depression and anxiety, positions this theory well as a foundational principle to support psychotherapy for these conditions. EFIT has been formulated for the first time this year in the book that will serve as the therapy manual for this study. The current study aims to examine EFIT outcomes as compared to a control group (a wait-list control followed by online CBT intervention after the wait period). In particular, this research project aims to distinguish differences in initial and follow-up outcomes between EFIT versus control, and demonstrate significant changes in attachment/emotions and mechanisms of change across EFIT sessions. The primary hypotheses are outlined below.

Detailed description: PROCEDURES

Recruitment Participants are recruited from the general population of individuals self-identifying as having symptoms of depression and/or anxiety in each study site (Ottawa, Denver, Victoria). Study advertisements are posted and circulated through post-secondary institutions, online, and within psychotherapy treatment centres. Participants experiencing depression and/or anxiety are invited to contact the research coordinator of the project via the email listed on recruitment material. All interested participants receive a telephone screen by research research assistants to assess potential eligibility. Participants who are deemed potentially eligible are informed that they will be contacted by an assessor to be invited for an initial study assessment session to determine final eligibility.

Baseline assessment Assessors are individuals with clinical experience in psychotherapy or counselling at each of the study sites. Informed consent is reviewed and participants have the opportunity to have all their questions and concerns addressed. Assessors administer the diagnostic criteria modules of the ADIS-5 during this session. Assessments take place either within the private practice locations at each study site or the university offices of the investigators in a research session lasting approximately 1-2 hours. During the pandemic while it is not safe to meet in person, secure encrypted video call platforms are used to hold these sessions. Responses are evaluated by the assessors' supervisors, at which point final eligibility is determined. The assessments and therapy take place either within the private practice locations at each study site as specified or the university offices of the co-investigators, or online using a secure encrypted video call platform when it is unsafe to meet for in-person sessions due to the pandemic. After completion of the baseline assessment session, eligible participants are given access to an online questionnaire to complete at their own convenience. After completion of the questionnaire, participants are randomly assigned to study condition.

Random assignment Once participants have been deemed eligible to take part, and have completed the baseline questionnaire, they are randomly assigned to the EFIT (treatment) condition or the waitlist plus online CBT (control group) condition by the research co-ordinator. A list of numbers (i.e., 1-40 for Ottawa, 1-28 for Victoria, and 1-20 for Denver) are generated for each city, reflecting the total number of EFIT and control clients for that city. Within those groups, a separate randomized list (i.e., 20 total numerical values for Ottawa, 14 for Victoria, and 10 for Denver) is generated using Research Randomizer, an online tool for random assignment that has been used in previous RCT studies. As participants are deemed eligible, they are added onto the list and their number will determine whether they will take part in either the EFIT intervention or the control group.

Interventions:

EFIT Treatment Group Twenty-two experienced EFT therapists trained in the EFIT model will provide 15 sessions of EFIT treatment to approximately 2 clients each. Therapy will be carried out in private practices or the university offices of researchers located in each of the study sites, or online using a secure encrypted video call platform when not possible to meet in person due to the pandemic. Each site is associated with an EFT centre: Ottawa Institute of Couple and Family Therapy in Ottawa, Centre for EFT Vancouver Island in Victoria, and Colorado Centre for EFT in Denver. Study therapists will receive an average of 1 hour of supervision per week in groups of 3-4 therapists. Each therapy session will be video recorded and treatment fidelity will be confirmed through the coding of video tapes. After each therapy session, therapists will ask participants to complete a brief online questionnaire that takes approximately 10 minutes to complete. The link to the online questionnaire will be sent to each therapist by the research co-ordinator.

Wait-List plus online CBT Control Group Participants randomly assigned to the wait-list control group will wait 15 weeks, following which time they will be given an online transdiagnostic cognitive-behavioural treatment (MoodGym) for depression and anxiety that has been empirically validated after they have completed the 15-week wait period. They will be given access to complete 15 weeks of the online intervention. These participants will also be requested to complete a brief online questionnaire on a weekly basis - this questionnaire is identical to the questionnaire given to EFIT participants after each therapy session with the exception that it does not include the Working Alliance Inventory (WAI) or the Post-session Resolution Questionnaire (PSRQ) as these questionnaires are only relevant to therapy sessions.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of Major Depressive Disorder with co-morbid symptoms of anxiety
* Inclusion cut offs: Participants must score in the mild-to severe range on BDI-II and mild-moderate on the BAI
* At least 18 years old

Exclusion Criteria:

* Psychotropic medication change in 6 weeks prior to enrollment or anticipated during the study period (this allows us to include people who are taking a medication but mitigates the risk of medication changes as a problematic factor; assessed in phone screen)
* Current DSM diagnosis of bipolar disorder, schizophrenia-spectrum disorder, PTSD, eating disorder, personality disorder, or substance abuse or dependence

Primary outcomes:
measure: Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)
timeFrame: Change from baseline to completion of the 15 week intervention.
measure: Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)
timeFrame: Change from baseline to completion of the 15 week wait period.
measure: Beck Depression Inventory-2 (BDI-2)
timeFrame: Change from baseline to week 5, week 7, completion of 15-week wait period (control condition), and 3, 6, 9 and 12 months following completion of the wait-period.
measure: Beck Depression Inventory-2 (BDI-2)
timeFrame: Change from baseline to week 5, week 7, completion of 15-week intervention, and 3, 6, 9 and 12 months following the intervention.
measure: Beck Anxiety Inventory (BAI)
timeFrame: Change from baseline to week 5, week 7, and completion of 15-week wait period (control condition) and at 3, 6, 9, and 12 months after completing the wait-period
measure: Beck Anxiety Inventory (BAI)
timeFrame: Change from baseline to week 5, week 7 and completion of 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
measure: Outcome Questionnaire-30.2
timeFrame: Change from baseline, to across each weekly treatment session for 15 weeks, to after completion of the 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
measure: Outcome Questionnaire-30.2
timeFrame: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
measure: Patient-Reported Outcomes Measurement Information System-Anxiety Scale (PROMIS Anxiety)
timeFrame: Change from baseline, to across each weekly treatment session for 15 weeks, to after completion of the 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
measure: Patient-Reported Outcomes Measurement Information System-Anxiety Scale (PROMIS Anxiety)
timeFrame: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
measure: Patient-Reported Outcomes Measurement Information System-Depression Scale (PROMIS Depression)
timeFrame: Change from baseline, to across each weekly treatment session for 15 weeks, to after completion of the 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
measure: Patient-Reported Outcomes Measurement Information System-Depression Scale (PROMIS Depression)
timeFrame: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
Secondary outcomes:
measure: Childhood Trauma Questionnaire-Short Form
timeFrame: Baseline
measure: Trauma Symptom Inventory-2
timeFrame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
measure: Trauma Symptom Inventory-2
timeFrame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
measure: Experiences in Close Relationships Questionnaire (ECR)
timeFrame: Change from baseline, to across each weekly treatment session for 15 weeks, to after completion of the 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
measure: Experiences in Close Relationships Questionnaire (ECR)
timeFrame: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
measure: Reflective Function Questionnaire-8 (RFQ)
timeFrame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
measure: Reflective Function Questionnaire-8 (RFQ)
timeFrame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
measure: Inventory of Interpersonal Problems-32
timeFrame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
measure: Inventory of Interpersonal Problems-32
timeFrame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
measure: Difficulties in Emotion Regulation Scale
timeFrame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
measure: Difficulties in Emotion Regulation Scale
timeFrame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
measure: Leuven Affect and Pleasure Scale
timeFrame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
measure: Leuven Affect and Pleasure Scale
timeFrame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
measure: Rosenberg Self-Esteem Scale
timeFrame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
measure: Rosenberg Self-Esteem Scale
timeFrame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
measure: Patient-Reported Outcomes Measurement Information System-Meaning (PROMIS Meaning)
timeFrame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
measure: Patient-Reported Outcomes Measurement Information System-Meaning (PROMIS Meaning)
timeFrame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
measure: Multi-dimensional Assessment of Interoceptive Awareness
timeFrame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
measure: Multi-dimensional Assessment of Interoceptive Awareness
timeFrame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
measure: Post Session Resolution Questionnaire (PSQR)
timeFrame: Weekly for 15 weeks of the experimental condition
measure: Working Alliance Inventory
timeFrame: Weekly for 15 weeks of the experimental condition
measure: Sociodemographic Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: Nanaimo
country: Canada
facility: Vancouver Island Centre for Emotionally Focused Therapy
state: British Columbia
city: Ottawa
country: Canada
facility: Saint Paul University
state: Ontario
Study officials:
affiliation: Saint Paul University
name: Stephanie Wiebe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.
citation: Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
citation: Demyttenaere K, Mortier P, Kiekens G, Bruffaerts R. Is there enough "interest in and pleasure in" the concept of depression? The development of the Leuven Affect and Pleasure Scale (LAPS). CNS Spectr. 2019 Apr;24(2):265-274. doi: 10.1017/S1092852917000578. Epub 2017 Nov 9.
citation: Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.
citation: Horowitz LM, Rosenberg SE, Baer BA, Ureno G, Villasenor VS. Inventory of interpersonal problems: psychometric properties and clinical applications. J Consult Clin Psychol. 1988 Dec;56(6):885-92. doi: 10.1037//0022-006x.56.6.885. No abstract available.
citation: Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.
citation: Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.