An Attachment Based Approach for Anxiety and Depression

NCT04719780 | Completed

• 1 other identifier: 1360.9/19
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 3

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.

Conditions

Depression, Anxiety

Keywords

Randomized control trial; Emotionally focused therapy; Depression; Anxiety

Outcome Measures

Primary Outcomes (12)

• Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)

  The ADIS-5 is a structured interview intended to help clinicians diagnose psychological disorders based on DSM-5 criteria. The ADIS-5 also allows for differential diagnosis and has been widely used in clinical research. Assessors will administer the ADIS-5 and determine whether or not the participants the criteria for a diagnosis of anxiety and/or depression, and to assess change upon completion of the 15-week intervention.

  Change from baseline to completion of the 15 week intervention.

• Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)

  The ADIS-5 is a structured interview intended to help clinicians diagnose psychological disorders based on DSM-5 criteria. The ADIS-5 also allows for differential diagnosis and has been widely used in clinical research. Assessors will administer the ADIS-5 and determine whether or not the participants the criteria for a diagnosis of anxiety and/or depression, and to assess change at post 15-week wait period.

  Change from baseline to completion of the 15 week wait period.

• Beck Depression Inventory-2 (BDI-2)

  The Beck Depression Inventory-2 is a 21-item self-report questionnaire used to assess the severity of depressive symptoms (e.g., sadness, guilt, crying, suicidal thoughts, etc.). Participants are presented with a list of themes and are asked to choose a statement that best fits their mood over the past two weeks. Each statement has a corresponding numerical value. The sum all statements are calculated for scoring purposes. A score of 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and a score above 29 indicates severe depression. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI after session 5 and 7.

  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.

• Beck Depression Inventory-2 (BDI-2)

  The Beck Depression Inventory-2 is a 21-item self-report questionnaire used to assess the severity of depressive symptoms (e.g., sadness, guilt, crying, suicidal thoughts, etc.). Participants are presented with a list of themes and are asked to choose a statement that best fits their mood over the past two weeks. Each statement has a corresponding numerical value. The sum all statements are calculated for scoring purposes. A score of 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and a score above 29 indicates severe depression. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI after session 5 and 7.

  Change from baseline to week 5, week 7, completion of 15-week intervention, and 3, 6, 9 and 12 months following the intervention.

• Beck Anxiety Inventory (BAI)

  The Beck Anxiety Inventory is a 21-item self-report questionnaire used to assess common symptoms of anxiety (e.g., rapid heartbeat, sweating, numbness, trembling, etc.). Participants are presented with a list of common symptoms of anxiety and are asked to note how much they experienced each over the past week from a four item Likert scale ("not at all", "mildly", "moderately", and "severely"). The total score is calculated by finding the sum of all 21 items; a score of 0-21 indicated low anxiety, 22-35 indicates moderate anxiety, and a score of 36 and above indicates potentially concerning levels of anxiety. Both of the Beck inventories used in this study have been widely used in clinical research and possess good reliability and validity. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI-2 after session 5 and 7.

  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

• Beck Anxiety Inventory (BAI)

  The Beck Anxiety Inventory is a 21-item self-report questionnaire used to assess common symptoms of anxiety (e.g., rapid heartbeat, sweating, numbness, trembling, etc.). Participants are presented with a list of common symptoms of anxiety and are asked to note how much they experienced each over the past week from a four item Likert scale ("not at all", "mildly", "moderately", and "severely"). The total score is calculated by finding the sum of all 21 items; a score of 0-21 indicated low anxiety, 22-35 indicates moderate anxiety, and a score of 36 and above indicates potentially concerning levels of anxiety. Both of the Beck inventories used in this study have been widely used in clinical research and possess good reliability and validity. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI-2 after session 5 and 7.

  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

• Outcome Questionnaire-30.2

  The Outcome Questionnaire-30.2 is a brief 30-item instrument intended to measure client progress before, during, and following clinical interventions. This questionnaire is was adapted from the OQ-45, is highly sensitive to session-by-session changes, and possesses high levels of reliability and validity. Over the course of the study, this questionnaire will be repeatedly administered in order to monitor participants' progress through the EFIT and waitlist conditions. This questionnaire will also be administered during the 4 follow-up time points.

  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

• Outcome Questionnaire-30.2

  The Outcome Questionnaire-30.2 is a brief 30-item instrument intended to measure client progress before, during, and following clinical interventions. This questionnaire is was adapted from the OQ-45, is highly sensitive to session-by-session changes, and possesses high levels of reliability and validity. Over the course of the study, this questionnaire will be repeatedly administered in order to monitor participants' progress through the EFIT and waitlist conditions. This questionnaire will also be administered during the 4 follow-up time points.

  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.

• Patient-Reported Outcomes Measurement Information System-Anxiety Scale (PROMIS Anxiety)

  The Patient-Reported Outcomes Measurement Information System-Anxiety scale is an 8-item tool designed to measure participants' self-reported anxiety symptoms over the past week. Participants are asked to respond to eight anxiety-related statements on a 5-point Likert scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always).

  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

• Patient-Reported Outcomes Measurement Information System-Anxiety Scale (PROMIS Anxiety)

  The Patient-Reported Outcomes Measurement Information System-Anxiety scale is an 8-item tool designed to measure participants' self-reported anxiety symptoms over the past week. Participants are asked to respond to eight anxiety-related statements on a 5-point Likert scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always).

  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.

• Patient-Reported Outcomes Measurement Information System-Depression Scale (PROMIS Depression)

  The Patient-Reported Outcomes Measurement Information System-Depression scale is an 8-item scale used to measure participants' self-reported depression symptoms over the past week. Participants are asked to respond to eight depression-related statements on the same 5-point Likert scale as the PROMIS-Anxiety measure.

  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

• Patient-Reported Outcomes Measurement Information System-Depression Scale (PROMIS Depression)

  The Patient-Reported Outcomes Measurement Information System-Depression scale is an 8-item scale used to measure participants' self-reported depression symptoms over the past week. Participants are asked to respond to eight depression-related statements on the same 5-point Likert scale as the PROMIS-Anxiety measure.

  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 (22)

• Childhood Trauma Questionnaire-Short Form

  Baseline

• Trauma Symptom Inventory-2

  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

• Trauma Symptom Inventory-2

  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

• Experiences in Close Relationships Questionnaire (ECR)

  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

• Experiences in Close Relationships Questionnaire (ECR)

  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.

Study Arms (2)

Waitlist Control Group (CBT)

ACTIVE COMPARATOR

Individuals in this arm (n=44) are provided with a transdiagnostic cognitive-behavioural treatment for depression and anxiety (MoodGym) that has been empirically validated after their 15-week wait period is complete.

Behavioral: Self-Help CBT Training

EFIT Group

EXPERIMENTAL

Individuals in the EFIT Group (n=44) will receive 12-15 sessions of EFIT in order to treat their symptoms of depression and anxiety.

Behavioral: Emotionally Focused Therapy for Individuals

Interventions

Emotionally Focused Therapy for Individuals BEHAVIORAL

Emotionally Focused Therapy for Individuals (EFIT) is formulated as a transdiagnostic treatment to treat depression and anxiety, adapted from the well-studied Emotionally Focused Therapy. EFIT has been formulated as an attachment-based alternative to current cognitive approaches (e.g., Cognitive Behavioural Therapy). 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 Group

Self-Help CBT Training BEHAVIORAL

Individuals in the Waitlist Control Group will receive access to MoodGym, a self-help online program that helps teach CBT interventions. This access will last 15 weeks and is self-driven, meaning participants proceed through the program at their own pace.

Also known as: MoodGym

Waitlist Control Group (CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of Major Depressive Disorder with co-morbid symptoms of anxiety
• At least 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Paul University: lead
• International Centre for Excellence in Emotionally Focused Therapy: collaborator

Study Sites (3)

University of Colorado Denver

Denver, Colorado, 80204, United States

Location

Vancouver Island Centre for Emotionally Focused Therapy

Nanaimo, British Columbia, V9V 1A3, Canada

Location

Saint Paul University

Ottawa, Ontario, K1S 1C4, Canada

Location

Related Publications (8)

• 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.

  PMID: 28768327 BACKGROUND

• 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.

  PMID: 3204199 BACKGROUND

• 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.

  PMID: 29117870 BACKGROUND

• 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.

  PMID: 27392018 BACKGROUND

• 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.

  PMID: 3204198 BACKGROUND

• 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.

  PMID: 23133619 BACKGROUND

• 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.

  PMID: 9881538 BACKGROUND

• Wiebe SA, Johnson SM, Allan R, Campbell TL, Greenman PS, Fairweather DR, Ismail M, Tasca GA. A randomized controlled trial of emotionally focused individual therapy (EFIT) for depression and anxiety. Psychotherapy (Chic). 2025 Sep;62(3):414-423. doi: 10.1037/pst0000586. Epub 2025 Jul 10.

  PMID: 40638305 DERIVED

Related Links

• Applied longitudinal data analysis: Modeling change and event occurrence
• Attachment Theory in Practice: Emotionally Focused Therapy with Individuals, Couples and Families
• Childhood Trauma Questionnaire: A retrospective self-report

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Emotion-Focused Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Stephanie Wiebe, PhD

  Saint Paul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: January 22, 2021
• Study Start: December 9, 2019
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (2)