Targeted ACT Compared to Supportive Therapy for Depression RCT

NCT06900608 | Completed

• 1 other identifier: WMich
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acceptance and Commitment Therapy (ACT) has demonstrated efficacy in reducing depressive symptoms, primarily compared to no treatment or minimal treatment controls. This study compared the efficacy of ACT targeting cognitive defusion (CD, 3 sessions) and values-based activity scheduling (VBAS, 3 sessions) to supportive therapy (ST). Both treatments offered six sessions, a rationale for the approach, related techniques, and homework assignments. A parallel group randomized controlled efficacy trial design was used. Participants were stratified by gender identification and depression severity and then randomly allocated, according to a predetermined sequence, 2:1 to ACT or ST. Dependent measures were collected during acute treatment (pre, mid, and post-treatment) and follow-up at one-month.

Conditions

Acceptance and Commitment Therapy; Supportive Therapy

Outcome Measures

Primary Outcomes (9)

• Demographic Questionnaire

  Pre-treatment

• Rosenberg Self-Esteem Scale

  The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale asking participants to rate their level of agreement (on a scale 0-4) with statements describing general feelings about themselves. Higher scores represent a more positive self-evaluation. Scores range from 0 to 40.

  Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment

• Brief Symptom Inventory-Global Severity Index

  The Brief Symptom Inventory-Global Severity Index (BSI) is a 53-item questionnaire that provides an overview of psychological symptoms and their severity. Items are endorsed on a Likert scale (0-not at all to 4-extremely) with higher scores indicating higher rates of general distress. Scores can range from 0 to 212.

  Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment

• Psychiatric Diagnostic Screening Questionnaire (PDSQ)

  The Psychiatric Diagnostic Screening Questionnaire (PDSQ) consists of a) 125 item "yes/no" screener used to assess for symptoms of 13 psychopathologies and b) semi-structured interview(s) as indicated by endorsement of scores above the cut-off on any given psychopathology subscale based on the 125-item screener. Participants whose interview for major depressive disorder was positive for 2-4 symptoms were considered to meet criteria for minor depression, while those with 5-9 symptoms were considered to meet criteria for major depressive disorder. Each "yes" indicates one symptom, with a range of 0-9 symptoms within the depressive disorder category.

  Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment

• Beck Depression Inventory - II (BDI)

  The Beck Depression Inventory - II (BDI) is a 21-item self-report scale assessing the severity of depressive symptoms. Higher scores indicate higher rates of depressive symptoms and intensity, with scores ranging from 0-63.

  Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment

• Acceptance and Action Questionnaire - II (AAQ-II)

  The Acceptance and Action Questionnaire - II (AAQ-II) is a 7-item scale measuring experiential avoidance and psychological flexibility. Each item is scored on a 1 (never true) - 7 (always true) scale with higher scores indicate greater inflexibility. Scores range from 7-49.

  Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment

• Automatic Thoughts Questionnaire (ATQ)

  The Automatic Thoughts Questionnaire (ATQ) contains 30-items measuring the frequency and believability of negative self-statements, with higher scores indicating higher frequency or believability of thoughts. Each item is scored on a 1-5 scale (ranging from "not at all" to "all the time"), with total score ranging from 30-150.

  Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment

• Environmental Reward Observation Scale (EROS)

  The Environmental Reward Observation Scale (EROS) consists of 10 items using a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree) assessing whether affect and behavior increases as a result of contact with positively rewarding activities. Higher scores indicate larger increases when in contact with positively rewarding activities. Total scores range from 10-40.

  Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment

• Valued Living Questionnaire (VLQ)

  The Valued Living Questionnaire (VLQ) is a 20-item self-report measure. Participants' rate, on a scale of 1-10, first the importance of values in 10 domains (e.g., family, work, education, relationships) and then the consistency of action taken towards those values during the last week. When used as an omnibus measure the VLQ is scored by taking the mean of the products of the Importance and Consistency ratings. Higher scores indicate higher consistency or higher importance of each value. Total scores can range from 10-100.

  Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL

Behavioral: Acceptance and Commitment Therapy

Supportive Therapy

ACTIVE COMPARATOR

Behavioral: Treatment as usual

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

A 6-session ACT intervention was implemented targeting Cognitive Defusion (CD) and Values-Based Activity Scheduling (VBAS). During the first 3 sessions, the therapist taught participants how to defuse from negative self-thoughts using didactic and experiential techniques and emphasized the relationship between negative thoughts and the self and learning to observe negative thoughts for what they are - thoughts, words, ideas, and evaluations. During sessions 4-6, the therapist used similar techniques to focus on behaving in meaningful ways without letting negative thoughts dictate behavior. During these VBAS sessions, the participant identified their values and worked with the therapist to decide on goals that were values-consistent, and focused on those foals without letting negative thoughts and emotions get in the way of living toward them.

Acceptance and Commitment Therapy

Treatment as usual BEHAVIORAL

The 6-session supportive therapy (ST) condition emphasized the exploration of feelings; helping the client to become aware of and talk about emotional experiences with no attempt to change thoughts, behaviors, or the client's experiences directly (Greenberg et al., 1998). Psychoeducation emphasized the untoward effects of not acknowledging or exploring feelings and benefits of identification and talking about feelings. The therapist used open-ended questions, reflective listening, empathy, and clarification questions. Therapists did not give advice, offer solutions, make interpretations, or disagree with/confront the client. For homework, the participants were asked to complete "awareness homework," involving monitoring of presence, intensity, and duration of emotions with no prescription to change them or do anything differently.

Also known as: Supportive Therapy

Supportive Therapy

Eligibility Criteria

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

You may qualify if:

• years or older
• Scored one SD below the mean on the RSES and BSI
• Proficiency in English
• If taking medication for psychiatric reasons, stable medication use for at least eight weeks prior to enrollment and agreement to no changes in dosing during study participation.

You may not qualify if:

• Receiving other forms of psychological treatment
• Meeting PDSQ Interview criteria for psychosis, panic disorder, substance use, or endorsement of significant suicidal ideation

Sponsors & Collaborators

• Western Michigan University: lead

MeSH Terms

Interventions

Acceptance and Commitment Therapy; Therapeutics; Palliative Care

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 28, 2025
• Study Start: February 1, 2010
• Primary Completion: December 30, 2011
• Study Completion: December 31, 2011
• Last Updated: March 28, 2025

Record last verified: 2025-03