- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06900608
Targeted ACT Compared to Supportive Therapy for Depression RCT
March 21, 2025 updated by: Western Michigan University
Targeted Acceptance and Commitment Therapy Compared to Supportive Therapy for Depressive Symptoms: a Pilot Randomized Controlled Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 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.
Exclusion Criteria:
- Receiving other forms of psychological treatment
- Meeting PDSQ Interview criteria for psychosis, panic disorder, substance use, or endorsement of significant suicidal ideation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acceptance and Commitment Therapy
|
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.
|
|
Active Comparator: Supportive Therapy
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic Questionnaire
Time Frame: Pre-treatment
|
Pre-treatment
|
|
|
Rosenberg Self-Esteem Scale
Time Frame: Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment
|
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
Time Frame: Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment
|
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)
Time Frame: Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment
|
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)
Time Frame: Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment
|
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)
Time Frame: Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment
|
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)
Time Frame: Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment
|
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)
Time Frame: Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment
|
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)
Time Frame: Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2010
Primary Completion (Actual)
December 30, 2011
Study Completion (Actual)
December 31, 2011
Study Registration Dates
First Submitted
March 10, 2025
First Submitted That Met QC Criteria
March 21, 2025
First Posted (Actual)
March 28, 2025
Study Record Updates
Last Update Posted (Actual)
March 28, 2025
Last Update Submitted That Met QC Criteria
March 21, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- WMich
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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