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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acceptance and Commitment Therapy
Behavioral: 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
Behavioral: Treatment as usual
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:
  • Supportive Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western Michigan University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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