Depression DisorderNCT06900608
Targeted ACT Compared to Supportive Therapy for Depression RCT
A study testing Acceptance and Commitment Therapy and Treatment as usual in people with Depression Disorder and Distress, Emotional, run by Western Michigan University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Disorder, Distress, Emotional
- What is being tested?
- Acceptance and Commitment Therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2010to 31 Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Receiving other forms of psychological treatment
- Meeting PDSQ Interview criteria for psychosis, panic disorder, substance use, or endorsement of significant suicidal ideation
About this study
Official title: 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.
- Conditions
- Depression Disorder, Distress, Emotional
- Being tested
- Acceptance and Commitment Therapy, Treatment as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
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.
Treatment as usualBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Not described Receives: Behavioral: Acceptance and Commitment Therapy |
| Supportive Therapy | Active comparator | Not described Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Questionnaire
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-treatment, 3 weeks, 6 weeks/post-treatment, and 1 month after post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Feb 2010
- Primary completion30 Dec 2011
- Study completion31 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Michigan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900608
- Sponsor's protocol ID
- WMich
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Acceptance and Commitment Therapy Compared to Supportive Therapy for Depressive Symptoms: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06900608
- Acronym / sponsor ID
- WMich
- Conditions
- Depression Disorder, Distress, Emotional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Western Michigan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 30 Dec 2011 (actual)
- Study completion
- 31 Dec 2011 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment Therapy |
| Supportive Therapy | Active comparator | Behavioral: Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Receiving other forms of psychological treatment
- Meeting PDSQ Interview criteria for psychosis, panic disorder, substance use, or endorsement of significant suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyA 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. | Behavioural | Acceptance and Commitment Therapy |
| Treatment as usualAlso: Supportive TherapyThe 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. | Behavioural | Supportive Therapy |
Primary outcome
Demographic Questionnaire
Time frame: 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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy and Treatment as usual in people with Depression Disorder and Distress, Emotional, run by Western Michigan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Questionnaire (time frame: Pre-treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.