DepressionNCT07541482
Pilot Randomized Trial of BA-GSH in VA PC-MHI
A study testing Behavioral Activation-Guided Self-Help in people with Depression, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Symptoms of depression are highly prevalent among Veterans. However, fewer than 30% of individuals with these symptoms receive any psychotherapy in the Veterans Health Administration (VHA). This is due to many factors, which may include provider availability and patient preferences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Activation-Guided Self-Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2027to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- participants will be included in the study if they are patients at the study site
- score a 10 to 20 on the PHQ-9 (moderate to moderately severe)
- can follow the self-help program, which requires reading materials in English and documenting/tracking work between meetings with a provider
Who cannot join
- score greater than 10 on the GAD-7
- PCMHI ineligible (i.e., in specialty mental health)
- currently enrolled in a VA or non-VA psychotherapy that would interfere with the study intervention
- participants will also be excluded if demonstrating high risk of suicidal ideation/behavior based on the C-SSRS
- cognitive impairment conditions that may interfere with the ability to complete the program
- conditions that threaten safety (e.g., uncontrolled psychosis, mania/bipolar, moderate to severe substance use disorders)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Maribel Plasencia, PhD, 713-440-4400, maribel.plasencia@va.gov
Maribel Plasencia, BA MS PhD
About this study
Official title: Pilot Randomized Trial of Behavioral Activation-Guided Self-Help for Depression in VA Primary Care-Mental Health Integration (HSR4-024-25M)
Symptoms of depression are highly prevalent among Veterans. However, fewer than 30% of individuals with these symptoms receive any psychotherapy in the Veterans Health Administration (VHA). This is due to many factors, which may include provider availability and patient preferences. Guided self-help (GSH), which involves coaching sessions with patients who are following a fully developed self-help program, has the potential to increase access to care for these Veterans, particularly if implemented within a stepped care model of mental health treatment delivery and if delivered by a diverse set of providers. The VHA's primary care-mental health integration (PCMHI) service, which focuses on short courses of care for mild to moderate symptoms, may be an ideal place in which to deploy GSH. The current project seeks conduct a pilot randomized trial of a GSH program for depression adapted for PCMHI based on behavioral activation.
Read the detailed description
Elevated symptoms of depression in approximately 10% of Veterans and are associated with functional impairment and suicidality. Cognitive behavioral therapy (CBT) is a first line intervention for these conditions, yet few Veterans receive this treatment, in part due to the limited availability of mental health providers trained in CBT. The stepped care model offers one approach to addressing access by offering effective yet less resource-intensive treatments upon entry into mental health care for individuals with mild to moderate symptoms, stepping up the intensity and level of care as needed. Guided self-help (GSH) is one low intensity treatment format that could increase accessibility of CBT for depression and GAD. In GSH, patients follow a self-help version of an evidence-based behavioral intervention with coaching from a provider. A meta-analysis found that GSH is as effective as traditional psychotherapy treatments for depression and anxiety disorders. VHA's Primary Care Mental Health-Integration (PCMHI) Service may be the ideal setting in which to deploy GSH. However, GSH is not widely used within VHA, and existing CBT interventions for depression require adaptation to the GSH format and PCMHI setting.
The specific aim of this project is to conduct a pilot randomized trial of Behavioral Activation-GSH (BA-GSH) for depression (15 Veterans assigned to BA-GSH; 15 assigned to treatment as usual) in PCMHI by a variety of types of providers within this setting. This pilot will evaluate the acceptability and feasibility of BA-GSH and explore preliminary effectiveness.
- Conditions
- Depression
- Being tested
- Behavioral Activation-Guided Self-Help
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation-Guided Self-HelpBehavioural
This intervention is based on behavioral activation. It includes a self-help program that is paired with guidance from a provider.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation-Guided Self-Help | Experimental | For this arm, participants will work through a self-help program based on behavioral activation paired with guidance from a provider in VA Primary Care-Mental Health Integration. Receives: Behavioral: Behavioral Activation-Guided Self-Help |
| Enhanced Usual Care | No intervention | For this arm, a note will be entered into the participants medical record that indicates the participant's enrollment in the study and documents whether depression scores are elevated. This note includes a statement that encourages providers to deliver care in their usual and customary fashion and actively monitor aspects related to depression as part of the patient's overall care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment
This proportion will be presented as the number of patients recruited into the study program over the number of patients potentially eligible.
Measured: Baseline, 16-20 weeks post-baseline
Preliminary Effectiveness: Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 measures depressive symptom severity over the previous two weeks. Participants self-report how often they have experienced a particular symptom on a scale of 0 to 3 (0 = not at all and 3 = nearly every day).
Measured: Baseline, 16-20 weeks post-baseline
Attrition
This proportion will be presented as the number of patients who discontinue the program over the total number of recruited participants over the trial period.
Measured: Baseline, 16-20 weeks post-baseline
Client Satisfaction Questionnaire-8
The CSQ-8 evaluates general satisfaction with a service and scores range from 8 to 32. Higher scores indicate higher satisfaction.
Measured: 16-20 weeks post-baseline
Program Completion
This proportion will be presented as the number of patients who complete 70% of the intervention over the total number of patients recruited into the study arm.
Measured: 16-20 weeks post-baseline
Secondary outcomes (4)
Preliminary Effectiveness: Beck Depression Inventory-II
The BDI-II is a 21-item measure of depressive symptoms where individuals report the severity of their symptoms over the past two weeks.
Measured: Baseline, 16-20 weeks post-baseline
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 measures anxiety symptom severity over the previous two weeks. Participants rate the frequency of their symptoms from 0 to 3 (0 = not at all and 3 = nearly every day).
Measured: Baseline, 16-20 weeks post-baseline
Quality of Life Scale (QOLS)
The QOLS is a 16-item measure in which participants report their level of satisfaction (7 = delighted and 1 = terrible) with various aspects of life (e.g., close friends).
Measured: Baseline, 16-20 weeks post-baseline
Veterans Rand-12 (VR-12)
The VR-12, formerly known as the Veterans SF-12, is a measure derived from the RAND 12-Item Health Survey (SF-12). This instrument measures Health Related Quality of Life by asking participants about their health and the extent to which physical or emotional problems interfere with various activities
Measured: Baseline, 16-20 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Oct 2027 (estimated)
- Primary completion15 Jul 2029 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Maribel Plasencia, BA MS PhD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541482
- Sponsor's protocol ID
- HSR4-024-25M-T
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of Behavioral Activation-Guided Self-Help for Depression in VA Primary Care-Mental Health Integration (HSR4-024-25M)
- ClinicalTrials.gov ID
- NCT07541482
- Acronym / sponsor ID
- HSR4-024-25M-T
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Oct 2027 (estimated)
- Primary completion
- 15 Jul 2029 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 21 Apr 2026 (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.
Symptoms of depression are highly prevalent among Veterans. However, fewer than 30% of individuals with these symptoms receive any psychotherapy in the Veterans Health Administration (VHA). This is due to many factors, which may include provider availability and patient preferences. Guided self-help (GSH), which involves coaching sessions with patients who are following a fully developed self-help program, has the potential to increase access to care for these Veterans, particularly if implemented within a stepped care model of mental health treatment delivery and if delivered by a diverse set of providers. The VHA's primary care-mental health integration (PCMHI) service, which focuses on short courses of care for mild to moderate symptoms, may be an ideal place in which to deploy GSH. The current project seeks conduct a pilot randomized trial of a GSH program for depression adapted for PCMHI based on behavioral activation.
Detailed description
Elevated symptoms of depression in approximately 10% of Veterans and are associated with functional impairment and suicidality. Cognitive behavioral therapy (CBT) is a first line intervention for these conditions, yet few Veterans receive this treatment, in part due to the limited availability of mental health providers trained in CBT. The stepped care model offers one approach to addressing access by offering effective yet less resource-intensive treatments upon entry into mental health care for individuals with mild to moderate symptoms, stepping up the intensity and level of care as needed. Guided self-help (GSH) is one low intensity treatment format that could increase accessibility of CBT for depression and GAD. In GSH, patients follow a self-help version of an evidence-based behavioral intervention with coaching from a provider. A meta-analysis found that GSH is as effective as traditional psychotherapy treatments for depression and anxiety disorders. VHA's Primary Care Mental Health-Integration (PCMHI) Service may be the ideal setting in which to deploy GSH. However, GSH is not widely used within VHA, and existing CBT interventions for depression require adaptation to the GSH format and PCMHI setting.
The specific aim of this project is to conduct a pilot randomized trial of Behavioral Activation-GSH (BA-GSH) for depression (15 Veterans assigned to BA-GSH; 15 assigned to treatment as usual) in PCMHI by a variety of types of providers within this setting. This pilot will evaluate the acceptability and feasibility of BA-GSH and explore preliminary effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation-Guided Self-Help | Experimental | Behavioral: Behavioral Activation-Guided Self-HelpFor this arm, participants will work through a self-help program based on behavioral activation paired with guidance from a provider in VA Primary Care-Mental Health Integration. |
| Enhanced Usual Care | No intervention | –For this arm, a note will be entered into the participants medical record that indicates the participant's enrollment in the study and documents whether depression scores are elevated. This note includes a statement that encourages providers to deliver care in their usual and customary fashion and actively monitor aspects related to depression as part of the patient's overall care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participants will be included in the study if they are patients at the study site
- score a 10 to 20 on the PHQ-9 (moderate to moderately severe)
- can follow the self-help program, which requires reading materials in English and documenting/tracking work between meetings with a provider
Key exclusion criteria (6 listed)
- score greater than 10 on the GAD-7
- PCMHI ineligible (i.e., in specialty mental health)
- currently enrolled in a VA or non-VA psychotherapy that would interfere with the study intervention
- participants will also be excluded if demonstrating high risk of suicidal ideation/behavior based on the C-SSRS
- cognitive impairment conditions that may interfere with the ability to complete the program
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 |
|---|---|---|
| Behavioral Activation-Guided Self-HelpThis intervention is based on behavioral activation. It includes a self-help program that is paired with guidance from a provider. | Behavioural | Behavioral Activation-Guided Self-Help |
Primary outcome
Participant recruitment
Time frame: Baseline, 16-20 weeks post-baseline
This proportion will be presented as the number of patients recruited into the study program over the number of patients potentially eligible.
Preliminary Effectiveness: Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 16-20 weeks post-baseline
The PHQ-9 measures depressive symptom severity over the previous two weeks. Participants self-report how often they have experienced a particular symptom on a scale of 0 to 3 (0 = not at all and 3 = nearly every day).
Attrition
Time frame: Baseline, 16-20 weeks post-baseline
This proportion will be presented as the number of patients who discontinue the program over the total number of recruited participants over the trial period.
Client Satisfaction Questionnaire-8
Time frame: 16-20 weeks post-baseline
The CSQ-8 evaluates general satisfaction with a service and scores range from 8 to 32. Higher scores indicate higher satisfaction.
Program Completion
Time frame: 16-20 weeks post-baseline
This proportion will be presented as the number of patients who complete 70% of the intervention over the total number of patients recruited into the study arm.
4 secondary outcomes
Preliminary Effectiveness: Beck Depression Inventory-II
Time frame: Baseline, 16-20 weeks post-baseline
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, 16-20 weeks post-baseline
Quality of Life Scale (QOLS)
Time frame: Baseline, 16-20 weeks post-baseline
Veterans Rand-12 (VR-12)
Time frame: Baseline, 16-20 weeks post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Maribel Plasencia, BA MS PhD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation-Guided Self-Help in people with Depression, run by VA Office of Research and Development at 1 site in United States.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maribel Plasencia, PhD ((713) 440-4400, maribel.plasencia@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment (time frame: Baseline, 16-20 weeks post-baseline). The study lists 5 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 21 Apr 2026.