An interventional study of Mental Health Link in Depression, sponsored by VA Office of Research and Development. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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Among 101 studies in Depression by VA Office of Research and Development — 20 open to participants now, 23 under way, 1 of them phase 3. Depression · VA Office of Research and Development.
Among the 101 studies in Depression by VA Office of Research and Development, this one is the 29th largest by planned enrollment of the 95 interventional ones that give a count, is one of 7 that started in 2027, is one of 79 with no phase, reaches primary completion later than 21 of the 22 other live ones, and was the 101st registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →20 of the 101 studies in Depression by VA Office of Research and Development are open now, in 1 country. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
Ages 18–75
VA Office of Research and Development · Sites in United States
Ages 40–80
VA Office of Research and Development · Sites in United States
Ages 18+
VA Office of Research and Development · Sites in United States
Ages 18–65
VA Office of Research and Development · Sites in United States
Women only
By country, each count listing its studies:
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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101 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 9 · Phase 3 4 · Phase 4 1
First in 2004; this study’s year is marked. 7 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 192 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 120 across the 95 interventional studies, 322 across the 6 observational. Of the 78 that completed or were terminated, 68 (87%) have results posted.
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VA Office of Research and Development is the lead sponsor of 1,773 studies on the registry; 393 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
6 of the studies in Depression by VA Office of Research and Development that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05553353VA Office of Research and DevelopmentDosing rTMS for Depression Post-SCI | 2027-04-15 |
| NCT05917119VA Office of Research and DevelopmentBright Light Therapy for OSA | 2027-05-31 |
| NCT04003285VA Office of Research and DevelopmentAllopregnanolone in Chronic Complex Traumatic Brain Injury | 2027-06-01 |
| NCT04877197VA Office of Research and DevelopmentBehavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care | 2027-06-30 |
| NCT06162741VA Office of Research and DevelopmentType I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans | 2027-07-01 |
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Among the 101 studies in Depression by VA Office of Research and Development, from their registry updates:
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Overview:
Depression is common among Veterans. About 1 in 6 Veterans experiences depression at any given time, and about half may experience it during their lifetime. Without treatment, depression can contribute to substance use, poor health, suicide, and early death. However, many people delay or do not receive treatment. Fewer than one-third of Veterans with depression use psychotherapy. Although the VA is working to improve access to mental health care, staffing shortages can lead to long wait times. These waiting periods may provide an opportunity to support Veterans and help them prepare for treatment.
Mental Health Link:
The research team developed Mental Health Link (MHL), a text-based process that supports Veterans while they wait for mental health services. MHL helps patients better understand their emotions and symptoms and offers simple coping strategies they can use right away while waiting.
Study Goals:
The study will examine whether MHL helps Veterans during the wait period and with treatment engagement. The study will also ask Veterans and providers about what helps or prevents MHL from being used in routine care.
Study Design:
Over five years, the study will compare MHL with usual care at three VA sites. It will include 192 Veterans referred to psychotherapy for depression. The results will show whether MHL improves participation in treatment and helps Veterans while they wait for services.
In the future, these findings may help the VA expand MHL and other effective mental health and suicide-prevention services.
Background: Depression is one of the most prevalent mental health concerns among Veterans. Nearly 1 in 6 Veterans has the disorder at any given time and 50% of Veterans meet criteria for depression at some point in their lives. Depression is associated with significant adverse outcomes, and untreated can result in drug abuse, poor health outcomes, suicide and other-cause mortality. Adults with depression often delay and underutilize treatment, and such delays in care are associated with low treatment utilization.
Significance: Psychotherapy utilization rates for depression among Veterans over the past two decades have stayed below 34%. VHA has organizational priorities to decrease system barriers through various strategies. Despite these efforts, the VHA has a critical national staffing shortage. Fortunately, mental health visit wait times can be leveraged as an opportune moment to support and prepare Veteran patients for upcoming visits. Currently, there are no tools to provide support to Veterans while they wait for mental health services.
Innovation and Impact: To address this gap in care, our team developed and pilot-tested Mental Health Link (MHL),an innovative solution that does not rely on reducing wait times, but rather leverages wait times to provide support and prepare Veterans for care. MHL is a semi-autonomous text-based tool designed to improve emotional and symptom awareness, and provide support during wait periods through sharing easy to implement coping strategies.
Specific Aims. Aim 1: Determine the effect of MHL on psychotherapy initiation and adherence (number of sessions completed). Aim 2: Determine the effect of MHL on emotional awareness, a sense of connectedness, and satisfaction with the VA and mental health service. Aim 3: Identify determinants, strategies, and perceived outcomes in a subsample of MHL users (n = 24) and their providers (n = 24) to inform an implementation research logic model and intervention mapping.
Methodology: The investigators propose a 3-site, 5-year mixed-method hybrid I randomized control trial (RCT) using an altered Zelen design to compare MHL to usual care in a sample of Veterans (N = 192) referred to psychotherapy for depression. In Aim 1, the investigators will employ logistic regression and poison regression to estimate the difference between the intervention and control groups in treatment initiation rates and number of sessions (i.e., treatment adherence), respectively. In Aim 2, the investigators will employ repeated measures MANCOVAs to test for the interaction between time and group on proposed outcomes: positive and negative emotional awareness, sense of connectedness and satisfaction. For Aim 3 the investigators will use a qualitative matrix-analysis framework to analyze focus group data to identify other factors related to Aims 1 and 2 outcomes for triangulation and key determinants of implementation of MHL into clinical flow. Next Steps/Implementation. By identifying determinants of implementation the investigators will target facilitators and barriers to integrate MHL into the mental health service workflow. This work will also provide evidence of effectiveness outcomes. Overall, findings will facilitate the development of a follow-up Merit, Type II Hybrid RCT, focused on implementation and effectiveness outcomes. In the long-term, this work will support the implementation and sustainment of evidence-based mental health and suicide prevention practices by optimizing access to care, using value-based care systems.
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-Veterans who receive a referral to psychotherapy for depression in a specialty care clinic (i.e., Mental Health Clinic at the VA or through VA Community Care)
Exclusion Criteria:
Participants receive the fully automated MHL intervention through VA Qualtrics while awaiting their first specialty mental health appointment. Following the baseline survey, a welcome text activates twice-weekly check-ins and twice-weekly support messages until two days before the appointment. Check-ins collect patient-generated feedback on mood, PHQ-8 symptoms, daily event appraisals, emotions, and emotion intensity. Participants may skip any task. Support messages provide practical coping strategies. PHQ-8 scores ≥15 or heightened negative emotions trigger automated messages with contact information for the participant's existing care providers, the Veterans Crisis Line (call, chat, or text), and 911. At completion, a data manager prepares a summary of check-in data, uploads it to the medical chart, and alerts the participant's providers.
Behavioral: Mental Health Link
Veterans assigned to this control arm receive usual care while awaiting their initial specialty mental health appointment. They may passively wait or receive psychiatric care or brief supportive psychotherapy through primary care. Half of the Veterans randomized to usual care will be invited to join an observational study examining their experiences with and use of mental health services. These participants will complete baseline and exit surveys to improve prediction and understanding of treatment initiation and utilization, because medical chart data alone have not produced robust predictive models. All study procedures are conducted for research purposes only, although the procedures and measures are similar to those used in standard mental health care.
Mental Health Link (MHL) is a text-based process that supports Veterans with depression while they wait to begin mental health care. Twice a week, it helps Veterans check in on daily events, emotions, and depression symptoms while offering brief, practical coping strategies based on evidence-based therapies, including cognitive behavioral therapy, behavioral activation, and acceptance and commitment therapy. MHL was tailored with input from Veterans to improve emotional awareness and monitor changes in symptoms.
Effectiveness of Intervention as Assessed by Rate of Depression Treatment Initiation
The investigators will evaluate % mental health treatment initiation relative to the control arm. Treatment initiation is defined as initial mental health appointment being completed.
Time frame: An average of 30 weeks
Effectiveness of Intervention as Assessed by Rate of Depression Treatment Adherence
The investigators will evaluate number of mental health treatment sessions completed relative to the control arm. Treatment adherence is defined as continuing treatment past initiation.
Time frame: An average of 30 weeks
Emotional Awareness
Emotional awareness will be derived based on statistical modeling.
Time frame: An average of 30 weeks
Social Connectedness Scale
Sense of Connectedness. On a scale from 0-10, how connected do you feel to the mental health service at your VA? Please write about your experience with Mental Health Link (MHL) that may have affected your sense of connectedness to the VA mental health service.
Time frame: Week 1 and an average of 30 weeks
Client Satisfaction Questionnaire
Satisfaction with services. The Client Satisfaction Questionnaire consists of eight items, each rated on a 4-point Likert scale ranging from negative to positive responses (e.g., 1 = none of my needs met, 4 = almost all of my needs met).
Time frame: Week 1 and an average of 30 weeks
Barriers and Facilitators of Mental Health Link (MHL) Future Implementation
Barriers and facilitators of Mental Health Link (MHL) future implementation will be assessed through qualitative interviews with Veterans and mental health providers.
Time frame: An average of 30 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2027; primary completion for Dec 2031, 55 months later.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 55 months is above that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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