Self-Help Intervention for Post 9/11 Veterans With Depression or PTSD Symptoms

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

It is important to provide support and resources for the many post-9/11 Veterans with mental health symptoms and poor psychosocial functioning who do not engage in psychotherapy. One of the biggest reasons post-9/11 Veterans do not seek treatment is a preference to handle problems on their own. This study examines a self-help intervention that teaches Veterans healthy coping strategies they can use on their own and how to seek out recovery support services such as mental health treatment or whole-person care if they decide to do so in the future. This study will compare the impact of self-help and standard resources at improving mental health and resource utilization. Two hundred Veterans will complete 6 brief assessments across 40 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veteran age >= 18 years who served on or after September 11, 2001

Enrolled at Syracuse or Durham VA Healthcare System (had an encounter in primary care or Military 2VA clinic in past 24 months)

Screen positive for current symptoms of MDD (PHQ-2) or PTSD (PC-PTSD-5)

Report current functional impairment (PHQ-9 item 10)

Disqualifiers

Inability to communicate in English

Visual impairment that precludes reading self-help materials

Hearing impairment that precludes completing telephone assessments

Cognitive impairment that precludes providing informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resilience Training for Veterans (REST-V)

    Behavioral

    A 6-week self-help intervention tailored for post-9/11 Veterans offering guidance on cognitive-behavioral self-management coping strategies plus when and how to access recovery support services including mental health treatment. Materials are sent once a week for 6 weeks, and participants can opt to receive weekly reminder text messages or up to 3 brief telephone support calls.

  • Usual resources

    Other intervention

    Standard printed resource/treatment information provided in VHA usual care to post-9/11 Veterans. Covers similar domains as the intervention materials and provides information on a variety of VA and community resources for Veterans. Materials are sent once.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Intervention conditionExperimental treatment 1 intervention
Group B: Control conditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Inventory of Psychosocial Functioning (IPF)

An 80-item self-report measure of mental-health related psychosocial functional impairment over the past 30 days. The IPF yields domain scores for up to 7 domains (e.g., work, family, self care), with only those domains relevant for the individual being scored, and an overall score. The overall IPF score is an unweighted average of all calculated domain scores, scaled to a range of 0-100. Higher scores indicate greater psychosocial functional impairment (i.e., lower scores = better functioning).

Time frame
Weeks 0 to 8, 24, and 40

Secondary outcomes

1

Brief Symptom Inventory-18 (BSI-18) Global Severity Index

An 18-item self-report measure of general psychological distress over the past 7 days serves as a cross-cutting mental health outcome not specific to any one mental health diagnosis. The Global Severity Index (GSI) uses all three 6-item subscales (depression, anxiety, somatization), with a total raw score range of 0-72. Raw scores can be converted to T-scores using normative data. Higher scores indicate greater distress.

Time frame
Weeks 0 to 8, 24, and 40
2

Patient Health Questionnaire-9 (PHQ-9)

A 9-item self-report measure of depression symptom severity over the past 2 weeks. The total PHQ-9 score is the sum of all 9 items and can range from 0-27. Higher scores indicate greater depression symptom severity.

Time frame
Weeks 0 to 8, 24, and 40
3

Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

A 20-item self-report measure of PTSD symptom severity over the past month. The total PCL-5 score is the sum of all 20 items and can range from 0-80. Higher scores indicate greater PTSD symptom severity.

Time frame
Weeks 0 to 8, 24, and 40
4

Columbia Suicide Severity Rating Scale (C-SSRS) item 2

This self-report item assesses suicidal ideation over the past month with yes or no response options. The full C-SSRS used in VHA will be administered, but this outcome focuses specifically on active suicidal ideation.

Time frame
Weeks 0 to 8, 24, and 40

Other outcomes

1

RSSU part 1a: VHA Outpatient Mental Health Treatment

Outpatient mental health treatment within the Veterans Health Administration (VHA) will be assessed using electronic health record (EHR) data. The cumulative total count of three care components occurring across the 40-week study period will be used: (1) encounters of outpatient psychotherapy in primary care (Primary Care Mental Health Integration) or specialty mental health care (outpatient behavioral health, PTSD clinic, substance treatment clinic, or OEF/OIF/OND mental health clinic), (2) encounters of medication management visits with psychiatric prescribers, and (3) psychotropic medication fill or refill not tied to a specific medication management visit (e.g., through primary care). Medication fills/refills identified from the EHR will only be counted if the participant also self-reports taking the medication for at least 4 weeks (assessed every 8 weeks).

Time frame
Weeks 0 to 40
2

RSSU part 1b: Non-VHA Outpatient Mental Health Treatment

Mental health treatment outside VHA will be assessed using self-report occurring every 8 weeks. The cumulative total count of three care components occurring across the 40-week study period will be used: (1) encounters of outpatient psychotherapy (e.g., in community clinic or with therapist in the community), (2) encounters of medication management visits with non-VHA psychiatric prescribers, and (3) psychotropic medication fill or refill not tied to a specific medication management visit (e.g., through non-VHA primary care). Medication fills/refills will only be counted if the participant also self-reports taking the medication for at least 4 weeks (assessed every 8 weeks).

Time frame
Weeks 0 to 40
3

RSSU part 2: Other Relevant VHA Whole-Person Health Care

Other relevant VHA whole-person health care will be assessed using EHR data. The cumulative total count of encounters with the following outpatient services/programs will be used: Whole Health (e.g., Whole Health Coaching, Whole Health classes), Complementary and Integrative Health (acupuncture, biofeedback, clinical hypnosis, massage therapy, meditation, guided imagery, tai chi / qigong, yoga), Social work, Case management (e.g., Military 2 VA, Healthcare for Homeless Veterans), Peer support, Vocational rehabilitation, and Veterans Justice Outreach.

Time frame
Weeks 0 to 40
4

RSSU part 3: Informal Resources

Informal resource use or use of self-directed resources or approaches to support mental health and wellness will be measured via self-report every 8 weeks. To reduce recall bias and assessment reactivity while balancing participant burden, a two-pronged approach will be used. First, open-ended prompts will elicit behaviors over the past 8 weeks related to 5 categories (categorized per codebook): Socialization, VA Resources \& Benefits, Health \& Wellbeing, Self-Help for Mental Health, and Preparation for Mental Health Treatment. Then, participants will report how often they engaged in each behavior over the past week only using the FATS Likert-scale from 0 (not at all) to 4 (every day). Scores across the 5 categories will be summed for a total score for each time period. An average score will be created using the total scores from weeks 8, 16, 24, 32, and 40. For the exploratory mediation analysis, an average score using the total scores from weeks 8, 16, and 24 only will be created.

Time frame
Weeks 0 to 40

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