Clinical trial NCT05187156: Assessing and Enhancing Social Support
Official title: Assessing and Enhancing Social Support to Improve Treatment Outcomes Among Veterans With PTSD (CDA 19-208)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Stress Disorders, Post-Traumatic
Social Support
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Posttraumatic stress disorder (PTSD) is a common and impairing problem among Veterans, many of whom first seek treatment in primary care settings. PTSD is linked to reduced quality of life and increased rates of suicide. Additionally, social support, defined as the availability of others to provide emotional or practical support when needed, is frequently poor for Veterans with PTSD. For Veterans with PTSD, poor social support negatively impacts PTSD treatment engagement and outcomes, interfering with PTSD recovery. There is a need for additional brief, primary care-based treatments for PTSD that also work to improve social support in traumatized Veterans. The proposed research seeks to evaluate and refine such an intervention and establish a protocol for routinely measuring social support to inform treatment. This intervention and measurement protocol will likely improve Veterans' mental health and social relationships.

Detailed description: Background: PTSD is a significant problem for Veterans, most of whom are initially treated for posttraumatic stress disorder (PTSD) in Primary Care Mental Health Integration (PCMHI). Poor social support in this population is a risk factor for suicidal ideation, all-cause mortality, and worse treatment engagement and response. Preliminary research shows that approximately 60% of Veterans with PTSD present to specialty care intake appointments with poor social support. However, none of the existing PCMHI-based treatments for PTSD explicitly focus on social support generation or reengagement. Moreover, although the limited existing research suggests that the routine assessment of social support to guide treatment planning (also known as measurement-based care, or MBC) improves treatment outcomes in civilian populations, social support is not routinely monitored as part of evidence-based treatments for PTSD. Thus, this CDA-2 will first identify an appropriate instrument for routinely measuring social support in the context of clinical care to improve PTSD treatment, and, subsequently, evaluate a novel PCMHI-based PTSD treatment as part of a stepped care model for Veterans who report poor social support and are at great risk of PTSD treatment non-response. Significance/Impact: The proposed research addresses several HSR\&D research priorities, including evaluating the impact of social determinants of health, namely, social support, on the quality and outcomes of care; testing new models of mental health care to improve outcomes; and intervening with vulnerable Veterans with PTSD and suicide risk. By measuring and improving social support to enhance PTSD treatment, the proposed research plan explicitly addresses a key factor that impedes treatment outcomes for a sensitive population of Veterans. Innovation: Although poor social support is widely recognized as among the strongest predictors of PTSD development and maintenance, none of the existing PCMHI-based treatments for PTSD target or measure social support as a primary treatment focus. The proposed CDA-2 research is thus highly novel. No past or present HSR\&D-funded studies have tested methods for monitoring or improving social support in PCMHI-based treatment among Veterans with PTSD, despite its association with poor clinical outcomes. Specific Aims: 1) Select an instrument for MBC of social support in clinical settings for Veterans with PTSD. 2) Iteratively refine and conduct a one-arm pilot test a brief, PCMHI-based behavioral activation and social engagement intervention for PTSD based on key stakeholder (e.g., Veteran and PCMHI provider) feedback. 3) Conduct a two-arm pilot randomized clinical trial (RCT) comparing the intervention to usual care in PCMHI. Methodology: Aim 1 will use quantitative data gathered in an online survey from 210 Veterans to assess the degree to which four measures of social support (identified via systematic review and clinical utility ranking) are acceptable, reliable, and sensitive, and select the best measure for use in Aim 2's pilot. Aim 2 will involve the iterative refinement of the PTSD and social support intervention following, and followed by, qualitative interviews with key stakeholders. Aim 2 will obtain data on participant acceptability, provider fidelity, and social-support-related MBC. The pilot RCT comparing the social support and PTSD intervention to usual care in Aim 3 will evaluate the feasibility and acceptability of recruitment, randomization, intervention engagement, evaluation strategy, and outcome measurement of clinical outcomes (e.g., PTSD, depression symptoms, and social support), as well as mechanisms of change (e.g., disclosure) and multiple stepped-care outcomes (e.g., clinically-indicated evidence-based psychotherapy initiation/retention). Next Steps/Implementation: This work will support future trials establishing effectiveness and implementation potential of the intervention, as well as a model of MBC of social support. Future research will explore MBC and PCMHI-based interventions for poor social support in related conditions.

Eligibility criteria: Inclusion Criteria:

Veterans will be eligible for participation if they:

* are currently enrolled in a Primary Care Clinic at VA Puget Sound Health Care System (VAPSHCS) (including Women's Clinic) or VAPSHCS Primary Care Mental Health Integration (PCMHI)
* meet criteria for clinical or subclinical PTSD consistent with PTSD treatment in PCMHI defined as \> 33 on the PTSD Checklist for DSM 5 (PCL-5)
* are willing to have therapy sessions audiotaped for the purposes of fidelity assessment
* plan to live in Washington state for 6 months following entry into the study to prevent delivery of care across state lines

Exclusion Criteria:

* presence of severe mental illness (e.g., active psychosis and/or bipolar disorder)
* a psychiatric in-patient admission in the past 30 days
* medical record suicide flag
* a behavioral flag in the medical record
* individuals with impaired decision making capacity (as measured by evidence in the medical record of moderate-severe TBI, uncontrolled psychosis, dementia, communication flag, or inability to provide informed consent)
* individuals who are illiterate or have limited or no English proficiency
* medication change in the last month
* current or recent (last 6 months) participation in specialty mental health
* current participation in CPT or PE, to ensure that Veterans are representative of PCMHI

Inclusion/exclusion criteria will be assessed via chart review.

Primary outcomes:
measure: Percent completing treatment
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Percentage declined participation
timeFrame: up to 16 weeks
measure: PTSD Checklist for DSM-5
timeFrame: change from baseline to up to 20 weeks
measure: PROMIS Depression Short Form 8
timeFrame: change from baseline to up to 20 weeks
measure: Change in social support
timeFrame: change from baseline to up to 20 weeks
measure: Interpersonal Needs Questionnaire - Thwarted Belongingness Subscale
timeFrame: change from baseline to up to 20 weeks
Other outcomes:
measure: Counts of outpatient mental health visits by type
timeFrame: number occurring between up to 16 weeks and up to 40 weeks
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Sarah B Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: