Assessing and Enhancing Social Support

NCT05187156 | Withdrawn

• 2 other identifiers: CDX 22-004CDA 19-208
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Stress Disorders, Post-Traumatic; Social Support

Outcome Measures

Primary Outcomes (1)

• Percent completing treatment

  number completing treatment/number enrolled (ratio of the two variables)

  Up to 16 weeks

Secondary Outcomes (5)

• Percentage declined participation

  up to 16 weeks

• PTSD Checklist for DSM-5

  change from baseline to up to 20 weeks

• PROMIS Depression Short Form 8

  change from baseline to up to 20 weeks

• Change in social support

  change from baseline to up to 20 weeks

• Interpersonal Needs Questionnaire - Thwarted Belongingness Subscale

  change from baseline to up to 20 weeks

Other Outcomes (1)

• Counts of outpatient mental health visits by type

  number occurring between up to 16 weeks and up to 40 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Veterans will participate in a novel intervention to improve PTSD and social support

Behavioral: Behavioral Activation and Social Engagement

Treatment as usual

ACTIVE COMPARATOR

Veterans will participate in usual care in PCMHI

Behavioral: Treatment as usual

Interventions

Behavioral Activation and Social Engagement BEHAVIORAL

brief, PCMHI-based psychotherapy using behavioral activation principles and focused attention on enhancement of social support

Intervention

Treatment as usual BEHAVIORAL

treatment as usual in PCMHI includes participation in any other skills-based groups or brief individual psychotherapy and medication management offered in PCMHI

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Sarah B Campbell, PhD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: February 1, 2023
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)