Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05187156
Status:
WITHDRAWN
Last Update Posted:
2023-02-15
First Post:
2021-12-23
Brief Title:
Assessing and Enhancing Social Support
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Assessing and Enhancing Social Support to Improve Treatment Outcomes Among Veterans With PTSD CDA 19-208
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI has transitioned to working outside of the VA - study will not continue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 SignificanceImpact The proposed research addresses several HSRD 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 HSRD-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 eg 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 2s 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 eg PTSD depression symptoms and social support as well as mechanisms of change eg disclosure and multiple stepped-care outcomes eg clinically-indicated evidence-based psychotherapy initiationretention Next StepsImplementation 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDA 19-208 | OTHER_GRANT | Department of Veterans Affairs | None |