Integrated Health Care for PTSD
A Hybrid I Evaluation of Integrative Health Care for PTSD
1 other identifier
interventional
300
1 country
4
Brief Summary
The goal of this clinical trial is to determine whether which types of integrative care, meaning a combination of psychotherapy and mind-body interventions, lead to the most changes in functioning among Veterans with posttraumatic stress disorder (PTSD). The main aims are:
- 1.To evaluate the impact of integrative care approaches on functional outcomes among Veterans with PTSD.
- 2.To examine factors relevant to the implementation of integrated treatments for PTSD from the perspective of patients, providers and administrators in the VA Healthcare System.
- 3.Complete assessments at the beginning of the study and 12- and 24-weeks later.
- 4.Engage in 12 weeks of integrated care, with the type being randomly assigned.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2025
CompletedFirst Posted
Study publicly available on registry
October 24, 2025
CompletedStudy Start
First participant enrolled
January 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2029
January 7, 2026
October 1, 2025
3.5 years
October 22, 2025
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inventory of Psychosocial Functioning (IPF)
The IPF is a self-report measure of functioning across several domains. It is summarized in a mean score with higher scores indicating greater functional impairment.
weeks 0, 12 and 24
Secondary Outcomes (3)
Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5R)
weeks 0, 12 and 24
Quick Inventory of Depressive Symptomatology (QIDS)
weeks 0, 12 and 24
Insomnia Severity Index (ISI)
weeks 0, 12 and 24
Study Arms (4)
Usual care
ACTIVE COMPARATORInformation about local and national complementary and integrative health programs
Yoga and meditation
EXPERIMENTALHatha yoga classes via videoconferencing and self-learning of Mantram Repetition Program
Wellness
EXPERIMENTALWeekly exercise/nutrition classes to support lifestyle changes
Positive affect
EXPERIMENTALWeekly classes focused on increasing positive affect and social support
Interventions
12 weekly 60-minute hatha yoga classes and access to video-based training in a portable mantra-based meditation practice
12 weekly 60-minute classes to provide education about exercise and nutrition and facilitate lifestyle changes
12 weekly 60-minute classes to teach strategies for increasing positive affect and to provide social connection
Provision of written information about local and national complementary and integrative care resources
Eligibility Criteria
You may qualify if:
- clinical diagnosis
- eligibility for Cognitive Processing Therapy (CPT) at a participating VA site
- able to consent to study activities
You may not qualify if:
- current, active engagement in one of the included approaches (per clinician judgment)
- medical conditions that contraindicate engaging in the experimental interventions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
VA Central Arkansas Healthcare System
Little Rock, Arkansas, 72205-5446, United States
VA San Diego Healthcare System
San Diego, California, 92161, United States
VA Portland Healthcare System
Portland, Oregon, 97239-2964, United States
VA North Texas Healthcare System
Dallas, Texas, 75216-7167, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2025
First Posted
October 24, 2025
Study Start
January 5, 2026
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
September 30, 2029
Last Updated
January 7, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data and supporting information will be available within 1 year of the conclusion of the trial and archived according to the standards of the hosting archives.
- Access Criteria
- Unique research resources will be readily available for research purposes to members of academic institutions, non-profit organizations, and commercial partners after the completion of data analysis, presentations, and publications
Deidentified datasets will be made available via National Institutes of Mental Health Data Archive (NDA). The study protocol, statistical analysis plan and ICF/HIPAA form will be available on clinical.trials.gov.