Integrated Health Care for PTSD

June 10, 2026 updated by: Veterans Medical Research Foundation

A Hybrid I Evaluation of Integrative Health Care for PTSD

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.

Participants will:

  1. Complete assessments at the beginning of the study and 12- and 24-weeks later.
  2. Engage in 12 weeks of integrated care, with the type being randomly assigned.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ariel J Lang, PhD, MPH
  • Phone Number: x5359 858-552-8585
  • Email: ariel.lang@va.gov

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205-5446
    • California
      • San Diego, California, United States, 92161
        • Recruiting
        • VA San Diego Healthcare System
        • Contact:
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Not yet recruiting
        • Durham VA Healthcare System
        • Contact:
        • Principal Investigator:
          • Stephanie Wells, PhD
    • Oregon
      • Portland, Oregon, United States, 97239-2964
        • Recruiting
        • VA Portland Healthcare System
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75216-7167
        • Recruiting
        • VA North Texas Healthcare System
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • clinical diagnosis
  • eligibility for Cognitive Processing Therapy (CPT) at a participating VA site
  • able to consent to study activities

Exclusion Criteria:

  • current, active engagement in one of the included approaches (per clinician judgment)
  • medical conditions that contraindicate engaging in the experimental interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care
Information about local and national complementary and integrative health programs
Other: Information
Provision of written information about local and national complementary and integrative care resources
Experimental: Yoga and meditation
Hatha yoga classes via videoconferencing and self-learning of Mantram Repetition Program
Other: Information
Provision of written information about local and national complementary and integrative care resources
Behavioral: Yoga and meditation
12 weekly 60-minute hatha yoga classes and access to video-based training in a portable mantra-based meditation practice
Experimental: Wellness
Weekly exercise/nutrition classes to support lifestyle changes
Other: Information
Provision of written information about local and national complementary and integrative care resources
Behavioral: Wellness
12 weekly 60-minute classes to provide education about exercise and nutrition and facilitate lifestyle changes
Experimental: Positive affect
Weekly classes focused on increasing positive affect and social support
Other: Information
Provision of written information about local and national complementary and integrative care resources
Behavioral: Positive affect
12 weekly 60-minute classes to teach strategies for increasing positive affect and to provide social connection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inventory of Psychosocial Functioning (IPF)
Time Frame: weeks 0, 12 and 24
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5R)
Time Frame: weeks 0, 12 and 24
The CAPS-5R is a clinician-administered measure of PTSD symptom severity summarized in a total score with higher scores indicating greater symptom severity.
weeks 0, 12 and 24
Quick Inventory of Depressive Symptomatology (QIDS)
Time Frame: weeks 0, 12 and 24
The QIDS is a self-report measure of depression severity summarized by a total score for which higher scores reflect greater symptom severity.
weeks 0, 12 and 24
Insomnia Severity Index (ISI)
Time Frame: weeks 0, 12 and 24
The ISI is a self-report measure that assesses the consequences of and distress related to insomnia summarized by a total score in which higher scores indicate greater sleep disruption.
weeks 0, 12 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veterans Medical Research Foundation

Collaborators

United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

October 22, 2025

First Submitted That Met QC Criteria

October 22, 2025

First Posted (Actual)

October 24, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT94252510881

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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