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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Veterans Medical Research Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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