Posttraumatic Stress Disorder (PTSD)NCT07220681
Integrated Health Care for PTSD
A study testing Yoga and meditation, Wellness and Positive affect in people with Posttraumatic Stress Disorder (PTSD), run by Veterans Medical Research Foundation at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Yoga and meditation, Wellness and Positive affect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Apr 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis
- eligibility for Cognitive Processing Therapy (CPT) at a participating VA site
- able to consent to study activities
Who cannot join
- current, active engagement in one of the included approaches (per clinician judgment)
- medical conditions that contraindicate engaging in the experimental interventions
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Haley Suit, MA contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
VA North Texas Healthcare System
Dallas, Texas, 75216-7167
Bella Etingen, PhD, bella.etingen@va.gov
- Recruiting
Durham VA Healthcare System
Durham, North Carolina, 27705
Stephanie Wells, PhD, (919) 286-0411, stephanie.wells2@va.gov
Stephanie Wells, PhD
- Recruiting
VA Central Arkansas Healthcare System
Little Rock, Arkansas, 72205-5446
Kathleen Grubbs, PhD, 501-257-1000, kathleen.grubbs@va.gov
Brandon Griffin, PhD, brandon.griffin2@va.gov
- Recruiting
VA Portland Healthcare System
Portland, Oregon, 97239-2964
Maya O'Neil, PhD, 503-220-8262, maya.oneil@va.gov
- Recruiting
VA San Diego Healthcare System
San Diego, California, 92161
Ariel J Lang, PhD, MPH, 8585528585 ext. x5359, ariel.lang@va.gov
Edith Bonilla, MSW, edith.bonilla@va.gov
About this study
Official title: 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:
- To evaluate the impact of integrative care approaches on functional outcomes among Veterans with PTSD.
- 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.
Read more
Participants will:
- Complete assessments at the beginning of the study and 12- and 24-weeks later.
- Engage in 12 weeks of integrated care, with the type being randomly assigned.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Yoga and meditation, Wellness, Positive affect, Information
- Keywords
- PTSD, complementary and integrative health, Veterans, implementation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga and meditationBehavioural
12 weekly 60-minute hatha yoga classes and access to video-based training in a portable mantra-based meditation practice
WellnessBehavioural
12 weekly 60-minute classes to provide education about exercise and nutrition and facilitate lifestyle changes
Positive affectBehavioural
12 weekly 60-minute classes to teach strategies for increasing positive affect and to provide social connection
InformationOther
Provision of written information about local and national complementary and integrative care resources
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Information about local and national complementary and integrative health programs Receives: Other: Information |
| Yoga and meditation | Experimental | Hatha yoga classes via videoconferencing and self-learning of Mantram Repetition Program Receives: Behavioral: Yoga and meditation; Other: Information |
| Wellness | Experimental | Weekly exercise/nutrition classes to support lifestyle changes Receives: Behavioral: Wellness; Other: Information |
| Positive affect | Experimental | Weekly classes focused on increasing positive affect and social support Receives: Behavioral: Positive affect; Other: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: weeks 0, 12 and 24
Secondary outcomes (3)
Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5R)
The CAPS-5R is a clinician-administered measure of PTSD symptom severity summarized in a total score with higher scores indicating greater symptom severity.
Measured: weeks 0, 12 and 24
Quick Inventory of Depressive Symptomatology (QIDS)
The QIDS is a self-report measure of depression severity summarized by a total score for which higher scores reflect greater symptom severity.
Measured: weeks 0, 12 and 24
Insomnia Severity Index (ISI)
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.
Measured: weeks 0, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start23 Apr 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Hybrid Type 1 study, simultaneously assessing efficacy and gathering information relevant to implementation * "Drop the loser" adaptive design, whereby any experimental condition lagging behind the other conditions will be discontinued after interim analysis
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220681
- Sponsor's protocol ID
- HT94252510881
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid I Evaluation of Integrative Health Care for PTSD
- ClinicalTrials.gov ID
- NCT07220681
- Acronym / sponsor ID
- HT94252510881
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- PTSD, complementary and integrative health, Veterans, implementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the impact of integrative care approaches on functional outcomes among Veterans with PTSD.
- 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:
- Complete assessments at the beginning of the study and 12- and 24-weeks later.
- Engage in 12 weeks of integrated care, with the type being randomly assigned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- * Hybrid Type 1 study, simultaneously assessing efficacy and gathering information relevant to implementation * "Drop the loser" adaptive design, whereby any experimental condition lagging behind the other conditions will be discontinued after interim analysis
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: InformationInformation about local and national complementary and integrative health programs |
| Yoga and meditation | Experimental | Behavioral: Yoga and meditation, Other: InformationHatha yoga classes via videoconferencing and self-learning of Mantram Repetition Program |
| Wellness | Experimental | Behavioral: Wellness, Other: InformationWeekly exercise/nutrition classes to support lifestyle changes |
| Positive affect | Experimental | Behavioral: Positive affect, Other: InformationWeekly classes focused on increasing positive affect and social support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis
- eligibility for Cognitive Processing Therapy (CPT) at a participating VA site
- able to consent to study activities
Key exclusion criteria (2 listed)
- current, active engagement in one of the included approaches (per clinician judgment)
- medical conditions that contraindicate engaging in the experimental interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga and meditation12 weekly 60-minute hatha yoga classes and access to video-based training in a portable mantra-based meditation practice | Behavioural | Yoga and meditation |
| Wellness12 weekly 60-minute classes to provide education about exercise and nutrition and facilitate lifestyle changes | Behavioural | Wellness |
| Positive affect12 weekly 60-minute classes to teach strategies for increasing positive affect and to provide social connection | Behavioural | Positive affect |
| InformationProvision of written information about local and national complementary and integrative care resources | Other | Positive affect, Usual care, Wellness, Yoga and meditation |
Primary outcome
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.
3 secondary outcomes
Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5R)
Time frame: weeks 0, 12 and 24
Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: weeks 0, 12 and 24
Insomnia Severity Index (ISI)
Time frame: weeks 0, 12 and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haley Suit, MA contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and meditation, Wellness and Positive affect in people with Posttraumatic Stress Disorder (PTSD), run by Veterans Medical Research Foundation at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariel J Lang, PhD, MPH (858-552-8585 ext. x5359, ariel.lang@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of Psychosocial Functioning (IPF) (time frame: weeks 0, 12 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.