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RecruitingNCT07220681Updated Sep 23, 2026

Integrated Health Care for PTSD

An interventional study of Yoga and meditation and Wellness in Posttraumatic Stress Disorder (PTSD), sponsored by Veterans Medical Research Foundation. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Veterans Medical Research Foundation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Posttraumatic Stress Disorder (PTSD)

Keywords

  • PTSD
  • complementary and integrative health
  • Veterans
  • implementation
03

In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's planned enrollment of 300 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

Veterans Medical Research Foundation is the lead sponsor of 43 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • current, active engagement in one of the included approaches (per clinician judgment)
  • medical conditions that contraindicate engaging in the experimental interventions
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    Usual care

    Information about local and national complementary and integrative health programs

    Other: Information

  • Experimental
    Yoga and meditation

    Hatha yoga classes via videoconferencing and self-learning of Mantram Repetition Program

    Behavioral: Yoga and meditation · Other: Information

  • Experimental
    Wellness

    Weekly exercise/nutrition classes to support lifestyle changes

    Behavioral: Wellness · Other: Information

  • Experimental
    Positive affect

    Weekly classes focused on increasing positive affect and social support

    Behavioral: Positive affect · Other: Information

Interventions

  • BehavioralYoga and meditation

    12 weekly 60-minute hatha yoga classes and access to video-based training in a portable mantra-based meditation practice

  • BehavioralWellness

    12 weekly 60-minute classes to provide education about exercise and nutrition and facilitate lifestyle changes

  • BehavioralPositive affect

    12 weekly 60-minute classes to teach strategies for increasing positive affect and to provide social connection

  • OtherInformation

    Provision of written information about local and national complementary and integrative care resources

06

What researchers measure

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.

    Time frame: weeks 0, 12 and 24

Secondary outcomes

  1. 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.

    Time frame: weeks 0, 12 and 24

  2. 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.

    Time frame: weeks 0, 12 and 24

  3. 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.

    Time frame: weeks 0, 12 and 24

07

Study locations

5 of 5 sites recruiting
  • VA Central Arkansas Healthcare System
    Little Rock, Arkansas 72205-5446, United States
    Recruiting
  • VA San Diego Healthcare System
    San Diego, California 92161, United States
    Recruiting
  • Durham VA Healthcare System
    Durham, North Carolina 27705, United States
    Recruiting
    • Stephanie Wells, PhD · Contactstephanie.wells2@va.gov · (919) 286-0411
    • Stephanie Wells, PhD · Principal investigator
  • VA Portland Healthcare System
    Portland, Oregon 97239-2964, United States
    Recruiting
  • VA North Texas Healthcare System
    Dallas, Texas 75216-7167, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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

Data sharing details ↗ · nda.nih.gov

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Jun 2029, 38 months after the start.

Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 38 months is close to that.

Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2025
First posted
Oct 24, 2025
StartActual
Apr 23, 2026
Primary completionEst.
Jun 30, 2029
CompletionEst.
Sep 30, 2029
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07220681
Lead sponsor
Veterans Medical Research Foundation
Collaborators
United States Department of Defense
Responsible party
Sponsor
First posted
Oct 24, 2025
Start date
Apr 23, 2026
Primary completion
Jun 30, 2029 (estimated)
Completion
Sep 30, 2029 (estimated)
Last update
Sep 23, 2026

Study contacts

Ariel J Lang, PhD, MPH
Contact
ariel.lang@va.gov
858-552-8585 ext. x5359
Haley Suit, MA
Contact
haley.suit@va.gov

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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