Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
300 participants
INTERVENTIONAL
2026-01-05
2029-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* "Drop the loser" adaptive design, whereby any experimental condition lagging behind the other conditions will be discontinued after interim analysis
TREATMENT
DOUBLE
Study Groups
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Usual care
Information about local and national complementary and integrative health programs
Information
Provision of written information about local and national complementary and integrative care resources
Yoga and meditation
Hatha yoga classes via videoconferencing and self-learning of Mantram Repetition Program
Yoga and meditation
12 weekly 60-minute hatha yoga classes and access to video-based training in a portable mantra-based meditation practice
Information
Provision of written information about local and national complementary and integrative care resources
Wellness
Weekly exercise/nutrition classes to support lifestyle changes
Wellness
12 weekly 60-minute classes to provide education about exercise and nutrition and facilitate lifestyle changes
Information
Provision of written information about local and national complementary and integrative care resources
Positive affect
Weekly classes focused on increasing positive affect and social support
Positive affect
12 weekly 60-minute classes to teach strategies for increasing positive affect and to provide social connection
Information
Provision of written information about local and national complementary and integrative care resources
Interventions
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Yoga and meditation
12 weekly 60-minute hatha yoga classes and access to video-based training in a portable mantra-based meditation practice
Wellness
12 weekly 60-minute classes to provide education about exercise and nutrition and facilitate lifestyle changes
Positive affect
12 weekly 60-minute classes to teach strategies for increasing positive affect and to provide social connection
Information
Provision of written information about local and national complementary and integrative care resources
Eligibility Criteria
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Inclusion Criteria
* eligibility for Cognitive Processing Therapy (CPT) at a participating VA site
* able to consent to study activities
Exclusion Criteria
* medical conditions that contraindicate engaging in the experimental interventions
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Veterans Medical Research Foundation
OTHER
Responsible Party
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Locations
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VA Phoenix Healthcare System
Phoenix, Arizona, United States
VA Central Arkansas Healthcare System
Little Rock, Arkansas, United States
VA San Diego Healthcare System
San Diego, California, United States
VA Portland Healthcare System
Portland, Oregon, United States
VA North Texas Healthcare System
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Brandi Luedtke, PhD
Role: primary
Kathleen Grubbs, PhD
Role: primary
Brandon Griffin, PhD
Role: backup
Ariel J Lang, PhD, MPH
Role: primary
Maya O'Neil, PhD
Role: primary
Bella Etingen, PhD
Role: primary
Other Identifiers
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HT94252510881
Identifier Type: -
Identifier Source: org_study_id