Anxiety & Depression Association of America

Integrated Health Care for PTSD

Purpose

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.

Condition

Posttraumatic Stress Disorder (PTSD)

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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 Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Primary Purpose: Treatment
Masking: Double (Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
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	Behavioral: Yoga and meditation 12 weekly 60-minute hatha yoga classes and access to video-based training in a portable mantra-based meditation practice Other: Information Provision of written information about local and national complementary and integrative care resources
Experimental Wellness	Weekly exercise/nutrition classes to support lifestyle changes	Behavioral: Wellness 12 weekly 60-minute classes to provide education about exercise and nutrition and facilitate lifestyle changes Other: Information Provision of written information about local and national complementary and integrative care resources
Experimental Positive affect	Weekly classes focused on increasing positive affect and social support	Behavioral: Positive affect 12 weekly 60-minute classes to teach strategies for increasing positive affect and to provide social connection Other: Information Provision of written information about local and national complementary and integrative care resources

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Veterans Medical Research Foundation

Study Contact

Ariel J Lang, PhD, MPH
858-552-8585
ariel.lang@va.gov

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.