Integrated Health Care for PTSD

Veterans Medical Research Foundation

Status: Not yet enrolling

Conditions: Posttraumatic Stress Disorder (PTSD)

Treatments: Other: Information; Behavioral: Wellness; Behavioral: Positive affect; Behavioral: Yoga and meditation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07220681

HT94252510881

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 4 patient groups

Usual care

Active Comparator group

Description:

Information about local and national complementary and integrative health programs

Treatment:

Other: Information

Yoga and meditation

Experimental group

Description:

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

Treatment:

Behavioral: Yoga and meditation

Other: Information

Wellness

Experimental group

Description:

Weekly exercise/nutrition classes to support lifestyle changes

Treatment:

Other: Information

Behavioral: Wellness

Positive affect

Experimental group

Description:

Weekly classes focused on increasing positive affect and social support

Treatment:

Behavioral: Positive affect

Other: Information