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Integrated Health Care for PTSD

ConditionPosttraumatic Stress Disorder (PTSD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVeterans Medical Research Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

clinical diagnosis

eligibility for Cognitive Processing Therapy (CPT) at a participating VA site

able to consent to study activities

Disqualifiers

current, active engagement in one of the included approaches (per clinician judgment)

medical conditions that contraindicate engaging in the experimental interventions

Trial design

Design model

Parallel

Treatments tested in this trial

  • Yoga and meditation

    Behavioral

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

  • Wellness

    Behavioral

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

  • Positive affect

    Behavioral

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

  • Information

    Other intervention

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

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: Usual careActive comparator 1 intervention
Group B: Yoga and meditationExperimental treatment 2 interventions
Group C: WellnessExperimental treatment 2 interventions
Group D: Positive affectExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Veterans Medical Research Foundation

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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