Posttraumatic Stress Disorder (PTSD)
Conditions
Keywords
PTSD, complementary and integrative health, Veterans, implementation
Brief 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.
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
Sponsors
Veterans Medical Research Foundation
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inventory of Psychosocial Functioning (IPF) | weeks 0, 12 and 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5R) | weeks 0, 12 and 24 | The CAPS-5R is a clinician-administered measure of PTSD symptom severity summarized in a total score with higher scores indicating greater symptom severity. |
| Quick Inventory of Depressive Symptomatology (QIDS) | weeks 0, 12 and 24 | The QIDS is a self-report measure of depression severity summarized by a total score for which higher scores reflect greater symptom severity. |
| Insomnia Severity Index (ISI) | weeks 0, 12 and 24 | 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. |
Countries
United States
Contacts
CONTACTAriel J Lang, PhD, MPH
CONTACTHaley Suit, MA
Outcome results
None listed