Music-instruction Intervention for Treatment of Post-traumatic Stress Disorder: A Randomized Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 40
- Primary Endpoint
- Post-Traumatic Stress Disorder (PTSD) Symptoms
Study Overview
Brief Summary
The purpose of this study was to examine the feasibility and potential effectiveness of an active, music-instruction intervention in improving psychological health and social functioning among Veterans suffering from moderate to severe Post-traumatic Stress Disorder (PTSD).
Detailed Description
The study was designed as a prospective, delayed-entry randomized pilot trial. Regression-adjusted difference in means were used to examine the intervention's effectiveness with respect to PTSD symptomatology (primary outcome) as well as depression, perceptions of cognitive failures, social functioning and isolation, and health-related quality of life (secondary outcomes).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Veterans who (i) had at least one visit for mental health treatment in the prior six months with a primary diagnosis of PTSD (ICD9CM 309.81-83) and (ii) exhibited moderate to severe PTSD symptoms at the time of enrollment (Posttraumatic Stress Disorder Checklist >=50)
Exclusion Criteria
- •Veterans who were currently participating in an intense psychotherapy program (residential or outpatient)
- •Veterans who were already receiving guitar lessons from a Guitars for Vets volunteer
Arms & Interventions
Immediate Entry Group
Following the baseline interview, veterans randomized to the immediate entry group directly engaged in the Guitars for Vets Intervention and were interviewed at the end of the intervention period, roughly 6 weeks later. The intervention content and duration (6 weeks) was the same across both groups.
Intervention: Guitars for Vets Intervention (Other)
Delayed Entry Group
Those randomized to the delayed entry group had their baseline interview repeated at the end of the delayed entry period (4 weeks) prior to receiving the 6-week Guitars for Vets Intervention as well as after intervention completion. The intervention content and duration (6 weeks) was the same across both groups.
Intervention: Guitars for Vets Intervention (Other)
Outcomes
Primary Outcomes
Post-Traumatic Stress Disorder (PTSD) Symptoms
Time Frame: 6 weeks
Post-Traumatic Stress Disorder (PTSD) symptoms as measured by the PTSD Checklist Civilian (PCLC), a self-report scale that measures PTSD presence and severity. The 17 items correspond to Diagnostic and Statistical Manual DSM-IV symptoms of PTSD. The level of distress produced by each symptom is rated from 1 (not at all) to 5 (extremely). A score \>50 on this measure is considered clinically significant (maximum score = 85).
Secondary Outcomes
- Perceptions of Cognitive Failures(6 weeks)
- Social Functioning(6 weeks)
- Health-Related Quality of Life(6 weeks)
- Depression(6 weeks)
Investigators
Liliana Pezzin
Professor of Medicine
Medical College of Wisconsin