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Clinical Trials/NCT03759171
NCT03759171
Completed
Not Applicable

Music-instruction Intervention for Treatment of Post-traumatic Stress Disorder: A Randomized Pilot Study

Medical College of Wisconsin0 sites40 target enrollmentOctober 1, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Disorders, Post-Traumatic
Sponsor
Medical College of Wisconsin
Enrollment
40
Primary Endpoint
Post-Traumatic Stress Disorder (PTSD) Symptoms
Status
Completed
Last Updated
7 years ago

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).

Registry
clinicaltrials.gov
Start Date
October 1, 2010
End Date
September 30, 2011
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Liliana Pezzin

Professor of Medicine

Medical College of Wisconsin

Eligibility Criteria

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

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)

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