Music-instruction Intervention for Treatment of Post-traumatic Stress Disorder

NCT ID: NCT03759171

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-01
• Study Completion Date: 2011-09-30

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).

Conditions

Stress Disorders, Post-Traumatic; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Guitars for Vets Intervention

Intervention Type: OTHER

This was an active intervention providing veterans with an acoustic guitar, guitar pick, tuning instruments, a music book, practice CDs, and individual and group sessions of music instruction during a 6-week intervention period. Six tailored 1-hour individual guitar instruction sessions were scheduled (1 session per week). In addition to the 6 tailored individual lessons, the intervention provided 3 group sessions. Veterans were given a guitar that they could keep upon completion of the program. The same instructor was assigned to a subject for the duration of the study, and group sessions were supervised by the Education Director of Guitars for Vets.

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.

Group Type: EXPERIMENTAL

Guitars for Vets Intervention

Intervention Type: OTHER

This was an active intervention providing veterans with an acoustic guitar, guitar pick, tuning instruments, a music book, practice CDs, and individual and group sessions of music instruction during a 6-week intervention period. Six tailored 1-hour individual guitar instruction sessions were scheduled (1 session per week). In addition to the 6 tailored individual lessons, the intervention provided 3 group sessions. Veterans were given a guitar that they could keep upon completion of the program. The same instructor was assigned to a subject for the duration of the study, and group sessions were supervised by the Education Director of Guitars for Vets.

Interventions

Guitars for Vets Intervention

This was an active intervention providing veterans with an acoustic guitar, guitar pick, tuning instruments, a music book, practice CDs, and individual and group sessions of music instruction during a 6-week intervention period. Six tailored 1-hour individual guitar instruction sessions were scheduled (1 session per week). In addition to the 6 tailored individual lessons, the intervention provided 3 group sessions. Veterans were given a guitar that they could keep upon completion of the program. The same instructor was assigned to a subject for the duration of the study, and group sessions were supervised by the Education Director of Guitars for Vets.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: collaborator

Milwaukee VA Medical Center

FED

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Liliana Pezzin

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PRO00019269

Identifier Type: -

Identifier Source: org_study_id