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

NCT03759171 | Completed

• 1 other identifier: PRO00019269
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Stress Disorders, Post-Traumatic; Depression

Outcome Measures

Primary Outcomes (1)

• Post-Traumatic Stress Disorder (PTSD) Symptoms

  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).

  6 weeks

Secondary Outcomes (4)

• Depression

  6 weeks

• Perceptions of Cognitive Failures

  6 weeks

• Social Functioning

  6 weeks

• Health-Related Quality of Life

  6 weeks

Study Arms (2)

Immediate Entry Group

EXPERIMENTAL

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.

Other: Guitars for Vets Intervention

Delayed Entry Group

EXPERIMENTAL

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.

Other: Guitars for Vets Intervention

Interventions

Guitars for Vets Intervention 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; Immediate Entry Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• VA Office of Research and Development: collaborator
• Milwaukee VA Medical Center: collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Delayed entry, randomized trial

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 29, 2018
• Study Start: October 1, 2010
• Primary Completion: September 30, 2011
• Study Completion: September 30, 2011
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share