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Completed

NCT Number: NCT03759171

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

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).

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Key information

Conditions

Stress Disorders, Post-Traumatic Behavior Behavioral Symptoms Depression Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Depression

    Time frame: 6 weeks

    Depression was assessed using the Beck Depression Inventory-II (BDI-II), a 21-item self-report scale measuring the presence and severity of depressive symptoms over the two weeks preceding test administration. Each answer ranges in score from 0-3. Total scores indicate minimal (0-13), mild (14-19), moderate (20-28), and severe (29-63; maximum = 63) levels of reported depression.

  2. Perceptions of Cognitive Failures

    Time frame: 6 weeks

    The Cognitive Failures Questionnaire (CFQ) was used as a self-reported measure of everyday cognitive lapses for perception, memory, and motor function, such as forgetting appointments or having word finding difficulty. Total scores range from 0 to 100 with higher numbers indicating worse outcomes.

  3. Social Functioning

    Time frame: 6 weeks

    The University of California, Los Angeles (UCLA) Loneliness Scale was administered to assess subjective feelings of social isolation. This is a 20-item scale summed to give a total score ranging from 0-60 with higher numbers indicating worse outcomes.

  4. Health-Related Quality of Life

    Time frame: 6 weeks

    The European Quality of Life (EuroQoL) Scale, a validated preference-based scale for which population norms are available in the US and elsewhere, was used as the global evaluation of veteran's health-related quality of life. The 5-item EuroQoL measure combines data on activity restrictions (ADL, IADL limitations), limitations in participation (usual major activity and other social activities) and self- perceived health status (excellent, good, fair or poor) to measure one's overall satisfaction with health and well-being. Scores range from -0.594 to 1.000, higher values represent better outcomes.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Milwaukee VA Medical Center
  • VA Office of Research and Development

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 29, 2018
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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