Depression Clinical Trial
Official title:
Music-instruction Intervention for Treatment of Post-traumatic Stress Disorder: A Randomized Pilot Study
Verified date | November 2018 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 40 |
Est. completion date | September 30, 2011 |
Est. primary completion date | September 30, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin | Milwaukee VA Medical Center, VA Office of Research and Development |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Depression | 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. | 6 weeks | |
Secondary | Perceptions of Cognitive Failures | 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. | 6 weeks | |
Secondary | Social Functioning | 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. | 6 weeks | |
Secondary | Health-Related Quality of Life | 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. | 6 weeks |
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