Guitars for Vets: Evaluating Psychological Outcome of a Novel Music Therapy
1 other identifier
interventional
40
1 country
1
Brief Summary
Post traumatic Stress disorder (PTSD) is a common condition for persons who have served in the Armed services during combat or deployment. Treatments include medications, cognitive behavioral therapy, and other social support mechanisms. Our aim in this project is to critically evaluate the effects of a novel music therapy intervention on the symptoms of PTSD. Estimates developed by the Global Burden of Disease Study reveal that mental illness accounts for over 15% of the burden of disease on health and productivity in established market economies--more than the disease burden caused by all cancers combined.\[1\] Perhaps no industry has had the burden of mental disorders affect its labor force as severely and pervasively as the Armed Forces. Post-Traumatic Stress Disorder (PTSD) is a common sequelae of severe emotional trauma that is often associated with combat exposure. The condition has been well documented in returning soldiers and is characterized by recurrent and distressing thoughts and feelings related to the trauma, persistent avoidance of reminders of the trauma, and increased arousal that disturbs sleep, concentration, and the ability to modulate anger. Persons suffering from PTSD often have difficulty relating to others, leading to loneliness and isolation, which further intensifies their psychiatric symptoms. Current treatment options for PTSD include psychotherapy, medication management, or a combination of those. Although these treatments have been shown to be effective, returning soldiers are often hesitant to seek and adhere to mental health therapies. PTSD-related avoidance, including difficulty trusting, may serve as a barrier to seeking or completing treatments. Furthermore, some PTSD medications have unacceptable side-effects in some individuals. The need is great, therefore, to identify and promote safe, effective strategies for self-management of PTSD among Veterans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 26, 2010
CompletedFirst Posted
Study publicly available on registry
October 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 7, 2015
July 1, 2011
1.2 years
October 26, 2010
April 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Post traumatic stress disorder Checklist (PCL)
after 6 weeks of intervention with music training
Secondary Outcomes (1)
depression, social participation, wellness
after 6 weeks of intervention with music training
Study Arms (1)
Arm 1
EXPERIMENTALpatients with PTSD are randomized to either entering immediately a 6 week treatment with music therapy, or being in the delay group that enters the treatment arm after 6 weeks. This is a delayed entry RCT.
Interventions
The treatment is a 6 week music therapy intervention. Subjects receive 1 hour individual lesson and a 1 hour group session weekly for 6 weeks. they are given a guitar following completion of the study
Eligibility Criteria
You may qualify if:
- Veterans in the Zablocki VA catchment area with symptomatic post traumatic stress disorder
You may not qualify if:
- Current involvement in intense treatment for a psychiatric illness or substance abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-1000, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy R. Dillingham, MD MS
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2010
First Posted
October 28, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
April 7, 2015
Record last verified: 2011-07