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Guitars for Vets: Evaluating Psychological Outcome of a Novel Music Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01229904
First Posted: October 28, 2010
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
October 26, 2010
October 28, 2010
April 7, 2015
October 2010
December 2011   (Final data collection date for primary outcome measure)
Post traumatic stress disorder Checklist (PCL) [ Time Frame: after 6 weeks of intervention with music training ]
Neuropsychological, quality of life, and PTSD outcomes [ Time Frame: after 6 weeks of intervention with music training ]
Complete list of historical versions of study NCT01229904 on ClinicalTrials.gov Archive Site
depression, social participation, wellness [ Time Frame: after 6 weeks of intervention with music training ]
Not Provided
Not Provided
Not Provided
 
Guitars for Vets: Evaluating Psychological Outcome of a Novel Music Therapy
Guitars for Vets: Evaluating Psychological Outcome of a Novel Music Therapy

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.

Background:

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.

Objectives:

The objective was to assess the effectiveness of a novel music therapy on ammelorating the effects of PTSD. Specifically a 6 week guitar training program under the direction of seasoned instructors through a partnership with Guitars for Vets was assessed before and after intervention.

Methods:

In this trial we recruited veterans in the Milwaukee region and the Zablocki VA Medical Center with significant PTSD symptoms. Forty subjects were recruited and randomized to either an immediate entry or a 6 week delayed entry group. Both groups received the intervention, but the delayed group received it after a 6 week period.

Each subject received a guitar that they keep after the study, music, supplies and instructions. They each had an hour of individual training each week and a weekly group instruction session.

Status:

The data collection and analyses are complete, we are writing the final manuscript. In addition, we submitted a grant for a multicenter MERIT funded project this past June. Unfortunately it will not be funded. We plan to resubmit at the next cycle.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
Behavioral: music therapy with guitar lessons
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
Experimental: Arm 1
patients 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.
Intervention: Behavioral: music therapy with guitar lessons
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Veterans in the Zablocki VA catchment area with symptomatic post traumatic stress disorder

Exclusion Criteria:

Current involvement in intense treatment for a psychiatric illness or substance abuse.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01229904
PPO 10-075
No
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Timothy R. Dillingham, MD MS Clement J. Zablocki VA Medical Center, Milwaukee, WI
VA Office of Research and Development
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP