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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01229904
First received: October 26, 2010
Last updated: April 23, 2012
Last verified: July 2011
  Purpose

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.


Condition Intervention
Post-Traumatic Stress Disorder
Behavioral: music therapy with guitar lessons

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Guitars for Vets: Evaluating Psychological Outcome of a Novel Music Therapy

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Post traumatic stress disorder Checklist (PCL) [ Time Frame: after 6 weeks of intervention with music training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • depression, social participation, wellness [ Time Frame: after 6 weeks of intervention with music training ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229904

Locations
United States, Wisconsin
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
Investigators
Principal Investigator: Timothy R. Dillingham, MD MS Zablocki VA Medical Center, Milwaukee
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01229904     History of Changes
Other Study ID Numbers: PPO 10-075
Study First Received: October 26, 2010
Last Updated: April 23, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014