NCT01229904

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 7, 2015

Status Verified

July 1, 2011

Enrollment Period

1.2 years

First QC Date

October 26, 2010

Last Update Submit

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

EXPERIMENTAL

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

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

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Timothy R. Dillingham, MD MS

    Clement J. Zablocki VA Medical Center, Milwaukee, WI

    PRINCIPAL INVESTIGATOR

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

Locations