Post-Traumatic Stress DisorderNCT01229904
Guitars for Vets: Evaluating Psychological Outcome of a Novel Music Therapy
A study testing music therapy with guitar lessons in people with Post-Traumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- music therapy with guitar lessons
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans in the Zablocki VA catchment area with symptomatic post traumatic stress disorder
Who cannot join
- Current involvement in intense treatment for a psychiatric illness or substance abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-1000
About this study
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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- music therapy with guitar lessons
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapy with guitar lessonsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: music therapy with guitar lessons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post traumatic stress disorder Checklist (PCL)
Measured: after 6 weeks of intervention with music training
Secondary outcomes (1)
depression, social participation, wellness
Measured: after 6 weeks of intervention with music training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Timothy R. Dillingham, MD MS, Principal investigator, Clement J. Zablocki VA Medical Center, Milwaukee, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229904
- Sponsor's protocol ID
- PPO 10-075
- Status last verified
- Jul 2011
- First submitted
- 26 Oct 2010
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guitars for Vets: Evaluating Psychological Outcome of a Novel Music Therapy
- ClinicalTrials.gov ID
- NCT01229904
- Acronym / sponsor ID
- PPO 10-075
- Conditions
- Post-Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: music therapy with guitar lessonspatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans in the Zablocki VA catchment area with symptomatic post traumatic stress disorder
Key exclusion criteria (1 listed)
- Current involvement in intense treatment for a psychiatric illness or substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music therapy with guitar lessonsThe 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 | Behavioural | Arm 1 |
Primary outcome
Post traumatic stress disorder Checklist (PCL)
Time frame: after 6 weeks of intervention with music training
1 secondary outcome
depression, social participation, wellness
Time frame: after 6 weeks of intervention with music training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy R. Dillingham, MD MS principal investigator
Clement J. Zablocki VA Medical Center, Milwaukee, WI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music therapy with guitar lessons in people with Post-Traumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post traumatic stress disorder Checklist (PCL) (time frame: after 6 weeks of intervention with music training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.