Stress Disorder, Post TraumaticTRACERNCT03990064
Benefits of Relaxation by Music Therapy on PTSD Symptoms
A study testing musicotherapy in people with Stress Disorder, Post Traumatic, run by Institut de Recherche Biomedicale des Armees at 1 site in France.
Trial summary
PTSD is a debilitating mental disorder that may develop after experiencing or witnessing a life-threatening event. With appropriate care, treatment efficiency is variable and around 20% of the patients do not respond to psychological treatment. Complementary treatments are needed. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress Disorder, Post Traumatic
- What is being tested?
- musicotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 1 Jul 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PTSD
Who cannot join
- neurological diseases
- addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of Cerebral Metabolism and Connectivity in Post Traumatic Stress Disorder (PTSD): Exploratory Study of Neurofunctional Modulation of Emotions by Music Therapy
PTSD is a debilitating mental disorder that may develop after experiencing or witnessing a life-threatening event. With appropriate care, treatment efficiency is variable and around 20% of the patients do not respond to psychological treatment. Complementary treatments are needed.
as PTSD implied autonomic nervous system (ANS) dysfonction, complementary treatment focusing on ANS regulation, as welle as musicotherapy, may have an interest.
Read the detailed description
The aim is to evaluate the impact of musicotherapy on PTSD symptoms, and severity using a RCT Symptoms will be evaluated using questionaires (PCL and quality of life) severity will be measured using neurological soft signs assessment, connectomic functions and ANS regulation
- Conditions
- Stress Disorder, Post Traumatic
- Being tested
- musicotherapy
- Keywords
- effective connectomic neurological soft signs
- 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.
musicotherapyOther
receptive music therapy. The musical style of the session was chosen by the patient. The validated 'U' technique was employed.
| Study group | Role | What they receive |
|---|---|---|
| musicotherapy | Experimental | daily sessions of music listening during 2 months, associated with their standard treatment, Receives: Other: musicotherapy |
| waiting list | No intervention | waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in PTSD symptoms
questionnaire Posttraumatic CheckList 5 (PCL5; threshold =33)
Measured: change from PTSD symptoms at two months and at six months
Secondary outcomes (4)
change in neurological soft signs
questionnaire EPSID " Psychomotor assessment scale of neurological soft signs no threshold
Measured: change from neurological soft signs at two months and at six months
change in effective connectomic
Magnetic Resonance Imaging
Measured: change from effective connectomic at two months and at six months
Autonomous nervous system regulation
heart rate variability during 5 min at rest
Measured: change from Autonomous nervous system regulation at two months and at six months
change in biological stress
blood cytokines, BDNF
Measured: change from biological stress at two months and at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Feb 2020
- Primary completion1 Feb 2020
- Study completion1 Jul 2022
Why it stopped: not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorder, Post TraumaticStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- musicotherapy versus waiting list
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche Biomedicale des Armees
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marion Trousselard, Institut de Recherche Biomedicale des Armees
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990064
- Sponsor's protocol ID
- 2018-A02182-53
- Acronym
- TRACER
- Status last verified
- Aug 2022
- First submitted
- 8 May 2019
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Cerebral Metabolism and Connectivity in Post Traumatic Stress Disorder (PTSD): Exploratory Study of Neurofunctional Modulation of Emotions by Music Therapy
- ClinicalTrials.gov ID
- NCT03990064
- Acronym / sponsor ID
- TRACER / 2018-A02182-53
- Conditions
- Stress Disorder, Post Traumatic
- Keywords
- effective connectomic neurological soft signs
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Institut de Recherche Biomedicale des ArmeesOther government
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 18 Jun 2019 (actual)
- 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.
PTSD is a debilitating mental disorder that may develop after experiencing or witnessing a life-threatening event. With appropriate care, treatment efficiency is variable and around 20% of the patients do not respond to psychological treatment. Complementary treatments are needed.
as PTSD implied autonomic nervous system (ANS) dysfonction, complementary treatment focusing on ANS regulation, as welle as musicotherapy, may have an interest.
Detailed description
The aim is to evaluate the impact of musicotherapy on PTSD symptoms, and severity using a RCT Symptoms will be evaluated using questionaires (PCL and quality of life) severity will be measured using neurological soft signs assessment, connectomic functions and ANS regulation
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- musicotherapy versus waiting list
| Arm | Type | Receives |
|---|---|---|
| musicotherapy | Experimental | Other: musicotherapydaily sessions of music listening during 2 months, associated with their standard treatment, |
| waiting list | No intervention | –waiting list |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- PTSD
Key exclusion criteria (2 listed)
- neurological diseases
- addiction
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 |
|---|---|---|
| musicotherapyreceptive music therapy. The musical style of the session was chosen by the patient. The validated 'U' technique was employed. | Other | musicotherapy |
Primary outcome
change in PTSD symptoms
Time frame: change from PTSD symptoms at two months and at six months
questionnaire Posttraumatic CheckList 5 (PCL5; threshold =33)
4 secondary outcomes
change in neurological soft signs
Time frame: change from neurological soft signs at two months and at six months
change in effective connectomic
Time frame: change from effective connectomic at two months and at six months
Autonomous nervous system regulation
Time frame: change from Autonomous nervous system regulation at two months and at six months
change in biological stress
Time frame: change from biological stress at two months and at six months
Results and safety
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing musicotherapy in people with Stress Disorder, Post Traumatic, run by Institut de Recherche Biomedicale des Armees at 1 site in France.
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 2 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: stopped early, as of the sponsor's last update on 4 Aug 2022. 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 France. 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 was stopped early (reason given: not enough patients). Results are not available in the source record.
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?
change in PTSD symptoms (time frame: change from PTSD symptoms at two months and at six months). 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 4 Aug 2022.