Post Traumatic Stress DisorderVIMUTRAUNCT04664907
Videomusic and Psychic Trauma
A study testing Videomusic listening in people with Post Traumatic Stress Disorder, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer.
Trial summary
This project is interested in the flow of consciousness and its modalizations during psychological trauma (post-traumatic stress disorder) and its resolution. It is based on the premise that in PTSD, consciousness becomes more rigid, less fluid, due to the memory always imposing itself on the consciousness. 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?
- Videomusic listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jul 2021
- 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
- Male or female at least 18 years of age
- Patients diagnosed with Simple Post Traumatic Stress according to DSM 5 criteria
- Patient able to express consent prior to participation in the study
- Patient affiliated to or beneficiary of a social security regimen
Who cannot join
- Other serious psychiatric pathologies
- Serious chronic pathologies, especially neurological ones
- Epilepsy
- Blindness or deafness
- Psychiatric decompensation
- Pregnant Women
- Patient under judicial protection (guardianship, curatorship...) or justice safeguard
- Any other reason that, in the opinion of the investigator, could interfere with study objective evaluation
About this study
Official title: Phenomenological Crossing of the Psychic Trauma and Its Resolution. Imagination at the Heart of the Treatment: Video-music as a Metaphor for Psychological Trauma and Its Resolution.
This project is interested in the flow of consciousness and its modalizations during psychological trauma (post-traumatic stress disorder) and its resolution. It is based on the premise that in PTSD, consciousness becomes more rigid, less fluid, due to the memory always imposing itself on the consciousness. The resolution of the trauma and the subsequent reduction of anxiety might improve the fluidity of consciousness and thus lead to an overall improvement in the psychological state of PTSD patients. In cases of PTSD, music has been shown to reduce anxiety from the very first session and has a very positive effect on all PTSD symptoms.
In this project the following elements will be evaluated : on one hand, the changes in consciousness and its fluidity and, on the other hand, the evolution of anxiety following the listening of a new kind of work, videomusic (which associates a video scenario with music) exemplifying (metaphorizing) the trauma and its resolution.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Videomusic listening
- Keywords
- Psychic trauma, Phenomenology, Consciousness, Anxiety, Music, Videomusic
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videomusic listeningOther
Patients will attend a 8 min videomusic session and questionnaires will be performed before and after this session.
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from post traumatic stress disorder | Experimental | Not described Receives: Other: Videomusic listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consciousness fluidity using a questionnaire dedicated to this measure
Consciousness fluidity will be assessed before and after videomusic listening from the scores obtained at a questionnaire Evaluating Qualitatively the Fluidity of Consciousness (EQFC). Minimum and maximum values are 1 for "Never" and 6 for "Always". For some items, 1 indicates a better outcome and for some it is the contrary.
Measured: 4 weeks
Secondary outcomes (4)
Qualitative analysis of experiential phenomenological interview
Experiential phenomenological interview will be analyzed according to qualitative analyze criteria (occurrence frequencies)
Measured: 4 weeks
Salience-resonances method
Experiential phenomenological interview will be analyzed according to salience-resonance method
Measured: 4 weeks
Patient anxiety
Patient anxiety level will be analyzed before and after videomusic listening thanks to State-Trait Anxiety Inventory (STAI) scale and scores obtained will be correlated with EQFC scores. For each item scores go from 1 to 4. For some of them 1 means "Not at all" and 4 "A lot" and for others it is the contrary. A global score superior to 65 indicates a high level of anxiety and a global score inferior or equal to 35 a very low level of anxiety.
Measured: 4 weeks
Post traumatic stress disorder phenomenological definition
Principal component analysis will be performed to find potential correlations between population initial characteristics and improvement of consciousness fluidity after videomusic listening
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: Denied by Human Subjects Protection Board
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Dias Alves, MD, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664907
- Sponsor's protocol ID
- 2020-CHITS-07
- Other IDs
- 2020-A02649-30
- Acronym
- VIMUTRAU
- Status last verified
- Oct 2022
- First submitted
- 25 Nov 2020
- Last updated
- 13 Oct 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenomenological Crossing of the Psychic Trauma and Its Resolution. Imagination at the Heart of the Treatment: Video-music as a Metaphor for Psychological Trauma and Its Resolution.
- ClinicalTrials.gov ID
- NCT04664907
- Acronym / sponsor ID
- VIMUTRAU / 2020-CHITS-07
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Psychic trauma, Phenomenology, Consciousness, Anxiety, Music, Videomusic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Denied by Human Subjects Protection Board
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 11 Dec 2020 (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.
This project is interested in the flow of consciousness and its modalizations during psychological trauma (post-traumatic stress disorder) and its resolution. It is based on the premise that in PTSD, consciousness becomes more rigid, less fluid, due to the memory always imposing itself on the consciousness. The resolution of the trauma and the subsequent reduction of anxiety might improve the fluidity of consciousness and thus lead to an overall improvement in the psychological state of PTSD patients. In cases of PTSD, music has been shown to reduce anxiety from the very first session and has a very positive effect on all PTSD symptoms.
In this project the following elements will be evaluated : on one hand, the changes in consciousness and its fluidity and, on the other hand, the evolution of anxiety following the listening of a new kind of work, videomusic (which associates a video scenario with music) exemplifying (metaphorizing) the trauma and its resolution.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from post traumatic stress disorder | Experimental | Other: Videomusic listening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female at least 18 years of age
- Patients diagnosed with Simple Post Traumatic Stress according to DSM 5 criteria
- Patient able to express consent prior to participation in the study
- Patient affiliated to or beneficiary of a social security regimen
Key exclusion criteria (8 listed)
- Other serious psychiatric pathologies
- Serious chronic pathologies, especially neurological ones
- Epilepsy
- Blindness or deafness
- Psychiatric decompensation
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 |
|---|---|---|
| Videomusic listeningPatients will attend a 8 min videomusic session and questionnaires will be performed before and after this session. | Other | Patients suffering from post traumatic stress disorder |
Primary outcome
Consciousness fluidity using a questionnaire dedicated to this measure
Time frame: 4 weeks
Consciousness fluidity will be assessed before and after videomusic listening from the scores obtained at a questionnaire Evaluating Qualitatively the Fluidity of Consciousness (EQFC). Minimum and maximum values are 1 for "Never" and 6 for "Always". For some items, 1 indicates a better outcome and for some it is the contrary.
4 secondary outcomes
Qualitative analysis of experiential phenomenological interview
Time frame: 4 weeks
Salience-resonances method
Time frame: 4 weeks
Patient anxiety
Time frame: 4 weeks
Post traumatic stress disorder phenomenological definition
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 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.
Manuel Dias Alves, MD study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Questions about this trial
What is this clinical trial studying?
A study testing Videomusic listening in people with Post Traumatic Stress Disorder, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Consciousness fluidity using a questionnaire dedicated to this measure (time frame: 4 weeks). 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 13 Oct 2022.