NCT04664907

Brief 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. 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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 25, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

November 25, 2020

Last Update Submit

October 12, 2022

Conditions

Keywords

Psychic traumaPhenomenologyConsciousnessAnxietyMusicVideomusic

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (4)

  • Qualitative analysis of experiential phenomenological interview

    4 weeks

  • Salience-resonances method

    4 weeks

  • Patient anxiety

    4 weeks

  • Post traumatic stress disorder phenomenological definition

    4 weeks

Study Arms (1)

Patients suffering from post traumatic stress disorder

EXPERIMENTAL
Other: Videomusic listening

Interventions

Patients will attend a 8 min videomusic session and questionnaires will be performed before and after this session.

Patients suffering from post traumatic stress disorder

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Manuel Dias Alves, MD

    Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 11, 2020

Study Start

January 1, 2021

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share