Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06129981
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-08-21
Brief Title:
TREATMENT OF POST-TRAUMATIC STRESS DISORDER USING AUGMENTED IMAGINATION EXPOSURE PSYCHOTHERAPY WITH VOCAL FEEDBACK AN ACCEPTABILITY STUDY
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
Treatment of Post-traumatic Stress Disorder by Exposure Psychotherapy in Augmented Imagination by Vocal Feedback Acceptability Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAUMAVOICE
Brief Summary:
We now have many pharmacological and psychotherapeutic treatments for patients suffering from Post Traumatic Stress Disorder PTSD including cognitive and behavioral therapy CBT by reactivation of traumatic memories Despite remarkable initial efficacy only one-third of patients treated with CBT show lasting clinical improvement On the other hand the associated drop-out rates vary from 17 to 33 which may be linked to the difficulty of the task which implies reactivating the traumatic memory Bradley et al 2005
Alternative treatments for PTSD include blocking chemo-facilitated memory reconsolidation with a beta-blocker propranolol Briefly reconsolidation theory posits that a recalled memory becomes unstable again before consolidating again into long-term memory hence the term reconsolidation During this phase of transitory plasticity the memory can be modulated in particular its emotional charge The use of propranolol has shown its benefit during this phase in patients suffering from PTSD Brunet et al 2018 However the use of this facilitated chemo therapy is limited to patients with no contraindication to taking beta-blockers In this context a non-medicinal alternative to attenuate the emotional strength of the memory has a therapeutic interest
One of the ways in which our emotional experience can be modulated is through the perception of our emotional behavior According to the theory of self-perception Bem 1972 individuals become aware or conscious of their attitudes emotions and other internal states in part by inferring them from the observation of their own behaviors Thus when individuals produce sounds or facial expressions typical of specific emotions such as joy sadness or anger they will tend to experience an emotional state congruent with their vocal or facial production Hatfield and Hsee 1995
Work on the influence of voice perception in particular is experiencing a new boom due to technical developments in the fields of acoustic signal processing In particular Dr Aucouturiers team has created a software device to directly modify the emotional tone of speech formulated orally For example for happy manipulation the pitch of the voice is changed with a pitch shifting algorithm to make it more positive the dynamic range of the voice is increased with a compression algorithm to make it more confident and its spectral content is modified with a high-pass filter to make it brighter The results of this work Aucouturier et al 2016 Rachman et al 2018 Goupil et al 2021 showed an emotional vocal feedback effect the subjective evaluation that participants make of their emotional state after modification by the device goes in the direction of the emotion created by the platform even though the participants are typically unaware of the operated modulation The non-detection of the transformation being a necessary condition for observing the effect of VF on the emotional state of the participant
The rationale of this study is to test the use of a real-time vocal transformation paradigm during exposure therapy by reactivation of traumatic memory in imagination in patients During this therapy the patient is asked to read aloud the very detailed script of the traumatic event We want to test whether manipulating the emotional tone of the patients voice online when reading can have a facilitating impact on the process of reducing the emotional charge associated with the traumatic script In order to justify the use of the audio headphones as well as the microphone and to ensure us of the non-detectability of the transformation operated on the voice we will explain to our patients that this device hearing his voice in a headphone during the session of re-exposure to a memory aims to increase immersion Our main objective will be to assess the acceptability of this augmented form of psychotherapy and our secondary objectives will be to assess its technical feasibility and provide initial elements to assess its effectiveness The results will be compared with data from the literature on the usual treatment imaginary exposure therapy with or without propranolol according to the indications
Alternative treatments for PTSD include blocking chemo-facilitated memory reconsolidation with a beta-blocker propranolol Briefly reconsolidation theory posits that a recalled memory becomes unstable again before consolidating again into long-term memory hence the term reconsolidation During this phase of transitory plasticity the memory can be modulated in particular its emotional charge The use of propranolol has shown its benefit during this phase in patients suffering from PTSD Brunet et al 2018 However the use of this facilitated chemo therapy is limited to patients with no contraindication to taking beta-blockers In this context a non-medicinal alternative to attenuate the emotional strength of the memory has a therapeutic interest
One of the ways in which our emotional experience can be modulated is through the perception of our emotional behavior According to the theory of self-perception Bem 1972 individuals become aware or conscious of their attitudes emotions and other internal states in part by inferring them from the observation of their own behaviors Thus when individuals produce sounds or facial expressions typical of specific emotions such as joy sadness or anger they will tend to experience an emotional state congruent with their vocal or facial production Hatfield and Hsee 1995
Work on the influence of voice perception in particular is experiencing a new boom due to technical developments in the fields of acoustic signal processing In particular Dr Aucouturiers team has created a software device to directly modify the emotional tone of speech formulated orally For example for happy manipulation the pitch of the voice is changed with a pitch shifting algorithm to make it more positive the dynamic range of the voice is increased with a compression algorithm to make it more confident and its spectral content is modified with a high-pass filter to make it brighter The results of this work Aucouturier et al 2016 Rachman et al 2018 Goupil et al 2021 showed an emotional vocal feedback effect the subjective evaluation that participants make of their emotional state after modification by the device goes in the direction of the emotion created by the platform even though the participants are typically unaware of the operated modulation The non-detection of the transformation being a necessary condition for observing the effect of VF on the emotional state of the participant
The rationale of this study is to test the use of a real-time vocal transformation paradigm during exposure therapy by reactivation of traumatic memory in imagination in patients During this therapy the patient is asked to read aloud the very detailed script of the traumatic event We want to test whether manipulating the emotional tone of the patients voice online when reading can have a facilitating impact on the process of reducing the emotional charge associated with the traumatic script In order to justify the use of the audio headphones as well as the microphone and to ensure us of the non-detectability of the transformation operated on the voice we will explain to our patients that this device hearing his voice in a headphone during the session of re-exposure to a memory aims to increase immersion Our main objective will be to assess the acceptability of this augmented form of psychotherapy and our secondary objectives will be to assess its technical feasibility and provide initial elements to assess its effectiveness The results will be compared with data from the literature on the usual treatment imaginary exposure therapy with or without propranolol according to the indications
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A02423-40 | OTHER | ID-RCB numberANSM | None |