Ignite Creation Date:
2024-05-06 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05057624
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-03-03
First Post:
2021-08-31
Brief Title:
Gaze-Contingent Music Reward Treatment for PTSD
Sponsor:
Yuval Y Neria
Organization:
Research Foundation for Mental Hygiene Inc
Study Overview
Official Title:
Gaze-Contingent Music Reward Treatment GC-MRT for PTSD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-02
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:
None
Brief Summary:
The present study is a double-blind trial that seeks to examine the feasibility acceptability and efficacy of a recently developed eye-tracking-based gaze-contingent music reward therapy GC-MRT in individuals with posttraumatic stress disorder PTSD
The specific aims of this study are to 1 examine the efficacy of GC-MRT in PTSD and 2 elucidate its underpinnings ie attention control reward processes and exposure via counter-conditioning
The investigators hypothesize that
1 GC-MRT will produce greater reductions in symptoms compared to PC at post-treatment and follow-up diverting attention away from threat
2 GC-MRT-exp will produce greater reductions in symptoms compared to PC at post-treatment follow-up exposure via counter-conditioning by rewarding threat stimuli
3 Exploratory analysis will compare the reductions in symptoms of GC-MRT compared to GC-MRT-exp at post-treatment follow-up
The specific aims of this study are to 1 examine the efficacy of GC-MRT in PTSD and 2 elucidate its underpinnings ie attention control reward processes and exposure via counter-conditioning
The investigators hypothesize that
1 GC-MRT will produce greater reductions in symptoms compared to PC at post-treatment and follow-up diverting attention away from threat
2 GC-MRT-exp will produce greater reductions in symptoms compared to PC at post-treatment follow-up exposure via counter-conditioning by rewarding threat stimuli
3 Exploratory analysis will compare the reductions in symptoms of GC-MRT compared to GC-MRT-exp at post-treatment follow-up
Detailed Description:
GC-MRT is designed to shift participants attention away from threat and toward neutral stimuli by introducing a contingency between viewing patterns and music pre-chosen by participants Participants view matrices of faces with neutral and angry expressions Viewing the neutral faces triggers music the participant previously requested and viewing the angry faces turns the music off The researchers will compare this condition GC- MRT to two additional conditions In the exposure condition GC-MRT-exp the investigators will reverse the music contingency such that viewing the angry faces triggers the music while viewing the neutral faces turns the music off In the placebo control PC condition music plays continuously
The goal of this study is to 1 examine the efficacy of GC-MRT in PTSD and 2 elucidate its underpinnings ie attention control reward processes and exposure via counter-conditioning
Attention control is the ability to shift attention deliberately based on goal-directed behavior Accordingly deficits in attention control can result in volatile shifts in attention leading to increase attention allocation to threat in the environment
Reward functioning is the ability to seek out and enjoy stimuli of positive motivational valence and is considered a crucial driving force of behavior guiding the organism towards positive and rewarding experiences ranging from food and gender to money music and positive social interactions
Allocating visual attention to rewarding stimuli is considered a reward-related attentional feature
Counter-conditioning is an alternative to exposure therapy involving pairing of the feared stimulus with an appetitivepositive outcome ie increasing the rewardingpositive value of the feared stimulus in which repeated trials are supposed to reduce the fear response and replace it by an appetitive response Indeed studies have shown counter-conditioning to be more effective at reducing fear than traditional exposure therapy
The investigators hypothesize that
1 GC-MRT will produce greater reductions in symptoms compared to PC at post-treatment and follow-up diverting attention away from threat
2 GC-MRT-exp will produce greater reductions in symptoms compared to PC at post-treatment follow-up exposure via counter-conditioning by rewarding threat stimuli
3 Exploratory analysis will compare the reductions in symptoms of GC-MRT compared to GC-MRT-exp at post-treatment follow-up
Subject population Seventy-five subjects with PTSD will participate in this study
Methods The sample N 75 will be randomized equally into three groups Group 1 will receive a 4-week 8 sessions course of GC-MRT where music will play only when viewing neutral faces Group 2 will receive a 4-week 8 sessions course of GC-MRT-exp where music will play only when viewing angry faces and Group 3 will receive a 4-week 8-sessions course of non-GC-MRT ie placebo control PC where music will play throughout the trials
The pictures of the faces used in the intervention will include 50 male and 50 female Race-wise they are homogenous Varying the different faces by race is not feasible as these faces were chosen from an established picture data-base ie the Karolinska Directed Emotional Faces database KDEF based on the affective ratings of each face Importantly this composition of faces is similar to one used in an attention assessment task for which our pilot data shows significant group differences in dwell time which is the attentional target of the intervention Hence we do not expect this to affect the results
The goal of this study is to 1 examine the efficacy of GC-MRT in PTSD and 2 elucidate its underpinnings ie attention control reward processes and exposure via counter-conditioning
Attention control is the ability to shift attention deliberately based on goal-directed behavior Accordingly deficits in attention control can result in volatile shifts in attention leading to increase attention allocation to threat in the environment
Reward functioning is the ability to seek out and enjoy stimuli of positive motivational valence and is considered a crucial driving force of behavior guiding the organism towards positive and rewarding experiences ranging from food and gender to money music and positive social interactions
Allocating visual attention to rewarding stimuli is considered a reward-related attentional feature
Counter-conditioning is an alternative to exposure therapy involving pairing of the feared stimulus with an appetitivepositive outcome ie increasing the rewardingpositive value of the feared stimulus in which repeated trials are supposed to reduce the fear response and replace it by an appetitive response Indeed studies have shown counter-conditioning to be more effective at reducing fear than traditional exposure therapy
The investigators hypothesize that
1 GC-MRT will produce greater reductions in symptoms compared to PC at post-treatment and follow-up diverting attention away from threat
2 GC-MRT-exp will produce greater reductions in symptoms compared to PC at post-treatment follow-up exposure via counter-conditioning by rewarding threat stimuli
3 Exploratory analysis will compare the reductions in symptoms of GC-MRT compared to GC-MRT-exp at post-treatment follow-up
Subject population Seventy-five subjects with PTSD will participate in this study
Methods The sample N 75 will be randomized equally into three groups Group 1 will receive a 4-week 8 sessions course of GC-MRT where music will play only when viewing neutral faces Group 2 will receive a 4-week 8 sessions course of GC-MRT-exp where music will play only when viewing angry faces and Group 3 will receive a 4-week 8-sessions course of non-GC-MRT ie placebo control PC where music will play throughout the trials
The pictures of the faces used in the intervention will include 50 male and 50 female Race-wise they are homogenous Varying the different faces by race is not feasible as these faces were chosen from an established picture data-base ie the Karolinska Directed Emotional Faces database KDEF based on the affective ratings of each face Importantly this composition of faces is similar to one used in an attention assessment task for which our pilot data shows significant group differences in dwell time which is the attentional target of the intervention Hence we do not expect this to affect the results
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