Gaze-Contingent Music Reward Treatment for PTSD

Gaze-Contingent Music Reward Treatment (GC-MRT) for PTSD

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 (i.e. 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.

Study Overview

• Status: Withdrawn
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Other: Placebo GC-MRT; Other: GC-MRT; Other: Exposure

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 (i.e. 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 appetitive/positive outcome (i.e., increasing the rewarding/positive 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 (i.e. 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 (i.e., 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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males and females between the ages of 18 and 80
• Current DSM-5 diagnosis of PTSD
• CAPS-V score greater than or equal to 25
• Fluent in English and willing to give informed written consent and participate responsibly in the protocol.
• Normal or corrected-to-normal vision
• Mini Mental Status Exam score greater than or equal to 24.

Exclusion Criteria:

• History of psychiatric diagnosis of psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder
• Current severe depression determined by a a) score greater than 25 on the Hamilton Rating Scale for Depression (HAM-D-17) and evaluation and b)clinical assessment
• Suicidal ideation or behavior
• Current or past diagnosis of obsessive compulsive disorder, bipolar disorder, epilepsy, or brain injury as determined by a Structured Clinical Interview for DSM-5 (SCID-5) interview
• Current or past organic mental disorder, seizure disorder, epilepsy or brain injury as determined by a clinical evaluation
• Diagnosis of probable Alzheimer's disease, Vascular Dementia, or Parkinson's Disease, as determined by a clinical evaluation and Mini Mental Status Exam (MMSE)
• Current unstable or untreated medical illness
• Drug or alcohol misuse- severe alcohol/cannabis disorder or any other substance use disorder except nicotine.
• Recurrent psychotropic medication change or initiation within the last 3 months
• Initiation of psychotherapy within the last 3 months
• Current or past Attention Deficit Hyperactivity Disorder (ADHD) diagnosis
• Chronic pain that may affect sitting down and still for approximately 30 minutes
• Current cognitive impairments as a result of a traumatic brain injury, as determined by a clinical evaluation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: non-GC-MRT; Placebo- music will play at all times during the trials.	Other: Placebo GC-MRT; Participants will hear music continuously throughout the trials, without regard to the faces they look at.; Other Names: Control
Active Comparator: GC-MRT; Music will only play when participants view angry faces and will stop when they look at neutral faces.	Other: GC-MRT; Participants will hear music as a reward for looking at neutral faces and the music will stop when they focus on angry faces.
Experimental: GC-MRT-exp; Music will only play when participants look at neutral faces and will stop when they view angry faces.	Other: Exposure; Participants will hear music of their choice when they focus on angry faces, and when they look at neutral faces the music will stop.; Other Names: GC-MRT-Exp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD symptoms over time	Reduction in symptoms as measured by the Clinician Administered PTSD Scale (Caps-5: ranging from 0-80 ). from pre- to post-treatment. Lower scores mean better outcome	Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
Change in depressive symptoms over time	Change in symptoms as measured by the Hamilton Depression Rating Scale (HDRS-17; range 0-52) from pre- to post-treatment.	Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
Change in anxiety symptoms over time	Change in symptoms as measured by the Hamilton Anxiety Rating Scale (HAM-A); range 0-56) from pre- to post-treatment.	Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
Changes in illness severity and improvement over time	Reduction in overall symptoms as measured by the Clinical Global Impressions scale (illness severity rated 0 to 7, with higher scores indicating more severe illness; improvement rated 0 to 7, with higher scores indicating less improvement.)	Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
Change in the severity of PTSD symptoms over time.	Assesses for change in individual symptoms of PTSD and PTSD severity as measured by the Posttraumatic Stress Disorder Checklist (PCL-5). The severity of 20 PTSD symptoms is rated from 0 to 4, with higher numbers indicative of greater severity (score range of 0 to 80.)	Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
Changes in suicidal ideation and depressive symptoms over time.	Assessment and monitoring of depressive symptoms and suicidal ideation, as measured through the Beck Depression Inventory-II (BDI-II). Scores range from 0 to 63, with higher scores reflecting more severe depression.	each treatment session (weeks 2-10)
Change in the ability to experience pleasure over time.	Change in anhedonia from pre- to post-treatment assessment will be assessed using the The Snaith-Hamilton Pleasure Scale (SHAPS: score range: 0-14, higher scores indicate less ability to experience pleasure).	Baseline, at 5 weeks (midpoint), posttreatment at 10 weeks, follow up at 3 months from last session
Change in the ability to feel social pleasure over time	Change in anhedonia from pre- to post-treatment assessment will be assessed using the the Revised Social Anhedonia Scale (SHAPS: score range: 0-14, higher scores indicate less ability to experience pleasure).	Baseline, at 5 weeks (midpoint), posttreatment at 10 weeks, follow up at 3 months from last session
Change in people's experiences of music as a reward over time.	Change in people's experiences of music as a reward and their relationship to music, as measured by the Barcelona Music Reward Questionnaire (BMRQ score range: 40-60, with higher scores indicate greater experiences of music as a reward)	Baseline, at 5 weeks (midpoint), posttreatment at 10 weeks, follow up at 3 months from last session

Collaborators and Investigators

• Sponsor: Research Foundation for Mental Hygiene, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2022
• Primary Completion (Estimated): September 14, 2024
• Study Completion (Estimated): March 14, 2025

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: # 7960

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No