Gaze-Contingent Music Reward Treatment for PTSD

NCT05057624 | Withdrawn

• 1 other identifier: # 7960
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 (i.e. attention control, reward processes, and exposure via counter-conditioning). The investigators hypothesize that:

1. 1.GC-MRT will produce greater reductions in symptoms compared to PC at post-treatment and follow-up (diverting attention away from threat).
2. 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. 3.Exploratory analysis will compare the reductions in symptoms of GC-MRT compared to GC-MRT-exp at post-treatment follow-up.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (3)

non-GC-MRT

PLACEBO COMPARATOR

Placebo- music will play at all times during the trials.

Other: Placebo GC-MRT

GC-MRT

ACTIVE COMPARATOR

Music will only play when participants view angry faces and will stop when they look at neutral faces.

Other: GC-MRT

GC-MRT-exp

EXPERIMENTAL

Music will only play when participants look at neutral faces and will stop when they view angry faces.

Other: Exposure

Interventions

Placebo GC-MRT OTHER

Participants will hear music continuously throughout the trials, without regard to the faces they look at.

Also known as: Control

non-GC-MRT

GC-MRT OTHER

Participants will hear music as a reward for looking at neutral faces and the music will stop when they focus on angry faces.

GC-MRT

Exposure OTHER

Participants will hear music of their choice when they focus on angry faces, and when they look at neutral faces the music will stop.

Also known as: GC-MRT-Exp

GC-MRT-exp

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 27, 2021
• Study Start: April 1, 2022
• Primary Completion: September 14, 2024
• Study Completion: March 14, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share