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Gaze-Contingent Music Reward Treatment for PTSD

Primary Purpose

Posttraumatic Stress Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo GC-MRT
GC-MRT
Exposure
Sponsored by
Yuval Y Neria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Experimental

    Arm Label

    non-GC-MRT

    GC-MRT

    GC-MRT-exp

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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
    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.
    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.
    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.)
    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.)
    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.
    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).
    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).
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2021
    Last Updated
    February 15, 2022
    Sponsor
    Yuval Y Neria
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05057624
    Brief Title
    Gaze-Contingent Music Reward Treatment for PTSD
    Official Title
    Gaze-Contingent Music Reward Treatment (GC-MRT) for PTSD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    September 14, 2024 (Anticipated)
    Study Completion Date
    March 14, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yuval Y Neria

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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: GC-MRT will produce greater reductions in symptoms compared to PC at post-treatment and follow-up (diverting attention away from threat). 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). 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 (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: GC-MRT will produce greater reductions in symptoms compared to PC at post-treatment and follow-up (diverting attention away from threat). 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). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posttraumatic Stress Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    non-GC-MRT
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo- music will play at all times during the trials.
    Arm Title
    GC-MRT
    Arm Type
    Active Comparator
    Arm Description
    Music will only play when participants view angry faces and will stop when they look at neutral faces.
    Arm Title
    GC-MRT-exp
    Arm Type
    Experimental
    Arm Description
    Music will only play when participants look at neutral faces and will stop when they view angry faces.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo GC-MRT
    Other Intervention Name(s)
    Control
    Intervention Description
    Participants will hear music continuously throughout the trials, without regard to the faces they look at.
    Intervention Type
    Other
    Intervention Name(s)
    GC-MRT
    Intervention Description
    Participants will hear music as a reward for looking at neutral faces and the music will stop when they focus on angry faces.
    Intervention Type
    Other
    Intervention Name(s)
    Exposure
    Other Intervention Name(s)
    GC-MRT-Exp
    Intervention Description
    Participants will hear music of their choice when they focus on angry faces, and when they look at neutral faces the music will stop.
    Primary Outcome Measure Information:
    Title
    Change in PTSD symptoms over time
    Description
    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
    Time Frame
    Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
    Title
    Change in depressive symptoms over time
    Description
    Change in symptoms as measured by the Hamilton Depression Rating Scale (HDRS-17; range 0-52) from pre- to post-treatment.
    Time Frame
    Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
    Title
    Change in anxiety symptoms over time
    Description
    Change in symptoms as measured by the Hamilton Anxiety Rating Scale (HAM-A); range 0-56) from pre- to post-treatment.
    Time Frame
    Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
    Title
    Changes in illness severity and improvement over time
    Description
    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.)
    Time Frame
    Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
    Title
    Change in the severity of PTSD symptoms over time.
    Description
    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.)
    Time Frame
    Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
    Title
    Changes in suicidal ideation and depressive symptoms over time.
    Description
    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.
    Time Frame
    each treatment session (weeks 2-10)
    Title
    Change in the ability to experience pleasure over time.
    Description
    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).
    Time Frame
    Baseline, at 5 weeks (midpoint), posttreatment at 10 weeks, follow up at 3 months from last session
    Title
    Change in the ability to feel social pleasure over time
    Description
    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).
    Time Frame
    Baseline, at 5 weeks (midpoint), posttreatment at 10 weeks, follow up at 3 months from last session
    Title
    Change in people's experiences of music as a reward over time.
    Description
    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)
    Time Frame
    Baseline, at 5 weeks (midpoint), posttreatment at 10 weeks, follow up at 3 months from last session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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