Posttraumatic Stress DisorderNCT05057624
Gaze-Contingent Music Reward Treatment for PTSD
A study testing GC-MRT and Exposure in people with Posttraumatic Stress Disorder, run by Research Foundation for Mental Hygiene, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- GC-MRT and Exposure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Placebo GC-MRT, GC-MRT, Exposure
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo GC-MRTOther
Also called Control
Participants will hear music continuously throughout the trials, without regard to the faces they look at.
GC-MRTOther
Participants will hear music as a reward for looking at neutral faces and the music will stop when they focus on angry faces.
ExposureOther
Also called GC-MRT-Exp
Participants will hear music of their choice when they focus on angry faces, and when they look at neutral faces the music will stop.
| Study group | Role | What they receive |
|---|---|---|
| non-GC-MRT | Placebo comparator | Placebo- music will play at all times during the trials. Receives: 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. Receives: 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. Receives: Other: Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.)
Measured: 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.)
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: Baseline, at 5 weeks (midpoint), posttreatment at 10 weeks, follow up at 3 months from last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Apr 2022 (estimated)
- Primary completion14 Sep 2024 (estimated)
- Study completion14 Mar 2025 (estimated)
Why it stopped: Due to a lack of funding, this study was not initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057624
- Sponsor's protocol ID
- # 7960
- Status last verified
- Feb 2025
- First submitted
- 31 Aug 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaze-Contingent Music Reward Treatment (GC-MRT) for PTSD
- ClinicalTrials.gov ID
- NCT05057624
- Acronym / sponsor ID
- # 7960
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to a lack of funding, this study was not initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 14 Sep 2024 (estimated)
- Study completion
- 14 Mar 2025 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-GC-MRT | Placebo comparator | Other: Placebo GC-MRTPlacebo- music will play at all times during the trials. |
| GC-MRT | Active comparator | Other: GC-MRTMusic will only play when participants view angry faces and will stop when they look at neutral faces. |
| GC-MRT-exp | Experimental | Other: ExposureMusic will only play when participants look at neutral faces and will stop when they view angry faces. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo GC-MRTAlso: ControlParticipants will hear music continuously throughout the trials, without regard to the faces they look at. | Other | non-GC-MRT |
| GC-MRTParticipants will hear music as a reward for looking at neutral faces and the music will stop when they focus on angry faces. | Other | GC-MRT |
| ExposureAlso: GC-MRT-ExpParticipants will hear music of their choice when they focus on angry faces, and when they look at neutral faces the music will stop. | Other | GC-MRT-exp |
Primary outcome
Change in PTSD symptoms over time
Time frame: Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
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
Time frame: Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
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
Time frame: Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
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
Time frame: Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
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.
Time frame: Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
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.
Time frame: each treatment session (weeks 2-10)
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.
Time frame: Baseline, at 5 weeks (midpoint), posttreatment at 10 weeks, follow up at 3 months from last session
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
Time frame: Baseline, at 5 weeks (midpoint), posttreatment at 10 weeks, follow up at 3 months from last session
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.
Time frame: 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 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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing GC-MRT and Exposure in people with Posttraumatic Stress Disorder, run by Research Foundation for Mental Hygiene, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms over time (time frame: Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.