Music Therapy + CBT for Pediatric Anxiety

Overseen By Daniel S Pine, M.D.

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Mental Health (NIMH)

Must not be taking: Psychotropic medications

Disqualifiers: Other mental health, serious medical, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether combining music therapy with cognitive behavioral therapy (CBT) benefits children with anxiety disorders more than CBT alone. The new approach, gaze-contingent music reward therapy (GCMRT), uses music that responds to participants' gaze on images, potentially enhancing therapy effectiveness. Children and teens aged 8 to 17 with separation anxiety, generalized anxiety, or social anxiety, who are not on medication and can attend in-person sessions, may be suitable candidates. Participants will attend weekly sessions for 12 weeks, involving both therapy types, and complete tasks and questionnaires. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any psychotropic medications to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Gaze-Contingent Music Reward Therapy (GCMRT) was well-tolerated in past studies. These studies did not find any major side effects, suggesting the therapy is safe for children with anxiety disorders. GCMRT involves computer tasks where music plays or stops based on the child's gaze. This method has shown promise in reducing anxiety symptoms without causing harm. The therapy is currently in a Phase 2 trial, indicating that earlier testing demonstrated some level of safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Gaze-Contingent Music Reward Therapy (GCMRT) for pediatric anxiety because it offers a novel approach by integrating music therapy with cognitive behavioral therapy (CBT). Unlike traditional treatments like medication or standard CBT alone, GCMRT uniquely uses music as a reward mechanism that stops when children focus on negative emotions, encouraging them to shift their attention. This method leverages the engaging power of music to potentially enhance emotional regulation and resilience in young patients, promising a more interactive and enjoyable treatment experience.

What evidence suggests that GCMRT combined with CBT might be an effective treatment for pediatric anxiety?

Research has shown that Gaze-Contingent Music Reward Therapy (GCMRT) could help treat anxiety in children when combined with cognitive behavioral therapy (CBT). In earlier studies, GCMRT led to greater reductions in social anxiety symptoms compared to a group that did not receive this therapy. In this trial, researchers will assign participants to different arms to evaluate GCMRT's effectiveness. The active form of the therapy pairs music with visual tasks, rewarding children when they look away from negative images, while the sham condition plays music continuously. This approach aims to change how children focus their attention, potentially lowering anxiety. Although still under study, early results are promising for helping young people manage anxiety better. ^{1 3 4 6 7}

Who Is on the Research Team?

Daniel S Pine, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Are You a Good Fit for This Trial?

This trial is for children aged 8 to 17 with separation, generalized, or social anxiety disorder. They must already be part of protocol 01-M-0192 and can commit to weekly clinic visits for CBT sessions and computer-based tasks over a period of about 13 weeks.

Inclusion Criteria

All subjects will have IQ>70 as assessed by a WASI or assessment by trained clinical staff which will have occurred under Protocol 01-M-0192

Subjects must speak, read and write English to be able to participate

I am between 8 and 17 years old.

Exclusion Criteria

Any serious medical conditions

Any mental health diagnosis aside from an anxiety disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)

I am currently taking medication for mental health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial CBT Treatment

Participants receive Cognitive Behavioral Therapy (CBT) once a week for 4 weeks

4 weeks

4 visits (in-person)

GCMRT and CBT Treatment

Participants receive CBT and one of two types of Gaze-Contingent Music Reward Therapy (GCMRT) for 8 weeks

8 weeks

8 visits (in-person)

Final Assessment

Participants complete final questionnaires and research tasks

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gaze-Contingent Music Reward Therapy

Trial Overview The study tests if adding Gaze-Contingent Music Reward Therapy (GCMRT) to Cognitive Behavioral Therapy (CBT) is more effective than CBT alone in treating pediatric anxiety. Participants will engage in both therapies with regular questionnaires and tasks tracking their progress.

How Is the Trial Designed?

Group I: Active-GCMRT Active Control 1 Intervention

In the active form of the therapy, music stops when subjects view negative valence faces.

Group II: Sham-GCMRT Placebo Group 1 Intervention

In the control condition, music plays continuously.

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH)

Lead Sponsor

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Music therapy and music medicine have been shown to have positive effects on children and adolescents with various psychiatric disorders, including mood/anxiety disorders and substance abuse, highlighting their potential as effective treatment options.

The article discusses the need for further research to better understand the mechanisms of action and to strengthen the evidence base for music therapy in psychiatric treatment, while also providing practical suggestions for healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy and music medicine for children and adolescents. Yinger, OS., Gooding, L.[2022]

Active music therapy, when integrated with cognitive-behavioral therapy (CBT) group counseling, effectively reduced academic anxiety in participants after two weeks of treatment.

The study utilized a quasi-experimental design with repeated measures, indicating that the positive effects of the therapy were observed not only immediately after treatment but also during follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral-Active Music Pastoral Therapy for Millennials' Academic Anxiety: How & Why? Situmorang, DDB.[2021]

The Music Attentiveness Screening Assessment (MASA) shows promise in measuring auditory attention in children aged 5 to 9, with a significant correlation to established auditory attention measures, indicating its potential utility in clinical settings.

Test-retest reliability for the MASA was moderately high for one item (r = .84) but lower for another (r = .63), suggesting that while MASA can assess attention, further refinement and validation are needed for consistent results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Construct validity and reliability of the Music Attentiveness Screening Assessment (MASA). Waldon, EG., Broadhurst, E.[2019]

Exposure therapy significantly reduced phobia symptoms in participants with spider phobia compared to progressive muscle relaxation, indicating its effectiveness as a treatment.

Higher reward sensitivity, reflected in brain activation patterns during reward anticipation, was associated with better outcomes in exposure therapy, suggesting that individual differences in reward processing can influence treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The predictive value of neural reward processing on exposure therapy outcome: Results from a randomized controlled trial. Papalini, S., Lange, I., Bakker, J., et al.[2019]

Gaze-contingent music reward therapy (GC-MRT) was found to be as effective as a selective serotonin reuptake inhibitor (SSRI) in reducing symptoms of social anxiety disorder in a study involving 105 adults over 12 weeks.

GC-MRT uniquely reduced participants' attention to threatening stimuli, indicating it may help modify attention biases associated with social anxiety, making it a promising alternative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention Bias Modification Treatment Versus a Selective Serotonin Reuptake Inhibitor Or Waiting List Control for Social Anxiety Disorder: A Randomized Clinical Trial. Arad, G., Azriel, O., Pine, DS., et al.[2023]

Gaze-Contingent Music Reward Therapy (GC-MRT) was found to be feasible and acceptable for treating anxiety in children aged 7 to 10, with all 12 participants completing the 8-session therapy.

Clinician and parent reports indicated significant reductions in anxiety symptoms after treatment, although children's self-reports did not show significant changes, suggesting the need for further testing in randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaze-Contingent Music Reward Therapy for Clinically Anxious 7- to 10-Year-Olds: An Open Multiple Baseline Feasibility Study. Linetzky, M., Kahn, M., Lazarov, A., et al.[2021]

A randomized controlled trial with 40 patients showed that gaze-contingent music reward therapy significantly reduced symptoms of social anxiety disorder compared to a control condition, with effects maintained at a 3-month follow-up.

The therapy not only decreased dwell time on threatening faces during treatment but also generalized to other threatening stimuli, indicating its potential effectiveness in altering attentional biases in social anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial. Lazarov, A., Pine, DS., Bar-Haim, Y.[2018]

In a study involving 126 mechanically ventilated patients in intensive care units, preferred music playlists were analyzed to understand their impact on managing anxiety through patient-directed music listening interventions.

The findings highlight the importance of music selection in therapeutic interventions, suggesting that involving a board-certified music therapist can enhance the effectiveness of music listening protocols in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial. Heiderscheit, A., Johnson, K., Chlan, LL.[2023]

A study of 788 university students identified six main reasons for listening to music, with Anxiety Sensitivity (AS) linked to using music for Coping and Conformity, which help relieve negative emotions.

The findings suggest that individuals with higher AS may use music as a tool for emotional regulation, highlighting the potential for music therapy to support those at risk for anxiety and related mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons for Listening to Music Vary by Listeners' Anxiety Sensitivity Levels. Pridy, CB., Watt, MC., Romero-Sanchiz, P., et al.[2022]

Citations

1. osf.io osf.io/tywuk/resources

Gaze-Contingent Music Reward Therapy Augmentation of ... This randomized controlled trial will compare the efficacy of Gaze-Contingent Music Reward Therapy (GCMRT) vs. a control form of GCMRT, both added to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7646125/

Gaze-Contingent Music Reward Therapy for Clinically ... Attention bias modification treatment augmenting effects on cognitive behavioral therapy in children with anxiety: Randomized controlled trial.

3. ctv.veeva.com ctv.veeva.com/study/gaze-contingent-music-therapy-augmentation-of-cbt-for-pediatric-anxiety

Gaze-Contingent Music Therapy Augmentation of CBT for ... Study Description: This study compares the efficacy of Gaze-Contingent Music Reward Therapy (GCMRT) and a control form of GCMRT, both added to concurrent ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-2-gaze-contingent-music-therapy-augmentation-cbt-pediatric-anxiety-trial-nct06595953

Gaze-Contingent Music Therapy Augmentation of CBT ... Benefits: Participation in this study may help improve the understanding and treatment of anxiety disorders in children and teenagers. If the combination of ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28103714/

Gaze-Contingent Music Reward Therapy for Social Anxiety ... Results: Gaze-contingent music reward therapy yielded greater reductions of symptoms of social anxiety disorder than the control condition ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06595953/gaze-contingent-music-therapy-augmentation-of-cbt-for-pediatric-anxiety

Gaze-Contingent Music Therapy Augmentation of CBT for ... This study compares the efficacy of Gaze-Contingent Music Reward Therapy (GCMRT) and a control form of GCMRT, both added to concurrent therapy.

7. researchgate.net researchgate.net/publication/312587373_Gaze-Contingent_Music_Reward_Therapy_for_Social_Anxiety_Disorder_A_Randomized_Controlled_Trial

Gaze-Contingent Music Reward Therapy for Social Anxiety ... Results: Gaze-contingent music reward therapy yielded greater reductions of symptoms of social anxiety disorder than the control condition ...