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

Trial Summary

What is the purpose of this trial?

Background: Anxiety disorders are becoming more common among children and teenagers. Anxiety can lead to long-term physical and mental problems, such as depression. Treatments for anxiety disorders include medications as well as cognitive behavioral therapy (CBT); CBT is a form of talking therapy. Both approaches work in only about 50 percent of cases. A new approach, called gaze-contingent music reward therapy (GCMRT), may help. Objective: To find out whether GCMRT combined with CBT is more effective than CBT alone. Eligibility: Children aged 8 to 17 years with separation anxiety disorder; generalized anxiety disorder; or social anxiety disorder. They must be enrolled in protocol 01-M-0192. Design: Participants will come to the clinic once a week for 4 weeks for CBT. Sometimes the participant will meet with the doctor alone; sometimes their parent may be present. They will do some computer-based tasks: They may be asked to push a button when a target appears; they may look at pictures of faces while the computer tracks their eye movements. Participants will take questionnaires each week. They will answer questions about their anxiety symptoms, feelings, and behavior. For the next 8 weeks, participants will participate in both CBT and 1 of 2 types of GCMRT. GCMRT is a computer-based task. Participants will look at pictures with many faces in them; while they do this, pleasant music will play and stop playing over a 12-minute period. Participants will have a final visit in week 13. They will take questionnaires. They will do final research tasks. Each visit lasts about 2 hours....

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Gaze-Contingent Music Reward Therapy for pediatric anxiety?

Research shows that Gaze-Contingent Music Reward Therapy (GC-MRT) is feasible and acceptable for young children with anxiety disorders, with significant reductions in anxiety symptoms reported by parents and clinicians after treatment. However, more studies are needed to confirm its effectiveness, as child-reported anxiety did not change significantly. ^{1 2 3 4 5}

Is Gaze-Contingent Music Reward Therapy safe for children with anxiety?

The available research on Gaze-Contingent Music Reward Therapy (GC-MRT) for children with anxiety disorders suggests that it is generally safe. In a study involving 12 children aged 7 to 10, all participants completed the therapy without any reported safety concerns. ^{1 2 3 6 7}

How is Music Therapy + CBT for Pediatric Anxiety different from other treatments?

Music Therapy + CBT for Pediatric Anxiety is unique because it combines music therapy, which uses music to improve mental health, with cognitive behavioral therapy (CBT), a method that helps change negative thought patterns. This combination offers a novel approach by integrating the emotional and cognitive benefits of music with the structured problem-solving techniques of CBT, which is different from standard drug treatments or therapies that focus on only one method. ^{1 2 3 8 9}

Research Team

Daniel S Pine, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Gaze-Contingent Music Reward Therapy for Clinically Anxious 7- to 10-Year-Olds: An Open Multiple Baseline Feasibility Study. [2021]

3. United States 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The predictive value of neural reward processing on exposure therapy outcome: Results from a randomized controlled trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Reasons for Listening to Music Vary by Listeners' Anxiety Sensitivity Levels. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Construct validity and reliability of the Music Attentiveness Screening Assessment (MASA). [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Music therapy and music medicine for children and adolescents. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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