Music Therapy + CBT for Pediatric Anxiety

Recruiting in Palo Alto (17 mi)

Overseen by Daniel S Pine, M.D.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: National Institute of Mental Health (NIMH)

Must not be taking: Psychotropic medications

Disqualifiers: Other mental health, serious medical, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

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}

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.

Trial 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 (Behavioural Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

National Institutes of Health Clinical Center Bethesda, MD

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH) Lead Sponsor

References

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

Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial. [2018] Patients with social anxiety disorder exhibit increased attentional dwelling on social threats, providing a viable target for therapeutics. This randomized controlled trial examined the efficacy of a novel gaze-contingent music reward therapy for social anxiety disorder designed to reduce attention dwelling on threats.

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] This multiple-baseline open pilot trial examined feasibility, compliance, acceptability, and preliminary indices of efficacy of Gaze-Contingent Music Reward Therapy (GC-MRT) for anxious 7- to 10-year-old children. GC-MRT is a novel therapy for anxiety disorders that relies on eye-tracking technology and operant conditioning principles to divert attention toward neutral over threat stimuli, with music serving as a reward. Using a multiple-baseline design, 12 children (M age&#160;=&#160;8.3&#160;years, SD&#160;=&#160;.72, range&#160;=&#160;7-10; 4 girls) with social anxiety disorder, generalized anxiety disorder, or separation anxiety disorder received 8 therapy sessions. Clinical status was determined via semistructured interviews and questionnaires. Patients were randomized to wait 1, 3, or 5&#160;weeks between initial assessment and beginning of therapy. Self-reported anxiety was recorded weekly, and comprehensive clinical assessments were obtained pre- and posttreatment. All 12 patients completed the full course of GC-MRT within the allocated therapy period. Therapy credibility rates were moderate to high as reported by both children and parents. Clinician-rated anxiety levels remained consistent during baseline measurement and decreased significantly following treatment. Parent-reports also yielded significant reductions in child anxiety symptoms from pre- to posttreatment. However, child-reported anxiety did not change significantly. The results provide preliminary evidence for feasibility, acceptability, and efficacy of GC-MRT for young children with anxiety disorders. Efficacy should now be tested in randomized controlled trials.

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] Social anxiety disorder is common and impairing. The efficacy of pharmacotherapy is moderate, highlighting the need for alternative therapies. This study compared the efficacy of gaze-contingent music reward therapy (GC-MRT), an eye-tracking-based attention bias modification treatment, with a selective serotonin reuptake inhibitor (SSRI) treatment or a waiting list control condition in reducing social anxiety disorder symptoms. Superior clinical effects of similar magnitude were expected for the active treatments relative to the control condition.

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] Exposure is the gold standard treatment for phobic anxiety and is thought to represent the clinical application of extinction learning. Reward sensitivity might however also represent a predictive factor for exposure therapy outcome, as this therapy promotes positive experiences and involves positive comments by the therapist. We hypothesized that high reward sensitivity, as expressed by elevated reward expectancy and reward value, can be associated with better outcome to exposure therapy specifically.

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

Reasons for Listening to Music Vary by Listeners' Anxiety Sensitivity Levels. [2022] Listening to music aids regulation of emotional arousal and valence (positive vs. negative). Anxiety sensitivity (AS; fear of arousal-related sensations) increases the risk for emotion dysregulation and associated coping behaviors such as substance use and exercise avoidance. The relationship between AS and music listening, however, has received very little attention. This study (1) used exploratory factor analysis of 53 items drawn from three previously validated measures of reasons for music listening to identify the core reasons for listening to music among university students and (2) explored associations between AS and reasons for music listening. Undergraduates (N = 788; 77.7% women; Mage = 19.20, SDage = 2.46) completed the Anxiety Sensitivity Index-3, Motives for Listening to Music Questionnaire, Barcelona Musical Reward Questionnaire, and Brief Music in Mood Regulation Scale. Six core reasons for music listening were identified: Coping, Conformity, Revitalization, Social Enhancement, Connection, and Sensory-Motor. Over and above age and gender, AS was associated with Coping and Conformity-reasons that involve relief from aversive emotions. AS also was associated with listening for Connection reasons. AS was not associated with Revitalization, Social Enhancement, or Sensory-Motor-reasons that involve rewards such as heightened positive emotions. Results suggest that individual differences may influence why people incorporate music listening into their day-to-day lives. Further longitudinal and experimental research is needed to establish directionality and causality in the observed relationship of AS to relief-oriented reasons for music listening. Findings may guide music therapists' efforts to tailor treatment for individuals at risk for anxiety and related mental health problems.

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] Objective: Music listening interventions are utilized in a wide variety of clinical settings to help patients manage stress, anxiety, pain, discomfort, as well as attendant influences on sedative exposure, delirium, and cognitive functioning. While the body of research regarding the use of music-based listening interventions continues to grow, there is a paucity of information in the literature about specific music used for listening interventions. The purpose of this secondary analysis is to examine the music that study participants identified as their preferred music and listened to during the study. Design: This secondary analysis is based on data from a parent study, which was a three-arm randomized controlled trial attesting a patient-directed music (PDM) listening protocol to manage the psychophysiological symptom of anxiety. Setting: Twelve intensive care units in a major metropolitan area in the United States. Subjects: Participants included the 126 mechanically ventilated patients enrolled and randomized to the PDM listening arm of the study. Results: Data presented in this study include playlists from the 12 genres patients self-identified as preferred with specific groups and artists requested for music listening during the study. Discographies of the playlists are also included. Conclusions: The efficacy of interventions is impacted by the design of the intervention and the selection of music utilized. Implications of this analysis further explore the role of a board-certified music therapist (MT-BC) in designing and implementing a music listening intervention. The specialized knowledge on the therapeutic use and benefits of music that an MT-BC possesses supports the development of quality study intervention and appropriate implementation. The review of the music utilized in the parent study provides detailed information about the music utilized to inform future research focused on music listening interventions to effectively build on previous studies. Clinical Trial Registration: ClinicalTrials.gov NCT00440700.

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

Construct validity and reliability of the Music Attentiveness Screening Assessment (MASA). [2019] Music as alternate engagement (MAE) can be used effectively to distract children during painful or anxiety-provoking medical procedures. For such interventions to be successful, it would seem important to assess the degree to which a child can attend to musical stimuli.

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

Music therapy and music medicine for children and adolescents. [2022] This article summarizes the research on music therapy and music medicine for children and adolescents with diagnoses commonly treated by psychiatrists. Music therapy and music medicine are defined, effects of music on the brain are described, and music therapy research in psychiatric treatment is discussed. Music therapy research with specific child/adolescent populations is summarized, including disorders usually diagnosed in childhood, substance abuse, mood/anxiety disorders, and eating disorders. Clinical implications are listed, including suggestions for health care professionals seeking to use music medicine techniques. Strengths and weaknesses of music therapy treatment are discussed, as well as areas for future research.

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

Cognitive Behavioral-Active Music Pastoral Therapy for Millennials' Academic Anxiety: How & Why? [2021] This study used quasi-experimental design with repeated measures (pre-test, post-test, and follow-up). Based on the post-test and the follow-up comparison, active music therapy was effective in reducing academic anxiety after two weeks of the treatment. Active music therapy which are integrated in CBT group counseling not only can overcome individual problems, but the therapies can also help individuals analyze their own thoughts and behavior.