A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
The researchers are doing this study to compare how music therapy and cognitive behavioral therapy, given virtually, may be able to reduce anxiety in people who have had cancer. In addition, this study will see if certain factors affect how well participants respond to music therapy or cognitive behavioral therapy. For example, the researchers will see if personal characteristics (like age, sex, race, and education) and ways of thinking (like expectations of therapy) may affect how well participants respond.

Official Title
-----------------
Music Therapy vs. Cognitive-Behavioral Therapy for Cancer-related Anxiety (MELODY)

Conditions
-----------------
Survivorship

Intervention / Treatment
-----------------
* Other: Music Therapy
* Other: Cognitive Behavioral Therapy
* Other: assessments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English- or Spanish-speaking 18 years or older Prior cancer diagnosis of any type or stage Free of oncological disease, or stable disease with no evidence of progression Score of ≥8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS) Report anxiety symptoms lasting at least one month Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MT or CBT Access to Zoom and a quiet/private location Exclusion Criteria: Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted therapies are allowed). Active suicidal ideation, bipolar disorder, schizophrenia, or substance abuse Score of ≥10 indicative of cognitive impairment on the Blessed Orientation-Memory-Concentration Received a treatment course of seven or greater MT or CBT sessions for anxiety symptoms within the last six months Unable to provide informed consent for themselves

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The proposed MELODY trial is a two-arm, parallel group, randomized clinical trial (RCT) to compare the effectiveness of music therapy (M) versus cognitive behavioral therapy (CBT) for anxiety and co-morbid symptoms in a diverse, heterogeneous sample of 300 cancer survivors.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Therapy (MT)<br>MT is a non-pharmacological, evidence-based intervention, in which board-certified music therapists engage patients in personally tailored experiences with music to achieve therapeutic goals. Patients will receive a workbook with materials for each session These experiences range from music-guided relaxation to more active forms of musical engagement, including singing and improvising music. | Other: Music Therapy<br>* Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.<br>Other: assessments<br>* Participants will complete study assessments prior to randomization (week 0) and at weeks 4, 8, 16, and 26. A subgroup of 60 survivors will complete optional semi-structured interviews after treatment to understand their unique experiences with MT or CBT. All participants will be followed for 26 weeks.<br>|
| Active Comparator: Cognitive Behavioral Therapy (CBT)<br>Cognitive behavioral therapy (CBT) is an evidence-based, nonpharmacological intervention delivered by licensed mental health providers. Informed by the cognitive behavior model of anxiety, CBT focuses on the relationship between thoughts, behaviors, and emotions and how thoughts and behaviors can exacerbate or reduce anxiety. | Other: Cognitive Behavioral Therapy<br>* Participants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom.<br>Other: assessments<br>* Participants will complete study assessments prior to randomization (week 0) and at weeks 4, 8, 16, and 26. A subgroup of 60 survivors will complete optional semi-structured interviews after treatment to understand their unique experiences with MT or CBT. All participants will be followed for 26 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HADS anxiety score changes | Using the seven-item anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS). A score of ≥8 indicates presence of anxiety symptoms. | 8 weeks | 
| HADS anxiety score changes | Using the seven-item anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS). A score of ≥8 indicates presence of anxiety symptoms. | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Music Therapy, Cognitive Behavioral Therapy, Anxiety, 21-516