A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Music Therapy (MT) 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
Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.
Other: assessments
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.
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Active Comparator: Cognitive Behavioral Therapy (CBT) 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
Participants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom.
Other: assessments
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.
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Outcome Measures
Primary Outcome Measures
- HADS anxiety score changes [8 weeks]
Using the seven-item anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS). A score of ≥8 indicates presence of anxiety symptoms.
- HADS anxiety score changes [26 weeks]
Using the seven-item anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS). A score of ≥8 indicates presence of anxiety symptoms.
Eligibility Criteria
Criteria
Inclusion Criteria:
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English- or Spanish-speaking
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18 years or older
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Prior cancer diagnosis of any type or stage
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Free of oncological disease
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Score of ≥8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
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Report anxiety symptoms lasting at least one month
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Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MT or CBT
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Access to Zoom and a quiet/private location
Exclusion Criteria:
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Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted therapies are allowed).
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Active suicidal ideation, bipolar disorder, schizophrenia, or substance abuse
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Score of ≥10 indicative of cognitive impairment on the Blessed Orientation-Memory-Concentration
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Received a treatment course of seven or greater MT or CBT sessions for anxiety symptoms within the last six months
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Unable to provide informed consent for themselves
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Baptist Alliance MCI | Miami | Florida | United States | 33143 |
2 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- Patient-Centered Outcomes Research Institute
Investigators
- Principal Investigator: Jun Mao, MD, MSCE, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-516