Protocol for a randomized controlled trial of brief behavioral activation among older adult cancer survivors.

INTRODUCTION: As many as 35% of older adult cancer survivors (OACS; i.e., ≥65 years old) have clinically significant depression. OACS often experience fatigue, mild cognitive impairment, and increased medical comorbidities post-cancer that make them susceptible to depression. Behavioral activation (BA) is an empirically supported depression treatment in geriatric psychiatry that guides individuals to reengage in pleasurable and rewarding activities and has great potential for addressing the needs of OACS. This manuscript presents the protocol for a pilot randomized controlled trial (RCT) testing the efficacy of a brief BA intervention adapted to address the needs of OACS (BBA-OACS) by telephone and videoconference delivery. MATERIALS AND METHODS: An RCT will be conducted at Memorial Sloan Kettering Cancer Center (MSK) in New York City. Participants will be randomized to either BA as a target intervention or supportive psychotherapy (SP) as a standard of care control intervention for outpatient oncology. The target intervention includes 10 weekly sessions of BA consisting of psychoeducation about depression and the rationale for BA, life areas and values assessment, compilation of a list of enjoyable and important activities across values, activity scheduling, and self-monitoring of satisfaction and mood. The standard of care control intervention includes 10 weekly sessions of SP consisting of reassurance, guidance, encouragement, and support for patients with cancer. OACS who have a history of cancer, report elevated depressive symptoms, are fluent in English, and can communicate via telephone or videoconference will be recruited from the MSK Survivorship Clinics across all disease types. Seventy participants will be recruited for the study (10 training cases, 30 in each RCT arm). The primary aim is to evaluate implementation outcomes (i.e., acceptability, feasibility, and fidelity) of BA, relative to SP, for cancer survivorship. The secondary aim is to determine the preliminary effects of BA on depressive symptoms (primary outcome), anxiety, coping, and increased activity level (secondary outcomes) compared to SP. Participants will be asked to complete a set of three surveys pre- and post-intervention. DISCUSSION: If successful, BBA-OACS would provide frontline clinicians with an accessible, evidence-based treatment for OACS. Future research will evaluate the efficacy of BA in a larger trial and its impact on depression and other healthcare outcomes. TRIAL REGISTRATION: This study is registered under ClinicalTrials.gov (ID NCT05574127).

Telehealth-Based Music Therapy Versus Cognitive Behavioral Therapy for Anxiety in Cancer Survivors: Rationale and Protocol for a Comparative Effectiveness Trial.

BACKGROUND: Cancer survivors represent one of the fastest growing populations in the United States. Unfortunately, nearly 1 in 3 survivors experience anxiety symptoms as a long-term consequence of cancer and its treatment. Characterized by restlessness, muscle tension, and worry, anxiety worsens the quality of life; impairs daily functioning; and is associated with poor sleep, depressed mood, and fatigue. Although pharmacological treatment options are available, polypharmacy has become a growing concern for cancer survivors. Music therapy (MT) and cognitive behavioral therapy (CBT) are evidence-based, nonpharmacological treatments that have demonstrated effectiveness in treating anxiety symptoms in cancer populations and can be adapted for remote delivery to increase access to mental health treatments. However, the comparative effectiveness of these 2 interventions delivered via telehealth is unknown. OBJECTIVE: The aims of the Music Therapy Versus Cognitive Behavioral Therapy for Cancer-related Anxiety (MELODY) study are to determine the comparative effectiveness of telehealth-based MT versus telehealth-based CBT for anxiety and comorbid symptoms in cancer survivors and to identify patient-level factors associated with greater anxiety symptom reduction for MT and CBT. METHODS: The MELODY study is a 2-arm, parallel-group randomized clinical trial that aims to compare the effectiveness of MT versus CBT for anxiety and comorbid symptoms. The trial will enroll 300 English- or Spanish-speaking survivors of any cancer type or stage who have experienced anxiety symptoms for at least 1 month. Participants will receive 7 weekly sessions of MT or CBT delivered remotely via Zoom (Zoom Video Communications, Inc) over 7 weeks. Validated instruments to assess anxiety (primary outcome), comorbid symptoms (fatigue, depression, insomnia, pain, and cognitive dysfunction), and health-related quality of life will be administered at baseline and at weeks 4, 8 (end of treatment), 16, and 26. Semistructured interviews will be conducted at week 8 with a subsample of 60 participants (30 per treatment arm) to understand individual experiences with the treatment sessions and their impact. RESULTS: The first study participant was enrolled in February 2022. As of January 2023, 151 participants have been enrolled. The trial is expected to be completed by September 2024. CONCLUSIONS: This study is the first and largest randomized clinical trial to compare the short- and long-term effectiveness of remotely delivered MT and CBT for anxiety in cancer survivors. Limitations include the lack of usual care or placebo control groups and the lack of formal diagnostic assessments for psychiatric disorders among trial participants. The study findings will help guide treatment decisions for 2 evidence-based, scalable, and accessible interventions to promote mental well-being during cancer survivorship. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46281.

Examining the links between spiritual struggles and symptoms of psychopathology in a national sample.

The present study investigated the relationship between spiritual struggles and various types of psychopathology symptoms in individuals who had and had not suffered from a recent illness. Participants completed self-report measures of religious variables and symptoms of psychopathology. Spiritual struggles were assessed by a measure of negative religious coping. As predicted, negative religious coping was significantly linked to various forms of psychopathology, including anxiety, phobic anxiety, depression, paranoid ideation, obsessive-compulsiveness, and somatization, after controlling for demographic and religious variables. In addition, the relationship between negative religious coping and anxiety and phobic anxiety was stronger for individuals who had experienced a recent illness. These results have implications for assessments and interventions targeting spiritual struggles, especially in medical settings.