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.

Depression as a risk factor for cancer: from pathophysiological advances to treatment implications.

Innate immune activation and inflammation have been posited to play a role in the pathophysiology of both depression and neoplastic growth. Cancer patients experience a threefold higher rate of depression than the general population within the first five years of diagnosis. Chronic depression is associated with increased cancer risk and shortened survival. Although the precise cellular and molecular mechanisms of this bidirectional relationship remain unclear, elevated concentrations of circulating plasma proinflammatory cytokines associated with depression may mediate the neuroendocrine, neural, and immune pathways that account for the relationship. Proinflammatory cytokines, in turn, are known to modulate key neurobiological correlates of depression including hypothalamic-pituitary-adrenal (HPA) axis dysregulation, monoamine neurotransmitter metabolism, and limbic system activity. Research is needed to determine whether optimal depression treatment improves cancer survival and to develop antidepressant strategies that target molecular and cellular mechanisms mediating inflammation and the neurobiological pathways influenced by the proinflammatory cytokines.

Cancer and post-traumatic stress disorder: diagnosis, pathogenesis and treatment considerations.

OBJECTIVE: The purpose of this article was to review the literature regarding diagnosis, pathogenesis, and treatment of post-traumatic stress disorder (PTSD) associated with cancer. METHOD: We surveyed studies examining the validity of diagnostic scales commonly used to measure PTSD in patients with cancer. Neurobiological underpinnings of PTSD and cancer, including inflammation as the physiological mechanism linking these comorbidities, were examined. Psychopharmacologic and psychotherapeutic treatment of PTSD symptoms in patients with cancer was reviewed. In addition, potential drug-drug interactions between psychotropic medications commonly used to treat PTSD and anti-cancer agents were reviewed. RESULTS: Multiple studies demonstrated the validity of the PTSD Checklist Civilian Version (PCL-C) in diagnosing PTSD in patients with cancer. Research has shown that PTSD as defined in DSM-IV appears to be a better model for conceptualizing distress in patients with cancer than a generalized "distress" model. Epidemiologic studies have shown an increased incidence of PTSD associated with cancer; however, literature regarding characteristics of PTSD in patients with cancer is cross-sectional in nature. SIGNIFICANCE OF RESULTS: Future research focusing on longitudinal, prospective studies to identify patients at risk, determine causal or aggravating factors, and develop preventive interventions is needed. Further study of PTSD in patients with cancer may help increase recognition of this disorder, optimize treatment, and enhance the quality of life of these individuals.

The relation between body fat distribution and cardiovascular risk factors in patients with schizophrenia: a cross-sectional pilot study.

BACKGROUND: Obesity has recently become a concern for physicians treating schizophrenic patients. Obesity is associated with hypertension, dyslipidemia, and diabetes mellitus. In this pilot study, we investigate which anthropometric measurement, body mass index or waist circumference, is a better predictor of cardiovascular risk factors in patients with schizophrenia. METHOD: This cross-sectional study, conducted from January 2001 to January 2002, examined body fat distribution and its relation to cardiovascular risk factors in 62 patients with schizophrenia (DSM-IV) recruited from an outpatient psychiatric clinic. RESULTS: Chi-square analysis revealed that an increased waist circumference was associated with dyslipidemia (p < .01), hypertension (p < .05), and abnormal serum glucose (p < .05), whereas an increased body mass index was only associated with dyslipidemia (p < .05). In logistic regression analysis, after controlling for age, gender, race, ethnicity, smoking, and body mass index, increased waist circumference remained significantly associated with dyslipidemia (odds ratio = 2.08, 95% CI = 1.01 to 1.15, p < .05) and hypertension (odds ratio = 2.05, 95% CI = 1.02 to 1.17, p < .05). CONCLUSIONS: Waist circumference revealed a stronger correlation than body mass index to cardiovascular risk factors in patients with schizophrenia. We propose the measurement of waist circumference as a screening tool for cardiovascular risk factors in this population. Waist circumference measurement can provide an opportunity for primary prevention of coronary heart disease and diabetes mellitus in patients with schizophrenia.

A prospective trial of sustained-release bupropion for depression in HIV-seropositive and AIDS patients.

To date, the authors know of no prospective studies of sustained-release bupropion in depressed HIV-seropositive patients. The purpose of this study was to evaluate the efficacy and tolerability of sustained-release bupropion in 20 depressed HIV-positive adult outpatients. Twenty outpatients with HIV spectrum illness, a DSM-IV-diagnosed major depressive disorder confirmed with the Structured Clinical Interview for DSM-IV, and Mini-Mental State Examination scores >20 were recruited into a 6-week, open-label, flexible-dose study of sustained-release bupropion (100-300 mg/day). Twelve patients (60%) responded to sustained-release bupropion at a mean dose of 265 mg/day. Five patients (25%) discontinued study participation secondary to adverse events. Preliminary findings suggest that sustained-release bupropion is effective for the treatment of depression in HIV-positive patients, regardless of HIV clinical staging. Furthermore, it appears to be well tolerated in patients with AIDS-related medical conditions.