Behavioral activation for depression in patients with advanced cancer: study protocol for a multicenter randomized controlled trial.

BACKGROUND: Though behavioral activation (BA) has been shown to be effective for depression, evidence in patients with advanced cancer has not been established. This study aimed to examine the effectiveness of a BA program on depression in this population. METHODS: A randomized controlled trial with a wait-list control group (waiting group) of 38 patients with advanced cancer and depression will be conducted at three sites in Japan. The BA program consists of seven sessions. Outcome measures will be evaluated at three times in the intervention group; at the entry, at the end of the intervention and 4 months after the end of the intervention and four times in the waiting group: at the entry, before the intervention, at the end of the intervention, and 4 months after the end of the intervention. Primary outcome is Beck Depression Inventory-II (BDI-II) score. To examine the main effect of the intervention, two-way repeated measures analysis of variance (ANOVA) will be conducted, with timing and intervention status as the independent variables and BDI-II score as the dependent variable. One-way repeated measures ANOVA will be conducted to combine data from the intervention and control groups and examine changes in BDI-II scores by timing in both groups. Secondary endpoints (anxiety, quality of life, spirituality, degree of behavioral activation, value, and pain) will be evaluated with rating scales. Two-way repeated measures ANOVA will be conducted to examine whether there are differences between the groups before and after the intervention, with timing and intervention status as the independent variables and scores on each rating scale as the dependent variables. DISCUSSION: This multicenter randomized controlled trial is the first study to assess the effectiveness of BA on depression in patients with advanced cancer. Our findings will provide evidence about the effectiveness of BA on depression and provide an intervention option that is acceptable and feasible for the treatment of depression in this population. The results of this study will lead to improved mood and rebuilding to regain life purpose and value in this vulnerable population. TRIAL REGISTRATION NUMBER: jRCT, jRCT1030210687, Registered 22 March 2022, https://jrct.niph.go.jp/en-latest-detail/jRCT1030210687 .

Validity and reliability of the Japanese version of the Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE) questionnaire.

OBJECTIVE: The purpose of this study was to investigate the validity and reliability of the Japanese version of the Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire (PEACE-J) and to evaluate the association between the PEACE subscales and Japanese patient characteristics. METHODS: A cross-sectional web-based survey was conducted among 412 patients with cancer. This survey assessed medical and demographic factors, such as the PEACE, the Coping Inventory for Stressful Situations (CISS), and the Functional Assessment of Chronic Illness Therapy - Spiritual well-being (FACIT-Sp). The forward-backward translation method was used to develop the PEACE-J. The validity of PEACE-J was evaluated by exploratory and confirmatory factor analysis, and correlation analysis between each subscale of PEACE and FACIT-Sp and CISS. The Cronbach's α and the item-total correlation of each subscale of the PEACE questionnaire were calculated to assess internal consistency reliability. RESULTS: The factor analysis yielded two subscales corresponding to the original version: Cronbach's α coefficients were 0.84 and 0.86 for the Peaceful Acceptance of Illness subscale and the Struggle with Illness subscale, respectively. The PEACE subscales and the FACIT-Sp subscales and the CISS subscales were moderately associated with each other, including the Peaceful Acceptance to each subscale of FACIT (r = 0.22-0.55, p < 0.01); and the Peaceful Acceptance and the Struggle with Illness to CISS emotion-oriented coping (r = -0.36 and r = 0.45, p < 0.01, respectively). Married patients showed higher levels of peaceful acceptance than unmarried patients (p < 0.001). Poorer performance status, chemotherapy use, and recurrence or metastasis were significantly associated with higher levels of struggle with illness (p < 0.001). SIGNIFICANCE OF RESULTS: This study indicated that the PEACE-J is a valid and reliable measure of the patient's sense of acceptance, calmness or equanimity, and peace, as well as their sense of struggle or desperation concerning their illness.

The mediating effect of activity restriction on the relationship between perceived physical symptoms and depression in cancer survivors.

PURPOSE: Several studies have explored factors causing depression in cancer survivors, including perceived physical symptoms. Another critical factor in the depression symptomatology of cancer survivors is activity restriction (AR). We investigated how AR mediate the effects of perceived pain and fatigue on depression in cancer survivors. METHODS: Cancer survivors (n = 61; mean age 56.16 years) that were recruited through cancer support groups in Japan participated in this study. Participants completed a battery of questionnaires comprising demographic and clinical information, the Pain Catastrophizing Scale, the Cancer Fatigue Scale, the Activity Restriction Scale for Cancer Patients, and the Hospital Anxiety and Depression Scale. RESULTS: Mediation analysis indicated that AR partially mediates the effect of pain on depression. Direct paths from pain to AR, AR to depression, and pain to depression were significant (P < .005). Moreover, indirect paths from pain to AR, AR to depression, and pain to depression were also significant at the 95% level [0.04-0.13]. However, AR did not mediate the effect of fatigue on depression, and fatigue had a significant direct path to both AR and depression (P < .005). CONCLUSION: This study aimed to explore the mediating effect of AR in the relationships of perceived pain and fatigue and depression in cancer survivors. We found that AR mediates perceived pain to depression, however not for perceived fatigue. In addition, because AR was experienced in the face of any survivorship period, AR may need to be treated as a long-term effect of the cancer diagnosis.

Psychological treatments for mental health symptoms associated with COVID-19 infection: A scoping review.

The aim of this scoping review was to synthesize published studies and ongoing clinical trials of psychological interventions for mental health problems associated with COVID-19 infection. The study protocol was developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Extension for Scoping Reviews. We conducted systematic searches for studies published or registered between January 2020 and October 2022 using eight scientific databases and clinical trial registries, which identified 40 complete published studies and 53 ongoing clinical trials. We found that most studies were randomized controlled trials (74%) while the remaining used study designs of lower methodological quality. Most studies investigated interventions for acute COVID-19 patients (74%) and others explored post-COVID conditions (PCC) or recovered patients. Cognitive and behavioral therapies were the main intervention approaches (31%), followed by multidisciplinary programs (21%) and mindfulness (17%). The most frequently evaluated outcomes were anxiety (33%), depression (26%), quality of life (13%), and insomnia (10%). No studies on youths, older people, or marginalized communities were found. These findings summarize the burgeoning research on a range of psychological interventions for individuals infected with COVID-19. However, the field is in its infancy and further research to develop an evidence base for targeted care is necessary. The gaps identified in the current study also highlight the need for more research on youths, older people, and members of marginalized communities, and PCC patients. It is important to ascertain interventions and delivery strategies that are not only effective and affordable but also allow high scalability and accessibility.

Psychological treatments for the mental health symptoms among individuals infected with COVID-19: a scoping review protocol.

INTRODUCTION: Mental health symptoms such as depression, anxiety and sleep problems are commonly observed in individuals suffering from acute COVID-19 infection to post-COVID-19 syndrome. Studies have provided preliminary evidence for the efficacies of cognitive behavioural therapy, mindfulness-based interventions, acceptance and commitment therapy, and many other treatments for this population. Although there have been attempts to synthesise the literature on these psychological interventions, previous reviews have been limited in terms of the sources, symptoms and interventions that they included. Furthermore, most studies reviewed were conducted in early 2020, when COVID-19 had only recently been classified as a global pandemic. Since then, substantial research has been conducted. As such, we sought to provide an updated synthesis of the available evidence of treatments for the range of mental health symptoms associated with COVID-19. METHODS AND ANALYSIS: This scoping review protocol was developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Systematic searches were carried out on scientific databases (PubMed, Web of Science, PsycINFO and Scopus) and clinical trial registries (ClinicalTrials.gov, WHO ICTRP, EU Clinical Trials Register and Cochrane Central Register of Controlled Trials) to identify studies that have or will assess the efficacy or any aspects of psychological treatment for acute to post-COVID-19 syndrome. The search was conducted on 14 October 2022 and identified 17 855 potentially eligible sources/studies published since 1 January 2020 (duplicates removed). Six investigators will independently carry out titles and abstract screening, full-text screening and data charting and the results will be summarised using descriptive statistics and narrative synthesis. ETHICS AND DISSEMINATION: Ethical approval is not required for this review. The results will be disseminated through a peer-reviewed journal, conference presentations and/or academic newspapers. This scoping review has been registered with Open Science Framework (https://osf.io/wvr5t).