Feasibility and preliminary effectiveness of behavioral activation for cancer patients with depression

Background Behavioral activation (BA) is a psychotherapy that directly approaches patients’ most valued daily activities. BA may be particularly useful for treating depression in patients with cancer, but there is insufficient evidence in this population. This study aimed to verify the feasibility and preliminary effectiveness of BA for patients with depression with all types and stages of cancer. Methods This pre–post study without a control group was conducted in patients with cancer and depression. The program completion rate was compared with those of previous studies to verify feasibility. To examine the preliminary effectiveness of BA, outcomes were evaluated four times: before and immediately after the program, and 2 weeks and 3 months after the program ended. The primary outcome was the remission rate of depression determined using a binomial test and the 17-item version of the GRID Hamilton Rating Scale for Depression (HAMD17). Secondary outcomes were self-reported depression, anxiety, quality of life, changes in behavior, values, and perceived reward of activity and environmental factors. Pre- and post-program data were compared using paired-samples t-tests, and data obtained at four time points were analyzed using one-way repeated measures analysis of variance. Hedge’s g was computed for calculating effect sizes. Results Participants were recruited from February 2018 to January 2022. Of the 68 patients who were initially recruited, 32 were registered. The completion rate was 75% (24/32), which was similar to previous studies. The total HAMD17 score significantly improved after the program with large effect sizes (Hedge’s g =1.95). The remission rate of depression was 62.5% (20/32), which was above the defined threshold value (30%). All but two secondary outcomes significantly improved after the program (p<0.05). Conclusions This study suggested the feasibility and preliminary effectiveness of BA for patients with depression. To establish further evidence for the use of BA in patients with cancer, randomized controlled trials are needed. Trial Registration University Hospital Medical Information Network (UMIN CTR) UMIN000036104. Registered 6 March 2019 - Retrospectively registered, [https://center6.umin.ac.jp/cgi-open-bin/ctr\_e/ctr\_view.cgi?recptno=R000041129][1] ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial UMIN000036104 ### Funding Statement This study was supported by the JSPS KAKENHI (grant number JP 18K15405), Project Mirai Cancer Research Grants, the Pfizer Health Research Foundation, and the Foundation for Promotion of Cancer Research in Japan. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was approved by the National Cancer Center Institutional Review Board (approval number, 2017-276) in Japan. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present work are contained in the manuscript. * BA : behavioral activation HAMD17 : 17-item version of the GRID Hamilton Rating Scale for Depression CBT : cognitive behavioral therapy MMSE : Mini-Mental State Examination PS : performance status BDI-II : Beck Depression Inventory-II GAD-7 : Generalized Anxiety Disorder-7 FACT-G : Functional Assessment of Cancer Therapy-General BADS-SF : Behavioral Activation for Depression Scale-Short Form VQ : Valuing Questionnaire VQ-P : Valuing Questionnaire Progress VQ-O : Valuing Questionnaire Obstruction RPI : Reward Probability Index SD : standard deviation IQR: interquartile range NCCH : National Cancer Center Hospital [1]: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041129