PMID- 32518060 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20201022 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 9 IP - 9 DP - 2020 Sep 24 TI - Guided Self-Help Behavioral Activation Intervention for Geriatric Depression: Protocol for Pilot Randomized Controlled Trial. PG - e18259 LID - 10.2196/18259 [doi] LID - e18259 AB - BACKGROUND: Aging is a social concern. The increased incidence of depression in older populations in China poses a challenge to the health care system. Older adults who are depressed often suffer from a lack of motivation. Behavioral activation treatment, an evidence-based guided self-help treatment, is effective in reducing anhedonia and amotivation in depression; however, the efficacy of guided self-help behavioral activation in older adults with depression is not yet known. OBJECTIVE: The aim of this study is to pilot a self-help guided intervention for the treatment of depression in older adults. METHODS: This study has been designed as a pilot randomized controlled trial with inpatients (n=60; to be randomly allocated 1:1) between the ages of 60 and 70 and who have major depressive disorder. Patients attending clinical psychological clinics at the Mental Health Center of Chongqing will be randomized to either receive guided self-help behavioral activation (intervention) or to be on a 6-week waiting list (control). Participants in the treatment group will receive 6 sessions of guided self-help behavioral activation delivered over the telephone. The waiting list control group will receive the intervention after a period of 6 weeks. Exclusion criteria will be individuals who are at significant risk of harming themselves or others, who have a primary mental health disorder other than depression, or who have an intellectual disability that would hamper their ability to participate in the intervention. Effects of the treatment will be observed using outcomes in 3 domains: (1) clinical outcomes (symptom severity, recovery rate), (2) process variables (patient satisfaction, attendance, dropout), and (3) economic outcomes (cost and resource use). We will also examine mediators of outcomes in terms of patient variables (behavioral activation or inhibition motivation). We hypothesize that guided self-help behavioral activation will have a beneficial effect. RESULTS: The study was approved by the research ethics committee of the Mental Health Center of Chongqing in November 2019. As of July 2020, recruitment had not yet begun. Data collection is expected to be completed by December 2020. Data analysis is expected to be completed by June 2021. Results will then be disseminated to patients, to the public, to clinicians, and to researchers through publications in journals and presentations at conferences. CONCLUSIONS: This will be the first study in China to investigate guided self-help interventions for patients who are older adults and who are depressed, a group which is currently underrepresented in mental health research. The intervention is modular and adapted from an empirically supported behavioral activation treatment for depression. The generalizability and broad inclusion criteria are strengths. TRIAL REGISTRATION: Chinese Clinical Trial Register ChiCTR1900026066; http://www.chictr.org.cn/showprojen.aspx?proj=43548. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/18259. CI - (c)Xiaoxia Wang, Xiaoyan Zhou, Hui Yang. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.09.2020. FAU - Wang, Xiaoxia AU - Wang X AUID- ORCID: 0000-0001-7707-5607 AD - Department of Basic Psychology, College of Psychology, Army Medical University, Chongqing, China. FAU - Zhou, Xiaoyan AU - Zhou X AUID- ORCID: 0000-0002-9087-382X AD - Department of Clinical Psychology, Mental Health Center of Chongqing, Chongqing, China. FAU - Yang, Hui AU - Yang H AUID- ORCID: 0000-0001-8127-9274 AD - Department of Clinical Psychology, Mental Health Center of Chongqing, Chongqing, China. LA - eng PT - Journal Article DEP - 20200924 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC7545326 OTO - NOTNLM OT - behavior activation OT - behavior inhibition OT - behavior treatment OT - clinical OT - geriatric depression OT - guided self-help OT - psychiatry OT - psychology COIS- Conflicts of Interest: None declared. EDAT- 2020/06/11 06:00 MHDA- 2020/06/11 06:01 PMCR- 2020/09/24 CRDT- 2020/06/11 06:00 PHST- 2020/02/15 00:00 [received] PHST- 2020/06/09 00:00 [accepted] PHST- 2020/05/18 00:00 [revised] PHST- 2020/06/11 06:00 [pubmed] PHST- 2020/06/11 06:01 [medline] PHST- 2020/06/11 06:00 [entrez] PHST- 2020/09/24 00:00 [pmc-release] AID - v9i9e18259 [pii] AID - 10.2196/18259 [doi] PST - epublish SO - JMIR Res Protoc. 2020 Sep 24;9(9):e18259. doi: 10.2196/18259.