PMID- 33487800 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230923 IS - 0253-7176 (Print) IS - 0975-1564 (Electronic) IS - 0253-7176 (Linking) VI - 42 IP - 6 Suppl DP - 2020 Dec TI - Managing Depression in Diabetes Mellitus: A Multicentric Randomized Controlled Trial Comparing Effectiveness of Fluoxetine and Mindfulness in Primary Care: Protocol for DIAbetes Mellitus ANd Depression (DIAMAND) Study. PG - S31-S38 LID - 10.1177/0253717620971200 [doi] AB - BACKGROUND: Suboptimal management of depression in type 2 diabetes mellitus (T2DM) often translates into poor glycemic control, medical complications, and impaired quality of life. Feasibility and effectiveness of collaborative care models of depression in diabetes in low- and middle-income countries (LMICs) remain unexplored. DIAbetes Mellitus ANd Depression (DIAMAND) study, a multicentric single-blind randomized controlled trial (SBRCT) comparing effectiveness of fluoxetine and mindfulness in primary care settings, addresses this gap in scientific literature. METHODS: This trial conducted in diverse geographic settings of New Delhi, Bengaluru, and Bhubaneswar will comprise module-based training of primary care providers (PCPs) for screening, diagnosing, and managing depression in diabetes in phase I. Phase II will involve four-arm parallel group RCT on 350 participants with T2DM with comorbid depressive episode randomly allocated to receive fluoxetine, mindfulness therapy, fluoxetine plus mindfulness therapy, or treatment as usual at primary care settings. Interventions would include fluoxetine (up to 60 mg/day) and/or sessions of mindfulness for 16 weeks. Primary outcomes on standardized rating scales include depression scores (Hamilton Depression Rating Scale), treatment adherence (Adherence to Refill and Medication Scale), self-care (Diabetes Self-Management Questionnaire), diabetes-related distress (Diabetes Distress Scale), and glycemic control. Secondary outcomes include quality of life (World Health Organization Quality of Life Brief version [WHO-QOL BREF]) and mindfulness (Five Facets Mindfulness Questionnaire). DISCUSSION: This RCT will investigate the effectiveness of module-based training of PCPs and feasibility of collaborative care model for managing depression in T2DM in primary care settings in LMICs and effectiveness of fluoxetine and/or mindfulness in improving diverse outcomes of T2DM with major depression. CI - (c) 2020 Indian Psychiatric Society - South Zonal Branch. FAU - Chandra, Mina AU - Chandra M AD - Dept. of Psychiatry, Deaddiction Services & Resource Centre for Tobacco Control, Centre of Excellence in Mental Health, Atal Bihari Vajpayee Institute of Medical Sciences (Formerly PGIMER) and Dr Ram Manohar Lohia Hospital, New Delhi, India. FAU - Raveendranathan, Dhanya AU - Raveendranathan D AD - Dept. of Psychiatry, St. John's Medical College, Bengaluru, Karnataka, India. FAU - Johnson Pradeep R AU - Johnson Pradeep R AUID- ORCID: 0000-0003-0758-1664 AD - Dept. of Psychiatry, Medical Ethics, Institutional Ethics Committee, St. John's Medical College, Bengaluru, Karnataka, India. FAU - Patra, Suravi AU - Patra S AUID- ORCID: 0000-0001-6017-5222 AD - Dept. of Psychiatry, AIIMS Bhubaneswar, Bhubaneswar, Odisha, India. FAU - Rushi AU - Rushi AD - Dept. of Clinical Psychology, Centre of Excellence in Mental Health, Deaddiction Services & Resource Centre for Tobacco Control, Atal Bihari Vajpayee Institute of Medical Sciences (Formerly PGIMER) and Dr Ram Manohar Lohia Hospital, New Delhi, India. FAU - Prasad, Konasale AU - Prasad K AD - Dept. of Psychiatry and Bioengineering, University of Pittsburgh, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA. FAU - Brar, Jaspreet S AU - Brar JS AD - Dept. of Psychiatry, Community Care Behavioral Health Organization, Western Psychiatric Hospital of UPMC, Pittsburgh, Pennsylvania, USA. LA - eng GR - D43 TW009114/TW/FIC NIH HHS/United States PT - Journal Article DEP - 20201207 PL - United States TA - Indian J Psychol Med JT - Indian journal of psychological medicine JID - 7910727 PMC - PMC7802038 OTO - NOTNLM OT - Collaborative care OT - depression OT - mindfulness OT - randomized controlled trial OT - type 2 diabetes mellitus COIS- The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. EDAT- 2021/01/26 06:00 MHDA- 2021/01/26 06:01 PMCR- 2020/12/07 CRDT- 2021/01/25 05:36 PHST- 2021/01/25 05:36 [entrez] PHST- 2021/01/26 06:00 [pubmed] PHST- 2021/01/26 06:01 [medline] PHST- 2020/12/07 00:00 [pmc-release] AID - 10.1177_0253717620971200 [pii] AID - 10.1177/0253717620971200 [doi] PST - ppublish SO - Indian J Psychol Med. 2020 Dec;42(6 Suppl):S31-S38. doi: 10.1177/0253717620971200. Epub 2020 Dec 7.