Efficacy of Transdiagnostic Cognitive-behavioural Intervention in Older Adults with Common Mental Disorders and Its Impact on Sleep and Metabolic Outcomes: A Randomised Controlled Trial Protocol.

Background: Common mental disorders (CMDs) in older adults contribute to considerable disease burden and are associated with significant multimorbidity. With the increase in population ageing, the concerns related to multimorbidity are likely to increase. Cognitive-behavioural therapy (CBT) is an evidence-based approach for CMDs. More recently, transdiagnostic approaches to address shared mechanisms across disorders have been studied. Novelty: Despite a considerable body of literature on psychological interventions in higher-income countries, there is a notable lack of empirical studies examining the efficacy of transdiagnostic CBT (tCBT) in CMDs and older adults in India. In this study, we propose to test the effectiveness of a tCBT adapted for older adults, involving stakeholders. Objectives: To examine the efficacy of a tCBT for older adults with CMDs. Methods: A two-group parallel-arm randomised controlled design will be adopted to examine the efficacy of tCBT in older adults with CMDs. A total of 120 older adults (N = 60; intervention and control arm, respectively), meeting criteria for CMDs and scoring above the cut-off on Patient Health Questionnaire-9 and/or GAD-7, consenting for participation, will be randomised to receive either tCBT or treatment as usual plus psychoeducation (TAU + psychoeducation). The primary outcome (mood) will be measured using HAM-A and HAM-D. Secondary outcomes include sleep disturbances, repetitive negative thinking (RNT), metabolic effects, and quality of life. Participants will be assessed at baseline, post-intervention, and 3-month follow-up. The intervention will be adapted to older adults in India, based on a needs analysis with stakeholders (patients, caregivers, and experts). Expected Outcomes: There is a dearth of systematic studies in India on psychotherapy in older adults, particularly those that target multimorbidity and transdiagnostic processes such as sleep and RNT. This psychotherapy trial will provide important empirical data on the efficacy of evidence-based tCBT in older adults with CMDs.