Multimorbidity in Older Adults with Depression Study (MODS) (behavioural Activation to Improve Physical and Mental Functioning among Older People with Multiple Long-Term Conditions): Protocol for a Fully Powered Randomised Controlled Trial

Introduction Older adults (65 years or over) and those with long-term health conditions (LTCs), represent a ‘high risk’ group for depression, with a risk two-to-three times the general population. This can lead to poorer quality of life and be costly to health and social care services. In the Multimorbidity in Older Adults with Depression Study (MODS) we will test whether a brief psychological intervention (Behavioural Activation), helps to improve physical/mental functioning in this group compared to treatment as usual. Methods We will conduct a two-arm, parallel-group randomised controlled trial, to evaluate the clinical and cost-effectiveness of the MODS intervention. Participants will be recruited via general practices across England. To be included, participants must be aged 65 years or over, with two or more LTCs and either sub-threshold depression or major depression. Randomisation will be simple 1:1. Intervention participants will receive up to eight sessions delivered by MODS support workers, supported by a self-help booklet. Control participants will receive usual care. A process evaluation will be undertaken to evaluate the processes and mechanisms underpinning intervention delivery, and to inform the development of an implementation framework. Semi-structured interviews will be conducted with intervention participants, participant’s caregivers/supportive others, and health and social care professionals. Focus groups and semi-structured interviews will be conducted with MODS support workers. Outcome data will be collected at four, eight, and twelve-months post-randomisation. The primary outcome is self-reported quality of life and functioning at the four-month follow up. Secondary outcomes include depression, anxiety, physical functioning, loneliness, social isolation, chronic pain, health related quality of life, and health services use. Discussion This study builds on our previous work and will evaluate a brief psychological intervention to improve physical and mental health functioning for older adults with multiple long-term conditions. Trial Registration ClinicalTrials.Gov Identifier [ISRCTN44184899][1], registered on 11th August 2022. ### Competing Interest Statement Based upon the journal?s policy, the authors of this manuscript have the following competing interests. Simon Gilbody, Peter Coventry and Dean McMillan are supported by the NIHR Yorkshire and Humberside Applied Research Collaboration (ARC), David Ekers is supported by the North East and North Cumbria ARCs, and Carolyn Chew-Graham is supported by the NIHR West Midlands ARC. ### Clinical Trial ClinicalTrials.Gov Identifier [ISRCTN44184899][1], registered on 11th August 2022 ### Funding Statement Yes ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The MODS trial received ethical approval from the Yorkshire and The Humber – Leeds West Research Ethics Committee on 27th May 2022 (REC Ref: 22/YH/0071). The sponsor for MODS is Tees, Esk and Wear Valleys NHS Foundation Trust. Full informed consent obtained (written/online/verbal) as appropriate. 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. Not Applicable 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). Not Applicable I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Not Applicable No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN44184899