Efficacy of transdiagnostic cognitive behavioural intervention in older adults with common mental disorders and its impact on sleep and metabolic outcomes: A randomized controlled trial.

The objectives of this study are to examine the efficacy of a transdiagnostic cognitive behavioural intervention adapted for older adults in improving symptoms of depression and anxiety, in reducing repetitive negative thinking, improving sleep and  quality of life and to examine the impact of the transdiagnostic cognitive behavioural intervention metabolic parameters.

Exploratory objectives include, Treatment Satisfaction and acceptability of the intervention by older adults and to identify predictors of treatment response.

Sample for the study will include 120  older adults (55 years and above), meeting specified study criteria.  The primary end-point of the study  would be at the completion of the intervention.

The proposed study would be a randomized, controlled trial with two parallel arms, one arm will be the intervention arm (Transdiagnostic  CBT+ Treatment as usual), and a  control arm (Treatment as usual). The study will be conducted in clinical and outreach settings,  associated with the geriatric services of NIMHANS, where older adults seek treatment. Prior to the main trial, Module development & piloting, will be done by interviews with stakeholders (patients, care givers and treating clinicians) to determine components, length and duration of the intervention.

The clinic-based sample will be recruited from the geriatric services and other outpatient mental health settings of the NIMHANS, and the NIMHANS center for Well-being, an urban mental health setting, in Bangalore. The primary outcome will be a reduction in scores on PHQ9 and GAD-7. Secondary outcomes will include  Self-reported sleep quality and insomnia severity score (The Pittsburgh Sleep Quality Index, Insomnia Severity Index) , quality of life, ADL (EUROQOl-5L-5D;Everyday Abilities Scale for India (EASI), repetitive negative thinking (Penn State Worry Questionnaire), loneliness and metabolic parameters (HbA1c). The CGI-I will be used as a secondary outcome improvement measure. Homework compliance will be assessed at post treatment along with treatment satisfaction. Additionally, Training and supervision of therapists will assessment of treatment adherence and fidelity will be ensured. The intervention will be delivered in a blended format (on and offline) and is expected to range from 8-10 sessions, drawn from evidence based strategies. TAU group will additionally receive psychoeducation regarding CMDs and lifestyle and health.   Data will be analysed using An intent-to-treat analysis. RMANOVA/Linear Mixed effects model will be carried out to evaluate the efficacy of the intervention over time and across groups. Predictors of treatment outcome will be attempted using regression analysis.

Ethical considerations include obtaining the necessary approval from the Institute Ethics Committee,  registering in the ICMR clinical trials registry.    The capacity to consent to participate of participants in the study will be assessed.     Informed written consent will be obtained from all patients and they will be informed that their participation is voluntary and that they can withdraw at any point without having to provide any reason and with no adverse effect on their ongoing treatment.  Patients will be informed about randomization in the informed consent form. They will be informed that they will not receive any monetary benefits from participation, however, the compensation for daily wages/travel will be provided to all participants. Those requiring medication changes during the intervention will be noted and analyzed separately, and they will continue to receive psychological care from the team. Patients who require more sessions will be offered the intervention.