Study protocol for a randomised controlled trial: effect of an interdisciplinary psycho-educational intervention...

Caring for an older dependent adult with cognitive impairment can have negative consequences for the family caregiver. Interdisciplinary interventions are necessary to address their needs jointly and comprehensively. While attempts have been made to improve their situation from different disciplines in isolation, a collaborative approach is required to ensure the best possible outcome.

A parallel, randomized, controlled clinical trial with two arms will be conducted at the Teaching and Clinical Unit of Occupational Therapy (UDATO) and the Municipal Unit for Psychosocial Support for Older Adults (UMAPS), both of which belong to the University of Salamanca and are in agreement with the City Council of Salamanca, Spain. The trial will also be conducted at the University Assistance Complex of Salamanca (CAUSA). Family caregivers, aged 60 years or older, of dependent older adults with cognitive impairment will be recruited. Participants will be randomly assigned to an intervention group (IG) or a control group (CG). The IG will participate in an interdisciplinary psychoeducational programme co-led by psychology and occupational therapy professionals. The programme consists of 12 weekly sessions (90 min each) over 3 months, covering topics such as emotional regulation, caregiver burden, cognitive-behavioural strategies, problem-solving, functional stimulation, and promotion of autonomy. Three monthly reinforcement sessions will follow. The CG will receive routine follow-up and resource information. Outcomes will be assessed at baseline and post-intervention using validated instruments: the Caregiver Burden Interview (CBI), the CES-D Depression Scale, the Psychosocial Support Questionnaire (PSQ), the General Health Questionnaire (GHQ), the WHOQOL-AGE and the Bayer-ADL Scale.

This study aims to enhance conventional clinical practice for family caregivers of dependent older adults. This will be achieved through an interdisciplinary psychoeducational intervention that aims to reduce overload and depressive symptomatology, increase social support, improve health and perceived quality of life, and enhance understanding of the syndrome. The intervention will also focus on managing difficult situations associated with day-to-day caregiving, managing emotions and associated erroneous beliefs, and promoting self-care. Additionally, the study aims to improve the functionality of the cared-for person.

ClinicalTrials.gov Identifier: NCT06326151. Registration date: March 22, 2024.