A psychosocial intervention to support ALS informal caregivers: study protocol for a randomised controlled trial

Abstract

Background ALS informal caregivers show a worsening of burden and psychological well-being during the disease course of the patient. Perceived burden may be caused by a high demand on the caregiver and low feelings of control over fulfilling caregiver tasks, according to the Karasek demand-control model. Offering psychosocial support to increase feelings of control of the caregiver might increase the wellbeing of both caregiver and patient. This study aims to investigate the effectiveness of a psychosocial intervention to support ALS informal caregivers. Methods Caregiver-patients dyads (n=96) will be randomized to receive, additional to usual care, the psychosocial support program or online education in the control condition. The intervention is based on Acceptance and Commitment Therapy and will be offered online and face-to-face. Dyads will fill out questionnaires on five occasions (baseline, 3, 6, 9, and 12 months). The primary outcome measure is caregivers’ emotional functioning. Secondary outcome measures are caregiver burden and patients’ and caregivers’ quality of life. Included covariates are caregiver self-efficacy, patients’ physical functioning and patients’ behavior changes. A linear mixed model for repeated measures will be used for each outcome measure. Expected results We expect the support program will improve the wellbeing of caregivers and patients. Current stage The randomized controlled trial starts in 2016. Discussion At present, limited interventions are aiming at supporting ALS informal caregivers. If effective, the intervention will support caregivers in coping with the caregiving situation and may be offered as a standard service for ALS caregivers. Results will be available in 2018.