A pilot randomised controlled trial of an Acceptance and Commitment Therapy group intervention for family carers of people with dementia

INTERVENTION: F04.754.137 Sixty eligible participants will be randomised either to an intervention group (n=30) or a control group (waitlist) (n=30). Participants in the intervention group will receive eight group sessions of Acceptance and Commitment Therapy via video conferencing. Each group session will last 90 minutes and will have a maximum of si Xparticipants. The intervention will be delivered over eight weeks by a qualified Clinical Psychologist. Supporting materials (handouts) for each session will also be sent to participants via post. Participants in the control group will receive no intervention during the trial. They will be given an opportunity to participate in the same intervention at the end of the trial after the completion of the follow‐up assessment. CONDITION: F41.2 Generalized Anxiety; Mixed anxiety and depressive disorder PRIMARY OUTCOME: Anxiety will be assessed using the Generalised Anxiety Disorder Scale‐7 (GAD‐7) at three time points: baseline (0 weeks), post‐intervention (8 weeks post randomisation) and follow‐up (20 weeks post randomisation). The hypothesis of the study is that the group intervention will decrease participants level of anxiety. SECONDARY OUTCOME: The following measures will be completed at baseline (0 weeks), post‐intervention (8 weeks post randomisation) and follow‐up (20 weeks post randomisation): (1) Depression: Patient Health Questionnaire‐9 (PHQ‐9) and Hospital Anxiety and Depression Scale (HADS‐D); (2)Anxiety: Hospital Anxiety and Depression Scale (HADS‐A); (3) Carer burden: Zarit Burden Interview Short version; (4) Quality of life: Quality of Life of Alzheimer’s Disease (Qdv‐DA); (5) Experiential avoidance: Acceptance and Action Questionnaire‐II and Experiential Avoidance in Caregiving Questionnaire. INCLUSION CRITERIA: Be a family carer of a relative with a clinical diagnosis of dementia; aged 18 and over; identifying oneself as a primary carer in their family; providing a minimum of 28 hours of care each week; having a minimum of four years of formal education; having access to the internet and a device to access online sessions; scoring nine or higher on the Generalised Anxiety Disorder (GAD‐7) questionnaire.