A feasibility and acceptability randomised controlled trial of a manual based intervention for sleep difficulties in people living with dementia (dreams-start)

There are currently no known effective treatments for people with dementia with disturbed sleep although and families find it very difficult to cope with Trials of combined sleep hygiene and light therapy have been small, not powered to indicate feasibility and acceptability and shown 40-50% retention. We conducted this trial to test the feasibility and acceptability of a co-produced six-session manual-based intervention for sleep disturbance in people with dementia based on evidence; Dementia RElAted Manual for Sleep; STrAtegies for RelaTives (DREAMS-START). Eligible participants to this single-blind randomised trial, were those with dementia and sleep disturbances (scoring ≥4 on at least one Sleep Disorders Inventory item) which either the person with dementia or the carer found a problem; and having a family carer. Recruitment was in London, UK. Participants wore an actiwatch for two weeks pre-randomisation, 2:1 to intervention:Treatment as Usual via a site=stratified electronic randomisation list; and two weeks at the end of the study. Outcome assessors were masked to allocation. Trained, supervised psychology graduates delivered DREAMS-START, a manual based therapy to carers in the intervention group. The interactive sessions encompassed: Understanding sleep and dementia; Making a plan (incorporating actiwatch information and increasing light exposure); Daytime activity and routine; Difficult night-time behaviours; Taking care of your (carer's) sleep; and What works? Strategies for the future. Carers kept their manual, light box and relaxation recordings post-intervention. The co-primary outcomes were feasibility (≥50% eligible people consenting to the study): and acceptability (≥75% of intervention group attending ≥4 intervention sessions). Secondary outcomes were about efficacy at 3 months. 63/95 (66%; 95% CI: 56-76%) eligible referrals consented between 04/08/2016 and 24/03/2017; 62 (65%; 95% CI: 55-75%) were randomised. 37/42 (88%; 95% CI: 75-96%) adhered to the intervention. Therapist fidelity was high. 57/62 (92%) of those randomised were followed up at 3 months. Some actigraph follow-up data was available for 49/62 (79%) and 42 (68%) had event marker data. The intervention group had generally better secondary efficacy outcomes scores on validated outcome measures. A manual-based psychological treatment for sleep disorders in dementia is feasible and acceptable; Preliminary evidence suggests efficacy. A full trial is warranted.