Title: BEAT-IT: A randomised controlled trial comparing a behavioural activation treatment for depression in adults with learning disabilities with an attention control.
Funder: Chief Scientist Office (Scotland)

Abstract: Summary of projectDESIGN: A multi-centre single-blind randomized controlled design. Participants will be randomized stratified by centre to two groups: i) The manualised BEAT-IT behavioural activation intervention for depression and ii) an attention control group. Complimentary qualitative data will be gathered with a focus on change processes during the implementation of the treatment and future uptake in clinical services. SETTING: NHS specialist learning disabilities health services and social care settings where there is close collaboration with specialist health services. TARGET POPULATION: 150 adults : 1) with learning disability 2) aged over 18 3) who have a minimum of 2 hours weekly support from a carer 4) with depression assessed using DC-LD criteria and 5) who are able to provide informed consent. Adults will be excluded from the study if they: 1) are suicidal 2) have an IQ of 76 or higher 3) are experiencing factors preventing them from interacting with the carer and therapist or retaining information from the sessions or 4) refuse consent for their GP to be contacted. HEALTH TECHNOLOGY: A behavioural activation treatment for adults with learning disability and depression (BEAT-IT). BEAT-IT is delivered on an individual basis to participants by a Band 6 Psychology assistant (or other health professional) supported by carers. In line with NICE guidelines for behavioural activation in the general population there are 12 weekly sessions spanning four months. Maximum participation by the person with learning disabilities is achieved by flexibly implementing the sessions in accordance with the treatment manual. The focus of BEAT-IT is: i) Identifying avoidant behaviours linked to depressive symptoms and monitoring activity ii) Identifying life goals: recovering lost skills and interests iii) Psycho-education concerning the link between depression and activity iv) Graded exposure to reduce avoidant behaviours and iv) Targeting inherently reinforcing activity and activity likely to increase access to other positive reinforcers in three life domains: domestic tasks purposeful daytime activity and social/recreational activity.MEASUREMENT OF OUTCOMES AND COSTS: Outcome data will be collected at three time points: i) baseline ii) post intervention (4 months post randomisation) iii) follow-up (8 months post randomisation). The primary outcome measure of depressive symptoms (self-report on the Glasgow Depression Scale for adults with Learning Disabilities) has been validated for use with people with learning disabilities and used in the BEAT-IT pilot open trial. Other outcome measures include self-reports of anxiety carer proxy reports of depression and activity/engagement in community life. The economic analysis will compare the costs of the treatment with the quality of life benefits as measured by the EQ-5D in the 8 month follow-up period. The difference between treatment and control will be adjusted for any baseline differences in EQ-5D. In addition consideration will be given to potential cost-offsets associated with the treatment in terms of both direct costs to health and personal social services and direct costs to the subject and their carer. The base case perspective will be the NHS and personal social services supplemented by a broader analysis that considers patient/carer costs as required by NICE. The latter will be assessed very simply as the time burden associated with patients and their carers attending for contacts with the health/social services.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH