[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581548":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":31,"collaborators":18,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":18,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":18,"enrollmentInfo":42,"targetDuration":18,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":52,"overallStatus":54,"whyStopped":18,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":18},{"fullName":5,"class":6},"NHS Greater Glasgow and Clyde","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BeatIt2 for depression alongside Treatment as usual (TAU)","EXPERIMENTAL","BeatIt2 treatment manual and materials are developed and modelled for people with severe\u002Fprofound learning disabilities. They are designed to be delivered to the person alongside a family or paid carer providing them with regular support, on an outreach basis. It is a structured, time limited, manualised psychological therapy, developed to treat those with learning disabilities and depressive symptoms.\n\nThere is an initial training session for carers regarding their role in the treatment, then 12 sessions with the person with a learning disability and their carer, held weekly or fortnightly, spanning approximately 6 months.\n\nActivities are carried out with the individuals with learning disabilities at each session and elements of the intervention are delivered via carers. The three main phases are: i) assessment and socialisation into the intervention and establishing a relationship with the person with the disability, ii) working towards change, and iii) finishing therapy.",[13],"Behavioral: Behavioural Activation for depression (BeatIt2)",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment as usual","NO_INTERVENTION","This will include the existing treatments available in NHS and social care for adults with learning disability with depression, including anti-depressants, mood stabilizers, and any available nursing and psychological supports\u002Finterventions. Additionally, for all those in the study, the investigators will provide their General Practitioner and specialist services with a summary of the NICE guidelines on treatment of depression for adults with learning disabilities.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Behavioural Activation for depression (BeatIt2)","It is a structured, time limited, manualised psychological therapy, developed to treat those with learning disabilities and depressive symptoms.\n\nThere is an initial training session for carers regarding their role in the treatment, then 12 sessions with the person with a learning disability and their carer, held weekly or fortnightly, spanning approximately 6 months.\n\nActivities are carried out with the individuals with learning disabilities at each session and elements of the intervention are delivered via carers. The three main phases are: i) assessment and socialisation into the intervention and establishing a relationship with the person with the disability, ii) working towards change, and iii) finishing therapy. The first phase includes assessment of the person's pattern of daily activity, barriers and facilitators to engaging in activity, and examining the link between activity and mood. Specific attention is given to the role of communication and how scaffolding can be provid",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Andrew Professor Jahoda, BSc Hons, MPhil, PhD","CONTACT","0141 330 4988","Andrew.Jahoda@glasgow.ac.uk",{"type":32,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100581548","behavioural-activation-and-severe-learning-disabilities-100581548",false,"NCT06851741","Behavioural Activation and Severe Learning Disabilities","Behavioural Activation for Depression in Adults with Severe Learning Disabilities. a Feasibility Randomised Controlled Study of Behavioural Activation with Treatment As Usual (TAU) Vs TAU Alone","Inclusion Criteria:\n\n* Administratively defined severe\u002Fprofound learning disabilities, confirmed by carer report using the Vineland Adaptive Behaviour Scales 3rd edition. A severe\u002Fprofound learning disability will be confirmed by an ABC composite score of 50 or below (Sparrow et al., 2016). Individuals with severe\u002Fprofound learning disabilities can be characterised by high support needs, limited or no expressive or receptive verbal communication, and significant impairments across adaptive functioning skills.\n* 18 years old and over\n* Clinically significant unipolar depression, meeting the Diagnostic Criteria for Psychiatric Disorders for use with Adults with Learning Disabilities\n* Has a family member or paid carer who has supported them for a minimum of 6 months to complete the screening and baseline visits OR is able to obtain information for the previous 4 months prior to randomisation. The carer, or another named individual, should be available for weekly-fortnightly treatment sessions with the practitioner, and should currently provide a minimum of 10 hours support per week to the participant.\n\nExclusion Criteria:\n\n* Mild\u002Fmoderate learning disabilities\n* A presentation judged by the research team as likely to interfere with the successful engagement with the intervention (e.g. severe agitation, late-stage dementia, uncontrolled epilepsy).","ALL","18 Years",{"count":43,"type":44},50,"ESTIMATED","INTERVENTIONAL",[47],"NA","Research shows that people with severe learning disabilities get depressed at least as often as the wider population. Psychological therapies are recommended to treat depression, and some of these have been adapted for those people with learning disabilities who can talk about their problems. No research has properly tested a psychological therapy for people with severe learning disabilities and any mental health problem. The investigators recently completed a study that tested a psychological therapy (behavioural activation) for people with mild learning disabilities and depression. Behavioural activation improves people's mood by helping them to re-engage in activity that has meaning and purpose for them, rather than relying on talking or thinking skills. Because of this behavioural activation might be promising for people with severe learning disabilities and depression. Along with PAMIS, an organisation for families of people with more profound disabilities, the investigators have adapted the therapy for this group. The investigators now want to find out if it would be possible to carry out a research project about whether behavioural activation works for depressed adults with severe learning disabilities. This is called a feasibility study. The investigators would see if it is possible to recruit 50 adults with severe learning disabilities, and if they are willing to be randomly placed in a group who get behavioural activation or a group who get usual help from services. Other information about running a study would be collected, including about keeping in contact with participants and what measures are needed to find out if change is happening.",[50,51],"Intellectual Disabilities","Depression",[53,51],"Intellectual disability","NOT_YET_RECRUITING","2025-02-26",{"date":57,"type":58},"2025-02-28","ACTUAL",{"date":60,"type":44},"2025-03-04",{"date":62,"type":44},"2026-11-01",{"name":5,"class":6}]