Behavioural Activation and Severe Learning Disabilities
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNHS Greater Glasgow and Clyde
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Administratively defined severe/profound learning disabilities, confirmed by carer report using the Vineland Adaptive Behaviour Scales 3rd edition. A severe/profound learning disability will be confirmed by an ABC composite score of 50 or below (Sparrow et al., 2016). Individuals with severe/profound learning disabilities can be characterised by high support needs, limited or no expressive or receptive verbal communication, and significant impairments across adaptive functioning skills.
18 years old and over
Clinically significant unipolar depression, meeting the Diagnostic Criteria for Psychiatric Disorders for use with Adults with Learning Disabilities
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.
Disqualifiers
Mild/moderate learning disabilities
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioural Activation for depression (BeatIt2)
BehavioralIt is a structured, time limited, manualised psychological therapy, developed to treat those with learning disabilities and depressive symptoms. There 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. Activities 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
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: BeatIt2 for depression alongside Treatment as usual (TAU)Experimental treatment 1 intervention
Group B: Treatment as usualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Intellectual Disabilities Depression Scale (IDDS)
This is a 38-item behavioural checklist derived from DSM-III-R criteria, designed to measure the frequency of identified depressive behaviours within a four-week period. Minimum possible score is 0 and maximum possible score is 228. Higher scores indicate a higher frequency of depressive symptoms.
Time frame
Baseline, 4, 6, 8, 12 months post-baselineSecondary outcomes
1
Anxiety Depression and Mood Scale (ADAMS)
This scale is the only one that has been shown to be a reliable and valid measure of anxiety in adults with severe/profound intellectual disabilities. Since the investigators are already using two measures of depressive symptoms, only the anxiety sub-scale of the Anxiety, Depression and Mood Scale will be used in this study. Seven items will be used from the original 28-item measure. These items comprise the 'generalised anxiety' subscale, with informants reporting on their observations of these symptoms in the last 2 weeks. Items are scored on a four-point Likert scale that combines frequency and severity of symptoms. Minimum possible score is 0 and maximum possible score is 42. Higher scores indicate a higher frequency and severity of anxiety symptoms.
Time frame
Baseline & 12 months post-baseline2
Index of Community Involvement
This 16-item scale provides a measure of participation in social and community based activities during the previous 4 weeks. Minimum possible score is 0 and maximum is 80. Higher scores indicate a higher frequency of engagement in community activities.
Time frame
Baseline & 12 months post-baseline3
Index of Participation in Domestic Life
This scale measures participation in 13 household tasks during the previous 4 weeks. Minimum possible score is 0 and maximum possible score is 26. Higher scores indicate higher levels of independent participation in domestic tasks.
Time frame
Baseline & 12 months post-baseline4
EQ-5D-5L
This proxy report questionnaire assesses the participants' health related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Possible minimum score is 5 and possible maximum score is 25. Higher scores indicate more problems in these domains. There is an additional visual analogue scale with endpoints of 'the worst health you can image' and 'the best health you can image' on a 0 to 100 scale.
Time frame
Baseline & 12 months post-baselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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