Back to resultsBEAT-IT: Behavioural Activation and Severe Learning Disabilities
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Behavioural Activation
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Intellectual Disability
Eligibility Criteria
Inclusion Criteria:
- Severe/profound intellectual disabilities
- 18 years old and over
- Clinically significant unipolar depression
- 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.
Exclusion Criteria:
- Suicidal
- Mild/moderate intellectual disabilities
- Factors that prevent the person from interacting with the carer and therapist or retaining information from the therapy (e.g. late stage dementia, significant agitation, withdrawal arising from psychosis)
- Does not consent to her/his GP being contacted about their participation in the study.
Sites / Locations
- Institute of Health and Wellbeing, University of GlasgowRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Behavioural activation
Treatment as usual
Arm Description
The treatment is designed to be delivered to individuals alongside a carer who provides regular support to them. It is a structured, time limited, manualised psychological therapy, developed to treat those with an intellectual disability and depressive symptoms.
This will include the existing treatments available in NHS and social care for adults with intellectual disability with depression, including anti-depressants, mood stabilizers, and any available psychological interventions. Additionally, for all those in the study, we will provide their General Practitioner with a summary of the NICE guidelines on treatment of depression for adults with intellectual disabilities.
Outcomes
Primary Outcome Measures
Change from baseline on the Mood, Interest and Pleasure Questionnaire (MIPQ) at 24 weeks
A measure of the individuals mood and engagement in activities. The score range for each sub-scale is 0 - 24.
Total score range is 0 - 48. Lower scores indicate lower mood and lower levels of interest and pleasure (within the last 2 week)
Change from baseline on Intellectual Disabilities Depression Scale (IDDS) at 24 weeks
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. Each item is scored on a 7-point Likert scale from 0 (never) to 6 (always). All scores are summed to provide a total score, ranging from 0 to 228. Higher scores indicate a higher frequency of depressive symptoms.
Secondary Outcome Measures
Change from baseline on the Anxiety, Depression and Mood Scale at 24 weeks
This scale has been shown to be a reliable and valid measure of anxiety in adults with severe/profound intellectual disabilities. The 7 item 'generalised anxiety' sub-scale was used.
Items are rated on a four-point Likert scale for frequency from 0 (never) to 3 (always) and for severity 0 (not a problem) to 3 (severe problem). Items are based on informants' observations in the last 2 weeks. Scores are summed. The possible score range for frequency of anxiety symptoms is 0-21, total score range for severity of anxiety symptoms is 0 - 21 and total score is 0 - 42. Higher scores indicate a higher frequency of anxiety symptoms and higher severity of anxiety symptoms.
Change from baseline on the Modified Index of Community Involvement (ICI) at 24 weeks
This scale provides a measure of participation in social and community-based activities during the previous 4 weeks. This is a 16-item scale, measuring participation in social activities (5 items), community activities (10 items) and going on holiday (1 item).
The informant is asked to rate whether the participant has participated in any of these events in the last month (12 months for the item 'been on holiday'), and if so, how many times (once through to five times or more). All items are rated on a 6-point Likert scale (0 = not participated, 5 = participated 5x or more). All scores are summed. The possible score range for the social activities sub-scale is 0-25, the possible score range for the community activities subscale is 0-50 and the total scale score range is 0-80. Higher scores indicate a higher frequency of engagement in social and community activities.
Change from baseline on the Modified Index of Domestic Participation at 24 weeks
This scale measures participation in 13 household tasks during the previous 4 weeks. All items are rated on a three-point Likert scale (0 - no participation, 1 - participation with help, 2 - independent participation). Scores are summed, with a possible score range of 0 - 26. Higher scores indicate higher levels of independent participation in domestic tasks.
Change from baseline on the Emotional Difficulties self-efficacy scale at 24 weeks
This is a 10-item scale which measures the carer's confidence in supporting the person when they are feeling down. All item are scored on a 9-point Likert scale, where 0 indicates 'not at all confident' and 8 indicates 'extremely confident'. All scores are summed with a possible score range of 0 - 80. Higher scores indicate a higher level of self-confidence in supporting someone when they are feeling down.
Full Information
NCT ID
NCT04744259
First Posted
March 5, 2019
Last Updated
February 5, 2021
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow, Lancaster University
1. Study Identification
Unique Protocol Identification Number
NCT04744259
Brief Title
BEAT-IT: Behavioural Activation and Severe Learning Disabilities
Official Title
Behavioural Activation (BeatIt) for Depression in Adults With Severe Intellectual Disabilities. A Feasibility Randomised Controlled Study of BeatIt Versus Treatment as Usual
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow, Lancaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Depression is common, but no psychological interventions have been tested to see if they work for adults with severe intellectual disabilities. The research team recently successfully completed a full-scale trial of a psychological intervention, BeatIt, for depressed adults with mild/moderate intellectual disabilities. The aim of this study is to comprehensively evaluate the feasibility of modifying BeatIt for depressed adults with severe intellectual disabilities, collecting the information needed on likely recruitment, measures, and waiting list control arm options, to design a full-scale study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Intellectual Disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioural activation
Arm Type
Experimental
Arm Description
The treatment is designed to be delivered to individuals alongside a carer who provides regular support to them. It is a structured, time limited, manualised psychological therapy, developed to treat those with an intellectual disability and depressive symptoms.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
This will include the existing treatments available in NHS and social care for adults with intellectual disability with depression, including anti-depressants, mood stabilizers, and any available psychological interventions. Additionally, for all those in the study, we will provide their General Practitioner with a summary of the NICE guidelines on treatment of depression for adults with intellectual disabilities.
Intervention Type
Behavioral
Intervention Name(s)
Behavioural Activation
Intervention Description
A psychological intervention which aims to increase activity and reduce depressive symptoms.
Primary Outcome Measure Information:
Title
Change from baseline on the Mood, Interest and Pleasure Questionnaire (MIPQ) at 24 weeks
Description
A measure of the individuals mood and engagement in activities. The score range for each sub-scale is 0 - 24.
Total score range is 0 - 48. Lower scores indicate lower mood and lower levels of interest and pleasure (within the last 2 week)
Time Frame
Baseline and week 24
Title
Change from baseline on Intellectual Disabilities Depression Scale (IDDS) at 24 weeks
Description
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. Each item is scored on a 7-point Likert scale from 0 (never) to 6 (always). All scores are summed to provide a total score, ranging from 0 to 228. Higher scores indicate a higher frequency of depressive symptoms.
Time Frame
Baseline and week 24
Secondary Outcome Measure Information:
Title
Change from baseline on the Anxiety, Depression and Mood Scale at 24 weeks
Description
This scale has been shown to be a reliable and valid measure of anxiety in adults with severe/profound intellectual disabilities. The 7 item 'generalised anxiety' sub-scale was used.
Items are rated on a four-point Likert scale for frequency from 0 (never) to 3 (always) and for severity 0 (not a problem) to 3 (severe problem). Items are based on informants' observations in the last 2 weeks. Scores are summed. The possible score range for frequency of anxiety symptoms is 0-21, total score range for severity of anxiety symptoms is 0 - 21 and total score is 0 - 42. Higher scores indicate a higher frequency of anxiety symptoms and higher severity of anxiety symptoms.
Time Frame
Baseline and week 24
Title
Change from baseline on the Modified Index of Community Involvement (ICI) at 24 weeks
Description
This scale provides a measure of participation in social and community-based activities during the previous 4 weeks. This is a 16-item scale, measuring participation in social activities (5 items), community activities (10 items) and going on holiday (1 item).
The informant is asked to rate whether the participant has participated in any of these events in the last month (12 months for the item 'been on holiday'), and if so, how many times (once through to five times or more). All items are rated on a 6-point Likert scale (0 = not participated, 5 = participated 5x or more). All scores are summed. The possible score range for the social activities sub-scale is 0-25, the possible score range for the community activities subscale is 0-50 and the total scale score range is 0-80. Higher scores indicate a higher frequency of engagement in social and community activities.
Time Frame
Baseline and week 24
Title
Change from baseline on the Modified Index of Domestic Participation at 24 weeks
Description
This scale measures participation in 13 household tasks during the previous 4 weeks. All items are rated on a three-point Likert scale (0 - no participation, 1 - participation with help, 2 - independent participation). Scores are summed, with a possible score range of 0 - 26. Higher scores indicate higher levels of independent participation in domestic tasks.
Time Frame
Baseline and week 24
Title
Change from baseline on the Emotional Difficulties self-efficacy scale at 24 weeks
Description
This is a 10-item scale which measures the carer's confidence in supporting the person when they are feeling down. All item are scored on a 9-point Likert scale, where 0 indicates 'not at all confident' and 8 indicates 'extremely confident'. All scores are summed with a possible score range of 0 - 80. Higher scores indicate a higher level of self-confidence in supporting someone when they are feeling down.
Time Frame
Baseline and week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe/profound intellectual disabilities
18 years old and over
Clinically significant unipolar depression
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.
Exclusion Criteria:
Suicidal
Mild/moderate intellectual disabilities
Factors that prevent the person from interacting with the carer and therapist or retaining information from the therapy (e.g. late stage dementia, significant agitation, withdrawal arising from psychosis)
Does not consent to her/his GP being contacted about their participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Jahoda, PhD
Phone
01412110282
Email
Andrew.Jahoda@glasgow.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Craig Melville, PhD
Phone
01412113878
Email
Craig.Melville@glasgow.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Jahoda, PhD
Organizational Affiliation
Professor of Learning Disabilities
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Health and Wellbeing, University of Glasgow
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G120XH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Jahoda, PhD
First Name & Middle Initial & Last Name & Degree
Andrew Jahoda, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BEAT-IT: Behavioural Activation and Severe Learning Disabilities
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