DepressionNCT04744259
BEAT-IT: Behavioural Activation and Severe Learning Disabilities
A study testing Behavioural Activation in people with Depression, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Behavioural Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Feb 2019to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Institute of Health and Wellbeing, University of Glasgow
Glasgow, Scotland, G120XH
Andrew Jahoda, PhD
Andrew Jahoda, PhD
About this study
Official title: Behavioural Activation (BeatIt) for Depression in Adults With Severe Intellectual Disabilities. A Feasibility Randomised Controlled Study of BeatIt Versus Treatment as Usual
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.
- Conditions
- Depression
- Being tested
- Behavioural Activation
- Keywords
- Intellectual Disability
- Medical subject headings
- Depression, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural ActivationBehavioural
A psychological intervention which aims to increase activity and reduce depressive symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Behavioural activation | Experimental | 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. Receives: Behavioral: Behavioural Activation |
| Treatment as usual | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and week 24
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.
Measured: Baseline and week 24
Secondary outcomes (4)
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.
Measured: Baseline and week 24
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.
Measured: Baseline and week 24
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.
Measured: Baseline and week 24
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.
Measured: Baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start18 Feb 2019
- Primary completionDec 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Lancaster University
- Responsible party
- Sponsor
- Investigators
- Andrew Jahoda, PhD, Principal investigator, Professor of Learning Disabilities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744259
- Sponsor's protocol ID
- GN18MH490
- Status last verified
- Feb 2021
- First submitted
- 5 Mar 2019
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Activation (BeatIt) for Depression in Adults With Severe Intellectual Disabilities. A Feasibility Randomised Controlled Study of BeatIt Versus Treatment as Usual
- ClinicalTrials.gov ID
- NCT04744259
- Acronym / sponsor ID
- GN18MH490
- Conditions
- Depression
- Keywords
- Intellectual Disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow, Lancaster University
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioural activation | Experimental | Behavioral: Behavioural ActivationThe 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. |
| Treatment as usual | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural ActivationA psychological intervention which aims to increase activity and reduce depressive symptoms. | Behavioural | Behavioural activation |
Primary outcome
Change from baseline on the Mood, Interest and Pleasure Questionnaire (MIPQ) at 24 weeks
Time frame: Baseline and week 24
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
Time frame: Baseline and week 24
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.
4 secondary outcomes
Change from baseline on the Anxiety, Depression and Mood Scale at 24 weeks
Time frame: Baseline and week 24
Change from baseline on the Modified Index of Community Involvement (ICI) at 24 weeks
Time frame: Baseline and week 24
Change from baseline on the Modified Index of Domestic Participation at 24 weeks
Time frame: Baseline and week 24
Change from baseline on the Emotional Difficulties self-efficacy scale at 24 weeks
Time frame: Baseline and week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Jahoda, PhD principal investigator
Professor of Learning Disabilities
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural Activation in people with Depression, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Jahoda, PhD (01412110282, Andrew.Jahoda@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on the Mood, Interest and Pleasure Questionnaire (MIPQ) at 24 weeks (time frame: Baseline and week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.