Condition category
Mental and Behavioural Disorders
Date applied
02/02/2011
Date assigned
25/03/2011
Last edited
08/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Learning disabilities are common conditions which affect the way people’s minds are able to process information and learn (intellectual ability). Even in a mild form, they can make everyday activities more difficult, causing problems with household tasks, socialising or managing money. It has been found that many people suffering from a mild learning disability also experience problems with their mood, such as depression (extreme sadness) and anxiety. Cognitive behavioural therapy (CBT) is a type of talking therapy, which works by teaching people more effective ways to deal with their problems by changing the way they think and behave. Many studies have shown that CBT can be an extremely effective therapy for people suffering from problems with their mood, however little research has been done to find out whether this type of treatment could be effective for someone with mild learning disabilities. Studies have shown that people with mild learning disabilities have the skills needed to take part in CBT. The aim of this study is to test the effectiveness of CBT in treating those with mild learning disabilities that are experiencing problems with their mood.

Who can participate?
Adults with mild learning disabilities who are also experiencing mental health problems that affect their mood (such as depression or anxiety).

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive weekly one-to-one sessions of CBT for up to 16 weeks. These participants also continue to receive the usual service that they receive from the intellectual disability service, involving care management and emotional and social support. Participants in the second group continue to receive the usual service from the intellectual disability service, but do not receive any additional support throughout the 16 weeks of the study. At the start of the study and then again after 4 and 6 months, participants in both groups complete a number of questionnaires in order to find out whether the treatment has made any changes to their mood, quality of life or thinking ability (cognitive aspects).

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Camden and Islington Mental Health and Social Care Trust (UK)

When is the study starting and how long is it expected to run for?
March 2010 to August 2011

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Angela Hassiotis
a.hassiotis@ucl.ac.uk

Trial website

http://www.ucl.ac.uk/mentalhealthsciences/researchthemesandinterests/cbt

Contact information

Type

Scientific

Primary contact

Dr Angela Hassiotis

ORCID ID

Contact details

University College London
Department of Mental Health Sciences
Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
United Kingdom
+44 (0)20 7974 3737/88
a.hassiotis@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PB-PG-0807-14121

Study information

Scientific title

Cognitive behaviour therapy (CBT) for anxiety and depression in adults with mild intellectual disabilities (ID): a randomised controlled trial

Acronym

Study hypothesis

Is manualised cognitive behavioural therapy (CBT) treatment more clinically and cost effective than treatment as usual (TAU) for depression and/or anxiety for people with mild intellectual disabilities?

Ethics approval

The Joint UCL/UCLH Committees on Ethics of Human Research Committee Alpha approved on the 25th November 2008 (ref: 08AL 332)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression, anxiety

Intervention

1. CBT plus treatment as usual: Participants will receive up to 16 one-to-one manualised cognitive behavioural therapy treatment sessions over a period of 16 weeks (4 months) in addition to the usual service they receive from the intellectual disability service.
2. Treatment as usual (TAU): This is the standard treatment which would be available to any adult with an intellectual disability referred to the intellectual disability service. This includes care management, medical, non specific psychological input, nursing or social support.

Screening:
Potential participants will be screened for anxiety and/or depression using the Mini PAS-ADD (Psychiatric Assessment Schedules for Adults with Developmental Disabilities; Moss, 2002). Those identified as cases (greater than 10 for depression and greater than 7 for anxiety) will be eligible for the study. The range of scores indicating severity is between 11 - 32 for depression and 7 - 18 for anxiety.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Participants will be assessed to measure the severity of their cognitive aspects of anxiety and/or depression using two subscales of the Beck Youth Inventories (BYI). These will be Beck Anxiety Inventory Youth (BAI-Y) and Beck Depression Inventory Youth (BDI-Y). Both sub-scales will be administered at baseline, end of treatment (i.e. four months) and at follow-up (i.e. six months).

Secondary outcome measures

1. Costs will be measured by administration of the Client Service Receipt Inventory, intellectual disability version (CSRI-ID version) at baseline and end of treatment (i.e. four months)
2. A quality of life questionnaire (Manchester Short Assessment of Quality of Life) that consists of 16-items. Each item is rated on a seven-point satisfaction scale, from 1 = 'Couldn't be worse' to 7 = 'Couldn’t be better'. It will be administered at baseline and at the end of treatment (i.e. four months).
3. Satisfaction with treatment will be measured by using a modified client satisfaction questionnaire which will elicit the client's perception of the mental health service/intervention at baseline and end of treatment (i.e. four months)
4. There will also be an open question with prompts about the experience and process of therapy to both service users and their carers to gain a better understanding of how the intervention was perceived and valued

Overall trial start date

01/03/2010

Overall trial end date

31/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged 16 years and over (either sex) who have mild intellectual disability (as determined on the service register)
2. A disorder with one of the following International Classification of Diseases, version 10 (ICD-10) codes: F32, F33, F34, F38, F40, F41 (anxiety, depression or mixed affective states)
3. Only participants with English as their main/spoken language

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Participants with co-morbid conditions of substance misuse, autism and those already receiving psychological treatment
2. Service users with moderate/severe intellectual disability

Recruitment start date

01/03/2010

Recruitment end date

31/08/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
W1W 7EJ
United Kingdom

Sponsor information

Organisation

Camden and Islington Mental Health and Social Care Trust (UK)

Sponsor details

Research and Development Office
West Wing
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
United Kingdom
+44 (0)20 3317 3763
lynis.lewis@camdenpct.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.candi.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21492437
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23827533

Publication citations

  1. Protocol

    Hassiotis A, Serfaty M, Azam K, Strydom A, Martin S, Parkes C, Blizard R, King M, Cognitive behaviour therapy (CBT) for anxiety and depression in adults with mild intellectual disabilities (ID): a pilot randomised controlled trial., Trials, 2011, 12, 95, doi: 10.1186/1745-6215-12-95.

Additional files

Editorial Notes