Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000528651
Ethics application status
Approved
Date submitted
8/05/2014
Date registered
19/05/2014
Date last updated
19/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Cognitive Behaviour Therapy in people with intellectual disability and anxiety: A pilot RCT
Scientific title
The effect of adapted cognitive behaviour therapy (CBT) versus a wait-list control on anxiety levels in adults with mild intellectual disability and anxiety
Secondary ID [1] 284499 0
Nil
Universal Trial Number (UTN)
U1111-1156-1269
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 291759 0
Intellectual Disability 291928 0
Condition category
Condition code
Mental Health 292120 292120 0 0
Anxiety
Mental Health 292282 292282 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a group cognitive behavioural therapy (CBT) program for anxiety, which has been adapted for use with adults with intellectual disability. The group will run for 6 weeks, with weekly sessions approximately 1.5-2 hours long. Participants will be taught anxiety-management strategies such as cognitive challenging, and will be given home practice tasks to complete between sessions.
Intervention code [1] 289260 0
Treatment: Other
Intervention code [2] 289399 0
Behaviour
Comparator / control treatment
The control group will be a wait-list control group. Participants in this group will receive the same pre and post measures as the intervention group, but will be placed on a 6-week waiting list while the intervention group receives the treatment. When the intervention group finishes treatment, the wait-list control group will then receive the same treatment.
Control group
Active

Outcomes
Primary outcome [1] 292028 0
Mean score on the Glasgow Anxiety Scale for Learning Disabilities
Timepoint [1] 292028 0
Baseline, post intervention (after 6 weeks)
Primary outcome [2] 292029 0
Clinical or sub-clinical diagnosis of an anxiety disorder on the PAS-ADD – Psychiatric Assessment Schedules for Adults with Developmental Disabilities.
Timepoint [2] 292029 0
Baseline, post-intervention (after 6 weeks)
Secondary outcome [1] 308025 0
Glasgow depression scale
Timepoint [1] 308025 0
Baseline, post-intervention (after 6 weeks)
Secondary outcome [2] 308026 0
Mean scores on the Developmental Behaviour Checklist (DBC)
Timepoint [2] 308026 0
Baseline, post-intervention (after 6 weeks)
Secondary outcome [3] 308027 0
Mean scores on the Depression Anxiety and Stress Scale (DASS)
Timepoint [3] 308027 0
Every session of the 6-week group
Secondary outcome [4] 308028 0
Mean score on the Satisfaction with Life Scale (SWLS)
Timepoint [4] 308028 0
Every session of the 6-week group

Eligibility
Key inclusion criteria
Participants must have an intellectual disability, have verbal ability, can read and write short sentences to be able to complete the workbooks, and be aged 18 years old or above.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not having an intellectual disability, not having verbal ability, not being able to read or write short sentences, under 18 years old.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The procedure for allocation concealment will be to contact the holder of the allocation schedule at a central administration site who will have sealed opaque envelopes with the participant allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method of sequence generation will be simple randomisation using an online sequence generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on the only two other RCTs in the literature that have investigated psychological treatments for people with intellectual disability and mental health problems (i.e. depression; McCabe, McGillivray & Newton, 2006, anger management problems;Taylor, Novaco, Gillmer, Robertson, & Thorne, 2005), 15-20 participants per group is needed to detect a medium to large effect size, and this sample size was confirmed by sample size calculators (http://www.bu.edu/orccommittees/iacuc/policies-and-guidelines/sample-size-calculations/).
Statistical analysis will be intention-to-treat.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/05/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289189 0
Charities/Societies/Foundations
Name [1] 289189 0
APEX Foundation for Research into Intellectual Disability
Country [1] 289189 0
Australia
Primary sponsor type
Individual
Name
Lynette Roberts at the Centre for Disability Studies, affiliate of the University of Sydney
Address
Centre for Disability Studies, affiliate of the University of Sydney
Level 1, Medical Foundation Building - K25
92-94 Parramatta Road
Camperdown NSW 2050 Australia
Country
Australia
Secondary sponsor category [1] 287859 0
None
Name [1] 287859 0
Address [1] 287859 0
Country [1] 287859 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290967 0
University of Sydney Ethics Committee
Ethics committee address [1] 290967 0
Ethics committee country [1] 290967 0
Australia
Date submitted for ethics approval [1] 290967 0
Approval date [1] 290967 0
17/03/2014
Ethics approval number [1] 290967 0
2014/044

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47970 0
Dr Lynette Roberts
Address 47970 0
Centre for Disability Studies, affiliate of the University of Sydney
Level 1, Medical Foundation Building - K25
92-94 Parramatta Road
Camperdown NSW 2050 Australia
Country 47970 0
Australia
Phone 47970 0
+61-2-9036-3600
Fax 47970 0
Email 47970 0
[email protected]
Contact person for public queries
Name 47971 0
Lynette Roberts
Address 47971 0
Centre for Disability Studies, affiliate of the University of Sydney
Level 1, Medical Foundation Building - K25
92-94 Parramatta Road
Camperdown NSW 2050 Australia
Country 47971 0
Australia
Phone 47971 0
+61-2-9036-3600
Fax 47971 0
Email 47971 0
[email protected]
Contact person for scientific queries
Name 47972 0
Lynette Roberts
Address 47972 0
Centre for Disability Studies, affiliate of the University of Sydney
Level 1, Medical Foundation Building - K25
92-94 Parramatta Road
Camperdown NSW 2050 Australia
Country 47972 0
Australia
Phone 47972 0
+61-2-9036-3600
Fax 47972 0
Email 47972 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.