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Trial registered on ANZCTR


Registration number
ACTRN12609000348257
Ethics application status
Approved
Date submitted
2/05/2009
Date registered
25/05/2009
Date last updated
5/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial of Cognitive Behavioural Therapy with adult clients diagnosed with Asperger's Disorder, to treat anxiety and depression
Scientific title
A trial of Cognitive Behavioural Therapy with adult clients diagnosed with Asperger's Disorder, to treat anxiety and depression
Secondary ID [1] 283694 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 4790 0
depression 4791 0
asperger's disorder 4792 0
Condition category
Condition code
Mental Health 5030 5030 0 0
Autistic spectrum disorders
Mental Health 237134 237134 0 0
Anxiety
Mental Health 237135 237135 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 individual 50 minute sessions per client, held once per week for a total of 12 weeks, using Cognitive Behavioural Therapy approaches including psycho education, relaxation training, and correction of maladaptive cognitions.
Intervention code [1] 4477 0
Behaviour
Intervention code [2] 4564 0
Other interventions
Comparator / control treatment
Multiple baseline design, tracking anxiety and depression self reports using patient questionnaires, before, during and after initiation of treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5869 0
Depression Anxiety Stress Scales (Lovibond and Lovibond, 2004)
Timepoint [1] 5869 0
weekly for 15 weeks (including before and after treatment sessions)
Primary outcome [2] 237955 0
anxiety and depression score self reports
Timepoint [2] 237955 0
three tims daily for 15 weeks (including before and after treatment sessions)
Secondary outcome [1] 242053 0
client reports on progress
Timepoint [1] 242053 0
weekly for 12 weeks during treatment period

Eligibility
Key inclusion criteria
Over 18
diagnosed with Asperger's Disorder
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
not able to evidence diagnosis,
comorbid conditions / complexities making it apparent a short term intervention is inappropriate
not self referred
prviously known to researcher

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
multiple baseline design; 8 clients starting in staggered weeks
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4887 0
Self funded/Unfunded
Name [1] 4887 0
Address [1] 4887 0
Country [1] 4887 0
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide
South Australia 5001
Country
Australia
Secondary sponsor category [1] 4421 0
None
Name [1] 4421 0
Address [1] 4421 0
Country [1] 4421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6952 0
University of SA Human Research Ethics Committee
Ethics committee address [1] 6952 0
University of South Australia
GPO Box 2471
Adelaide
South Australia 5001
Ethics committee country [1] 6952 0
Australia
Date submitted for ethics approval [1] 6952 0
22/03/2009
Approval date [1] 6952 0
30/03/2009
Ethics approval number [1] 6952 0
P038/09

Summary
Brief summary
To evaluate use of cognitive behavioural therapy to treat anxiety and depression in clients with Asperger's Disorder
Trial website
Trial related presentations / publications
08/02/2011
The study has been completed and submitted as part of requirements for the degree of Doctor of Psychology (Clinical) at the University of SA. The following is the abstract of the thesis:
A program was provided to seven adult clients previously diagnosed with Asperger’s disorder (AsD) who responded to a letter offering a program using cognitive behavioural therapy (CBT) approaches to clients with AsD who also experienced difficulty with anxiety, depression, or handling social situations. Four clients presented with clinically significant levels of depression and/or anxiety. For three of these, Depression Anxiety Stress Scales (DASS) questionnaire results indicated positive clinically significant change. The fourth client showed some desired changes in behaviour. Three clients presented with sub-clinical levels of anxiety and depression prior to treatment. While there were some decreases in DASS scores for these clients, they were not clinically significant. All clients reported they found the program helpful and that they had learned and implemented skills found helpful in their daily lives. Psycho-education, behavioural skills like progressive relaxation and an impulse control strategy called 'Stop 1, 2, 3, Cool it Breathing,' (S123CIB) and cognitive strategies such as identifying and then challenging thoughts identified as leading to feelings expressed through inappropriate actions were found helpful. The findings of this report are encouraging and supportive of use of CBT with clients with AsD, although the small numbers involved mean that findings are tentative, and suggestive of areas of further research rather than conclusive.
Public notes

Contacts
Principal investigator
Name 29561 0
Dr Piet Crosby
Address 29561 0
PO 3144
Melbourne St
North Adelaide 5006
South Australia
Country 29561 0
Australia
Phone 29561 0
61417706145
Fax 29561 0
Email 29561 0
pietcrosby@internode.on.net
Contact person for public queries
Name 12808 0
Dr Piet Crosby
Address 12808 0
PO 3144 Melbourne St
North Adelaide
South Australia 5006
Country 12808 0
Australia
Phone 12808 0
+61 417706145
Fax 12808 0
Email 12808 0
pietcrosby@internode.on.net
Contact person for scientific queries
Name 3736 0
Dr Piet Crosby
Address 3736 0
PO 3144 Melbourne St
North Adelaide
South Australia 5006
Country 3736 0
Australia
Phone 3736 0
+61 417706145
Fax 3736 0
Email 3736 0
Piet.Crosby@postgrads.unisa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary