Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000469011
Ethics application status
Approved
Date submitted
3/06/2010
Date registered
9/06/2010
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of motivational interviewing prior to cognitive behavioural treatment for social phobia
Scientific title
In adults with a Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnosis of Social Phobia , does a motivational interviewing intervention prior to a cognitive behavioural treatment (CBT) compared to published studies of CBT outcome, enhance changes in engagement with treatment and social phobia symptoms?
Secondary ID [1] 251943 0
None
Universal Trial Number (UTN)
U1111-1115-4408
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Phobia 257516 0
Condition category
Condition code
Mental Health 257676 257676 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Motivational Interviewing (MI), cognitive-behavioural treatment.
Motivational Interviewing will occur in weeks 1-3. Cognitivebehavioural treatment will occur in weeks 4-15.
All treatment sessions will be conducted by clinical psychologists.
The preparatory MI sessions will be based on the principles of motivational interviewing outlined in Westra & Dozois (2008) with a focus on ambivalence about anxiety change and about the treatment procedures used to effect that change. The program will be based on the four main principles of MI (empathy, rolling with resistance, developing discrepancy and enhancing self-efficacy). Homework exercises are optional.
Motivational Interviewing will be delivered on an individual basis for one-hour per week for three weeks.

The cognitive behavioural treatment program includes the basic principles of standard CBT such as cognitive restructuring, exposure, and skills training. In addition, it includes components of attentional training, cognitive change at the schema level, detailed focus on dropping safety behaviours, and extensive performance feedback to increase the participant’s perceptions of their performance and modify their normally negative self-evaluations to be more consistent with those of independent observers. A major component of the technique utilises video feedback following performance of a role play in group. These exercises are then reinforced during exposure by identifying novel methods of obtaining feedback in the real world. The skills learned in session are practised by participants in weekly homework exercises.
Cognitive-Behavioural Treatment will be delivered in a group format for 2.5 hours once a week for 12 weeks.
Intervention code [1] 256610 0
Treatment: Other
Intervention code [2] 256624 0
Behaviour
Comparator / control treatment
Comparison with the effect sizes for studies of cognitive-behavioural treatment for social phobia published between 1997 and 2010.
Control group
Historical

Outcomes
Primary outcome [1] 258580 0
% of participants meeting diagnostic criteria for social phobia as assessed by the Anxiety Disorders Interview Schedule
Timepoint [1] 258580 0
At baseline, post intervention and 3 months after completion of the intervention
Primary outcome [2] 258581 0
Mean scores on the Social Phobia Scale/Social Interaction Anxiety Scales which assess fear and avoidance of situations where there is the prospect of being observed by others and distress when meeting or talking to other people (interaction fears).
Timepoint [2] 258581 0
At baseline, post intervention and 3 months after the completion of the intervention
Secondary outcome [1] 264448 0
Mean Homework Ratings as measured by the Homework Rating Scale which assesses participant understanding, completion, and barriers to completion of the homework tasks set on a weekly basis.
Timepoint [1] 264448 0
At the beginning of each treatment session other than the first session.

Eligibility
Key inclusion criteria
People who meet DSM-IV criteria for social phobia. If multiple anxiety disorders are present, social phobia must be the principal diagnosis based on severity and life interference
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
current, active suicidal ideation, organic mental disorders, a co-morbid psychotic disorder, or current, unmanaged substance dependence. Participants will be required to be fluent in their use of English.

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)
Participants who contact the Emotional Health Clinic and who are assessed to meet the inclusion and exlusion criteria will be invited to participate in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2010
Actual
11/06/2010
Date of last participant enrolment
Anticipated
Actual
30/11/2010
Date of last data collection
Anticipated
Actual
31/12/2011
Sample size
Target
30
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 257103 0
University
Name [1] 257103 0
Macquarie University
Country [1] 257103 0
Australia
Primary sponsor type
Individual
Name
Dr Lorna Peters
Address
Department of Psychology
Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 256363 0
None
Name [1] 256363 0
Address [1] 256363 0
Country [1] 256363 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259144 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 259144 0
Ethics committee country [1] 259144 0
Australia
Date submitted for ethics approval [1] 259144 0
11/02/2010
Approval date [1] 259144 0
10/06/2010
Ethics approval number [1] 259144 0
5201000100(R)

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

Contacts
Principal investigator
Name 31258 0
Address 31258 0
Country 31258 0
Phone 31258 0
Fax 31258 0
Email 31258 0
Contact person for public queries
Name 14505 0
Ms Leigh Carpenter
Address 14505 0
Department of Psychology
Macquarie University NSW 2109
Country 14505 0
Australia
Phone 14505 0
+612 9850 8034
Fax 14505 0
Email 14505 0
Leigh.Carpenter.mq.edu.au
Contact person for scientific queries
Name 5433 0
Dr Lorna Peters
Address 5433 0
Department of Psychology
Macquarie University NSW 2109
Country 5433 0
Australia
Phone 5433 0
+612 9850 6727
Fax 5433 0
Email 5433 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.