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Trial registered on ANZCTR


Registration number
ACTRN12611001279910
Ethics application status
Approved
Date submitted
12/12/2011
Date registered
13/12/2011
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing cognitive behavioural treatment outcomes 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 a supportive counselling intervention prior to CBT, enhance changes in engagement with treatment and social phobia symptoms?
Secondary ID [1] 273350 0
None
Universal Trial Number (UTN)
U1111-1125-7230
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Phobia 279118 0
Condition category
Condition code
Mental Health 279312 279312 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Motivational interviewing (MI), cognitive-behavioural treatment (CBT).

Motivational interviewing will occur in weeks 1-3. Cognitive behavioural treatment will occur in weeks 4-15.

All treatment sessions will be conducted by clinical psychologists.

The 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 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. MI will be delivered on an individual basis for one hour per week for three weeks.

The CBT 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. CBT will be delivered in a group format for 2.5 hours once a week for 12 weeks.
Intervention code [1] 283693 0
Behaviour
Comparator / control treatment
Supportive counselling; CBT.
Supportive counselling will be delivered in weeks 1-3 and CBt in weeks 4-15. All treatments will be delivered by clinical psychologists.
Supportive counselling will be centred on the time course of social anxiety. Therapists will be explicitly instructed to steer away from discussing the impact of social anxiety, motivation for treatment, expectations regarding treatment and CBT skills. Rather the therapist will focus on the participant’s childhood and family of origin and features of their development.
Control group
Active

Outcomes
Primary outcome [1] 279924 0
% or participants meeting diagnostic criteria for social phobia as assessed by the Anxiety Disorders Interview Schedule
Timepoint [1] 279924 0
At baseline, post intervention and 6 months after completion of the intervention.
Secondary outcome [1] 294790 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 [1] 294790 0
At baseline, post intervention and 6 months after completion of the intervention
Secondary outcome [2] 294791 0
Mean Homework Ratings as measured by the Homework rating Scale which assesses participant understanding, completion, and barriers to completion of homework tasks set on a weekly basis.
Timepoint [2] 294791 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; comorbid psychotic disorder; 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
Randomised controlled 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 exclusion criteria will be invited to participate in the study. Participants will agree to participate will be randomly allocated to receive either 3 session of motivational interviewing or three sessions of supportive counselling prior to 12 weeks of CBT.
The assignment of individuals to each block will be conducted by administrative staff via opaque envelopes at the clinic who will remain blind to the treatment condition allocated to each block throughout the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator will be used to allocate groups of 8 participants (to allow for group-delivery of the CBT component) to either motivational interviewing prior to CBT or supportive counselling prior to CBT..
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2012
Actual
8/02/2012
Date of last participant enrolment
Anticipated
1/02/2015
Actual
1/02/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
211
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284176 0
Government body
Name [1] 284176 0
National Health & Medical Research Council
Country [1] 284176 0
Australia
Primary sponsor type
Individual
Name
Dr Lorna Peters
Address
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
North Ryde NSW 2109
Country
Australia
Secondary sponsor category [1] 269130 0
None
Name [1] 269130 0
Address [1] 269130 0
Country [1] 269130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286135 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 286135 0
Ethics committee country [1] 286135 0
Australia
Date submitted for ethics approval [1] 286135 0
09/11/2011
Approval date [1] 286135 0
13/12/2011
Ethics approval number [1] 286135 0

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

Contacts
Principal investigator
Name 33365 0
Dr Lorna Peters
Address 33365 0
Centre for Emotional Health, Department of Psychology, Balaclava Rd, North Ryde, Macquarie University, NSW 2109
Country 33365 0
Australia
Phone 33365 0
+61298506727
Fax 33365 0
Email 33365 0
[email protected]
Contact person for public queries
Name 16612 0
Dr Lorna Peters
Address 16612 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
North Ryde NSW 2109
Country 16612 0
Australia
Phone 16612 0
+61 2 9850 6727
Fax 16612 0
Email 16612 0
[email protected]
Contact person for scientific queries
Name 7540 0
Dr Lorna Peters
Address 7540 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
North Ryde NSW 2109
Country 7540 0
Australia
Phone 7540 0
+61 2 9850 6727
Fax 7540 0
Email 7540 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.