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Trial registered on ANZCTR


Registration number
ACTRN12615000929505
Ethics application status
Approved
Date submitted
14/08/2015
Date registered
7/09/2015
Date last updated
4/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of cognitive behavioural therapy for social anxiety disorder, and the use of stress and sex hormones for predicting response to treatment
Scientific title
Efficacy of cognitive behavioural therapy for social anxiety disorder, and the use of stress and sex hormones for predicting response to treatment
Secondary ID [1] 287275 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety Disorder 295905 0
Condition category
Condition code
Mental Health 296158 296158 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete three sessions of cognitive-behaviour therapy (CBT) per week over four weeks (12 sessions in total). Each session will involve the participant and the therapist meeting in an individual treatment format to reduce the factors maintaining the participant's anxiety (i.e., unhelpful thoughts and unhelpful behaviours). To reduce the unhelpful thoughts, cognitive interventions are used and to reduce the unhelpful behaviours exposure therapy is used. Exposure therapy involves gradually confronting feared stimuli in a controlled and systematic way. The sessions involve:
Session 1 - Psychoeducation
Session 2 - Introduction to cognitive distortions and challenging unhelpful cognitions
Session 3 - Challenging unhelpful cognitions
Session 4 - Advanced cognitive strategies - challenging core beliefs
Session 5 - Introduction to exposure therapy and the development of an exposure hierarchy
Session 6 - Exposure I (saliva sample collection)
Session 7 - Exposure II
Session 8 - Exposure III (saliva sample collection)
Session 9 - Exposure IV
Session 10 - Exposure V (saliva sample collection)
Session 11 - Exposure VI
Session 12 - Relapse prevention.

Participants will provide a saliva sample (10ml saliva) via the passive drool method immediately before and 30 minutes after exposure therapy in sessions 6, 8, and 10 in order to examine the endogenous cortisol response to exposure therapy.

Therapy sessions will be delivered individually with either a provisional or registered psychologist. The duration of sessions will be 60 minutes. The treatment is manualised and the content of sessions will include psycho-education, cognitive restructuring and in-vivo exposure.

Adherence to the treatment will be measured by monitoring session attendance. Between session adherence will be measured based on homework compliance (a rating on a scale of 0-4 is given to each participant at each session based on the homework compliance).
Intervention code [1] 292584 0
Behaviour
Intervention code [2] 292585 0
Treatment: Other
Comparator / control treatment
This is an uncontrolled trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295838 0
Social Phobia Inventory (which will measure the severity of social anxiety symptoms)
Timepoint [1] 295838 0
Baseline
Post-treatment
3-month follow up
Secondary outcome [1] 316667 0
Social Phobia Scale (which will measure the severity of social anxiety symptoms)
Timepoint [1] 316667 0
Baseline
Post-treatment
3-month follow up
Secondary outcome [2] 316668 0
Social Interaction Anxiety Scale (which will measure the severity of social anxiety symptoms)
Timepoint [2] 316668 0
Baseline
Post-treatment
3-month follow up
Secondary outcome [3] 316669 0
Depression Anxiety Stress Scales (which will measure symptoms of depression, anxiety, and stress)
Timepoint [3] 316669 0
Baseline
Post-treatment
3-month follow up
Secondary outcome [4] 316670 0
Sheehan Disability Scale (which will measure functional impairment)
Timepoint [4] 316670 0
Baseline
Post-treatment
3-month follow up
Secondary outcome [5] 316671 0
Mini Social Phobia Inventory (which will measure the severity of social anxiety symptoms)
Timepoint [5] 316671 0
Each treatment session
Secondary outcome [6] 316877 0
Cortisol levels will be measured from saliva sample
Timepoint [6] 316877 0
Session 6
Session 8
Session 10
Secondary outcome [7] 316878 0
Estrogen levels will be measured from saliva sample
Timepoint [7] 316878 0
Session 6
Session 8
Session 10
Secondary outcome [8] 316881 0
Progesterone levels will be measured from saliva sample
Timepoint [8] 316881 0
Session 6
Session 8
Session 10

Eligibility
Key inclusion criteria
- Primary diagnosis of SAD
- Aged 18 and 65 years
- Able to read and write English fluently
- Able to attend treatment sessions 3 times per week.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant (due to hormonal/cortisol changes)
- Severe depression, suicidality or psychosis
- History of abnormal menstrual cycles, hormonal disorder or endometriosis
- Intellectual or cognitive impairment that interferes with ability to provide informed consent or to engage in CBT
- History of brain injury or neurological disorder.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Pre-treatment to post-treatment and pre-treatment to 3-month changes on outcome measures will be analysed with multi-level linear models. Within-group effect sizes using Cohen's d will be calculated based on pooled standard deviations for both the entire sample using the estimated marginal means and completer samples. Clinically significant change will be determined using the Jacobson and Truax (1991) criteria based on the primary outcome measure (SPIN). Clinically significant change will be determined based on those participants meeting the Jacobson and Truax (1991) criteria for reliable change as well as scoring 2 standard deviations below the pre-treatment mean on the SPIN.
Acceptability will be measured with descriptive statistics only.
Cortisol measures will be taken at baseline and following exposure therapy in sessions 6, 8 and 10. To test whether baseline cortisol (prior to exposure) predicts response to CBT we will use regression with baseline cortisol level as the IV and the subjective units of distress scale (0-100 point scale of anxiety) as the DV. Change in cortisol levels across sessions will also be used as a predictor variable alongside pre-treatment social anxiety measures, and depression severity to assess capacity of cortisol change to predict treatment outcome (indexed by change on the total SPIN scores).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Both investigators left the institution for new positions and it was not possible to continue data collection.
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)
TAS

Funding & Sponsors
Funding source category [1] 291836 0
University
Name [1] 291836 0
University of Tasmania
Address [1] 291836 0
School of Medicine
Faculty of Health
University of Tasmania
Private Bag 30
Hobart
TAS 7001
Country [1] 291836 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Division of Psychology
School of Medicine
Faculty of Health
University of Tasmania
Private Bag 30
Hobart
TAS 7001
Country
Australia
Secondary sponsor category [1] 290504 0
None
Name [1] 290504 0
Address [1] 290504 0
Country [1] 290504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293353 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 293353 0
Ethics committee country [1] 293353 0
Australia
Date submitted for ethics approval [1] 293353 0
Approval date [1] 293353 0
10/08/2015
Ethics approval number [1] 293353 0
H0014961

Summary
Brief summary
The main aims of the current study are to: (a) investigate the efficacy of intensive individual cognitive behavioural therapy (CBT) for social anxiety disorder (SAD) and (b) examine the capacity of the stress hormone cortisol to predict treatment response to intensive CBT in individuals with SAD. This project will test these aims in a preliminary, single group open trial design. Treatment will consist of three 60-minute sessions of CBT each week over four weeks, (12 hours in total). Saliva samples will be collected at 3 of these 12 sessions in order to measure cortisol levels in response to exposure therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59526 0
Dr Bethany Wootton
Address 59526 0
School of Psychology
Department of Behavioural, Cognitive and Social Sciences
University of New England
Armidale
NSW, 2350
Country 59526 0
Australia
Phone 59526 0
+61 2 6773 5798
Fax 59526 0
Email 59526 0
bwootton@une.edu.au
Contact person for public queries
Name 59527 0
Dr Bethany Wootton
Address 59527 0
School of Psychology
Department of Behavioural, Cognitive and Social Sciences
University of New England
Armidale
NSW, 2350
Country 59527 0
Australia
Phone 59527 0
+61 2 6773 5798
Fax 59527 0
Email 59527 0
bwootton@une.edu.au
Contact person for scientific queries
Name 59528 0
Dr Bethany Wootton
Address 59528 0
School of Psychology
Department of Behavioural, Cognitive and Social Sciences
University of New England
Armidale
NSW, 2350
Country 59528 0
Australia
Phone 59528 0
+61 2 6773 5798
Fax 59528 0
Email 59528 0
bwootton@une.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