Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001068459
Ethics application status
Approved
Date submitted
4/08/2016
Date registered
9/08/2016
Date last updated
9/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the effects of a brief cognitive intervention on a range of cognitive processes for individuals with social anxiety disorder.
Scientific title
Negative rumination in social anxiety: A randomized trial investigating the effects of a brief intervention on cognitive processes before, during and after a social situation in individuals with social anxiety disorder .
Secondary ID [1] 289851 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social anxiety disorder 299791 0
Condition category
Condition code
Mental Health 299718 299718 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive restructuring intervention administered by a post graduate student in clinical psychology. Intervention delivered face to face, delivered once and takes approximately 30 minutes to complete. Is delivered in a lab at the University of Sydney. Intervention is structured but tailored to reflect an individuals unique concerns about the upcoming speech task they will be asked to participate in. One week following the intervention participants complete a 3 minute speech task on a topic of their choosing. The speech task is filmed to allow two independent judges to appraise it for performance at a later time point. No feedback is provided to the participant regarding performance.

Procedure is as follows:
The cognitive intervention involved initially presenting the results of a study by Rapee and Lim (1992) in which it was found that people with and without social phobia have a tendency to appraise their performance in a speech task more negatively then an independent judge. Following this a brief introduction to cognitive restructuring was provided by showing a completed thought monitoring form in which the thought “The rater’s will think I look stupid” had been challenged by looking at evidence against the thought, and the true probability and consequence of the thought. The participants were then guided in challenging any negative thoughts they had regarding the upcoming speech task by filling out a blank thought monitoring form. The cognitive intervention took approximately 30 minutes to complete.
Intervention code [1] 295536 0
Treatment: Other
Comparator / control treatment
Control group do not complete any intervention.

Note: Originally study design included two additional groups of individuals, both without Social Anxiety disorder, with one of these group receiving the intervention and the other serving as a control group without Social Anxiety Disorder. Delivering the intervention to the former group was ceased after approximately 5 participants due to it becoming apparent the intervention had little to no affect on this non-socially anxious group. While participants without social anxiety disorder were still recruited, and completed the same study protocol as the non-intervention group, their data was not included in the write up of this trial. It is hoped that this data will be used in analyses for separate studies in the future.
Control group
Active

Outcomes
Primary outcome [1] 299174 0
negative rumination as measured by the Thoughts Questionnaire.
Timepoint [1] 299174 0
1 week post intervention (both before and after a designated speech task) and two weeks post intervention
Primary outcome [2] 299175 0
State Anxiety as measured by the State Anxiety Rating.
Timepoint [2] 299175 0
immediately post intervention and 1 week post intervention (both before and after a designated speech task)
Primary outcome [3] 299176 0
performance appraisals as measured by the Speech Performance Questionnaire. An independent rater will also rate speech task performance using this questionnaire. When the Speech Performance Questionnaire is administered pre-speech task it is measuring anticipated performance.
Timepoint [3] 299176 0
Immediately post intervention, 1 week post intervention (both before and after a designated speech task) and 2 weeks post intervention. When the Speech Performance Questionnaire is administered pre-speech task it is measuring anticipated performance.
Secondary outcome [1] 326426 0
Self-efficacy as measured by the Ability Questionnaire
Timepoint [1] 326426 0
immediately post intervention and 1 week post intervention (both before and after a designated speech task
Secondary outcome [2] 326427 0
Attentional focus as measured by the Attentional Focus Questionnaire.
Timepoint [2] 326427 0
One week after the intervnetion (post speech task)

Eligibility
Key inclusion criteria
Only participants whom met criteria for a principal diagnosis of SAD, according to the Anxiety Disorder Interview Schedule for DSM-IV interview (ADIS-IV), were included. ADIS-IV intervention administered pre-intervention to determine eligibility.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants whom did not meet criteria for a principal diagnosis of SAD, according to the Anxiety Disorder Interview Schedule for DSM-IV interview, were excluded.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Power analysis was initially carried out with a different study design which was later modified. Originally study design included two additional groups of individuals, both without Social Anxiety disorder, with one of these group receiving the intervention and the other serving as a control group without Social Anxiety Disorder. Delivering the intervention to the former group was ceased after approximately 5 participants due to it becoming apparent the intervention had little to no affect on this non-socially anxious group. While participants without social anxiety disorder were still recruited, their data was not included in the study.

Sample size analysis was conducted on this original 2x2 study design. GPower indicated that a total sample size of 76 participants was required for this initial design with power of .8 and alpha set at .05 to detect a large effect size [Fc(3, 72) = 2.7318]. A revised sample size analyses was not conducted on the altered study design. However as this is a preliminary study, findings were aimed to guide future research designing more powerful interventions with a larger sample size. Sixty eight participants were ultimately included in the write up of this study, all of whom met criteria for a Social Anxiety Disorder diagnosis.

Statistical analyses include MANOVA's, Univariate ANOVA's and hierarchical regression.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/04/2015
Date of last participant enrolment
Anticipated
Actual
28/10/2015
Date of last data collection
Anticipated
Actual
11/11/2015
Sample size
Target
76
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294229 0
University
Name [1] 294229 0
The University of Sydney
Country [1] 294229 0
Australia
Primary sponsor type
Individual
Name
A/Prof Maree Abbott
Address
M02F - 88 Mallett Street - Building F
The University of Sydney
Camperdown, 2050
NSW
Country
Australia
Secondary sponsor category [1] 293058 0
Individual
Name [1] 293058 0
Matthew Modini
Address [1] 293058 0
M02F - 88 Mallett Street - Building F
The University of Sydney
Camperdown, 2050
NSW
Country [1] 293058 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295650 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [1] 295650 0
Research Integrity
Research Portfolio
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006
Australia
Ethics committee country [1] 295650 0
Australia
Date submitted for ethics approval [1] 295650 0
Approval date [1] 295650 0
10/01/2015
Ethics approval number [1] 295650 0
2013/1031

Summary
Brief summary
According to the cognitive models of Social Anxiety Disorder (SAD), negative rumination is a key maintaining factor in the vicious cycle of social anxiety. However, there is a lack of research investigating treatment effects on rumination in social anxiety, as well as other key cognitive variables. The current study aimed to determine the effectiveness of a brief intervention on a range of cognitive processes, most notably negative rumination. Furthermore, the predictors of negative rumination and state anxiety are investigated.
Specifically, we hypothesise that: 1)Participants in the cognitive restructuring condition will report reduced negative affect, state anxiety, negative rumination, and threat appraisals, as well as stronger performance appraisal, objective performance, and positive self-beliefs relating to the speech task as comparted to SAD individuals who do not receive the intervention.
2) Despite recent evidence suggestion that more cognitive processes are at play during pre-event rumination than post-event rumination, making the process potentially more difficult to address in a single-session intervention, we further anticipate that the cognitive intervention will significantly reduce both pre-and post-event rumination, comparted to the socially anxious group whom do not receive the intervention 3) The predictors of levels of negative rumination, both pre- and post, will mirror those reported by Previous research
Trial website
Trial related presentations / publications
Public notes
Note: Originally study design included two additional groups of individuals, both without Social Anxiety disorder, with one of these group receiving the intervention and the other serving as a control group without Social Anxiety Disorder. Delivering the intervention to the former group was ceased after approximately five participants due to it becoming apparent the intervention had little to no affect on this non-socially anxious group. While participants without social anxiety disorder were still recruited, and completed the study protocol, their data was not included in the analysis of this trial.

Contacts
Principal investigator
Name 68014 0
A/Prof Maree Abbott
Address 68014 0
M02F - 88 Mallett Street - Building F
The University of Sydney
Camperdown, 2050
NSW
Country 68014 0
Australia
Phone 68014 0
+61 2 9114 4342
Fax 68014 0
Email 68014 0
[email protected]
Contact person for public queries
Name 68015 0
Mr Matthew Modini
Address 68015 0
Rm 317, The Brain and Mind Centre
94-100 Mallett St Camperdown (M02F)
The University of Sydney
NSW 2050 Australia
Country 68015 0
Australia
Phone 68015 0
+61437193513
Fax 68015 0
Email 68015 0
[email protected]
Contact person for scientific queries
Name 68016 0
Mr Matthew Modini
Address 68016 0
Rm 317, The Brain and Mind Centre
94-100 Mallett St Camperdown (M02F)
The University of Sydney
NSW 2050 Australia
Country 68016 0
Australia
Phone 68016 0
+61437193513
Fax 68016 0
Email 68016 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
SourceTitleYear of PublicationDOI
EmbaseNegative rumination in social anxiety: A randomised trial investigating the effects of a brief intervention on cognitive processes before, during and after a social situation.2017https://dx.doi.org/10.1016/j.jbtep.2016.12.002
N.B. These documents automatically identified may not have been verified by the study sponsor.