Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000029392
Ethics application status
Approved
Date submitted
2/01/2017
Date registered
9/01/2017
Date last updated
13/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a brief meta-cognitive intervention on pre-event rumination in social anxiety
Scientific title
Effects of a meta-cognitive intervention on pre-event rumination in social anxiety
Secondary ID [1] 290819 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social anxiety disorder 301487 0
Condition category
Condition code
Mental Health 301194 301194 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Half the participants (randomly allocated) will complete a brief intervention in regards to pre-event rumination. The intervention will be administered individually. The advantages and disadvantages of pre-event rumination will be elicited and any erroneous advantages cognitively challenged and reappraised. Intervention is structured but tailored to reflect an individuals unique concerns. Once it is clear to the participants that the disadvantages outweigh the advantages, and that they have control over the rumination process, participants will then be instructed to not engage in pre-event rumination, in regards to the upcoming speech task they have been instructed to complete in a few days time (i.e., to ‘ban’ pre-event rumination). Intervention will be delivered by a registered psychologist, will be delivered face-to-face, and will take approximately 20 minutes to complete. The intervention will be video recorded with a subset analysed by a second research to assess fidelity.

four days following the intervention, all 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.
Intervention code [1] 296742 0
Treatment: Other
Comparator / control treatment
The control group will receive no treatment.
Control group
Active

Outcomes
Primary outcome [1] 300618 0
Negative pre-event rumination as measured by the Thoughts Questionnaire-Extended
Timepoint [1] 300618 0
1,2,3 and 4 days post-intervention
Secondary outcome [1] 330415 0
Change in state Anxiety as measured by the State Anxiety Rating.
Timepoint [1] 330415 0
Baseline and both before and after a designated speech task (4 days post-intervention)
Secondary outcome [2] 330416 0
Performance appraisals as measured by the Speech Performance Questionnaire. An independent rater will also rate speech task performance using this questionnaire.
Timepoint [2] 330416 0
Baseline and both before and after a designated speech task (4 days post-intervention)
Secondary outcome [3] 330417 0
Self-efficacy as measured by the Ability Questionnaire
Timepoint [3] 330417 0
Baseline and both before and after a designated speech task (4 days post-intervention)
Secondary outcome [4] 330418 0
Attentional focus as measured by the Attentional Focus Questionnaire.
Timepoint [4] 330418 0
After a designated speech task (4 days post-intervention)
Secondary outcome [5] 330419 0
Threat Appraisals as measured by the Probability and Consequences Questionnaire
Timepoint [5] 330419 0
Baseline and both before and after a designated speech task (4 days post-intervention)
Secondary outcome [6] 330420 0
Specific single questions created by research regarding how anxious they are about the upcoming speech, how often they have negatively thought about their speech task, how often and successful they were able to stop themselves engaging in negative rumination
Timepoint [6] 330420 0
1,2,3 and 4 days post-intervention

Eligibility
Key inclusion criteria
Only participants whom met criteria for a principal diagnosis of Social Anxiety DIsorder, according to the Anxiety Disorder Interview Schedule for DSM-5 interview (ADIS-5), will be included. ADIS-5 interview 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 do not meet criteria for a principal diagnosis of SAD, according to the Anxiety Disorder Interview Schedule for DSM-5 interview, will beexcluded.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2017
Actual
9/03/2017
Date of last participant enrolment
Anticipated
13/11/2017
Actual
12/06/2017
Date of last data collection
Anticipated
17/11/2017
Actual
12/06/2017
Sample size
Target
50
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295246 0
University
Name [1] 295246 0
The University of Sydney
Country [1] 295246 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] 294075 0
Individual
Name [1] 294075 0
Matthew Modini
Address [1] 294075 0
M02F - 88 Mallett Street - Building F
The University of Sydney
Camperdown, 2050
NSW
Country [1] 294075 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296585 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [1] 296585 0
Research Integrity
Research Portfolio
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006
Australia
Ethics committee country [1] 296585 0
Australia
Date submitted for ethics approval [1] 296585 0
19/12/2016
Approval date [1] 296585 0
13/02/2017
Ethics approval number [1] 296585 0
Project number: 2017/022

Summary
Brief summary
Negative rumination is a key maintaining factor in social anxiety disorder and the current study seeks to advance the limited literature on pre-event rumination in social anxiety. Given the lack of research investigating the effects of specific interventions on pre-event rumination, it is imperative to trial strategies that may reduce the frequency of pre-event rumination in individuals with social anxiety. This will have the positive benefit of assisting an individual with social anxiety to not enter a social situation in a negative self-focused processing mode and anticipating failure. One such strategy that has previously been suggested, but yet to be determined as efficacious, is instructing individuals with social anxiety to ban rumination as it serves no adaptive purpose for them. Additionally, the temporal pattern of pre-event rumination is unclear and determining this will assist in understanding this process for individuals with social anxiety and also make clearer when future interventions should be trialled. Specially this study aims are to investigate:
1. The effects of a brief intervention that instructs individuals to not engage in negative pre-event rumination.
2. The temporal pattern of pre-event rumination and determine optimal time points for future interventions to be delivered.
The present study hypothesises that:
1. Individuals with social anxiety disorder whom receive the brief intervention will report reduced negative pre-event rumination before a planned speech task, compared to a control group, and thus will report reduce state anxiety in relation to a speech task.
2. While it is suggested that frequency, uncontrollability, severity, and distress of pre-event rumination will increase in linear fashion in the days before the planned speech task, the lack of research regarding the experience of pre-event rumination for individuals with social anxiety precludes a firm hypothesis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71374 0
A/Prof Maree Abbott
Address 71374 0
M02F - 88 Mallett Street - Building F
The University of Sydney
Camperdown, 2050
NSW
Country 71374 0
Australia
Phone 71374 0
+61 2 9114 4342
Fax 71374 0
Email 71374 0
[email protected]
Contact person for public queries
Name 71375 0
Mr Matthew Modini
Address 71375 0
Rm 317, The Brain and Mind Centre
94-100 Mallett St Camperdown (M02F)
The University of Sydney
NSW 2050 Australia
Country 71375 0
Australia
Phone 71375 0
+61437193513
Fax 71375 0
Email 71375 0
[email protected]
Contact person for scientific queries
Name 71376 0
Mr Matthew Modini
Address 71376 0
Rm 317, The Brain and Mind Centre
94-100 Mallett St Camperdown (M02F)
The University of Sydney
NSW 2050 Australia
Country 71376 0
Australia
Phone 71376 0
+61437193513
Fax 71376 0
Email 71376 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
EmbaseBanning pre-event rumination in social anxiety: A preliminary randomized trial.2018https://dx.doi.org/10.1016/j.jbtep.2018.06.009
N.B. These documents automatically identified may not have been verified by the study sponsor.