Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000323921p
Ethics application status
Submitted, not yet approved
Date submitted
28/02/2020
Date registered
9/03/2020
Date last updated
9/03/2020
Date data sharing statement initially provided
9/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the efficacy of a brief psychotherapeutic intervention in reducing post-event rumination in individuals with Social Anxiety Disorder.
Scientific title
Investigating the efficacy of a brief metacognitive therapy (MCT) intervention in reducing post-event rumination in individuals with Social Anxiety Disorder.
Secondary ID [1] 300679 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety Disorder 316478 0
Condition category
Condition code
Mental Health 314727 314727 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants (in both the intervention and control conditions) will be asked to complete a 3 minute impromptu speech task. This involves speaking for 3 minutes about a topic of their choice. The speech is video recorded. Following this, those in the intervention condition receive a brief Metacognitive Therapy (MCT) intervention, which involves eliciting participants’ beliefs about post-event rumination, and challenging and reappraising any unhelpful beliefs that serve to maintain post-event rumination.

a) Materials: A video camera will be used to record the speech task and the intervention. The psychotherapeutic intervention will be delivered verbally, with no physical or other informational materials used.
b) Procedures: All participants complete the aforementioned speech task. Then, for those in the intervention condition, the experimenter will ask the participant about their beliefs surrounding post-event rumination (specifically, do they believe it is helpful or unhelpful to engage in post-event rumination, and in what way/s). The participant will provide their response verbally. Using psychotherapeutic principles such as Socratic questioning, the researcher will challenge and reappraise any beliefs that serve to maintain post-event rumination, and provide psycho-education regarding the unhelpfulness and controllability of post-event rumination. The participant will then be instructed to attempt to refrain from engaging in post-event rumination in relation to the speech task over the coming days.
c) Who: The intervention will be delivered by a doctoral level research student (Hayley Donohue) who is also a registered provisional psychologist and has undertaken postgraduate training in clinical psychology. She will be supervised by the chief investigator of the study who is a clinical psychologist and board-approved clinical supervisor.
d) Mode of delivery: Face-to-face, one-on-one format.
e) Dose: The intervention is a brief (20 minute), single-session intervention that is delivered once only, immediately following the speech task.
f) Location: The intervention will take place in a consultation room at the University of Sydney Psychology Clinic, Level 2, 94 Mallett St, Camperdown NSW 2050.
g) The intervention delivered by the researcher will be video recorded for fidelity purposes. The video will be rated for fidelity by an independent researcher within the School of Psychology at the University of Sydney.
Intervention code [1] 317004 0
Treatment: Other
Comparator / control treatment
Control condition receive no intervention.
Control group
Active

Outcomes
Primary outcome [1] 323080 0
Level of post-event rumination, as measured using scores on the post-event version of the Thoughts Questionnaire.
Timepoint [1] 323080 0
1 day, 2 days, 3 days and 4 days post-intervention.
Secondary outcome [1] 380723 0
Trait social anxiety symptoms, as measured by the Social Interaction Anxiety Scale (SIAS).
Timepoint [1] 380723 0
Prior to the intervention and 4 days post-intervention.
Secondary outcome [2] 380878 0
Trait social anxiety symptoms, as measured by the Social Phobia Scale (SPS)
Timepoint [2] 380878 0
Prior to the intervention and 4 days post-intervention.
Secondary outcome [3] 380879 0
Trait social anxiety symptoms, as measured by the Brief Fear of Negative Evaluation (BFNE)
Timepoint [3] 380879 0
Prior to the intervention and 4 days post-intervention.
Secondary outcome [4] 380881 0
Trait depression, anxiety and stress symptoms, as measured by the Depression Anxiety Stress Scales (DASS-21)
Timepoint [4] 380881 0
Prior to the intervention and 4 days post-intervention.
Secondary outcome [5] 380883 0
State anxiety symptoms, as measured by the State Anxiety Rating (SAR).
Timepoint [5] 380883 0
Prior to the intervention and 1, 2, 3 and 4 days post-intervention.
Secondary outcome [6] 380885 0
State social anxiety symptoms, as measured by the Speech Performance Questionnaire (SPQ).
Timepoint [6] 380885 0
Prior to the intervention and 1, 2, 3 and 4 days post-intervention.
Secondary outcome [7] 380887 0
Trait social anxiety symptoms, as measured by the Self Beliefs related to Social Anxiety (SBSA)
Timepoint [7] 380887 0
Prior to the intervention and 4 days post-intervention.
Secondary outcome [8] 380888 0
Metcognitive beliefs about worry, as measured by the Metacognitions Questionnaire (MCQ-30)
Timepoint [8] 380888 0
Prior to the intervention and 4 days post-intervention.
Secondary outcome [9] 380889 0
Metacognitive beliefs about socially anxious rumination, as measured by the Positive Beliefs About Rumination Scale (PBRS-SA).
Timepoint [9] 380889 0
Prior to the intervention and 4 days post-intervention.

Eligibility
Key inclusion criteria
Undergraduate psychology students at the University of Sydney who meet criteria for a principal diagnosis of Social Anxiety Disorder (SAD) as assessed by the Anxiety Disorders Interview Schedule (ADIS-5).
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who are actively suicidal or are currently experiencing psychotic symptoms will be excluded from the study.

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.
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 using GPower indicated that a total sample size of 76 participants is required with power of .8 and alpha set at .05 to detect a medium to large effect size [Fc(1, 74) = 3.9702]. Data will be analysed using SPSS. An Analysis of Variance (ANOVA) will be used to compare the effect the brief intervention has on post-event rumination and other symptom-related variables for the intervention group verses the no intervention group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/03/2020
Actual
Date of last participant enrolment
Anticipated
19/06/2020
Actual
Date of last data collection
Anticipated
26/06/2020
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 29543 0
2050 - Camperdown
Recruitment postcode(s) [2] 29544 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 305120 0
University
Name [1] 305120 0
University of Sydney
Country [1] 305120 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 305482 0
None
Name [1] 305482 0
Address [1] 305482 0
Country [1] 305482 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305493 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 305493 0
Ethics committee country [1] 305493 0
Australia
Date submitted for ethics approval [1] 305493 0
21/01/2020
Approval date [1] 305493 0
Ethics approval number [1] 305493 0
2020/25

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

Contacts
Principal investigator
Name 100550 0
A/Prof Maree Abbott
Address 100550 0
Clinical Psychology Unit, University of Sydney
Level 3, Building F
94 Mallett St
Camperdown NSW 2050
Country 100550 0
Australia
Phone 100550 0
+61 2 91144342
Fax 100550 0
Email 100550 0
[email protected]
Contact person for public queries
Name 100551 0
Maree Abbott
Address 100551 0
Clinical Psychology Unit, University of Sydney
Level 3, Building F
94 Mallett St
Camperdown NSW 2050
Country 100551 0
Australia
Phone 100551 0
+61 2 91144342
Fax 100551 0
Email 100551 0
[email protected]
Contact person for scientific queries
Name 100552 0
Maree Abbott
Address 100552 0
Clinical Psychology Unit, University of Sydney
Level 3, Building F
94 Mallett St
Camperdown NSW 2050
Country 100552 0
Australia
Phone 100552 0
+61 2 91144342
Fax 100552 0
Email 100552 0
[email protected]

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


What supporting documents are/will be available?




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.