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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

social anxiety disorder

Condition category

Condition code

Mental Health

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]

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]

negative rumination as measured by the Thoughts Questionnaire.

Timepoint [1]

1 week post intervention (both before and after a designated speech task) and two weeks post intervention

Primary outcome [2]

State Anxiety as measured by the State Anxiety Rating.

Timepoint [2]

immediately post intervention and 1 week post intervention (both before and after a designated speech task)

Primary outcome [3]

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]

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]

Self-efficacy as measured by the Ability Questionnaire

Timepoint [1]

immediately post intervention and 1 week post intervention (both before and after a designated speech task

Secondary outcome [2]

Attentional focus as measured by the Attentional Focus Questionnaire.

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

School of Psychology
Griffith Taylor Building (A19)
The University of Sydney NSW 2006
Australia

Country [1]

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]

Individual

Name [1]

Matthew Modini

Address [1]

M02F - 88 Mallett Street - Building F
The University of Sydney
Camperdown, 2050
NSW

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee, The University of Sydney

Ethics committee address [1]

Research Integrity
Research Portfolio
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/01/2015

Ethics approval number [1]

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

A/Prof Maree Abbott

Address

M02F - 88 Mallett Street - Building F
The University of Sydney
Camperdown, 2050
NSW

Country

Australia

Phone

+61 2 9114 4342

Fax

maree.abbott@sydney.edu.au

Contact person for public queries

Name

Matthew Modini

Address

Rm 317, The Brain and Mind Centre
94-100 Mallett St Camperdown (M02F)
The University of Sydney
NSW 2050 Australia

Country

Australia

Phone

+61437193513

Fax

mmod3234@uni.sydney.edu.au

Contact person for scientific queries

Name

Matthew Modini

Address

Rm 317, The Brain and Mind Centre
94-100 Mallett St Camperdown (M02F)
The University of Sydney
NSW 2050 Australia

Country

Australia

Phone

+61437193513

Fax

mmod3234@uni.sydney.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Negative rumination in social anxiety: A randomised trial investigating the effects of a brief intervention on cognitive processes before, during and after a social situation.	2017	https://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.

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