Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000151538
Ethics application status
Approved
Date submitted
28/01/2015
Date registered
17/02/2015
Date last updated
13/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Imagery Rescripting Group Cognitive Therapy (IR-GCT) versus traditional Group Cognitive Therapy (GCT) for performance anxiety: a randomised control trial
Scientific title
In patients with social anxiety disorder, does imagery rescripting group cognitive therapy, compared to standard verbal-based group cognitive therapy and a waitlist control, reduce symptoms of performance anxiety?
Secondary ID [1] 286064 0
Nil
Universal Trial Number (UTN)
U1111-1166-1775
Trial acronym
IVC RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety Disorder 294051 0
Condition category
Condition code
Mental Health 294355 294355 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All interventions will be condensed into a 90-minute group session.

Within the imagery-rescripting group cognitive therapy (IR-GCT) protocol, participants will identify past negative social memories that are associated with current imagery in performance situations. Participants will be guided to rescript images associated with these memories by visualising the memory (1) from their child perspective, (2) from the perspective of their ‘older self’ intervening to assist the child, and (3) from their child perspective observing their ‘older self’ intervening. Following IR, participants will reflect on their affect and bodily sensations and will identify any shifts in meaning of the original event.

The verbally-based group cognitive therapy (VB-GCT) intervention will address similar content to IR-GCT using traditional verbal-linguistic techniques (i.e., challenging evidence for and against meanings of the original event, challenging the overestimation of probability and consequences in performance situations) with no reference to imagery.

The waitlist control (WC) group will not receive an intervention until after the waiting period has lapsed.

All interventions will be provided by psychologists.
Intervention code [1] 291052 0
Treatment: Other
Comparator / control treatment
Verbally-based group cognitive therapy (VB-GCT), Waitlist Control (WC).

WC participants will be able to complete their preferred treatment after the final post-waitlist assessment (3 weeks after the initial assessment).
Control group
Active

Outcomes
Primary outcome [1] 294151 0
Changes in social anxiety symptoms, as measured by the Social Interaction Phobia Scale (SIPS)
Timepoint [1] 294151 0
At baseline, and at 1 and 2 weeks post-intervention
Primary outcome [2] 294152 0
Changes in physiological symptoms of social anxiety (skin conductance) during speech task
Timepoint [2] 294152 0
At baseline, and at 1 week post-intervention during speech tasks
Primary outcome [3] 294202 0
Memory Distress Scale
Timepoint [3] 294202 0
Immediately before and after the intervention
Secondary outcome [1] 312629 0
Peak and change in subjective units of distress (SUDS) during a speech task (0 = no anxiety, 100 = most severe anxiety ever experienced)
Timepoint [1] 312629 0
At baseline (peak SUDS during intervention and SUDS immediately post speech task), and at 1 week post-intervention (peak SUDS during intervention and SUDS immediately post speech task)
Secondary outcome [2] 312631 0
Assess the moderating effects of imagery vividness on IR-GCT pre-post symptom change, as measured by the Vividness of Visual Imagery Questionnaire
Timepoint [2] 312631 0
Pre-intervention
Secondary outcome [3] 312753 0
Negative Self-Beliefs Scale
Timepoint [3] 312753 0
At baseline, and 1 week post-intervention
Secondary outcome [4] 312754 0
Cognitive Avoidance Questionnaire - Transformation subscale
Timepoint [4] 312754 0
At baseline, and 1 week post-intervention
Secondary outcome [5] 312755 0
Repetitive Thinking Questionnaire.
Timepoint [5] 312755 0
1 week after baseline speech task, and 1 week after follow-up speech task
Secondary outcome [6] 312756 0
Willingness to perform another speech task (0 = not at all, 10 = completely)
Timepoint [6] 312756 0
Immediately after baseline and 1- week post-intervention speech tasks
Secondary outcome [7] 312757 0
Overt anxious behaviours during speech tasks (Behaviours Checklist)
Timepoint [7] 312757 0
During baseline and 1-week post-intervention speech tasks
Secondary outcome [8] 312822 0
Heart rate variability (ECG)
Timepoint [8] 312822 0
During baseline and 1-week post-intervention speech tasks

Eligibility
Key inclusion criteria
The research will involve adult participants who experience symptoms consistent with performance anxiety, as measured by the Social Interaction Phobia Scale (SIPS) and social anxiety module of the Mini International Neuropsychiatric Interview for DSM-IV (MINI).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be screened during the initial assessment using the suicidality module of the MINI to ensure that individual's at high risk of suicide can be referred to a more appropriate service. To participate in this study, individuals must be willing to not partake in any external psychological treatment between their baseline assessment and their post-treatment follow-up assessment.

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)
1. Participants submit their consent form and initial screening measures

2. Participants will be contacted by the assessing clinician to set up an initial interview to discuss their participation in the study. Screening measures will include questions about anxiety symptoms, thoughts associated with performance situations, and self-beliefs. The initial assessment interview will provide participants with further information about the study and ask a series of questions about their current mood. Participants will also be asked to present a short video-taped speech task and rate their associated anxiety. During the speech task skin conductance and heart rate will be measured to indicate emotional arousal.

3. The assessing clinician will forward eligible participants’ details to a researcher who is separate to the treating team. This researcher will randomly allocate the participant to a condition and will then inform the treating team of the participant’s treatment condition.

4. The treating clinician will then contact the participant and schedule a group treatment session.

5. After treatment, the treating clinician will inform the assessing clinician, who will remain blind and will complete the post-treatment assessment.

6. The blind will only be broken after all data has been collected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to three equally sized groups will be determined by the Random Sequence Generator at www.random.org
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
H1a: There will be significant Group x Time interactions such that participants receiving the active interventions (IR-GCT and VB-GCT) will demonstrate significantly greater therapeutic changes in the following outcome measures between pre-test and post-test relative to participants in the control condition.
*Social anxiety symptoms (Social Interaction Phobia Scale)
*Negative self-beliefs (NSPS)
*Imagery suppression (CAQ-Transformation subscale)
*Repetitive negative thinking (Repetitive Thinking Questionnaire)
*Superior therapeutic change will be demonstrated in the social interaction task by: greater reductions in physical arousal (skin conductance, heart rate variability), lower subjective anxiety (subjective units of distress scale, SUDS), increased willingness to complete another speech, and fewer overt anxious behaviours (Behaviours Checklist).

H1b: Participants receiving IR-GCT will demonstrate significantly greater therapeutic changes in these variables between pre-test and post-test relative to participants in the VB-GCT condition.

H2a: Participants receiving the active interventions (IR-GCT and VB-GCT) will demonstrate significantly higher peak arousal during the intervention than those in the control condition.

H2b: Participants receiving IR-GCT will demonstrate significantly higher peak arousal during the intervention than participants receiving VB-GCT.

H3a: Participants receiving the active interventions (IR-GCT and VB-GCT) will demonstrate significantly greater change in arousal during the intervention than those in the control condition.

H3b: Participants receiving IR-GCT will demonstrate significantly greater change in arousal during the intervention than participants receiving VB-GCT.

H4a: Participants receiving the active interventions (IR-GCT and VB-GCT) will demonstrate significantly greater accessibility of positive (relative to negative) memories (Memory Distress Scale) immediately following the intervention than those in the control condition.

H4b: Participants receiving IR-GCT will demonstrate significantly greater accessibility of positive (relative to negative) memories immediately following the intervention than participants receiving VB-GCT.

H5: The impact of IR-GCT on pre-post symptom change will be moderated by vividness of visual imagery (Vividness of Visual Imagery Questionnaire, VVIQ).

Analytic Plan

Hypotheses 1-5 will be tested with a series of mixed-model repeated measures (MMRM) analyses as implemented using the ‘gls’ function of the R package nlme. For the self-report outcomes, the models will include the fixed, categorical effects of group (imagery rescripting, verbal restructuring, waitlist), time (pre/post-treatment), and their interaction using a restricted maximum likelihood estimator. A heterogeneous unstructured (co)variance structure will be used to model within-subject errors. Estimated marginal means will be calculated at pre- and post-treatment using the emmeans package in R. This package will also be used to specify and test contrasts for group means across pre- and post-treatment for each of the outcome measures – for example to test whether the mean change in the imagery rescripting condition between pre- and post-treatment exceeded that of the verbal restructuring group.

Physiological outcomes (i.e., arousal via skin conductance; heart rate variability via ECG as measured before, during, and after the speech task [TSST]) will be modelled using a similar approach to that used for the self-report outcomes, but one additional factor will be included in the MMRM models, namely, TSST condition. MMRM models for physiological outcomes will therefore include the following fixed, categorical factors: group (imagery rescripting, verbal restructuring, waitlist), time (pre/post-treatment), and TSST condition (baseline [pre-speech task], speech task, post-speech task), and all two- and three-way interactions between the factors. Analyses of physiological outcomes will focus on differences between the groups on reactivity and recovery indices. Reactivity is the magnitude of psychophysiological responsiveness elicited by aversive, challenging, or engaging laboratory tasks. Recovery refers to changes in stressor-induced psychophysiological responses following stressor termination. Analyses will define reactivity as the mean difference in each physiological parameter before and during the TSST; whilst recovery will refer to the mean difference in physiological parameters during and after the TSST. We will use contrasts of cell means to derive these values, and subsequently test whether treatment resulted in differences between the groups in mean reactivity and recovery scores.

Standardized mean difference effect sizes (i.e., Cohen’s d) will be computed for each contrast by dividing the mean difference between groups by the pooled pre-treatment standard deviation. As a rule of thumb, d values of 0.2, 0.5 and 0.8 are often described as being ‘small’, ‘moderate’ and ‘large’ effects.

The estimated the number of participants required for an 80% probability of capturing ‘moderate’ interactions between group and time (and condition for the physiological outcomes) at a stringent alpha-level of .01 according to GPower (Version 3.1.2) is 60 (20 in each group).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/02/2015
Actual
23/03/2015
Date of last participant enrolment
Anticipated
1/10/2016
Actual
9/09/2016
Date of last data collection
Anticipated
Actual
23/09/2016
Sample size
Target
60
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 9158 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 290651 0
Government body
Name [1] 290651 0
Department of Health Western Australian Merit Award
Country [1] 290651 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 289343 0
None
Name [1] 289343 0
Nil
Address [1] 289343 0
Nil
Country [1] 289343 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292281 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 292281 0
Ethics committee country [1] 292281 0
Australia
Date submitted for ethics approval [1] 292281 0
Approval date [1] 292281 0
18/12/2014
Ethics approval number [1] 292281 0
HR 230/2014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 288 288 0 0
/AnzctrAttachments/367849-Ethics approval_HR230_2014.pdf

Contacts
Principal investigator
Name 54454 0
A/Prof Peter McEvoy
Address 54454 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Western Australia 6102
Country 54454 0
Australia
Phone 54454 0
+618 9266 5110
Fax 54454 0
Email 54454 0
[email protected]
Contact person for public queries
Name 54455 0
Peter McEvoy
Address 54455 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Western Australia 6102
Country 54455 0
Australia
Phone 54455 0
+618 9266 5110
Fax 54455 0
Email 54455 0
[email protected]
Contact person for scientific queries
Name 54456 0
Peter McEvoy
Address 54456 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Western Australia 6102
Country 54456 0
Australia
Phone 54456 0
+618 9266 5110
Fax 54456 0
Email 54456 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

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