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Trial registered on ANZCTR


Registration number
ACTRN12621000786897p
Ethics application status
Submitted, not yet approved
Date submitted
28/05/2021
Date registered
22/06/2021
Date last updated
22/06/2021
Date data sharing statement initially provided
22/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet Videoconferencing Delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder: A randomized controlled trial
Scientific title
A randomized controlled trial of Internet Videoconferencing Delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder in Adults
Secondary ID [1] 304264 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
generalized anxiety disorder 321987 0
Condition category
Condition code
Mental Health 319707 319707 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment will follow a manualized videoconference delivered cognitive behavioural (VCBT) intervention which is informed by the Intolerance of Uncertainty Model of GAD (Dugas & Robichaud, 2007; Robichaud et al., 2019).
The modes of treatment for this study will be cognitive behavioural therapy delivered via an internet videoconferencing platform.
Those in the immediate treatment condition will receive 10 weekly (50 minute) treatment sessions to be conducted via Zoom (Zoom Video Communications Inc., 2016). The treatment for this group will comprise six modules and will cover the following:
Module 1: psychoeducation (week 1)
Module 2: cognitive restructuring to challenge positive beliefs about worry (weeks 2-3) Module 3: behavioural experiments to develop a greater tolerance to uncertainty (weeks 4-5)
Module 4: problem solving training to reduce negative problem orientation (week 6-7)
Module 5: imaginal exposure to address cognitive avoidance (week 8-9)
Module 6: relapse prevention (week 10)

Participants will also be required to complete homework tasks between sessions. When the immediate treatment group concludes treatment the control group will receive a brief version of the same treatment taking place over 5 weeks (i.e., 5 weekly, 50 minute sessions). The same interventions will be covered however a smaller number of sessions will be dedicated to each intervention.

Treatment will be delivered by provisionally registered or fully registered psychologist(s) under the supervision of an experienced clinical psychologist. All treating psychologists will be thoroughly trained in the administration of the treatment protocol by the project investigators. All sessions will be recorded and at least 10% of sessions will be randomly selected for treatment compliance and integrity checking. Treating clinicians will receive weekly supervision to review client progress and address clinical issues arising from sessions.
Intervention code [1] 320601 0
Behaviour
Comparator / control treatment
The waitlist control group will receive access to a brief version of the program (5 weeks) after the immediate group has completed the treatment (10 weeks).
Control group
Active

Outcomes
Primary outcome [1] 327583 0
Generalized Anxiety Disorder Questionnaire – 7 item (GAD-7) (Spitzer et al., 2006)
Timepoint [1] 327583 0
Baseline
Mid treatment
Post treatment
3-month follow-up
Secondary outcome [1] 395737 0
Generalised Anxiety Disorder Dimensional Scale (GAD-D) (Lebeau et al., 2012)
Timepoint [1] 395737 0
Baseline
Mid treatment
Post treatment
3-month follow-up
Secondary outcome [2] 395738 0
Penn State Worry Questionnaire – 3-item (PSWQ-3) (Berle et al., 2011)
Timepoint [2] 395738 0
Baseline
Mid treatment
Post treatment
3-month follow-up
Secondary outcome [3] 395739 0
Overall Anxiety Severity and Impairment Scale (Norman et al., 2006)
Timepoint [3] 395739 0
Baseline
Mid treatment
Post treatment
3-month follow-up
Secondary outcome [4] 395740 0
Patient Health Questionnaire 9-Item (PHQ-9) (Kroenke et al., 2001)
Timepoint [4] 395740 0
Baseline
Mid treatment
Post treatment
3-month follow-up
Secondary outcome [5] 395741 0
Intolerance of Uncertainty Scale (IUS-12) (Carleton et al., 2007)
Timepoint [5] 395741 0
Baseline
Mid treatment
Post treatment
3-month follow-up
Secondary outcome [6] 395742 0
Core Beliefs Questionnaire (CBQ) - Trait Version (Wong et al., 2017)
Timepoint [6] 395742 0
Baseline
Mid treatment
Post treatment
3-month follow-up
Secondary outcome [7] 395743 0
Clinical Perfectionism Questionnaire (CPQ) (Fairburn et al., 2003)
Timepoint [7] 395743 0
Baseline
Mid treatment
Post treatment
3-month follow-up
Secondary outcome [8] 395744 0
NIMH Clinician Global Impression (CGI) Scale (self-report version) (Guy, 1976)
Timepoint [8] 395744 0
Baseline
Mid treatment
Post treatment
3-month follow-up
Secondary outcome [9] 395745 0
Sheehan Disability Scale (SDS) (Sheehan, 1983)
Timepoint [9] 395745 0
Baseline
Mid treatment
Post treatment
3-month follow-up
Secondary outcome [10] 395746 0
Working Alliance Inventory-Short Form Revised (WAI-SR) (Hatcher & Gillaspy, 2006)
Timepoint [10] 395746 0
Mid treatment
Post treatment
Secondary outcome [11] 395747 0
Client Satisfaction Questionnaire (CSQ) (Larsen et al., 1979)
Timepoint [11] 395747 0
Mid treatment
Post treatment
Secondary outcome [12] 395748 0
Acceptability Questionnaire (AQ)
Source:
Wootton, B. M., Karin, E., Titov, N., & Dear, B. F. (2019a). Self-guided internet–delivered cognitive behavior therapy (ICBT) for obsessive-compulsive symptoms: A randomized controlled trial [Article]. Journal of Anxiety Disorders, 66, Article 102111. https://doi.org/10.1016/j.janxdis.2019.102111
Wootton, B. M., Karin, E., Titov, N., & Dear, B. F. (2019b). Self-Guided Internet Delivered Cognitive Behavior Therapy (ICBT) for Obsessive-Compulsive Symptoms: A Randomized Controlled Trial. Journal of Anxiety Disorders(66), 102111. https://doi.org/https://doi.org/10.1016/j.janxdis.2019.102111
Timepoint [12] 395748 0
Mid treatment
Post treatment

Eligibility
Key inclusion criteria
1. Australian resident
2. Aged 18 or above
3. English as first language
4. Meet criteria for GAD as primary disorder and disorder is of at least ‘moderate severity’ (defined as a score of 4 on the DIAMOND module severity measure)
5. Medication free or on a stable dose of psychotropic medication
6. Not currently receiving regular psychological services for their GAD symptoms (defined as sessions at least once a week with a qualified mental health professional).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe depressive symptoms as assessed by a score of 20 or above on the PHQ-9
2. Are at suicide risk as assessed by a score of ‘2’ (more than half the days) or higher on item 9 of the PHQ-9 on the screening questions or via clinician judgement during the telephone interview using the C-SSRS
3. Engage in daily alcohol use or daily illicit drug use
4. Presence of a schizophrenia spectrum disorder as assessed by the DIAMOND
5. Significant cognitive/intellectual impairment as assessed during diagnostic interview
6. Medical condition that may interfere with treatment
7. Do not have access to a computer with a camera and stable internet on a regular basis

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 randomization will be conducted by the Chief Investigator (BW) using a random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A CONSORT-R compliant 2-group RCT will investigate the research questions. Participants will be randomly assigned to an immediate treatment group (n = 39) or a waitlist control group (n = 39). Group 1 will receive immediate access to a manualized high intensity VCBT intervention. Group 2 will receive treatment after Group 1 completes treatment.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308642 0
University
Name [1] 308642 0
University of Technology Sydney
Address [1] 308642 0
Discipline of Psychology, Graduate School of Health. University of Technology Sydney. PO Box 123 Broadway, Ultimo, NSW 2007.
Country [1] 308642 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Discipline of Psychology, Graduate School of Health. University of Technology Sydney. PO Box 123 Broadway, Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 309513 0
None
Name [1] 309513 0
Address [1] 309513 0
Country [1] 309513 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308568 0
University of Technology Sydney Health and Medical Research Ethics Committee (HMREC)
Ethics committee address [1] 308568 0
C/- Research Office
University of Technology Sydney
PO Box 123 Broadway NSW 2007
Ethics committee country [1] 308568 0
Australia
Date submitted for ethics approval [1] 308568 0
07/02/2021
Approval date [1] 308568 0
Ethics approval number [1] 308568 0

Summary
Brief summary
The primary aim of this study is to examine to acceptability and efficacy of an internet delivered VCBT for GAD. A secondary aim is to examine the acceptability and efficacy of a brief VCBT treatment for GAD. The aim of this study is to recruit and treat participants with generalized anxiety disorder using a cognitive behavioural treatment program administered remotely via internet videoconferencing. Participants in the treatment group will begin the program immediately, and their results will be compared with a waitlist control condition. Participants in Group 2 will receive access to a brief version of the program when Group 1 completes treatment (Week 10). Outcome measures will be administered at baseline, mid treatment, post treatment and 3 month follow-up. Based on the limited existing literature it is hypothesized that high intensity VCBT will 1) be acceptable to individuals with GAD; 2) result in significant reductions in symptoms, resulting in large within-group and between-group effect sizes at post-treatment and three-month follow up; and 3) brief VCBT will result in outcomes similar to those seen in standard face-to-face treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111170 0
A/Prof Bethany Wootton
Address 111170 0
Discipline of Psychology, Graduate School of Health. University of Technology Sydney. PO Box 123 Broadway, Ultimo, NSW 2007.
Country 111170 0
Australia
Phone 111170 0
+61 2 9514 3942
Fax 111170 0
Email 111170 0
bethany.wootton@uts.edu.au
Contact person for public queries
Name 111171 0
A/Prof Bethany Wootton
Address 111171 0
Discipline of Psychology, Graduate School of Health. University of Technology Sydney. PO Box 123 Broadway, Ultimo, NSW 2007.
Country 111171 0
Australia
Phone 111171 0
+61 2 9514 3942
Fax 111171 0
Email 111171 0
bethany.wootton@uts.edu.au
Contact person for scientific queries
Name 111172 0
A/Prof Bethany Wootton
Address 111172 0
Discipline of Psychology, Graduate School of Health. University of Technology Sydney. PO Box 123 Broadway, Ultimo, NSW 2007.
Country 111172 0
Australia
Phone 111172 0
+61 2 9514 3942
Fax 111172 0
Email 111172 0
bethany.wootton@uts.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results