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Trial registered on ANZCTR


Registration number
ACTRN12623000262606
Ethics application status
Approved
Date submitted
27/02/2023
Date registered
10/03/2023
Date last updated
10/03/2023
Date data sharing statement initially provided
10/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Experimenting with uncertainty: A strategy to help with excessive worry and anxiety
Scientific title
The effect of behavioural experiments targeting negative beliefs about uncertainty on intolerance of uncertainty and worry for adults with generalized anxiety disorder.
Secondary ID [1] 309086 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
generalized anxiety disorder 329158 0
Condition category
Condition code
Mental Health 326132 326132 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment will involve a brief behavioural experiment intervention targeting negative beliefs about uncertainty. This brief intervention will follow a similar protocol outlined in Hebert and Dugas (2019), and extensively described in Robichaud et al. (2019).

Those in the immediate treatment condition will recieive two individual weekly (30 minute) sessions delivered via an internet video conferencing platform (Zoom).

Uncertainty is a natural trigger for worry in humans. We use worry as a way to plan and prepare in order to make us feel certain. However, if we hold negative beliefs about uncertainty, that is, we expect uncertain events or situations to always turn out negatively and catastrophically this may become the fuel for the engine of excessive worry. Holding negative beliefs about uncertainty may also mean that as well as worrying, we may avoid uncertain situations, engage in excessive planning, rechecking, or reassurance seeking in order to feel more certain. One way to change how we think about uncertainty is to gradually re-introduce uncertain events into our life, and see whether the feared outcome actually happens and how we cope. This is called a behavioural experiment. Behavioural experiments targeting negative beliefs about uncertainty are devised individually with the person, and could include walking a different route, trying a new class, or delegating tasks to others.

The first session will include psychoeducation regarding the relationship between negative beliefs about uncertainty and excessive worry, along with exploring the person’s thoughts, feelings and behaviours they have towards situations that are unpredictable, novel or ambiguous (i.e., situational triggers for the feeling of uncertainty). Following this discussion, the clinician will collaborate with the participant to set up three behavioural experiments to test out their negative beliefs about uncertainty over the course of the next week. Participants will be asked to write down in a participant diary their experience of engaging in each of the three behavioural experiments.

The second session will involve debriefing with participants regarding how the behavioural experiments went, including how they went, what they learnt, as well as how they coped if the feared event did occur.

Following the one-week waitlist period, participants in the waitlist control condition will be offered the same two-session behavioural experiment intervention.

Treatment will be delivered by fully registered psychologists 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 video recorded and at least 10% of sessions will be randomly selected for treatment fidelity.
Intervention code [1] 325533 0
Behaviour
Comparator / control treatment
The waitlist control group will receive the same treatment (two week behavioural experiments interventions) following a one-week waitlist.
Control group
Active

Outcomes
Primary outcome [1] 334001 0
Intolerance of Uncertainty Scale - 27 (IUS-27; Freeston et al., 1994)
Timepoint [1] 334001 0
Pre-treatment (e.g., immediately preceding behavioural experiment session 1), post-treatment (e.g., immediately following behavioural experiment session 2), and 1 week follow-up (e.g., 1 week following post-treatment session)
Primary outcome [2] 334002 0
Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990)
Timepoint [2] 334002 0
Pre-treatment (e.g., immediately preceding behavioural experiment session 1), post-treatment (e.g., immediately following behavioural experiment session 2), and 1 week follow-up (e.g., 1 week following post-treatment session)
Secondary outcome [1] 419029 0
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders - Generalized Anxiety Disorder Section (DIAMOND; Tolin et al., 2016).
Timepoint [1] 419029 0
Pre-treatment (e.g., immediately preceding behavioural experiment session 1), post-treatment (e.g., immediately following behavioural experiment session 2), and 1 week follow-up (e.g., 1 week following post-treatment session)
Secondary outcome [2] 419030 0
Worry Behaviours Inventory (Mahoney et al., 2016)
Timepoint [2] 419030 0
Pre-treatment (e.g., immediately preceding behavioural experiment session 1), post-treatment (e.g., immediately following behavioural experiment session 2), and 1 week follow-up (e.g., 1 week following post-treatment session)
Secondary outcome [3] 419031 0
Meta-Cognitive Beliefs Questionnaire (MCQ-30; Wells, & Cartwright-Hatton 2004)
Timepoint [3] 419031 0
Pre-treatment (e.g., immediately preceding behavioural experiment session 1), post-treatment (e.g., immediately following behavioural experiment session 2), and 1 week follow-up (e.g., 1 week following post-treatment session)
Secondary outcome [4] 419032 0
Difficulties with Emotion Regulation-16 (DERS-16; Gratz, & Roemer, 2004)
Timepoint [4] 419032 0
Pre-treatment (e.g., immediately preceding behavioural experiment session 1), post-treatment (e.g., immediately following behavioural experiment session 2), and 1 week follow-up (e.g., 1 week following post-treatment session)
Secondary outcome [5] 419033 0
White Bear Suppression Inventory (WBSI); Wegner & Zanakos, 1994)
Timepoint [5] 419033 0
Pre-treatment (e.g., immediately preceding behavioural experiment session 1), post-treatment (e.g., immediately following behavioural experiment session 2), and 1 week follow-up (e.g., 1 week following post-treatment session)
Secondary outcome [6] 419034 0
Probability Cost Coping Questionnaire (PCCQ; Abbott, not published as of 03/03/2023)
Timepoint [6] 419034 0
Pre-treatment (e.g., immediately preceding behavioural experiment session 1), post-treatment (e.g., immediately following behavioural experiment session 2), and 1 week follow-up (e.g., 1 week following post-treatment session)
Secondary outcome [7] 419035 0
Negative problem orientation questionnaire (NPOQ; Robichaud & Dugas, 2005)
Timepoint [7] 419035 0
Pre-treatment (e.g., immediately preceding behavioural experiment session 1), post-treatment (e.g., immediately following behavioural experiment session 2), and 1 week follow-up (e.g., 1 week following post-treatment session)
Secondary outcome [8] 419036 0
Mindfulness Attention Awareness Scale (MAAS; Brown, & Ryan, 2003)
Timepoint [8] 419036 0
Pre-treatment (e.g., immediately preceding behavioural experiment session 1), post-treatment (e.g., immediately following behavioural experiment session 2), and 1 week follow-up (e.g., 1 week following post-treatment session)
Secondary outcome [9] 419037 0
Depression Anxiety Stress Scales (DASS 21; Lovibond & Lovibond, 1995)
Timepoint [9] 419037 0
Pre-treatment (e.g., immediately preceding behavioural experiment session 1), post-treatment (e.g., immediately following behavioural experiment session 2), and 1 week follow-up (e.g., 1 week following post-treatment session)

Eligibility
Key inclusion criteria
1. Adult (minimum 18 years old)
2. English speaking
3. Able and willing to provide written informed consent
4. Meets Diagnostic and Statistical Manual (DSM-5-TR, 2022) criteria for a current principal diagnosis of Generalized Anxiety Disorder (as assessed via the Diagnostic Interview for Anxiety Mood, OCD, and Related Neuropsychiatric Disorders [DIAMOND]; Tolin et al., 2018).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Principal mental health diagnosis other than Generalized Anxiety Disorder (as assessed via the DIAMOND; Tolin et al., 2018).
2. Current engagement in other psychological treatment
3. Current active psychotic symptoms
4. Current active suicidal or homicidal ideation, or significant risk of harm to self or others.
5. Significant cognitive/intellectual impairment as assessed during diagnostic interview
6. 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 using a random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be randomly assigned to an immediate treatment group (n = 20) or a waitlist control group (n = 20). Group 1 will receive immediate access to two-session behavioural experiment intervention, and Group 2 will receive treatment after a one-week wait period.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
An a priori power analysis was conducted using G*Power version 3.1.9.6 (Faul et al., 2007) for sample size estimation. With a significance criterion of a = .05 and power = .80, the minimum sample size needed to detect a large effect size (consistent with large effect sizes reported by Hebert & Dugas, 2019) is N = 36 for ANOVA (repeated measures [3], between groups [2]). Thus, the proposed sample size of N = 40 is more than adequate to test the study hypothesis.

The impact of behavioural experiments vs waitlist control on primary and secondary outcomes will be conducted using repeated measures analysis of variance (ANOVA). Significant interaction effects will be followed up with within group t-tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
Date of last participant enrolment
Anticipated
4/03/2024
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313292 0
University
Name [1] 313292 0
University of Technology Sydney
Country [1] 313292 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
University of Technology Sydney. PO Box 123 Broadway, Ultimo, NSW 2007.
Country
Australia
Secondary sponsor category [1] 315030 0
None
Name [1] 315030 0
Address [1] 315030 0
Country [1] 315030 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312519 0
University of Technology Sydney Health and Medical Research Ethics Committee (HMREC)
Ethics committee address [1] 312519 0
C/- Research Office
University of Technology Sydney
PO Box 123 Broadway NSW 2007
Ethics committee country [1] 312519 0
Australia
Date submitted for ethics approval [1] 312519 0
14/11/2022
Approval date [1] 312519 0
16/01/2023
Ethics approval number [1] 312519 0
UTS HREC REF NO. ETH22-7185

Summary
Brief summary
The primary aim of this study is to investigate the benefits of two sessions of behavioural experiments targeting negative beliefs about uncertainty compared to a waitlist control for generalized anxiety disorder. The secondary aim is to investigate the proposed mechanisms of action (i.e., intolerance of uncertainty, metacognitive beliefs, threat appraisals) that underpin generalized anxiety disorder. Participants in the treatment group will begin the intervention immediately, and their results will be compared with a waitlist control condition who will receive the same intervention after a one-week wait period.. Outcome measures will be administered at baseline, post treatment and 1-week follow-up. Based on existing studies of behavioural experiments for generalized anxiety disorder it is hypothesised that: 1) behavioural experiment condition will be more effective in reducing symptoms of excessive worry and anxiety than waitlist control at post-treatment and follow up; and 2) behavioural experiments will yield greater improvements in intolerance of uncertainty, metacognitive beliefs, and threat appraisals, compared to waitlist control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124950 0
Dr Alice Norton
Address 124950 0
Clinical Psychology Unit, Mallett St Building F (M02F), The University of Sydney, Camperdown, NSW, 2006.
Country 124950 0
Australia
Phone 124950 0
+61 2 9351 0988
Fax 124950 0
Email 124950 0
alice.norton@sydney.edu.au
Contact person for public queries
Name 124951 0
Ms Emily Wilson
Address 124951 0
UTS Graduate School of Health Primary Health Care Clinic (UTS Building 20), 100 Broadway, Chippendale NSW 2008
Country 124951 0
Australia
Phone 124951 0
+61 2 9514 1448
Fax 124951 0
Email 124951 0
emily.wilson@uts.edu.au
Contact person for scientific queries
Name 124952 0
Ms Emily Wilson
Address 124952 0
UTS Graduate School of Health Primary Health Care Clinic (UTS Building 20), 100 Broadway, Chippendale NSW 2008
Country 124952 0
Australia
Phone 124952 0
+61 2 9514 1448
Fax 124952 0
Email 124952 0
emily.wilson@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 Supporting Document Provided



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.