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Experimenting with uncertainty: A strategy to help with excessive worry and anxiety

Investigating Behavioural Experiments as a Treatment for Generalized Anxiety Disorder

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000262606
Enrollment
40
Registered
2023-03-10
Start date
2023-10-16
Completion date
2024-06-10
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 two-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; and 2) behavioural experiments will yield greater improvements in intolerance of uncertainty, metacognitive beliefs, and threat appraisals, compared to waitlist control.

Interventions

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 (60 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 t

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 (60 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 two-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.

Sponsors

University of Technology Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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).

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

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 11, 2026