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NOT YET RECRUITING
NCT07866794
NA

Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty Versus Applied Relaxation

Sponsor: Medical Research Council Cognition and Brain Sciences Unit

View on ClinicalTrials.gov

Summary

Many people find uncertainty distressing, but for some, it may become overwhelming and drive persistent anxiety, worry, and avoidance. This tendency is called intolerance of uncertainty (IU), and appears across many mental health conditions, including generalised anxiety, social anxiety, depression, and obsessive-compulsive disorder, which is why researchers describe it as a transdiagnostic feature. A type of therapy called Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) has been shown to reduce anxiety in previous trials. What remains to be known is how uncertainty changes when targeted directly, and whether the same mechanism applies across diagnoses. IU has mostly been measured using questionnaires, which indicate whether people find uncertainty difficult, but not what is actually happening when they encounter it. Recent research suggests that IU is not a single trait but a set of differences in how people estimate different kinds of uncertainty. Therefore, in addition to standard questionnaires, computer-based tasks will be used to explore an "uncertainty fingerprint" for each participant, capturing different aspects of uncertainty processing in a way that self-report measures cannot. In this study, the investigators are comparing CBT-IU, adapted to work across disorders, against Applied Relaxation. Applied relaxation is a well-established therapy that teaches people to notice and release physical tension but does not focus on uncertainty. Adults with high IU and anxiety symptoms (regardless of formal diagnosis) will be randomly allocated to one of the two 12-session group therapies. The investigators will measure anxiety and IU using standard questionnaires as the primary outcomes. Additionally, cognitive tasks will be used to measure the uncertainty fingerprint before therapy, immediately after, and three months later. The aim is to test whether reductions in IU are specific to CBT-IU rather than shared with an equally credible therapy that does not target uncertainty. Going beyond self-reports, the trial will then begin to resolve which specific aspects of uncertainty processing change, so that future treatments can be more precisely targeted and better matched to each person.

Official title: Outcomes and Behavioural Signatures of Coping With Uncertainty-Related Anxiety (OBSCURA) Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2026-09-21

Completion Date

2030-04-30

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU)

Manualised group-based transdiagnostic CBT-IU delivered over 12 sessions by a clinical psychologist and a co-facilitator. The modular intervention integrates evidence-based frameworks, including the Dugas and Robichaud CBT-IU model for GAD (Dugas \& Robichaud, 2007) and the Making Friends with Uncertainty (Mofrad et al., 2020). Modules cover: 1. Psychoeducation and awareness of uncertainty responses (Session 1-2); 2. Recognising and monitoring uncertainty (Sessions 3-4); 3. Structured problem-solving skills (Sessions 5-6); 4. Behavioural experiments with individualised uncertainty hierarchies (Session 7-10); and 5. Relapse prevention and maintenance planning (Sessions 11-12). Between-session home practice is set each week. Treatment fidelity is monitored via a per-session checklist, weekly clinical supervision with the trial lead, and independent rating of random audio-recorded sessions against the manual.

BEHAVIORAL

Group Transdiagnostic Applied Relaxation (AR)

Manualised group-based transdiagnostic Applied Relaxation delivered over 12 sessions by a clinical psychologist and a co-facilitator, following Öst (1987). Content is organised into five modules: 1. Psychoeducation, self-monitoring and 16-muscle-group Progressive Muscle Relaxation (PMR; Sessions 1-2); 2. Stepwise condensing of PMR (16-muscle → 7-muscle → 4-muscle → release-only → cue-controlled → rapid relaxation); introduction of diaphragmatic breathing; early cue detection. 3. Afterwards, the application phase begins, in which participants use rapid relaxation proactively at the first signs of tension (Sessions 3-7). Safe-place imagery and self-soothing as additional relaxation pathways (Sessions 8-9). 4. Participants consolidate all learned techniques into a personal Applied Relaxation toolkit (Session 10); and 5. Relapse prevention and maintenance planning. Between-session home practice is set each week. Treatment fidelity is monitored identically to the CBT-IU arm.

Locations (1)

MRC Cognition and Brain Sciences Unit (MRC-CBU), University of Cambridge

Cambridge, Cambridgeshire, United Kingdom