[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659494":3},{"organization":4,"outcomesModule":7,"designInfo":116,"detailedDescription":127,"studyPopulation":121,"armGroups":128,"interventions":141,"overallOfficials":156,"centralContacts":169,"locations":179,"responsibleParty":211,"collaborators":214,"id":218,"slug":219,"hasResults":220,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":220,"sex":226,"minAge":227,"maxAge":228,"enrollmentInfo":229,"targetDuration":121,"studyType":232,"phases":233,"briefSummary":235,"conditions":236,"keywords":241,"overallStatus":251,"whyStopped":121,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},{"fullName":5,"class":6},"Medical Research Council Cognition and Brain Sciences Unit","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":97},[9,13],{"measure":10,"description":11,"timeFrame":12},"Intolerance of Uncertainty Scale (IUS-12)","The reduced Intolerance of Uncertainty Scale (IUS-12; Carleton et al., 2007; Freeston et al., 1994) is a 12-item self-report measure of cognitive, emotional, and behavioural reactions to uncertainty. Higher scores indicate greater intolerance of uncertainty.","Prescreen, Baseline, post-treatment (Week 14), and 3-month follow-up",{"measure":14,"description":15,"timeFrame":12},"Generalized Anxiety Disorder-7 (GAD-7)","The GAD-7 (Spitzer et al., 2006) is a 7-item self-report measure of generalised anxiety symptom severity. Scores range from 0 to 21; higher scores indicate greater severity.",[17,20,23,27,30,33,36,39,42,45,48,51,54,57,61,64,67,70,73,76,79,82,85,88,91,94],{"measure":18,"description":19,"timeFrame":12},"Patient Health Questionnaire (PHQ-9)","The PHQ-9 (Kroenke et al., 2001) is a 9-item self-report measure of depressive symptom severity. Scores range from 0 to 27; higher scores indicate greater severity.",{"measure":21,"description":22,"timeFrame":12},"Work and Social Adjustment Scale (WSAS)","The WSAS (Mundt et al., 2002) is a 5-item self-report measure of functional impairment attributed to mental health problems across work, home management, social leisure, private leisure, and close relationships. Items are rated from 0 to 8. Higher scores indicate greater impairment.",{"measure":24,"description":25,"timeFrame":26},"Penn State Worry Questionnaire (PSWQ)","The PSWQ (Meyer et al., 1990) is a 16-item self-report measure of pathological worry validated in GAD populations. Higher scores indicate more pervasive and uncontrollable worry.","Baseline, post-treatment (Week 14), and 3-month follow-up",{"measure":28,"description":29,"timeFrame":26},"Affective Response to Daily Uncertainty Scale (ARDUS)","The ARDUS (Wang et al., 2026) is a 37-item self-report measure of how often individuals experience negative affect (worry, anxiety, low mood, or concern) when faced with uncertainty across six everyday domains: academic\u002Fprofessional, climate, financial, health, political, and social. Items are rated on a 6-point Likert scale from 0 (Never) to 5 (Always), with an additional option indicating that the type of uncertainty has not been encountered in the past year. Higher scores reflect greater affective reactivity to daily uncertainty.",{"measure":31,"description":32,"timeFrame":26},"Instrumental and Pavlovian Transport Volatility Learning Task","The Transport Volatility Learning Task is a probabilistic associative learning task assessing how participants track action-outcome contingencies in environments where outcome probabilities change over time. On each trial, participants encounter one of two cues (train lines) probabilistically associated with a binary outcome (delay vs no delay), with one cue carrying a higher probability of the aversive outcome at any given time. The underlying contingency reverses periodically, and volatility (the rate of contingency change) is manipulated across blocks to dissociate stable from volatile learning environments. Two task variants are administered to distinguish observational from instrumental learning: a prediction-only variant in which the cue is determined by the environment and participants predict the outcome, and a choice variant in which participants actively choose between cues and outcomes follow from their selection.",{"measure":34,"description":35,"timeFrame":26},"Social Evaluation Learning Task (SELT)","The SELT is an associative learning task assessing how individuals estimate and update beliefs under social-evaluative uncertainty (adapted from Lau et al., 2024). On each trial, participants are presented with a positive and a negative word and rate, on a continuous slider, the probability that an avatar (the \"rater\") will select that word to describe the target; they then receive feedback indicating which word the rater chose. The task crosses two referential conditions (self-referential, in which the participant is the target of evaluation, vs other-referential, in which a third character is the target) with rule conditions defining the underlying probability of positive feedback. After each block, participants make a global judgement of the rater's overall evaluative tendency, and at the end of the task participants make forced choices about preferred social partners for themselves and for the other-referential target.",{"measure":37,"description":38,"timeFrame":26},"Balloon Analogue Risk Task (BART)","The BART is a decision-making task in which participants accumulate points by inflating a virtual balloon and choose when to stop and bank their earnings (Lejuez et al., 2002). Each pump carries an unobserved probability of the balloon bursting and forfeiting that trial's points. Across blocks, the underlying probability distribution of the explosion point is manipulated to dissociate distinct components of uncertainty, including the mean and variance of the distribution.",{"measure":40,"description":41,"timeFrame":26},"Information Sampling Task (IST)","The IST is a task in which participants actively sample binary information to reduce uncertainty before committing to a categorical decision (Hauser et al., 2017). On each trial, participants are presented with a set of 25 hidden samples drawn from an underlying binary distribution and choose, one at a time, how many to reveal before deciding which of two categories the source distribution belongs to. A log of revealed samples remains on screen throughout. Two conditions are administered: a free-sampling condition in which sampling is unconstrained, and a costly-sampling condition in which each sample reveal incurs an explicit monetary cost against a fixed per-trial budget, with correct and incorrect decisions yielding gains and losses scaled to the number of samples taken.",{"measure":43,"description":44,"timeFrame":26},"Uncertain Face Selection Task","The Uncertain Face Selection Task is an emotion-categorisation task in which participants view facial expressions varying in perceptual ambiguity, achieved by morphing between happy and angry prototypes. The task comprises two blocks. In a forced-choice baseline block, participants categorise each briefly presented face as happy or angry under speeded response conditions, providing a measure of perceptual sensitivity to the morphed emotion continuum. In a subsequent free-response block, participants are given two additional options on each trial: re-viewing the same face before deciding (a checking response) or skipping the face entirely without categorising it (an avoidance response), with skipping carrying no time benefit so that it cannot be motivated by efficiency.",{"measure":46,"description":47,"timeFrame":26},"Ambiguous Cue Task (ACT)","The ACT is a perceptual decision-making paradigm assessing how participants interpret ambiguous cues with uncertain outcomes (adapted from Aylward et al., 2019). On each trial, participants are presented with a visual cue that lands at one of several orientations and must categorise it as belonging to one of two classes (horizontal vs vertical) under time pressure. The two classes are associated with asymmetric reward magnitudes, such that one categorisation yields a higher payoff than the other. Cue orientations span a continuum from clearly belonging to one class through fully ambiguous (intermediate) angles, allowing participants' classification of the ambiguous cues to be modelled as a function of perceptual evidence and prior expectations.",{"measure":49,"description":50,"timeFrame":26},"Translational Probabilistic Reward Learning Task (TPRLT)","The TPRLT is a probabilistic reward learning paradigm presented in a rodent-themed visual environment to advance cross-species translation of computational measures. On each trial, participants control an on-screen rat avatar and choose between two spatially-distinct response ports (left vs right). One port is associated with a higher probability of reward (a piece of cheese) at any given time, with the rewarded port determined probabilistically; the more rewarded option changes across the task, requiring participants to track and update reward contingencies through trial-and-error. Feedback (reward delivery vs no reward) is presented on each trial in a designated feedback zone.",{"measure":52,"description":53,"timeFrame":26},"Aversive Learning Task","In the Aversive Learning Task participants choose between two visually-distinct options (street images) on each trial. One option carries a higher probability of an aversive event (a pickpocketing incident resulting in a monetary loss), and participants must learn which option is currently safer through trial-and-error feedback. The safer option changes periodically across the task, so participants must continuously update their beliefs. Participants begin with an initial endowment, and accumulated losses are deducted from this balance. Two referential conditions are administered: a self-referential condition in which choices determine the participant's own outcome, and an other-referential condition in which the participant chooses on behalf of another participant whose monetary bonus is determined by the participant's performance, and reciprocally receives choices made on their behalf. This distinguishes between aversive learning for self from aversive learning for other.",{"measure":55,"description":56,"timeFrame":26},"Brief Fear of Negative Evaluation (BFNE)","The BFNE (Leary, 1983) is a 12-item self-report measure of apprehension about being evaluated unfavourably by others. Items are rated from 1 (not at all characteristic of me) to 5 (extremely characteristic of me). Higher scores indicate greater fear of negative evaluation.",{"measure":58,"description":59,"timeFrame":60},"Traumatic Experiences Checklist (TEC)","The TEC (Nijenhuis et al., 2002) is an inventory of 29 potentially traumatic events across the lifespan, spanning emotional neglect, emotional abuse, physical abuse, sexual harassment, sexual abuse, bodily threat, loss, and war-related experiences. Each event is rated for occurrence, age at occurrence, and subjective impact from 1 to 5, yielding indices of trauma frequency and severity.","Baseline",{"measure":62,"description":63,"timeFrame":26},"Difficulties in Emotion Regulation Scale (DERS)","The DERS (Gratz \\& Roemer, 2004) is a 36-item self-report measure of problems in emotion regulation. Items are rated from 1 to 5 across six subscales covering nonacceptance of emotional responses, difficulty engaging in goal-directed behaviour, impulse control difficulties, lack of emotional awareness, limited access to regulation strategies, and lack of emotional clarity. Higher scores indicate greater difficulties.",{"measure":65,"description":66,"timeFrame":26},"Emotional Reactivity Scale (ERS)","The ERS (Nock et al., 2008) is a 21-item self-report measure of the sensitivity, intensity, and persistence of emotional responses. Items are rated from 0 to 4. Higher scores indicate greater emotional reactivity.",{"measure":68,"description":69,"timeFrame":26},"Ruminative Responses Scale (RRS-10)","The RRS-10 (Treynor et al., 2003) is a 10-item self-report measure of ruminative responses to low mood. Items are rated from 1 to 4 and yield brooding and reflection subscale scores. Higher scores indicate greater rumination.",{"measure":71,"description":72,"timeFrame":26},"Beliefs About Losing Control Inventory (BALCI)","The BALCI (Radomsky \\& Gagné, 2020) is a 21-item self-report measure of negative beliefs about losing control over one's thoughts, behaviour, emotions, and bodily functions, and about the importance of staying in control. Items are rated from 0 to 4. Higher scores indicate stronger beliefs about losing control.",{"measure":74,"description":75,"timeFrame":26},"Worry Behaviours Inventory (WBI)","The WBI (Mahoney et al., 2016) is a self-report measure of behaviours used to prevent, control, or avoid worry, including checking, reassurance seeking, avoidance, and overpreparation. Items are rated from 0 to 4. Higher scores indicate greater use of worry-related behaviours.",{"measure":77,"description":78,"timeFrame":26},"Self-Concept Clarity Scale (SCCS)","The SCCS (Campbell et al., 1996) is a 12-item self-report measure of the degree to which self-beliefs are clearly defined, internally consistent, and temporally stable. Items are rated from 1 to 5. Higher scores indicate greater self-concept clarity.",{"measure":80,"description":81,"timeFrame":26},"Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ)","The ETMCQ (Campbell et al., 2021) is a 15-item self-report measure of an individual's stance towards accepting knowledge communicated by others. Items are rated from 1 to 7 and yield three subscale scores for trust, mistrust, and credulity.",{"measure":83,"description":84,"timeFrame":26},"Experiences in Close Relationships-Relationship Structures (ECR-RS)","The ECR-RS (Fraley et al., 2011) is a 9-item self-report measure of adult attachment. Items are rated from 1 to 7 and yield scores on two dimensions, attachment-related avoidance and attachment-related anxiety. Higher scores indicate greater attachment insecurity on each dimension. Here it is administered with reference to close relationships in general.",{"measure":86,"description":87,"timeFrame":26},"Brief Core Schema Scales (BCSS)","The BCSS (Fowler et al., 2006) is a 24-item self-report measure of core evaluative beliefs about the self and others. Respondents endorse each belief (no or yes) and, if endorsed, rate conviction from 1 to 4, yielding four subscale scores for negative-self, positive-self, negative-other, and positive-other schemas.",{"measure":89,"description":90,"timeFrame":26},"Multidimensional Assessment of Interoceptive Awareness - Version 2 (MAIA-2)","MAIA-2 (Mehling et al., 2018) is a self-report measure of interoceptive body awareness. In the 24-item form used here, items are rated from 0 to 5, spanning facets including noticing, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Higher scores indicate greater interoceptive awareness.",{"measure":92,"description":93,"timeFrame":26},"Grief and Response to Altered Core Experience of the Self Questionnaire (GRACES-Q)","The GRACES-Q (Shalev et al., unpublished) is a 25-item self-report measure of reaction and grief-like responses to changes to the self following the onset of a mental health condition. After identifying the earliest condition, its time of onset, and two open-ended reflections on the self before and after onset, respondents rate statements from 0 to 5 across five subscales covering identity discontinuity and self-alienation, longing and grieving the past self, grieving the future self, acceptance and moving forward, and dual-process oscillation.",{"measure":95,"description":96,"timeFrame":26},"Premenstrual Symptoms Screening Tool (PSST)","The PSST (Steiner et al., 2003) is a 19-item self-report screening measure of premenstrual symptoms, comprising 14 items covering emotional, behavioural, and physical symptoms and 5 items covering interference with daily functioning. Each item is rated from 1 (not at all) to 4 (severe).",[98,102,105,109,112],{"measure":99,"description":100,"timeFrame":101},"Working Alliance Inventory - Short Revised (WAI-SR)","The WAI-SR (Hatcher \\& Gillaspy, 2006) is a 12-item measure of perceived agreement with therapy goals and tasks and therapeutic bond, used to compare therapeutic alliance across arms.","Post-treatment (Week 14)",{"measure":103,"description":104,"timeFrame":60},"Beliefs About Psychological Services scale (BAPS)","The BAPS (Ægisdóttir \\& Gerstein, 2009) is an 18-item self-report measure of attitudes and beliefs about seeking professional psychological help. Items are rated from 1 to 6, and yield three subscale scores covering intent to seek services, stigma tolerance, and expertness. Higher scores indicate more positive beliefs about psychological services.",{"measure":106,"description":107,"timeFrame":108},"Credibility\u002FExpectancy Questionnaire (CEQ)","The CEQ (Devilly \\& Borkovec, 2000) is a 6-item self-report measure of how credible a participant finds a treatment rationale and how much improvement they expect from it. The measure assesses credibility and expectancy. Items are rated on mixed scales, most from 1 to 9 and two of the expectancy items from 0% to 100%, with higher scores indicating greater perceived credibility and stronger expectation of improvement.","End of Session 3, approximately Week 3 of therapy.",{"measure":110,"description":111,"timeFrame":101},"Group Climate Questionnaire (GCQ)","The GCQ (MacKenzie, 1983) is a 12-item measure of participants' perception of the group's therapeutic environment, used as a process\u002Fquality measure of the group intervention.",{"measure":113,"description":114,"timeFrame":115},"Clinical Outcomes in Routine Evaluation (CORE-10)","The CORE-10 (Barkham et al., 2013) is a 10-item self-report measure of general psychological distress and will be used to weekly monitoring throughout the trial. Items cover anxiety, depression, trauma, and physical problems, alongside three functioning items and one risk item, and ask how the respondent has felt over the past week.","Weekly, from Week 1 of the therapy up to Week 14",{"allocation":117,"interventionModel":118,"interventionModelDescription":119,"primaryPurpose":120,"observationalModel":121,"timePerspective":121,"maskingInfo":122},"RANDOMIZED","PARALLEL","Two parallel arms receive 12 weekly group-based therapy sessions (10 weekly + 2 fortnightly, 2 hours each, in groups of 6-9): CBT-IU (experimental) or Applied Relaxation (active control condition). Participants are randomised 1:1 using stratified minimisation on baseline GAD-7, PHQ-9, IUS-12 severity, and demographics. Outcome assessments occur at baseline, post-treatment (week 14), and 3-month follow-up.","BASIC_SCIENCE",null,{"masking":123,"maskingDescription":124,"whoMasked":125},"SINGLE","Researchers collecting primary and secondary outcomes at baseline, post-treatment, and follow-up are blind to treatment allocation. The trial statistician performing randomisation is blind to study objectives. The trial manager and administrators are not blinded in order to enable effective trial governance and participant communication.",[126],"OUTCOMES_ASSESSOR","Rationale. Intolerance of uncertainty (IU) is a recognised transdiagnostic risk factor for a broad range of mental health problems, including generalised anxiety, social anxiety, panic, depression, and obsessive-compulsive symptoms. Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) has demonstrated efficacy in previous randomised trials. However, it was primarily developed and tested in the context of generalised anxiety disorder and further inquiry into its effectiveness across diagnoses is required. To that end, a treatment that targets a clinical sample characterised by high IU rather than by a specific diagnosis would be more readily deployed than one tied to a single disorder.\n\nA second gap concerns how therapy changes uncertainty processing, and whether such changes drive clinical improvement. Existing interventions and trials rely heavily on self-report scales such as the Intolerance of Uncertainty Scale (IUS), which are informative about dispositional reactivity to uncertainty but are largely agnostic to how individuals represent different forms of uncertainty or why uncertainty is experienced as aversive. Recent work in computational psychiatry reframes IU not as a unitary disposition but as a set of individual differences in how people estimate distinct forms of uncertainty, the probability of outcomes, the volatility of the environment. Recent work also shows that experiences of IU may depend on the contextual factors that govern a situation. This suggests that distinct profiles of uncertainty processing may characterise different presentations of anxiety, and that identifying which of these profiles shift in response to IU-focused intervention is essential for refining both the construct of IU and the treatments that target it.\n\nAccordingly, the trial combines established IU questionnaires with a computational task battery designed to estimate distinct forms of uncertainty across contexts. The primary hypothesis of this study is that both therapies will reduce anxiety, with CBT-IU producing greater reduction in self-reported IU than applied relaxation. Applied Relaxation will serve as an active comparator matched on group format, duration, and therapist contact but which does not directly target uncertainty. To gain additional insights into the mechanisms underlying changes in IU, the computational battery will be used to construct an individualised \"uncertainty fingerprint\". Due to the novelty of this approach, these analyses will be exploratory, where the investigators will examine whether components of the fingerprint change differentially between arms, and whether such change relates to symptom reduction at 3-month follow-up.\n\nDesign. This is a single-blind, parallel-group mechanistic randomised controlled trial conducted at the MRC Cognition and Brain Sciences Unit (MRC-CBU), University of Cambridge, UK. The trial compares two active psychological treatments on anxiety and self-reported IU, with an embedded mechanistic component examining change in uncertainty processing. Adults scoring above threshold for IU and anxiety symptoms will be randomised to one of two 12-session group-based interventions running over 14 weeks: (1) Group Transdiagnostic CBT-IU, drawing on the Dugas and Robichaud model, and Making Friends with Uncertainty by Mofrad and colleagues; or (2) Applied Relaxation. Recruitment is transdiagnostic and no specific diagnostic category is required, consistent with the scope of the treatment manual and with IU being a transdiagnostic construct.\n\nBoth interventions comprise ten weekly plus two fortnightly 2-hour sessions, delivered in groups of 6-9 participants and co-facilitated by a clinical psychologist and an assistant.\n\nSample size was determined via a Bayesian hierarchical mediation simulation fitted with JAGS, using 1,000 replications per candidate design, to reflect the planned analysis and data structure: participants nested within therapy groups of 6-9, with the mediated effect a × b (with the IUS being the mediator) estimated alongside between-group variance under weakly informative priors. Effect size estimations were drawn from the Miller and McGuire (2023) meta-analysis. The trial is powered for a scenario with a = 0.89 (meta-analytic mean for the effect of CBT-IU on intolerance of uncertainty), b = 0.60 (the mediator-outcome path), and a between-group SD of 0.2, deliberately larger than the empirical SDs typically reported in the literature to provide a conservative scenario. Two criteria informed the target: power, defined as the proportion of replications in which the 95% highest-density interval (HDI) for the mediation effect excluded zero, and the width of that HDI as an index of estimation precision. Power exceeds 80% at 14 groups and nears 100% from 16 groups onward; at 16 groups the 95% HDI width is \\~0.77 and stabilises thereafter. Sixteen groups would therefore satisfy both criteria, but a target of 18 therapy groups (9 per arm; approximately N = 135 participants) was selected to account for attrition.\n\nOutcomes. The co-primary outcomes are the IUS-12 and the Generalized Anxiety Disorder-7 (GAD-7). Exploratory measures comprise a battery of computational tasks indexing learning and decision-making under uncertainty across cognitive contexts, from which the per-participant uncertainty fingerprint is derived. Secondary outcomes include the Penn State Worry Questionnaire (PSWQ) and the Patient Health Questionnaire (PHQ-9), the Work and Social Adjustment Scale (WSAS), and the Affective Response to Daily Uncertainty Scale (ARDUS), alongside measures of putative maintaining processes including worry behaviours, rumination, emotion regulation difficulties, emotional reactivity, fear of negative evaluation, and beliefs about losing control. Unless otherwise specified, all measures are administered at baseline, post-treatment (week 14), and 3-month follow-up. Treatment credibility and expectancy, working alliance, and group climate are collected as process measures, and the CORE-10 is administered weekly for monitoring. In addition, a lifetime history of potentially traumatic experiences (TEC) will be assessed at baseline as a candidate moderator of treatment response.\n\nRandomisation and blinding. Stratified minimisation based on baseline GAD-7 and IUS-12 severity scores and demographics, executed by the trial statistician who is blind to study objectives. Outcome assessors at baseline, post-treatment, and follow-up are blind to treatment allocation.",[129,135],{"label":130,"type":131,"description":132,"interventionNames":133},"Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU)","EXPERIMENTAL","Twelve group-based sessions (ten weekly + two fortnightly, \\~2 hours each with a 15-minute break, 6-9 participants per group) co-facilitated by a clinical psychologist and an assistant. The manualised intervention draws on established frameworks: the Dugas and Robichaud CBT-IU model for GAD (Dugas \\& Robichaud, 2007) and the Making Friends with Uncertainty (Mofrad et al., 2020) programme. Content is organised into five modules covering psychoeducation and awareness of uncertainty responses, recognising uncertainty in daily life, skills acquisition and structured problem-solving, behavioural experiments using individualised uncertainty hierarchies, and relapse prevention. Between-session home practice reinforces learning.",[134],"Behavioral: Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU)",{"label":136,"type":137,"description":138,"interventionNames":139},"Applied Relaxation (AR)","ACTIVE_COMPARATOR","Twelve group-based sessions (ten weekly + two fortnightly, \\~2 hours each with a 15-minute break, 6-9 participants per group) co-facilitated by a clinical psychologist and an assistant. The manualised intervention is based on Öst (1987) and adapted for transdiagnostic group delivery, progressing from foundational Progressive Muscle Relaxation through condensed and release-only variants to cue-controlled and rapid relaxation (\\~20-30 seconds), combined with diaphragmatic breathing, early cue detection, safe-place imagery, and self-soothing. Then, a formal application-training phase begins, in which participants use rapid relaxation proactively in daily life at the first signs of tension. Between-session home practice reinforces learning.",[140],"Behavioral: Group Transdiagnostic Applied Relaxation (AR)",[142,150],{"type":143,"name":144,"description":145,"armGroupLabels":146,"otherNames":147},"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).\n\nBetween-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.",[130],[148,149],"Transdiagnostic CBT-IU","Group CBT-IU",{"type":143,"name":151,"description":152,"armGroupLabels":153,"otherNames":154},"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.\n\nBetween-session home practice is set each week. Treatment fidelity is monitored identically to the CBT-IU arm.",[136],[155],"Applied Relaxation",[157,161,165],{"name":158,"affiliation":159,"role":160},"Rebecca Lawson, PhD","Psychology Department, University of Cambridge","STUDY_CHAIR",{"name":162,"affiliation":163,"role":164},"Tim Dalgleish, PhD","MRC Cognition and Brain Sciences Unit, University of Cambridge; Psychology Department, University of Cambridge","PRINCIPAL_INVESTIGATOR",{"name":166,"affiliation":167,"role":168},"Anna Bevan, PhD","MRC Cognition and Brain Sciences Unit, University of Cambridge","STUDY_DIRECTOR",[170,175],{"name":171,"role":172,"phone":173,"phoneExt":121,"email":174},"Ido Shalev, PhD","CONTACT","07541030621","is622@cam.ac.uk",{"name":176,"role":172,"phone":177,"phoneExt":121,"email":178},"Millie Lowther, PhD","07854235572","el634@cam.ac.uk",[180],{"facility":181,"status":121,"city":182,"state":183,"zip":184,"country":185,"countryCode":186,"cosmosGeoPoint":187,"geoPoint":192,"contacts":193},"MRC Cognition and Brain Sciences Unit (MRC-CBU), University of Cambridge","Cambridge","Cambridgeshire","CB2 7EF","United Kingdom","UK",{"type":188,"coordinates":189},"Point",[190,191],0.11667,52.2,{"lat":191,"lon":190},[194,195,196,198,199,200,201,202,205,207,209],{"name":171,"role":172,"phone":173,"phoneExt":121,"email":174},{"name":176,"role":172,"phone":177,"phoneExt":121,"email":178},{"name":197,"role":164,"phone":121,"phoneExt":121,"email":121},"Rebecca P Lawson, PhD",{"name":162,"role":164,"phone":121,"phoneExt":121,"email":121},{"name":166,"role":164,"phone":121,"phoneExt":121,"email":121},{"name":171,"role":164,"phone":121,"phoneExt":121,"email":121},{"name":176,"role":164,"phone":121,"phoneExt":121,"email":121},{"name":203,"role":204,"phone":121,"phoneExt":121,"email":121},"Sarah Daniels, MPhil","SUB_INVESTIGATOR",{"name":206,"role":204,"phone":121,"phoneExt":121,"email":121},"Nazia Jassim, PhD",{"name":208,"role":204,"phone":121,"phoneExt":121,"email":121},"Nace Mikus, PhD",{"name":210,"role":204,"phone":121,"phoneExt":121,"email":121},"Tim Sandhu, PhD",{"type":164,"investigatorFullName":212,"investigatorTitle":213,"investigatorAffiliation":5,"oldNameTitle":121,"oldOrganization":121},"Ido Shalev","Assistant Research Professor",[215],{"name":216,"class":217},"University of Cambridge","OTHER","100659494","group-transdiagnostic-cognitive-behavioural-therapy-for-intolerance-of-uncertainty-versus-applied-relaxation-100659494",false,"NCT07866794","Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty Versus Applied Relaxation","Outcomes and Behavioural Signatures of Coping With Uncertainty-Related Anxiety (OBSCURA) Trial","OBSCURA","Inclusion Criteria:\n\n* Normal or corrected-to-normal vision\n* Fluency in English\n* Capable of giving informed consent\n* Live locally\u002F within commutable distance to Cambridge\n* Intolerance of Uncertainty Scale - Short form (IUS-12) score \\> 28\n* Generalized Anxiety Disorder scale (GAD-7) score \\>= 8\n* Medication-free, or on a stable medication regimen prior to and throughout the study\n\nExclusion Criteria:\n\n* High risk of suicidal intent or self-harm (defined as an affirmative response on item 9 of the PHQ-9 above the clinical threshold, and\u002For corresponding clinical risk indicators during the SCID-5 interview)\n* Engagement with any other psychological treatment within the 3 months prior to the study or during the study period\n* Current diagnosis of obsessive-compulsive disorder (OCD)\n* Current substance use disorder\n* Acute psychosis\n* History of traumatic brain injury\n* Learning disability\n* Epilepsy\u002Fseizures\n* Severe cognitive impairment","ALL","18 Years","65 Years",{"count":230,"type":231},135,"ESTIMATED","INTERVENTIONAL",[234],"NA","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.\n\nA 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.\n\nIn 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.",[237,238,239,240],"Mental Disorders","Mood Disorders","Anxiety Disorders","Generalized Anxiety Disorder",[242,243,244,245,246,247,248,249,250],"Uncertainty","Cognitive Behavioural Therapy","Relaxation Therapy","Behaviour and Behaviour Mechanisms","Anxiety","Cognitive Science","Clinical Psychology","Group Psychotherapy","Intolerance of Uncertainty","NOT_YET_RECRUITING","2026-10-05",{"date":254,"type":255},"2026-10-08","ACTUAL",{"date":257,"type":231},"2026-09-21",{"date":259,"type":231},"2030-04-30",{"name":5,"class":6},1]