Group CBT for Intolerance of Uncertainty

February 6, 2026 updated by: Elizabeth Hebert, University of Manitoba

Facing the Unknown Together: Piloting a Group-based CBT Protocol for Intolerance of Uncertainty

Generalized anxiety disorder (GAD) is a debilitating condition involving excessive and uncontrollable worry and anxiety. Difficulty tolerating the uncertainties of life, known as intolerance of uncertainty (IU), has been shown to be key in the development and maintenance of GAD symptoms. A new, streamlined cognitive-behavioural treatment that targets IU has been shown to be effective in at reducing GAD symptoms, IU, and general psychopathology when delivered one-on-one with a therapist, as shown in a recently published pilot study. The individual format of this treatment is now being evaluated in a randomized controlled trial (RCT). The overall objective of this study is to pilot test a group version of the treatment protocol to determine if a future RCT of this group treatment is both warranted and feasible. We will also conduct a preliminary investigation into the group treatment's efficacy. A total of two pilot groups (N = 12-20) will be conducted with participants recruited from two clinical hospital sites in Winnipeg, Manitoba, Canada. The group treatment protocol will be delivered over the course of 12 weekly therapy sessions. Participants will complete assessment measures at pretreatment, posttreatment, and at a 3-month follow-up point. All assessments and treatment sessions will be conducted virtually via videoconferencing platform due to ongoing COVID-19 pandemic restrictions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
      • Winnipeg, Manitoba, Canada, R3J 0L3
        • Deer Lodge Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primary diagnosis of generalized anxiety disorder (GAD)
  • High Intolerance of uncertainty (IU)

Exclusion Criteria:

  • Comorbid psychosis, organic brain disorder, bipolar disorder, or current substance use disorder
  • Receiving concurrent psychological treatments or other counselling
  • Psychotropic medications must remain stable during the study period and for 3 months prior to intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IU Group Treatment
Clinical intervention arm
Behavioral: Behavioural Experiments for Intolerance of Uncertainty
Cognitive-behavioural treatment targeting intolerance of uncertainty using behavioural experiment technique

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MINI International Neuropsychiatric Interview
Time Frame: Pretreatment (prior to the intervention).
Diagnostic status as measured by the MINI (Sheehan et al., 1994). Clinical Severity Rating adapted from the ADIS, with scores ranging from 0-8 (higher scores indicating greater GAD severity)
Pretreatment (prior to the intervention).
MINI International Neuropsychiatric Interview
Time Frame: Posttreatment (after completing final session of the treatment intervention)
Diagnostic status as measured by the MINI (Sheehan et al., 1994).Clinical Severity Rating adapted from the ADIS, with scores ranging from 0-8 (higher scores indicating greater GAD severity)
Posttreatment (after completing final session of the treatment intervention)
MINI International Neuropsychiatric Interview
Time Frame: 3-month follow-up
Diagnostic status as measured by the MINI (Sheehan et al., 1994). Clinical Severity Rating adapted from the ADIS, with scores ranging from 0-8 (higher scores indicating greater GAD severity)
3-month follow-up
Worry and Anxiety Questionnaire
Time Frame: Pretreatment (prior to the intervention).
Self-reported GAD symptoms as measured by the WAQ (Dugas et al., 2001). Scores range from 0-80 with higher scores indicating higher GAD severity.
Pretreatment (prior to the intervention).
Worry and Anxiety Questionnaire
Time Frame: Posttreatment (after completing final session of the treatment intervention)
Self-reported GAD symptoms as measured by the WAQ (Dugas et al., 2001). Scores range from 0-80 with higher scores indicating higher GAD severity.
Posttreatment (after completing final session of the treatment intervention)
Worry and Anxiety Questionnaire
Time Frame: 3-month follow-up
Self-reported GAD symptoms as measured by the WAQ (Dugas et al., 2001). Scores range from 0-80 with higher scores indicating higher GAD severity.
3-month follow-up
Intolerance of Uncertainty Scale
Time Frame: Pretreatment (prior to the intervention).
Self-reported difficulties tolerating uncertainty (Freeston, Rhéaume, et al., 1994). Scores range from 27-135 with greater scores indicating greater intolerance of uncertainty.
Pretreatment (prior to the intervention).
Intolerance of Uncertainty Scale
Time Frame: Posttreatment (after completing final session of the treatment intervention)
Self-reported difficulties tolerating uncertainty (Freeston, Rhéaume, et al., 1994). Scores range from 27-135 with greater scores indicating greater intolerance of uncertainty.
Posttreatment (after completing final session of the treatment intervention)
Intolerance of Uncertainty Scale
Time Frame: 3-month follow-up
Self-reported difficulties tolerating uncertainty (Freeston, Rhéaume, et al., 1994). Scores range from 27-135 with greater scores indicating greater intolerance of uncertainty.
3-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression Anxiety Stress Scales
Time Frame: Pretreatment (prior to the intervention).
A measure of self-reported depression, anxiety, and stress symptoms (Lovibond & Lovibond, 1995). Higher scores on a subscale indicate greater severity in that symptom area (i.e., depression, anxiety, or stress, respectively).
Pretreatment (prior to the intervention).
Depression Anxiety Stress Scales
Time Frame: Posttreatment (after completing final session of the treatment intervention)
A measure of self-reported depression, anxiety, and stress symptoms (Lovibond & Lovibond, 1995). Higher scores on a subscale indicate greater severity in that symptom area (i.e., depression, anxiety, or stress, respectively).
Posttreatment (after completing final session of the treatment intervention)
Depression Anxiety Stress Scales
Time Frame: 3-month follow-up
A measure of self-reported depression, anxiety, and stress symptoms (Lovibond & Lovibond, 1995). Higher scores on a subscale indicate greater severity in that symptom area (i.e., depression, anxiety, or stress, respectively).
3-month follow-up
Penn State Worry Questionnaire
Time Frame: Pretreatment (prior to the intervention).
A measure of self-reported excessive worry (Meyer, Miller, Metzger, & Borkovec, 1990). Scores range from 16-80 with higher scores indicating greater worry severity.
Pretreatment (prior to the intervention).
Penn State Worry Questionnaire
Time Frame: Posttreatment (after completing final session of the treatment intervention)
A measure of self-reported excessive worry (Meyer, Miller, Metzger, & Borkovec, 1990). Scores range from 16-80 with higher scores indicating greater worry severity.
Posttreatment (after completing final session of the treatment intervention)
Penn State Worry Questionnaire
Time Frame: 3-month follow-up
A measure of self-reported excessive worry (Meyer, Miller, Metzger, & Borkovec, 1990). Scores range from 16-80 with higher scores indicating greater worry severity.
3-month follow-up
Five Dimensional Curiosity Scale
Time Frame: Pretreatment (prior to the intervention).
Self-reported tendency toward 5 dimensions of curiosity (Kashdan et al., 2018), with higher scores on each respective subscale indicating greater tendency toward a specific facet of curiousity.
Pretreatment (prior to the intervention).
Five Dimensional Curiosity Scale
Time Frame: Posttreatment (after completing final session of the treatment intervention)
Self-reported tendency toward 5 dimensions of curiosity (Kashdan et al., 2018), with higher scores on each respective subscale indicating greater tendency toward a specific facet of curiousity.
Posttreatment (after completing final session of the treatment intervention)
Five Dimensional Curiosity Scale
Time Frame: 3-month follow-up
Self-reported tendency toward 5 dimensions of curiosity (Kashdan et al., 2018), with higher scores on each respective subscale indicating greater tendency toward a specific facet of curiousity.
3-month follow-up
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time Frame: Pretreatment (prior to the intervention).
Self-reported quality of life (Endicott, Nee, Harrison, & Bulmental, 1993), with scores ranging from 14-70 (higher scores indicating greater overall quality of life).
Pretreatment (prior to the intervention).
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time Frame: Posttreatment (after completing final session of the treatment intervention)
Self-reported quality of life (Endicott, Nee, Harrison, & Bulmental, 1993), with scores ranging from 14-70 (higher scores indicating greater overall quality of life).
Posttreatment (after completing final session of the treatment intervention)
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time Frame: 3-month follow-up
Self-reported quality of life (Endicott, Nee, Harrison, & Bulmental, 1993), with scores ranging from 14-70 (higher scores indicating greater overall quality of life).
3-month follow-up
Treatment Acceptability/Adherence Scale
Time Frame: Midtreatment
Self-report measure of the participant's perception of the treatment's acceptability and their anticipated adherence to the intervention (Milosevic, Levy, Alcolado, & Radomsky, 2015). Scores range from 10 to 70 with greater scores indicating greater treatment acceptability and anticipated adherence.
Midtreatment
GAD Safety Behaviours Questionnaire
Time Frame: Pretreatment (prior to the intervention).
Self-reported tendency to use safety behaviours to manage anxiety (Hebert & Dugas, 2019). Scores range from 18 to 90 with higher scores indicating greater use of safety behaviours.
Pretreatment (prior to the intervention).
GAD Safety Behaviours Questionnaire
Time Frame: Posttreatment (after completing final session of the treatment intervention)
Self-reported tendency to use safety behaviours to manage anxiety (Hebert & Dugas, 2019). Scores range from 18 to 90 with higher scores indicating greater use of safety behaviours.
Posttreatment (after completing final session of the treatment intervention)
GAD Safety Behaviours Questionnaire
Time Frame: 3-month follow-up
Self-reported tendency to use safety behaviours to manage anxiety (Hebert & Dugas, 2019). Scores range from 18 to 90 with higher scores indicating greater use of safety behaviours.
3-month follow-up
IUS Past-Week
Time Frame: Weekly from session 1 to session 12 of treatment
Self-report measure assessing intolerance of uncertainty in the past week (Dugas, 2008). Scores range from 27-135 with greater scores indicating greater intolerance of uncertainty in the past week.
Weekly from session 1 to session 12 of treatment
Penn State Worry Questionnaire Past-Week
Time Frame: Weekly from session 1 to session 12 of treatment
Self-report measure of the tendency to worry excessively in the past week (Stöber, J., & Bittencourt, J., 1998). Scores range from 0 to 90 with greater scores indicating greater tendency to worry excessively in the past week.
Weekly from session 1 to session 12 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Hebert, PhD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H2019:412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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