Group CBT for Intolerance of Uncertainty

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: Suspended
• Conditions: Generalized Anxiety Disorder; Anxiety; Intolerance of Uncertainty
• Intervention / Treatment: Behavioral: Behavioural Experiments for Intolerance of Uncertainty

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
MINI International Neuropsychiatric Interview	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	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	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Depression Anxiety Stress Scales	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Elizabeth Hebert, PhD, University of Manitoba

Publications and helpful links

General Publications

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
• Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
• Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
• Hebert, E. A., & Dugas, M. J. (2019). Behavioral experiments for intolerance of uncertainty: Challenging the unknown in the treatment of generalized anxiety disorder. Cognitive and Behavioral Practice, 26(2), 421-436. https://doi.org/10.1016/j.cbpra.2018.07.007
• Sheehan, D. V., Lecrubier, Y., Janvas, J., Knapp, E., Weiller, E., Sheehan, M., et al. (1994). Mini International Neuropsychiatric Interview Version 4.4 (MINI). Tampa/Paris: University of South Florida/Inserm U302-Hôpital de la Salpêtrière.
• Dugas, M. J., Freeston, M. H., Provencher, M. D., Lachance, S., Ladouceur, R., & Gosselin, P. (2001). Journal de Thérapie Comportementale et Cognitive, 11(1), 31-36.
• Milosevic I, Levy HC, Alcolado GM, Radomsky AS. The Treatment Acceptability/Adherence Scale: Moving Beyond the Assessment of Treatment Effectiveness. Cogn Behav Ther. 2015;44(6):456-69. doi: 10.1080/16506073.2015.1053407. Epub 2015 Jun 19.
• Freeston, M. H., Rhéaume, J., Letarte, H., Dugas, M. J., & Ladouceur, R. (1994). Why do people worry? Personality and Individual Differences, 17, 791-802. https://doi.org/10.1016/0191-8869(94)90048-5
• Kashdan, T.B., Stiksma, M.C., Disabato, D., McKnight, P.E., Bekier, J., Kaji, J., & Lazarus, R. (in press). The five-dimensional curiosity scale: Capturing the bandwidth of curiosity and identifying four unique subgroups of curious people. Journal of Research in Personality
• Stober J, Bittencourt J. Weekly assessment of worry: an adaptation of the Penn State Worry Questionnaire for monitoring changes during treatment. Behav Res Ther. 1998 Jun;36(6):645-56. doi: 10.1016/s0005-7967(98)00031-x.
• Dugas, M.J. (2008). Échelle d'intolérance à l'incertitude - Dernière semaine. Montréal, Canada: Clinique des troubles anxieux, Hôpital du Sacré-Coeur de Montréal.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Generalized Anxiety Disorder
• Other Study ID 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