Group CBT for Intolerance of Uncertainty

NCT04512378 | Suspended

• 1 other identifier: H2019:412
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Generalized Anxiety Disorder; Intolerance of Uncertainty; Anxiety

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (18)

• Depression Anxiety Stress Scales

  Pretreatment (prior to the intervention).

• Depression Anxiety Stress Scales

  Posttreatment (after completing final session of the treatment intervention)

• Depression Anxiety Stress Scales

  3-month follow-up

• Penn State Worry Questionnaire

  Pretreatment (prior to the intervention).

• Penn State Worry Questionnaire

  Posttreatment (after completing final session of the treatment intervention)

Study Arms (1)

IU Group Treatment

EXPERIMENTAL

Clinical intervention arm

Behavioral: Behavioural Experiments for Intolerance of Uncertainty

Interventions

Behavioural Experiments for Intolerance of Uncertainty BEHAVIORAL

Cognitive-behavioural treatment targeting intolerance of uncertainty using behavioural experiment technique

IU Group Treatment

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (2)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Deer Lodge Centre

Winnipeg, Manitoba, R3J 0L3, Canada

Location

Related Publications (11)

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 2076086 BACKGROUND

• 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.

  PMID: 26091250 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 7726811 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 8290681 BACKGROUND

• 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.

  PMID: 9648338 BACKGROUND

• Dugas, M.J. (2008). Échelle d'intolérance à l'incertitude - Dernière semaine. Montréal, Canada: Clinique des troubles anxieux, Hôpital du Sacré-Coeur de Montréal.

  BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Elizabeth Hebert, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 13, 2020
• Study Start: February 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)