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Generalized Anxiety DisorderNCT04512378

Group CBT for Intolerance of Uncertainty

A study testing Behavioural Experiments for Intolerance of Uncertainty in people with Generalized Anxiety Disorder and Intolerance of Uncertainty, run by University of Manitoba at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years
What is being tested?
Behavioural Experiments for Intolerance of Uncertainty
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesCanada
Study dates
1 Feb 2021to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

  • Deer Lodge Centre

    Winnipeg, Manitoba, R3J 0L3

Other trials in Canada

About this study

Official title: 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.

Being tested
Behavioural Experiments for Intolerance of Uncertainty
Medical subject headings
Generalized Anxiety Disorder, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioural Experiments for Intolerance of UncertaintyBehavioural

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

Study groups in NCT04512378
Study groupRoleWhat they receive
IU Group TreatmentExperimentalClinical intervention arm
Receives: Behavioral: Behavioural Experiments for Intolerance of Uncertainty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Pretreatment (prior to the intervention).

  2. 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)

    Measured: Posttreatment (after completing final session of the treatment intervention)

  3. 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)

    Measured: 3-month follow-up

  4. 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.

    Measured: Pretreatment (prior to the intervention).

  5. 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.

    Measured: Posttreatment (after completing final session of the treatment intervention)

  6. 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.

    Measured: 3-month follow-up

  7. 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.

    Measured: Pretreatment (prior to the intervention).

  8. 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.

    Measured: Posttreatment (after completing final session of the treatment intervention)

  9. 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.

    Measured: 3-month follow-up

Secondary outcomes (18)
  1. 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).

    Measured: Pretreatment (prior to the intervention).

  2. 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).

    Measured: Posttreatment (after completing final session of the treatment intervention)

  3. 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).

    Measured: 3-month follow-up

  4. 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.

    Measured: Pretreatment (prior to the intervention).

  5. 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.

    Measured: Posttreatment (after completing final session of the treatment intervention)

  6. 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.

    Measured: 3-month follow-up

  7. 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.

    Measured: Pretreatment (prior to the intervention).

  8. 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.

    Measured: Posttreatment (after completing final session of the treatment intervention)

  9. 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.

    Measured: 3-month follow-up

  10. 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).

    Measured: Pretreatment (prior to the intervention).

  11. 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).

    Measured: Posttreatment (after completing final session of the treatment intervention)

  12. 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).

    Measured: 3-month follow-up

  13. 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.

    Measured: Midtreatment

  14. 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.

    Measured: Pretreatment (prior to the intervention).

  15. 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.

    Measured: Posttreatment (after completing final session of the treatment intervention)

  16. 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.

    Measured: 3-month follow-up

  17. 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.

    Measured: Weekly from session 1 to session 12 of treatment

  18. 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.

    Measured: Weekly from session 1 to session 12 of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2020
  2. Study start1 Feb 2021
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04512378
Sponsor's protocol ID
H2019:412
Status last verified
Jul 2026
First submitted
7 Aug 2020
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

  • 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.

    PubMed 2076086
  • 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.

    PubMed 26091250
  • 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

  • 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.

    PubMed 7726811
  • 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

  • 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.

    PubMed 8290681
  • 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.

    PubMed 9648338
  • Dugas, M.J. (2008). Échelle d'intolérance à l'incertitude - Dernière semaine. Montréal, Canada: Clinique des troubles anxieux, Hôpital du Sacré-Coeur de Montréal.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioural Experiments for Intolerance of Uncertainty in people with Generalized Anxiety Disorder and Intolerance of Uncertainty, run by University of Manitoba at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MINI International Neuropsychiatric Interview (time frame: Pretreatment (prior to the intervention).). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04512378, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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