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Group CBT for Intolerance of Uncertainty

Primary Purpose

Generalized Anxiety Disorder, Intolerance of Uncertainty, Anxiety

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Behavioural Experiments for Intolerance of Uncertainty
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Boniface General Hospital
  • Deer Lodge Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IU Group Treatment

Arm Description

Clinical intervention arm

Outcomes

Primary Outcome Measures

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)
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)
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)
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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).
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).
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).
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.
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.
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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 7, 2020
Last Updated
August 6, 2023
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT04512378
Brief Title
Group CBT for Intolerance of Uncertainty
Official Title
Facing the Unknown Together: Piloting a Group-based CBT Protocol for Intolerance of Uncertainty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Intolerance of Uncertainty, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IU Group Treatment
Arm Type
Experimental
Arm Description
Clinical intervention arm
Intervention Type
Behavioral
Intervention Name(s)
Behavioural Experiments for Intolerance of Uncertainty
Intervention Description
Cognitive-behavioural treatment targeting intolerance of uncertainty using behavioural experiment technique
Primary Outcome Measure Information:
Title
MINI International Neuropsychiatric Interview
Description
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)
Time Frame
Pretreatment (prior to the intervention).
Title
MINI International Neuropsychiatric Interview
Description
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)
Time Frame
Posttreatment (after completing final session of the treatment intervention)
Title
MINI International Neuropsychiatric Interview
Description
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)
Time Frame
3-month follow-up
Title
Worry and Anxiety Questionnaire
Description
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.
Time Frame
Pretreatment (prior to the intervention).
Title
Worry and Anxiety Questionnaire
Description
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.
Time Frame
Posttreatment (after completing final session of the treatment intervention)
Title
Worry and Anxiety Questionnaire
Description
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.
Time Frame
3-month follow-up
Title
Intolerance of Uncertainty Scale
Description
Self-reported difficulties tolerating uncertainty (Freeston, Rhéaume, et al., 1994). Scores range from 27-135 with greater scores indicating greater intolerance of uncertainty.
Time Frame
Pretreatment (prior to the intervention).
Title
Intolerance of Uncertainty Scale
Description
Self-reported difficulties tolerating uncertainty (Freeston, Rhéaume, et al., 1994). Scores range from 27-135 with greater scores indicating greater intolerance of uncertainty.
Time Frame
Posttreatment (after completing final session of the treatment intervention)
Title
Intolerance of Uncertainty Scale
Description
Self-reported difficulties tolerating uncertainty (Freeston, Rhéaume, et al., 1994). Scores range from 27-135 with greater scores indicating greater intolerance of uncertainty.
Time Frame
3-month follow-up
Secondary Outcome Measure Information:
Title
Depression Anxiety Stress Scales
Description
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).
Time Frame
Pretreatment (prior to the intervention).
Title
Depression Anxiety Stress Scales
Description
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).
Time Frame
Posttreatment (after completing final session of the treatment intervention)
Title
Depression Anxiety Stress Scales
Description
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).
Time Frame
3-month follow-up
Title
Penn State Worry Questionnaire
Description
A measure of self-reported excessive worry (Meyer, Miller, Metzger, & Borkovec, 1990). Scores range from 16-80 with higher scores indicating greater worry severity.
Time Frame
Pretreatment (prior to the intervention).
Title
Penn State Worry Questionnaire
Description
A measure of self-reported excessive worry (Meyer, Miller, Metzger, & Borkovec, 1990). Scores range from 16-80 with higher scores indicating greater worry severity.
Time Frame
Posttreatment (after completing final session of the treatment intervention)
Title
Penn State Worry Questionnaire
Description
A measure of self-reported excessive worry (Meyer, Miller, Metzger, & Borkovec, 1990). Scores range from 16-80 with higher scores indicating greater worry severity.
Time Frame
3-month follow-up
Title
Five Dimensional Curiosity Scale
Description
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.
Time Frame
Pretreatment (prior to the intervention).
Title
Five Dimensional Curiosity Scale
Description
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.
Time Frame
Posttreatment (after completing final session of the treatment intervention)
Title
Five Dimensional Curiosity Scale
Description
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.
Time Frame
3-month follow-up
Title
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Description
Self-reported quality of life (Endicott, Nee, Harrison, & Bulmental, 1993), with scores ranging from 14-70 (higher scores indicating greater overall quality of life).
Time Frame
Pretreatment (prior to the intervention).
Title
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Description
Self-reported quality of life (Endicott, Nee, Harrison, & Bulmental, 1993), with scores ranging from 14-70 (higher scores indicating greater overall quality of life).
Time Frame
Posttreatment (after completing final session of the treatment intervention)
Title
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Description
Self-reported quality of life (Endicott, Nee, Harrison, & Bulmental, 1993), with scores ranging from 14-70 (higher scores indicating greater overall quality of life).
Time Frame
3-month follow-up
Title
Treatment Acceptability/Adherence Scale
Description
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.
Time Frame
Midtreatment
Title
GAD Safety Behaviours Questionnaire
Description
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.
Time Frame
Pretreatment (prior to the intervention).
Title
GAD Safety Behaviours Questionnaire
Description
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.
Time Frame
Posttreatment (after completing final session of the treatment intervention)
Title
GAD Safety Behaviours Questionnaire
Description
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.
Time Frame
3-month follow-up
Title
IUS Past-Week
Description
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.
Time Frame
Weekly from session 1 to session 12 of treatment
Title
Penn State Worry Questionnaire Past-Week
Description
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.
Time Frame
Weekly from session 1 to session 12 of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hebert, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Deer Lodge Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3J 0L3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
2076086
Citation
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.
Results Reference
background
PubMed Identifier
26091250
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
7726811
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
8290681
Citation
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.
Results Reference
background
PubMed Identifier
9648338
Citation
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.
Results Reference
background
Citation
Dugas, M.J. (2008). Échelle d'intolérance à l'incertitude - Dernière semaine. Montréal, Canada: Clinique des troubles anxieux, Hôpital du Sacré-Coeur de Montréal.
Results Reference
background

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Group CBT for Intolerance of Uncertainty

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