Group CBT for Intolerance of Uncertainty

Study Overview
=================
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.

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

Conditions
-----------------
Generalized Anxiety Disorder, Intolerance of Uncertainty, Anxiety

Intervention / Treatment
-----------------
* Behavioral: Behavioural Experiments for Intolerance of Uncertainty


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IU Group Treatment<br>Clinical intervention arm | Behavioral: Behavioural Experiments for Intolerance of Uncertainty<br>* Cognitive-behavioural treatment targeting intolerance of uncertainty using behavioural experiment technique<br>|

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 |