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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Cognitive-behavioural treatment targeting intolerance of uncertainty using behavioural experiment technique
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Deer Lodge Centre
Winnipeg, Manitoba, Canada
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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3-month follow-up
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3-month follow-up
Five Dimensional Curiosity Scale
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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).
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weekly from session 1 to session 12 of treatment