Anxiety, Generalized Anxiety Disorder, Intolerance of Uncertainty
Conditions
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.
Interventions
Cognitive-behavioural treatment targeting intolerance of uncertainty using behavioural experiment technique
Sponsors
University of Manitoba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MINI International Neuropsychiatric Interview | Pretreatment (prior to the intervention). | 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 | Pretreatment (prior to the intervention). | 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 | Pretreatment (prior to the intervention). | Self-reported difficulties tolerating uncertainty (Freeston, Rhéaume, et al., 1994). Scores range from 27-135 with greater scores indicating greater intolerance of uncertainty. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Anxiety Stress Scales | Pretreatment (prior to the intervention). | 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 | Pretreatment (prior to the intervention). | 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 | Pretreatment (prior to the intervention). | 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 | Pretreatment (prior to the intervention). | 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 | Midtreatment | 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 | Pretreatment (prior to the intervention). | 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 | Weekly from session 1 to session 12 of treatment | 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 | Weekly from session 1 to session 12 of treatment | 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORElizabeth Hebert, PhD
University of Manitoba
Outcome results
None listed