Group CBT for Intolerance of Uncertainty

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04512378
• Other study ID #: H2019:412
• Status: Suspended
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 28, 2024

Study information

• Verified date: May 2024
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: December 28, 2024
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Generalized Anxiety Disorder
• Intolerance of Uncertainty

Intervention

Behavioral:
• Behavioural Experiments for Intolerance of Uncertainty
Cognitive-behavioural treatment targeting intolerance of uncertainty using behavioural experiment technique

Locations

Country	Name	City	State
Canada	Deer Lodge Centre	Winnipeg	Manitoba
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (11)

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.

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

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. — View 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

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

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

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. — View 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. — View 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. — View 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.

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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)
Primary	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
Primary	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).
Primary	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)
Primary	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
Primary	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).
Primary	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)
Primary	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	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).
Secondary	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)
Secondary	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
Secondary	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).
Secondary	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)
Secondary	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
Secondary	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).
Secondary	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)
Secondary	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
Secondary	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).
Secondary	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)
Secondary	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
Secondary	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
Secondary	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).
Secondary	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)
Secondary	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
Secondary	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
Secondary	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