Clinical trial NCT04512378: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Generalized Anxiety Disorder
Intolerance of Uncertainty
Anxiety
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: MINI International Neuropsychiatric Interview
timeFrame: Pretreatment (prior to the intervention).
measure: MINI International Neuropsychiatric Interview
timeFrame: Posttreatment (after completing final session of the treatment intervention)
measure: MINI International Neuropsychiatric Interview
timeFrame: 3-month follow-up
measure: Worry and Anxiety Questionnaire
timeFrame: Pretreatment (prior to the intervention).
measure: Worry and Anxiety Questionnaire
timeFrame: Posttreatment (after completing final session of the treatment intervention)
measure: Worry and Anxiety Questionnaire
timeFrame: 3-month follow-up
measure: Intolerance of Uncertainty Scale
timeFrame: Pretreatment (prior to the intervention).
measure: Intolerance of Uncertainty Scale
timeFrame: Posttreatment (after completing final session of the treatment intervention)
measure: Intolerance of Uncertainty Scale
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Depression Anxiety Stress Scales
timeFrame: Pretreatment (prior to the intervention).
measure: Depression Anxiety Stress Scales
timeFrame: Posttreatment (after completing final session of the treatment intervention)
measure: Depression Anxiety Stress Scales
timeFrame: 3-month follow-up
measure: Penn State Worry Questionnaire
timeFrame: Pretreatment (prior to the intervention).
measure: Penn State Worry Questionnaire
timeFrame: Posttreatment (after completing final session of the treatment intervention)
measure: Penn State Worry Questionnaire
timeFrame: 3-month follow-up
measure: Five Dimensional Curiosity Scale
timeFrame: Pretreatment (prior to the intervention).
measure: Five Dimensional Curiosity Scale
timeFrame: Posttreatment (after completing final session of the treatment intervention)
measure: Five Dimensional Curiosity Scale
timeFrame: 3-month follow-up
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
timeFrame: Pretreatment (prior to the intervention).
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
timeFrame: Posttreatment (after completing final session of the treatment intervention)
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
timeFrame: 3-month follow-up
measure: Treatment Acceptability/Adherence Scale
timeFrame: Midtreatment
measure: GAD Safety Behaviours Questionnaire
timeFrame: Pretreatment (prior to the intervention).
measure: GAD Safety Behaviours Questionnaire
timeFrame: Posttreatment (after completing final session of the treatment intervention)
measure: GAD Safety Behaviours Questionnaire
timeFrame: 3-month follow-up
measure: IUS Past-Week
timeFrame: Weekly from session 1 to session 12 of treatment
measure: Penn State Worry Questionnaire Past-Week
timeFrame: Weekly from session 1 to session 12 of treatment
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Deer Lodge Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Elizabeth Hebert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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
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.
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.
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.
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.
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
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.
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
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.
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.
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.