N/A
N=7
Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01958788 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV) — 5.5; 3.14; 2.43 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive-Behavioural Treatment (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Concordia University, Montreal
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV) |
5.5; 3.14; 2.43 | — |
| SECONDARY Worry and Anxiety Questionnaire (WAQ) |
38.36; 24.36; 25.43 | — |
| SECONDARY Intolerance of Uncertainty Scale (IUS) |
85.71; 55.00; 54.29 | — |
| SECONDARY Penn State Worry Questionnaire (PSWQ) |
61.57; 50.00; 51.14 | — |
| SECONDARY GAD Safety Behaviours Questionnaire (GAD-SBQ) |
47.00; 32.71; 36.14 | — |
| SECONDARY Beck Anxiety Inventory (BAI) |
23.71; 9.86; 12.57 | — |
| SECONDARY Beck Depression Inventory, 2nd Edition (BDI-II) |
14.71; 4.00; 5.57 | — |
Summary
Generalized Anxiety Disorder (GAD) is an anxiety disorder characterized by excessive and uncontrollable worry. Our research group has developed a cognitive-behavioural treatment (CBT) for GAD centered upon intolerance of uncertainty, a dispositional characteristic that arises from a set of negative beliefs about uncertainty and its consequences (Dugas & Robichaud, 2007). This CBT protocol has demonstrated good efficacy over four previous clinical trials: approximately 70% of participants fully remit from GAD following treatment and maintain these gains over extended follow-up periods. These results, while positive, do suggest that a substantial minority of individuals do not fully benefit from the existing treatment protocol. Across our randomized clinical trials, individuals who do not achieve diagnostic remission of GAD continue to endorse elevated levels of intolerance of uncertainty. This suggests that the current CBT protocol does not effectively reduce intolerance of uncertainty in some treated individuals. To address this, we have developed a modified version of the original CBT protocol that targets intolerance of uncertainty more directly. The goal of the current proposal is to determine whether this newly developed CBT protocol with fewer components can deliver comparable or superior GAD symptom reduction. A total of 7 participants with a primary diagnosis of GAD received the newly developed CBT protocol over 12 weekly sessions. Measures of GAD symptoms, psychopathology, and intolerance of uncertainty were administered at pre-, mid-, and post-treatment, as well as at 3- and 6-month follow-ups. The proposed study will provide information about the efficacy of this new CBT protocol in reducing GAD symptoms.
Eligibility Criteria
Inclusion Criteria
- Primary diagnosis of GAD (as assessed by semi-structured clinical interviews)
- Score of 58 or greater on the (Intolerance of Uncertainty Scale)
- Willingness to keep medication status stable while participating in the study
Exclusion Criteria
- Change in medication type or dose in 12 weeks before study entry
- Use of herbal products known to have central nervous system effects in the 2 weeks before study entry
- Evidence of suicidal intent
- Evidence of current substance abuse
- Evidence of current or past schizophrenia, bipolar disorder or organic mental disorder
- Current participation in other trials
- Concurrent psychotherapy during treatment phase of trial
- Evidence of anxiety symptoms due to a general medical condition
Data sourced from ClinicalTrials.gov (NCT01958788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.