Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder

NCT01958788 | Completed Results DMC

• 1 other identifier: MOP-69066-620
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Generalized Anxiety Disorder

Keywords

Cognitive-behavioral treatment; Generalized anxiety disorder; Worry; Behavioral experiments; Safety behaviors; Anxiety

Outcome Measures

Primary Outcomes (1)

• Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)

  The CSR is a severity rating scale ranging from 0-8. Scores of 4 or greater represent clinically significant symptoms, whereas scores lower than 4 indicate subclinical symptoms. Lower scores represent improved outcome. This measure was used to evaluate change from baseline in the severity of GAD symptoms as assessed by the ADIS-IV, a semi-structured clinical interview for Axis I disorders.

  Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up

Secondary Outcomes (6)

• Worry and Anxiety Questionnaire (WAQ)

  Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up

• Intolerance of Uncertainty Scale (IUS)

  Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up

• Penn State Worry Questionnaire (PSWQ)

  Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up

• GAD Safety Behaviours Questionnaire (GAD-SBQ)

  Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up

• Beck Anxiety Inventory (BAI)

  Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up

Study Arms (1)

Cognitive-Behavioural Treatment

EXPERIMENTAL

12 sessions of cognitive-behavioral treatment targeting negative beliefs about uncertainty

Behavioral: Cognitive-Behavioural Treatment

Interventions

Cognitive-Behavioural Treatment BEHAVIORAL

12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty.

Cognitive-Behavioural Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Concordia University, Montreal: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: collaborator

Study Sites (1)

Concordia University

Montreal, Quebec, H4B 1R6, Canada

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Limitations and Caveats

Small sample size due to clinical case replication series design. This reduced statistical power and types of statistical analyses that could be conducted. Participants were homogeneous in ethnicity and language, which may limit generalizability.

Results Point of Contact

• Title: Elizabeth Hebert
• Organization: Concordia University

el_heber@live.concordia.ca

1-514-848-2424

Study Officials

• Elizabeth A Hebert, M.A.

  Concordia University, Montreal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.A., Ph.D. Candidate

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 23, 2016
• Results First Posted: February 23, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)