- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03099772
CBT for GAD: Impact of Cognitive Processing on Treatment Outcome
Cognitive-Behavioural Treatment for Generalized Anxiety Disorder: Impact of Cognitive Processing on Short- and Long-Term Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: The investigators have developed a cognitive model of generalized anxiety disorder (GAD) that has intolerance of uncertainty as its central component. Based on this model, they have devised a cognitive-behavioural treatment (CBT) for GAD that helps affected individuals recognize, accept, and deal with the uncertainty of everyday life. Although the treatment leads to positive outcomes in most patients, a significant minority of treated individuals do not attain full remission. One potential avenue for improving the treatment of GAD is to identify disorder-specific modes of cognitive processing (or information processing) and to directly target these modes of processing in therapy. Accordingly, the investigators have carried out a series of related studies examining the relationship between cognitive processing and GAD. The findings from these studies show that individuals who have clinical or subclinical GAD (1) preferentially allocate their attention to uncertainty-related stimuli, and (2) make threatening appraisals of ambiguous information. Further, the data show that the tendency to make threatening appraisals of ambiguous information mediates the relationship between intolerance of uncertainty and the symptoms of GAD. This latter finding is consistent with cognitive theory, which asserts that information processing mediates the influence of cognitive vulnerability on the expression of symptoms of emotional disorders. This study aims to extend this line of research by investigating the impact of these cognitive processing biases on treatment outcome for patients with GAD.
Goals and hypotheses: The main goal of the study is to examine the impact of biases in cognitive processing on short- and long-term outcomes of cognitive-behavioural therapy for individuals with GAD. The study's main hypotheses are that: (1) preferential allocation of attention to uncertainty-related stimuli, assessed at pretreatment, will predict poorer response to treatment; (2) the tendency to appraise ambiguous information in a threatening manner, assessed at pretreatment, will predict poorer response to treatment; (3) preferential allocation of attention to uncertainty-related stimuli, assessed at posttreatment, will predict relapse during follow-up; and (4) the tendency to appraise ambiguous information in a threatening manner, assessed at posttreatment, will predict relapse during follow-up.
Method: The final sample consists of 80 adult patients with a principal diagnosis of GAD, recruited from the Anxiety Disorders Clinic of Sacré-Cœur Hospital of Montreal. Participants are assessed at 9 measurement times: pretreatment, midtreatment, posttreatment, and 3-, 6-, 9-, 12-, 15- and 18-month follow-up. Assessments include the Anxiety Disorders Interview Schedule for DSM-IV, a cognitive processing task (Ambiguous/Unambiguous Situations Diary), and a battery of standardized self-report measures. Treatment consists of an empirically supported CBT protocol for GAD, which is administered over 16 weekly sessions using a session-by-session treatment manual developed in earlier studies. Growth curve analysis with multilevel modeling will be the main analytic strategy used to determine the relationships between cognitive processing and change in a range of outcome variables while controlling for relevant clinical and sociodemographic variables.
Implications: The study has important theoretical and clinical implications. In terms of theory, it begins to bridge the gap between the considerable knowledge of the role of cognitive processing in anxiety and the lack of knowledge of the impact of cognitive processing on treatment outcomes. Surprisingly, although the role of cognitive processing in anxiety has been intensely studied, the impact of cognitive processing on GAD psychotherapy outcomes has never been examined. The proposed study also informs clinical practice as to the importance of (1) systematically assessing cognitive processing, and (2) integrating treatment interventions that specifically target biased cognitive processing into current GAD treatment protocols.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 18 years of age
- Primary diagnosis of GAD
- Stability of medication in 4 to 12 weeks before study entry (4 weeks for benzodiazepines, 12 weeks for other medications)
- Willingness to keep medication status stable while participating in the study
Exclusion Criteria:
- Use of herbal products known to have CNS effects in the 2 weeks before study entry
- Evidence of suicidal intent (based on clinical judgement)
- Evidence of current substance abuse, current or past schizophrenia, bipolar disorder or organic mental disorder
- Participation in other trials
- Evidence of anxiety symptoms due to a general medical condition based on clinical judgement (e.g., clinical hyperthyroidism, hypoglycemia, anemia)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBT-IU
Cognitive-behavioral therapy for intolerance of uncertainty
|
Cognitive-behavioral therapy for intolerance of uncertainty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in symptoms of GAD and comorbid conditions at 4 months
Time Frame: Baseline and 4 months
|
Anxiety Disorders Interview Schedule for DSM-IV
|
Baseline and 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in symptoms of GAD at 4 months
Time Frame: Baseline and 4 months
|
Worry and Anxiety Questionnaire
|
Baseline and 4 months
|
Change from Baseline in worry at 4 months
Time Frame: Baseline and 4 months
|
Penn State Worry Questionnaire
|
Baseline and 4 months
|
Change from Baseline in symptoms of depression at 4 months
Time Frame: Baseline and 4 months
|
Beck Depression Inventory, 2nd Edition
|
Baseline and 4 months
|
Change from Baseline in symptoms of anxiety at 4 months
Time Frame: Baseline and 4 months
|
Beck Anxiety Inventory
|
Baseline and 4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in tolerance for uncertainty at 4 months
Time Frame: Baseline and 4 months
|
Intolerance of Uncertainty Scale
|
Baseline and 4 months
|
Change from Baseline in interpretation bias at 4 months
Time Frame: Baseline and 4 months
|
Ambiguous-Unambiguous Situations Diary
|
Baseline and 4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michel J. Dugas, Ph.D., Concordia University, Montreal
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UH2005-093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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