CBT for GAD: Impact of Cognitive Processing on Treatment Outcome
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CBT-IU
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Cognitive-Behavioral Therapy
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBT-IU
Arm Description
Cognitive-behavioral therapy for intolerance of uncertainty
Outcomes
Primary Outcome Measures
Change from Baseline in symptoms of GAD and comorbid conditions at 4 months
Anxiety Disorders Interview Schedule for DSM-IV
Secondary Outcome Measures
Change from Baseline in symptoms of GAD at 4 months
Worry and Anxiety Questionnaire
Change from Baseline in worry at 4 months
Penn State Worry Questionnaire
Change from Baseline in symptoms of depression at 4 months
Beck Depression Inventory, 2nd Edition
Change from Baseline in symptoms of anxiety at 4 months
Beck Anxiety Inventory
Full Information
NCT ID
NCT03099772
First Posted
March 23, 2017
Last Updated
March 28, 2017
Sponsor
Concordia University, Montreal
Collaborators
Hopital du Sacre-Coeur de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT03099772
Brief Title
CBT for GAD: Impact of Cognitive Processing on Treatment Outcome
Official Title
Cognitive-Behavioural Treatment for Generalized Anxiety Disorder: Impact of Cognitive Processing on Short- and Long-Term Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2007 (Actual)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Concordia University, Montreal
Collaborators
Hopital du Sacre-Coeur de Montreal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Generalized anxiety disorder (GAD) is a condition characterized by chronic and excessive worry and anxiety. Over the past 15 years, the investigators have developed a cognitive-behavioural treatment that leads to the remission of GAD in approximately 60% to 75% of affected individuals. Although these numbers are encouraging, there remain a considerable proportion of patients who do not fully benefit from treatment. With the goal of improving treatment efficacy, the investigators have recently carried out a series of related studies on the way individuals with GAD and high worriers process uncertain or ambiguous information from their environment. The findings show that these individuals display biases in attention for, and appraisal of, uncertain or ambiguous information. Specifically, individuals with GAD and high worriers preferentially allocate their attention to uncertainty-related stimuli and appraise ambiguous information in a threatening manner. In this study, the investigators examine the impact of these information processing biases, measured at intake, on the efficacy of cognitive-behavioural treatment for GAD. The investigators also examine the impact of residual information processing biases, measured at posttreatment, on the maintenance of treatment gains over 18 months following treatment. The main hypotheses are (1) that high levels of pretreatment biases will predict poorer outcomes immediately following therapy, and (2) that high levels of posttreatment biases will predict relapse during the 18 months following therapy. If, as expected, information processing biases predict poor short- and long-term treatment outcomes for individuals with GAD, the investigators will expand the treatment to integrate strategies that directly target these biases in order to increase its efficacy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Cognitive-Behavioral Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-IU
Arm Type
Experimental
Arm Description
Cognitive-behavioral therapy for intolerance of uncertainty
Intervention Type
Behavioral
Intervention Name(s)
CBT-IU
Intervention Description
Cognitive-behavioral therapy for intolerance of uncertainty
Primary Outcome Measure Information:
Title
Change from Baseline in symptoms of GAD and comorbid conditions at 4 months
Description
Anxiety Disorders Interview Schedule for DSM-IV
Time Frame
Baseline and 4 months
Secondary Outcome Measure Information:
Title
Change from Baseline in symptoms of GAD at 4 months
Description
Worry and Anxiety Questionnaire
Time Frame
Baseline and 4 months
Title
Change from Baseline in worry at 4 months
Description
Penn State Worry Questionnaire
Time Frame
Baseline and 4 months
Title
Change from Baseline in symptoms of depression at 4 months
Description
Beck Depression Inventory, 2nd Edition
Time Frame
Baseline and 4 months
Title
Change from Baseline in symptoms of anxiety at 4 months
Description
Beck Anxiety Inventory
Time Frame
Baseline and 4 months
Other Pre-specified Outcome Measures:
Title
Change from Baseline in tolerance for uncertainty at 4 months
Description
Intolerance of Uncertainty Scale
Time Frame
Baseline and 4 months
Title
Change from Baseline in interpretation bias at 4 months
Description
Ambiguous-Unambiguous Situations Diary
Time Frame
Baseline and 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel J. Dugas, Ph.D.
Organizational Affiliation
Concordia University, Montreal
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CBT for GAD: Impact of Cognitive Processing on Treatment Outcome
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