CBT for GAD: Impact of Cognitive Processing on Treatment Outcome

NCT03099772 | Completed

• 1 other identifier: UH2005-093
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Generalized Anxiety Disorder

Keywords

Cognitive-Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in symptoms of GAD and comorbid conditions at 4 months

  Anxiety Disorders Interview Schedule for DSM-IV

  Baseline and 4 months

Secondary Outcomes (4)

• Change from Baseline in symptoms of GAD at 4 months

  Baseline and 4 months

• Change from Baseline in worry at 4 months

  Baseline and 4 months

• Change from Baseline in symptoms of depression at 4 months

  Baseline and 4 months

• Change from Baseline in symptoms of anxiety at 4 months

  Baseline and 4 months

Other Outcomes (2)

• Change from Baseline in tolerance for uncertainty at 4 months

  Baseline and 4 months

• Change from Baseline in interpretation bias at 4 months

  Baseline and 4 months

Study Arms (1)

CBT-IU

EXPERIMENTAL

Cognitive-behavioral therapy for intolerance of uncertainty

Behavioral: CBT-IU

Interventions

CBT-IU BEHAVIORAL

Cognitive-behavioral therapy for intolerance of uncertainty

CBT-IU

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Concordia University, Montreal: lead
• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: collaborator

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Michel J. Dugas, Ph.D.

  Concordia University, Montreal

  PRINCIPAL INVESTIGATOR

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: Affiliate Professor

Model Details: Open trial

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 4, 2017
• Study Start: April 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share