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Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder (CBT+IMT-GAD)

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive-behavioral therapy
Interpretation training
Sponsored by
Concordia University, Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Cognitive-behavioral therapy, Interpretation modification training, Randomized clinical trial, Adults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Principal diagnosis of GAD
  • Willingness to keep medication status stable while participating in the study
  • Willingness to undergo randomization

Exclusion Criteria:

  • Change in medication type or dose in 12 weeks before study entry
  • Use of herbal products known to have CNS 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

Sites / Locations

  • Hôpital du Sacré-Coeur de Montréal, Clinique des troubles anxieux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive-behavioral therapy with interpretation training

Cognitive-behavioral therapy with non-active training

Arm Description

14 sessions of cognitive-behavioral therapy combined with computerized interpretation modification training

14 sessions of cognitive-behavioral therapy combined with computerized non-active training

Outcomes

Primary Outcome Measures

Change from baseline in severity of GAD symptoms assessed by structured interview
Clinician's Severity Rating (CSR) scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
Change from baseline in severity of GAD symptoms
Worry and Anxiety Questionnaire (WAQ)
Change from baseline in severity of worry
Penn State Worry Questionnaire (PSWQ)

Secondary Outcome Measures

Change from baseline in somatic anxiety
Beck Anxiety Inventory (BAI)
Change from baseline in depressive symptoms
Beck Depression Inventory, 2nd edition (BDI-II)
Change from baseline in hostile attitudes
Aggression Questionnaire, Hostility subscale (AQ-Host)
Change from baseline in intolerance of uncertainty
Intolerance of Uncertainty Scale (IUS)
Change from baseline in beliefs about worry
Why Worry, 2nd edition (WW-II)
Change from baseline in problem orientation
Negative Problem Orientation Questionnaire (NPOQ)
Change from baseline in cognitive avoidance
Cognitive Avoidance Questionnaire (CAQ)

Full Information

First Posted
September 5, 2012
Last Updated
July 19, 2018
Sponsor
Concordia University, Montreal
Collaborators
Hopital du Sacre-Coeur de Montreal, Université du Québec à Trois-Rivières, Université de Sherbrooke, Toronto Metropolitan University, Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT01681329
Brief Title
Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder
Acronym
CBT+IMT-GAD
Official Title
Improving Outcomes for Adults With Generalized Anxiety Disorder: Combining Cognitive-Behavioral Treatment and Interpretation Modification Training
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (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, Université du Québec à Trois-Rivières, Université de Sherbrooke, Toronto Metropolitan University, Brown University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Generalized Anxiety Disorder (GAD) is a condition characterized by chronic and excessive worry and anxiety. Our group has developed a cognitive-behavioural treatment (CBT) for GAD that has been tested in four previous clinical trials. The findings show that 60 to 70% of affected individuals attain GAD remission and that 50 to 55% achieve high endstate functioning following the treatment. Although these numbers are encouraging, there remain a considerable proportion of individuals who do not fully benefit from treatment. In our most recent CIHR-funded treatment study, we assessed the impact of information processing on the efficacy of CBT for GAD. Our findings show: a) that the tendency to negatively interpret ambiguous information at pre-treatment was associated with greater GAD symptoms at post-treatment; and b) that patients who were less successful at changing their negative interpretation style were also less responsive to CBT. Given that computerized interpretation modification training has been shown to be effective for decreasing the negative interpretation style of anxious individuals, the goal of the current proposal is to determine whether such training can augment the efficacy of CBT for adults with GAD. A total of 138 individuals with a primary diagnosis of GAD will be randomly allocated to one of two conditions: a) CBT plus interpretation modification training or b) CBT plus non-active training. CBT will consist of 14 weekly sessions, with interpretation modification training (or non-active training) administered prior to each session. Measures of GAD symptoms, psychopathology, cognitive vulnerability, and interpretation style will be administered at pre-, mid-, and post-treatment, as well as at 6- and 12-month follow-ups. The proposed study will provide information about the efficacy, clinical usefulness, and mechanisms of interpretation modification training in combination with CBT.
Detailed Description
Generalized Anxiety Disorder (GAD) is characterized by excessive and uncontrollable worry and anxiety. In Canada, the point prevalence of GAD is 3 to 4%, and the personal and social costs of GAD are well documented. Over the past decade, new cognitive-behavioural treatments have been developed for GAD. Our group has also developed a cognitive-behavioural treatment (CBT) protocol for GAD, which focuses on intolerance of uncertainty. There are now four published randomized clinical trials of the treatment, with results suggesting that it is more efficacious than wait-list control, supportive therapy, and applied relaxation. Although these results are encouraging, 30 to 40% of affected individuals do not attain diagnostic remission and 45 to 50% do not achieve high endstate functioning at post-treatment. In an effort to augment the efficacy of the treatment protocol for GAD, we have recently examined a broad range of demographic and clinical variables that might predict a limited response to treatment. The results of our analyses suggest that a particular type of cognitive bias plays a key role in determining treatment response. Specifically, patients with a particularly negative interpretation style (i.e., the tendency to negatively interpret ambiguous information) have a greater probability of not attaining remission following CBT (they also show less improvement on other indicators of treatment outcome). In addition, change in interpretation style appears to mediate change in GAD symptoms over the course of CBT. Thus, the data suggest that treatment efficacy could be increased by adding training strategies that specifically address negatively biased interpretations of ambiguous information. Recently, a number of experimental investigations have shown that the tendency to negatively interpret ambiguous information can be decreased using computerized interpretation modification training. In fact, the data show that such changes can be maintained over time, can generalize to new situations, and can lead to corresponding changes in GAD symptoms and anxiety proneness. Thus, it appears that computerized interpretation modification training has the potential to increase the efficacy of current CBT protocols by directly targeting and decreasing the tendency to negatively interpret ambiguous information. The proposed randomized clinical trial addresses the following question: Can computerized interpretation modification training augment the efficacy of CBT for GAD? A total of 138 individuals with a primary diagnosis of GAD will be randomly allocated to one of two conditions: a) CBT plus interpretation modification training (CBT+IMT) or b) CBT plus non-active training (CBT+NA). CBT will consist of 14 weekly 50-minute sessions targeting intolerance of uncertainty via procedures such as problem-solving training and imaginal exposure. Participants randomized to the experimental condition will receive 10 minutes of computerized interpretation modification training prior to each CBT session. In interpretation modification training, respondents learn to endorse benign combinations and reject negative combinations of sentences and words, thus promoting new associative learning. Participants in the control condition will receive 10 minutes of non-active training, in which each sentence is paired with a word that is unrelated to the sentence or a word that is related to a non-threatening (and typically peripheral) aspect of the sentence. Measures of GAD symptoms, psychopathology, cognitive vulnerability, and interpretation style will be administered at pre-, mid-, and post-treatment, as well as at 6- and 12-month follow-ups. The proposed study will provide information about the efficacy, clinical usefulness, and mechanisms of interpretation modification training in combination with CBT. Given previous findings on the key role of negative interpretation style in anxiety, the proposed study has the potential to increase our understanding and ability to treat individuals with GAD.

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, Interpretation modification training, Randomized clinical trial, Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-behavioral therapy with interpretation training
Arm Type
Experimental
Arm Description
14 sessions of cognitive-behavioral therapy combined with computerized interpretation modification training
Arm Title
Cognitive-behavioral therapy with non-active training
Arm Type
Active Comparator
Arm Description
14 sessions of cognitive-behavioral therapy combined with computerized non-active training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Other Intervention Name(s)
Intolerance of uncertainty treatment
Intervention Description
Cognitive-behavioral therapy addressing intolerance of uncertainty, positive beliefs about worry, negative problem orientation, and cognitive avoidance
Intervention Type
Other
Intervention Name(s)
Interpretation training
Other Intervention Name(s)
Cognitive bias modification for interpretations
Intervention Description
Computerized interpretation training using Word-Sentence Association Paradigm
Primary Outcome Measure Information:
Title
Change from baseline in severity of GAD symptoms assessed by structured interview
Description
Clinician's Severity Rating (CSR) scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
Time Frame
Post-treatment (14 weeks)
Title
Change from baseline in severity of GAD symptoms
Description
Worry and Anxiety Questionnaire (WAQ)
Time Frame
Post-treatment (14 weeks)
Title
Change from baseline in severity of worry
Description
Penn State Worry Questionnaire (PSWQ)
Time Frame
Post-treatment (14 weeks)
Secondary Outcome Measure Information:
Title
Change from baseline in somatic anxiety
Description
Beck Anxiety Inventory (BAI)
Time Frame
Post-treatment (14 weeks)
Title
Change from baseline in depressive symptoms
Description
Beck Depression Inventory, 2nd edition (BDI-II)
Time Frame
Post-treatment (14 weeks)
Title
Change from baseline in hostile attitudes
Description
Aggression Questionnaire, Hostility subscale (AQ-Host)
Time Frame
Post-treatment (14 weeks)
Title
Change from baseline in intolerance of uncertainty
Description
Intolerance of Uncertainty Scale (IUS)
Time Frame
Post-treatment (14 weeks)
Title
Change from baseline in beliefs about worry
Description
Why Worry, 2nd edition (WW-II)
Time Frame
Post-treatment (14 weeks)
Title
Change from baseline in problem orientation
Description
Negative Problem Orientation Questionnaire (NPOQ)
Time Frame
Post-treatment (14 weeks)
Title
Change from baseline in cognitive avoidance
Description
Cognitive Avoidance Questionnaire (CAQ)
Time Frame
Post-treatment (14 weeks)
Other Pre-specified Outcome Measures:
Title
Change from baseline in interpretation of scrambled sentences
Description
Scrambled Sentence Task for GAD (SST-GAD)
Time Frame
Post-treatment (14 weeks)
Title
Change from baseline in interpretation of ambiguous scenarios
Description
Ambiguous/Unambiguous Situations Diary, Extended version (AUSD-Ext)
Time Frame
Post-treatment (14 weeks)
Title
Change from baseline in interpretation of ambiguous pictures
Description
Affective Picture Rating Task (APRT)
Time Frame
Post-treatment (14 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Principal diagnosis of GAD Willingness to keep medication status stable while participating in the study Willingness to undergo randomization Exclusion Criteria: Change in medication type or dose in 12 weeks before study entry Use of herbal products known to have CNS 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
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
Facility Information:
Facility Name
Hôpital du Sacré-Coeur de Montréal, Clinique des troubles anxieux
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3M 3A9
Country
Canada

12. IPD Sharing Statement

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Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder

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