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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Concordia University
Sponsor:
Collaborators:
Hopital du Sacre-Coeur de Montreal
Université du Québec à Trois-Rivières
Université de Sherbrooke
Ryerson University
Brown University
Information provided by (Responsible Party):
Michel Dugas, Ph.D., Concordia University
ClinicalTrials.gov Identifier:
NCT01681329
First received: September 5, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Generalized Anxiety Disorder
Behavioral: Cognitive-behavioral therapy
Other: Interpretation training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Outcomes for Adults With Generalized Anxiety Disorder: Combining Cognitive-Behavioral Treatment and Interpretation Modification Training

Resource links provided by NLM:


Further study details as provided by Concordia University:

Primary Outcome Measures:
  • Change from baseline in severity of GAD symptoms assessed by structured interview [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Clinician's Severity Rating (CSR) scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)

  • Change from baseline in severity of GAD symptoms [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Worry and Anxiety Questionnaire (WAQ)

  • Change from baseline in severity of worry [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Penn State Worry Questionnaire (PSWQ)


Secondary Outcome Measures:
  • Change from baseline in somatic anxiety [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Beck Anxiety Inventory (BAI)

  • Change from baseline in depressive symptoms [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Beck Depression Inventory, 2nd edition (BDI-II)

  • Change from baseline in hostile attitudes [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Aggression Questionnaire, Hostility subscale (AQ-Host)

  • Change from baseline in intolerance of uncertainty [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Intolerance of Uncertainty Scale (IUS)

  • Change from baseline in beliefs about worry [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Why Worry, 2nd edition (WW-II)

  • Change from baseline in problem orientation [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Negative Problem Orientation Questionnaire (NPOQ)

  • Change from baseline in cognitive avoidance [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Cognitive Avoidance Questionnaire (CAQ)


Other Outcome Measures:
  • Change from baseline in interpretation of scrambled sentences [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Scrambled Sentence Task for GAD (SST-GAD)

  • Change from baseline in interpretation of ambiguous scenarios [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Ambiguous/Unambiguous Situations Diary, Extended version (AUSD-Ext)

  • Change from baseline in interpretation of ambiguous pictures [ Time Frame: Post-treatment (14 weeks) ] [ Designated as safety issue: No ]
    Affective Picture Rating Task (APRT)


Estimated Enrollment: 138
Study Start Date: September 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-behavioral therapy with interpretation training
14 sessions of cognitive-behavioral therapy combined with computerized interpretation modification training
Behavioral: Cognitive-behavioral therapy
Cognitive-behavioral therapy addressing intolerance of uncertainty, positive beliefs about worry, negative problem orientation, and cognitive avoidance
Other Name: Intolerance of uncertainty treatment
Other: Interpretation training
Computerized interpretation training using Word-Sentence Association Paradigm
Other Name: Cognitive bias modification for interpretations
Active Comparator: Cognitive-behavioral therapy with non-active training
14 sessions of cognitive-behavioral therapy combined with computerized non-active training
Behavioral: Cognitive-behavioral therapy
Cognitive-behavioral therapy addressing intolerance of uncertainty, positive beliefs about worry, negative problem orientation, and cognitive avoidance
Other Name: Intolerance of uncertainty treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681329

Contacts
Contact: Michel J. Dugas, Ph.D. 514-848-2424 ext 2215 michel.dugas@concordia.ca

Locations
Canada, Quebec
Hôpital du Sacré-Coeur de Montréal, Clinique des troubles anxieux Recruiting
Montréal, Quebec, Canada, H3M 3A9
Principal Investigator: Michel J. Dugas, Ph.D.         
Sponsors and Collaborators
Concordia University
Hopital du Sacre-Coeur de Montreal
Université du Québec à Trois-Rivières
Université de Sherbrooke
Ryerson University
Brown University
Investigators
Principal Investigator: Michel J. Dugas, Ph.D. Concordia University
  More Information

No publications provided

Responsible Party: Michel Dugas, Ph.D., Professor of Psychology, Concordia University
ClinicalTrials.gov Identifier: NCT01681329     History of Changes
Other Study ID Numbers: MOP-82771-12-04
Study First Received: September 5, 2012
Last Updated: August 5, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Canadian Institutes of Health Research

Keywords provided by Concordia University:
Cognitive-behavioral therapy
Interpretation modification training
Randomized clinical trial
Adults

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014