NCT01681329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

5.8 years

First QC Date

September 5, 2012

Last Update Submit

July 19, 2018

Conditions

Generalized Anxiety Disorder

Keywords

Cognitive-behavioral therapyInterpretation modification trainingRandomized clinical trialAdults

Outcome Measures

Primary Outcomes (3)

  • 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)

    Post-treatment (14 weeks)

  • Change from baseline in severity of GAD symptoms

    Worry and Anxiety Questionnaire (WAQ)

    Post-treatment (14 weeks)

  • Change from baseline in severity of worry

    Penn State Worry Questionnaire (PSWQ)

    Post-treatment (14 weeks)

Secondary Outcomes (7)

  • Change from baseline in somatic anxiety

    Post-treatment (14 weeks)

  • Change from baseline in depressive symptoms

    Post-treatment (14 weeks)

  • Change from baseline in hostile attitudes

    Post-treatment (14 weeks)

  • Change from baseline in intolerance of uncertainty

    Post-treatment (14 weeks)

  • Change from baseline in beliefs about worry

    Post-treatment (14 weeks)

  • +2 more secondary outcomes

Other Outcomes (3)

  • Change from baseline in interpretation of scrambled sentences

    Post-treatment (14 weeks)

  • Change from baseline in interpretation of ambiguous scenarios

    Post-treatment (14 weeks)

  • Change from baseline in interpretation of ambiguous pictures

    Post-treatment (14 weeks)

Study Arms (2)

Cognitive-behavioral therapy with interpretation training

EXPERIMENTAL

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

Behavioral: Cognitive-behavioral therapyOther: Interpretation training

Cognitive-behavioral therapy with non-active training

ACTIVE COMPARATOR

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

Behavioral: Cognitive-behavioral therapy

Interventions

Cognitive-behavioral therapyBEHAVIORAL

Cognitive-behavioral therapy addressing intolerance of uncertainty, positive beliefs about worry, negative problem orientation, and cognitive avoidance

Also known as: Intolerance of uncertainty treatment
Cognitive-behavioral therapy with interpretation trainingCognitive-behavioral therapy with non-active training
Interpretation trainingOTHER

Computerized interpretation training using Word-Sentence Association Paradigm

Also known as: Cognitive bias modification for interpretations
Cognitive-behavioral therapy with interpretation training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Montreal, Quebec, H3M 3A9, Canada

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michel J. Dugas, Ph.D.

    Concordia University, Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 7, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 20, 2018

Record last verified: 2018-07

Locations

CA(1)