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6-Session Treatment for Generalized Anxiety Disorder

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Behavioural experiments for intolerance of uncertainty (BE-IU)
Sponsored by
Universite du Quebec en Outaouais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Cognitive-behavioural therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. at least 18 years of age;
  2. principal diagnosis of GAD;
  3. no change in medication type or dose in 4 to 12 weeks before study entry (4 weeks for benzodiazepines, 12 weeks for antidepressants and hypnotics);
  4. willingness to keep medication status stable while participating in the study;
  5. no use of herbal products known to have CNS effects in the 2 weeks before study entry;
  6. no evidence of suicidal intent (based on clinical judgement);
  7. no evidence of current substance abuse, current or past schizophrenia, bipolar disorder or organic mental disorder;
  8. no current participation in other trials;
  9. no concurrent psychotherapy during treatment phase of trial;
  10. no evidence of anxiety symptoms due to a general medical condition based on clinical judgement (e.g., clinical hyperthyroidism, hypoglycaemia, anaemia).

Exclusion Criteria:

-

Sites / Locations

  • Universite du Quebec en Outaouais

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioural experiments (CBT)

Waiting list

Arm Description

Behavioural experiments involve selecting a specific thought to be tested (e.g., "uncertainty makes me unable to act") and designing a detailed experiment to test out the thought.

6 week wait (with assessments) before being transferred to the experimental condition.

Outcomes

Primary Outcome Measures

Clinician's Severity Rating (CSR) of Anxiety Disorders Interview Schedule (ADIS)
Structured diagnostic interview

Secondary Outcome Measures

Penn State Worry Questionnaire
16-item self-report questionnaire measuring trait worry. Only the total score is reported (range: 16 to 80). Higher values represent a worse outcome.
Worry and Anxiety Questionnaire
11-item self-report questionnaire measuring diagnostic criteria for generalized anxiety disorder. Only the total score is reported (range: 7 to 35). Higher values represent a worse outcome.
Beck Anxiety Inventory
21-item self-report questionnaire measuring anxiety over the past week. Only the total score is reported (range: 0 to 63). Higher values represent a worse outcome.
Beck Depression Inventory-II
21-item self-report questionnaire measuring depressive symptoms over the past 2 weeks. Only the total score is reported (range: 0 to 63). Higher values represent a worse outcome.

Full Information

First Posted
February 8, 2018
Last Updated
November 2, 2020
Sponsor
Universite du Quebec en Outaouais
Collaborators
Canadian Institutes of Health Research (CIHR), Concordia University, Montreal, University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT03433625
Brief Title
6-Session Treatment for Generalized Anxiety Disorder
Official Title
Behavioural Experiments for Intolerance of Uncertainty: A 6-session Treatment for Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universite du Quebec en Outaouais
Collaborators
Canadian Institutes of Health Research (CIHR), Concordia University, Montreal, University College, London

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 chronic condition that is characterized by excessive and uncontrollable worry and anxiety. In Canada, 3 to 4% of the population suffer from GAD at any point in time. These individuals have a lowered quality of life and are at risk for many medical conditions such as coronary heart disease and cancer. Research suggests that both pharmacological and psychological approaches are effective for treating GAD in the short-term; however, psychological treatments appear to offer the greatest long-term benefits. There exist a number of effective psychological treatments for GAD, most of which fall into the category of cognitive-behavioural therapy or CBT. In the 1990s, a group of Canadian investigators developed a CBT protocol for GAD that included four components. Data from five clinical trials suggest that one of the four components is particularly important for treatment success: experiencing uncertainty rather than avoiding it in everyday life. Stated differently, learning to tolerate and deal with uncertainty appears to be the key to decreasing worry and anxiety. Given this finding, the investigators have developed a new treatment that exclusively targets intolerance of uncertainty: Behavioural Experiments for Intolerance of Uncertainty or BE-IU. The goal of the current proposal is to test the efficacy of BE-IU (6 weekly treatment sessions) by comparing it to a Waiting List (WL) control condition (6 weeks). A total of 50 participants with a primary diagnosis of GAD will be randomly assigned to either BE-IU or WL and will be assessed at 4 time points ranging from pre-treatment to 12-month follow-up. The conditions will be compared in terms of treatment efficacy and mechanisms. The investigators will also examine the predictors of change during the 12-months following treatment. The proposed study will produce data on the efficacy and mechanisms of a treatment for GAD that is less costly, less complex and easier to disseminate than treatments that are currently available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Cognitive-behavioural therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioural experiments (CBT)
Arm Type
Experimental
Arm Description
Behavioural experiments involve selecting a specific thought to be tested (e.g., "uncertainty makes me unable to act") and designing a detailed experiment to test out the thought.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
6 week wait (with assessments) before being transferred to the experimental condition.
Intervention Type
Behavioral
Intervention Name(s)
Behavioural experiments for intolerance of uncertainty (BE-IU)
Intervention Description
CBT
Primary Outcome Measure Information:
Title
Clinician's Severity Rating (CSR) of Anxiety Disorders Interview Schedule (ADIS)
Description
Structured diagnostic interview
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Penn State Worry Questionnaire
Description
16-item self-report questionnaire measuring trait worry. Only the total score is reported (range: 16 to 80). Higher values represent a worse outcome.
Time Frame
8 weeks
Title
Worry and Anxiety Questionnaire
Description
11-item self-report questionnaire measuring diagnostic criteria for generalized anxiety disorder. Only the total score is reported (range: 7 to 35). Higher values represent a worse outcome.
Time Frame
8 weeks
Title
Beck Anxiety Inventory
Description
21-item self-report questionnaire measuring anxiety over the past week. Only the total score is reported (range: 0 to 63). Higher values represent a worse outcome.
Time Frame
8 weeks
Title
Beck Depression Inventory-II
Description
21-item self-report questionnaire measuring depressive symptoms over the past 2 weeks. Only the total score is reported (range: 0 to 63). Higher values represent a worse outcome.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Intolerance of Uncertainty Scale
Description
27-item self-report questionnaire measuring negative beliefs about uncertainty. Only the total score is reported (range: 27 to 135). Higher values represent a worse outcome.
Time Frame
8 weeks
Title
Safety Behaviours Questionnaire
Description
18-item self-report questionnaire measuring the use of avoidance and safety behaviors. Only the total score is reported (range: 18 to 90). Higher values represent a worse outcome.
Time Frame
8 weeks
Title
Heart rate variability
Description
Heart rate monitoring with chest strap and Polar watch
Time Frame
8 weeks
Title
Acceptance and Action Questionnaire, second edition
Description
10-item self-report questionnaire measuring acceptance of internal experiences and commitment to valued action. Only the total score is reported (range 10 to 70). Higher values represent a better outcome.
Time Frame
8 weeks
Title
Pain Catastrophizing Scale
Description
13-item self-report questionnaire measuring negative beliefs about pain. Only the total score is reported (range: 0 to 52). Higher values represent a worse outcome.
Time Frame
8 weeks
Title
Agression Questionnaire
Description
12-item self-report questionnaire measuring the tendency to become angry. Only the total score is reported (range: 12 to 60). Higher values represent a worse outcome.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: at least 18 years of age; principal diagnosis of GAD; no change in medication type or dose in 4 to 12 weeks before study entry (4 weeks for benzodiazepines, 12 weeks for antidepressants and hypnotics); willingness to keep medication status stable while participating in the study; no use of herbal products known to have CNS effects in the 2 weeks before study entry; no evidence of suicidal intent (based on clinical judgement); no evidence of current substance abuse, current or past schizophrenia, bipolar disorder or organic mental disorder; no current participation in other trials; no concurrent psychotherapy during treatment phase of trial; no evidence of anxiety symptoms due to a general medical condition based on clinical judgement (e.g., clinical hyperthyroidism, hypoglycaemia, anaemia). Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel J Dugas, Ph.D.
Organizational Affiliation
Université du Québec en Outaouais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universite du Quebec en Outaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8X 3X7
Country
Canada

12. IPD Sharing Statement

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6-Session Treatment for Generalized Anxiety Disorder

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