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6-Session Treatment for Generalized Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT03433625
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : February 16, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Concordia University
University College, London
Information provided by (Responsible Party):
Michel Dugas, Ph.D., Universite du Quebec en Outaouais

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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: Behavioural experiments for intolerance of uncertainty (BE-IU) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioural Experiments for Intolerance of Uncertainty: A 6-session Treatment for Generalized Anxiety Disorder
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Behavioural experiments (CBT)
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.
Behavioral: Behavioural experiments for intolerance of uncertainty (BE-IU)
CBT

No Intervention: Waiting list
6 week wait (with assessments) before being transferred to the experimental condition.



Primary Outcome Measures :
  1. Clinician's Severity Rating (CSR) of Anxiety Disorders Interview Schedule (ADIS) [ Time Frame: 8 weeks ]
    Structured diagnostic interview


Secondary Outcome Measures :
  1. Penn State Worry Questionnaire [ Time Frame: 8 weeks ]
    16-item self-report questionnaire measuring trait worry. Only the total score is reported (range: 16 to 80). Higher values represent a worse outcome.

  2. Worry and Anxiety Questionnaire [ Time Frame: 8 weeks ]
    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.

  3. Beck Anxiety Inventory [ Time Frame: 8 weeks ]
    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.

  4. Beck Depression Inventory-II [ Time Frame: 8 weeks ]
    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.


Other Outcome Measures:
  1. Intolerance of Uncertainty Scale [ Time Frame: 8 weeks ]
    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.

  2. Safety Behaviours Questionnaire [ Time Frame: 8 weeks ]
    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.

  3. Heart rate variability [ Time Frame: 8 weeks ]
    Heart rate monitoring with chest strap and Polar watch

  4. Acceptance and Action Questionnaire, second edition [ Time Frame: 8 weeks ]
    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.

  5. Pain Catastrophizing Scale [ Time Frame: 8 weeks ]
    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.

  6. Agression Questionnaire [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433625


Contacts
Contact: Caroline Morrissette-Pronovost 819-595-3900 ext 2500 inquietude@uqo.ca

Locations
Canada, Quebec
Universite du Quebec en Outaouais Recruiting
Gatineau, Quebec, Canada, J8X 3X7
Contact: Caroline Morrissette-Pronovost    819-595-3900 ext 2500    inquietude@uqo.ca   
Contact: Gabrielle Marcotte-Beaumier    819-595-3900 ext 2500    anxiete@uqo.ca   
Sponsors and Collaborators
Universite du Quebec en Outaouais
Canadian Institutes of Health Research (CIHR)
Concordia University
University College, London
Investigators
Principal Investigator: Michel J Dugas, Ph.D. Université du Québec en Outaouais

Responsible Party: Michel Dugas, Ph.D., Professor of Psychology, Universite du Quebec en Outaouais
ClinicalTrials.gov Identifier: NCT03433625     History of Changes
Other Study ID Numbers: 2252
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michel Dugas, Ph.D., Universite du Quebec en Outaouais:
Cognitive-behavioural therapy

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders