Clinical trial NCT03433625: 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
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Cognitive-behavioural therapy
Lead sponsor: Universite du Quebec en Outaouais
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Concordia University, Montreal
name: University College, London
First posted: 2018-02-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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:

-

Primary outcomes:
measure: Clinician's Severity Rating (CSR) of Anxiety Disorders Interview Schedule (ADIS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Penn State Worry Questionnaire
timeFrame: 8 weeks
measure: Worry and Anxiety Questionnaire
timeFrame: 8 weeks
measure: Beck Anxiety Inventory
timeFrame: 8 weeks
measure: Beck Depression Inventory-II
timeFrame: 8 weeks
Other outcomes:
measure: Intolerance of Uncertainty Scale
timeFrame: 8 weeks
measure: Safety Behaviours Questionnaire
timeFrame: 8 weeks
measure: Heart rate variability
timeFrame: 8 weeks
measure: Acceptance and Action Questionnaire, second edition
timeFrame: 8 weeks
measure: Pain Catastrophizing Scale
timeFrame: 8 weeks
measure: Agression Questionnaire
timeFrame: 8 weeks
Locations:
city: Gatineau
country: Canada
facility: Universite du Quebec en Outaouais
state: Quebec
Study officials:
affiliation: Université du Québec en Outaouais
name: Michel J Dugas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: