6-Session Treatment for Generalized Anxiety Disorder

NCT03433625 | Completed

• 1 other identifier: 2252
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Keywords

Cognitive-behavioural therapy

Outcome Measures

Primary Outcomes (1)

• Clinician's Severity Rating (CSR) of Anxiety Disorders Interview Schedule (ADIS)

  Structured diagnostic interview

  8 weeks

Secondary Outcomes (4)

• Penn State Worry Questionnaire

  8 weeks

• Worry and Anxiety Questionnaire

  8 weeks

• Beck Anxiety Inventory

  8 weeks

• Beck Depression Inventory-II

  8 weeks

Other Outcomes (6)

• Intolerance of Uncertainty Scale

  8 weeks

• Safety Behaviours Questionnaire

  8 weeks

• Heart rate variability

  8 weeks

Study Arms (2)

Behavioural experiments (CBT)

EXPERIMENTAL

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)

Waiting list

NO INTERVENTION

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

Interventions

Behavioural experiments for intolerance of uncertainty (BE-IU) BEHAVIORAL

CBT

Behavioural experiments (CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Universite du Quebec en Outaouais: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Concordia University, Montreal: collaborator
• University College, London: collaborator

Study Sites (1)

Universite du Quebec en Outaouais

Gatineau, Quebec, J8X 3X7, Canada

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Michel J Dugas, Ph.D.

  Université du Québec en Outaouais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: February 8, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

CA (1)