Clinical Trial of a Group Self-management Support Program for Anxiety Disorders

May 7, 2024 updated by: Université de Sherbrooke

A Pragmatic Randomized Controlled Trial of a Group Self-management Support Program Versus Treatment-as-usual for Anxiety Disorders

Background. Self-management support is a complementary approach to treatment that aims to educate participants on the nature of anxiety and to improve their strategies to manage symptoms and well-being, thus presenting the potential to enhance recovery, improve outcomes, reduce recurrence rates and lower health care costs. There is limited evidence to support the effectiveness of group self-management support for anxiety disorders in community-based care.

Objectives. This study aims at examining the effectiveness of a virtual group self-management support program (SMS) for anxiety disorders as an add-on to treatment-as-usual (TAU) in community-based care settings. We will also assess the incremental cost/effectiveness ratio and the implementability of the intervention.

Methods. The trial is a pragmatic randomized controlled trial with a pre-treatment, post-treatment (4-month post-randomization), and follow-ups at 8, 12 and 24-months. Intervention. The experimental condition will consist of a 10-week SMS program for anxiety disorders in addition to TAU. The control condition will receive TAU without restrictions for anxiety disorders. Inclusion criteria will comprise being 18 years old or older, French-speaking, and presenting symptoms of anxiety disorders based on self-reported validated assessment scales. Patients will be recruited in the province of Quebec (Canada). Outcome measures: The primary outcome measure is the Beck Anxiety Inventory (BAI). The secondary outcome measures include self-reported instruments for anxiety and depressive symptoms, recovery, self-management, quality of life, and service utilisation. Statistical analysis: Intention-to-treat analysis. A mixed effects regression model will be used to account for between and within-subject variations in the analysis of the longitudinal effects of the intervention.

Expected outcomes. The rigorous evaluation of the SMS intervention in the real world will provide information to decision makers, health care managers, clinicians and patients regarding the added value of group SMS for patients with anxiety disorders. Widespread implementation of this intervention could lead to more efficient mental health care services, to better long-term outcomes and to a significant reduction in the extensive social and economic burden of anxiety disorders.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

414

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Université de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) aged 18 and over,
  • (2) fluent in spoken and written French,
  • (3) presence of symptoms of anxiety disorders based on self-reported validated assessment scales and semi-structured assessment interview,
  • (4) access to a computer or tablet connected to the internet with microphone and video camera

Exclusion Criteria:

  • (1) previous enrolment in the SMS intervention provided by Relief
  • (2) active suicidal intentions,
  • (3) severe depressive symptoms,
  • (4) active substance-related and addictive disorder,
  • (5) cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group self-management support
Group self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/).
Behavioral: Group self-management support program for anxiety disorders
The group SMS manualized program for anxiety disorders (https://monrelief.ca) aims at improving self-management capabilities through weekly 2.5-hours sessions with 10-15 patients over a 10-week period.This trial will focus solely on the virtual format of the program. The SMS program covers the following themes: getting to know your anxiety; building self-awareness; reconsidering your lifestyle habits; adopting a problem-solving method; avoidance and exposure; acceptance and committed action; seeing things differently; managing your emotions; receiving support from others; and consolidating your toolkit.
Other Names:
  • SMS+TAU
No Intervention: Treatment-as-usual
Treatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Beck Anxiety Inventory (BAI)
Time Frame: Baseline and post-treatment (4-month post-randomization)
Baseline and post-treatment (4-month post-randomization)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Beck Anxiety Inventory
Time Frame: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Change in Generalised Anxiety Disorder-7
Time Frame: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Change in Patient Health Questionnaire-9
Time Frame: Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Change in Recovery Assessment Scale - Revised
Time Frame: Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Change in Mental Health Self-Management Questionnaire
Time Frame: Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Change in Assessment of Quality of Life - 6 Dimensions
Time Frame: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Change in Health care use and indirect costs
Time Frame: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Health care costs for other mental health consultations (e.g. type of professional, duration, costs), psychotherapy experience (including CBT) and psychotropic medication.
Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Change in Administrative databases records
Time Frame: Starting 12 months prior to participant enrolment up to the 24-month post-randomization follow-up
Data will be obtained from provincial administrative databases for medical and biopsychosocial services, hospitalization's registry, and medication data.
Starting 12 months prior to participant enrolment up to the 24-month post-randomization follow-up

Other Outcome Measures

Outcome Measure
Time Frame
Gross Cohesion Scale
Time Frame: During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants)
During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants)
Working Alliance Inventory
Time Frame: During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants)
During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Canadian Institutes of Health Research (CIHR)
Relief

Investigators

  • Principal Investigator: Pasquale Roberge, Ph.D., Université de Sherbrooke
  • Principal Investigator: Janie Houle, Ph.D., Université du Québec à Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Actual)

March 16, 2024

Study Completion (Estimated)

December 21, 2026

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

November 5, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJT-169163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data that support the findings of this study will be available on request from the nominated principal investigator [PR]. The data will not be publicly available due to ethics approval restrictions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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