Clinical Trial of a Group Self-management Support Program for Anxiety Disorders
Primary Purpose
Panic Disorder, Agoraphobia, Social Anxiety Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group self-management support program for anxiety disorders
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder focused on measuring Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder, Anxiety disorders, Self-management support
Eligibility Criteria
Inclusion Criteria:
- (1) aged 18 and over,
- (2) fluent in spoken and written French,
- (3) meeting DSM-5 diagnostic criteria for at least one of the following anxiety disorders: Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Social Anxiety Disorder. The clinical assessment is based on a customized version of the Mini International Neuropsychiatric Interview (M.I.N.I.).
- (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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group self-management support
Treatment-as-usual
Arm Description
Group self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/).
Treatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up
Outcomes
Primary Outcome Measures
Change in Beck Anxiety Inventory (BAI)
Secondary Outcome Measures
Change in Beck Anxiety Inventory
Change in Generalised Anxiety Disorder-7
Change in Patient Health Questionnaire-9
Change in Recovery Assessment Scale - Revised
Change in Mental Health Self-Management Questionnaire
Change in Assessment of Quality of Life - 6 Dimensions
Change in Health care use and indirect costs
Health care costs for other mental health consultations (e.g. type of professional, duration, costs), psychotherapy experience (including CBT) and psychotropic medication.
Change in Administrative databases records
Data will be obtained from provincial administrative databases for medical and biopsychosocial services, hospitalization's registry, and medication data.
Full Information
NCT ID
NCT05124639
First Posted
October 27, 2021
Last Updated
December 9, 2021
Sponsor
Université de Sherbrooke
Collaborators
Canadian Institutes of Health Research (CIHR), Relief
1. Study Identification
Unique Protocol Identification Number
NCT05124639
Brief Title
Clinical Trial of a Group Self-management Support Program for Anxiety Disorders
Official Title
A Pragmatic Randomized Controlled Trial of a Group Self-management Support Program Versus Treatment-as-usual for Anxiety Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
Collaborators
Canadian Institutes of Health Research (CIHR), Relief
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 multicentre 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 meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for anxiety disorders: Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder. Patients will be recruited within four regions in 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder
Keywords
Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder, Anxiety disorders, Self-management support
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
414 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group self-management support
Arm Type
Experimental
Arm Description
Group self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/).
Arm Title
Treatment-as-usual
Arm Type
No Intervention
Arm Description
Treatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up
Intervention Type
Behavioral
Intervention Name(s)
Group self-management support program for anxiety disorders
Other Intervention Name(s)
SMS+TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Beck Anxiety Inventory (BAI)
Time Frame
Baseline and post-treatment (4-month post-randomization)
Secondary Outcome Measure Information:
Title
Change in Beck Anxiety Inventory
Time Frame
Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Title
Change in Generalised Anxiety Disorder-7
Time Frame
Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Title
Change in Patient Health Questionnaire-9
Time Frame
Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Title
Change in Recovery Assessment Scale - Revised
Time Frame
Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Title
Change in Mental Health Self-Management Questionnaire
Time Frame
Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Title
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
Title
Change in Health care use and indirect costs
Description
Health care costs for other mental health consultations (e.g. type of professional, duration, costs), psychotherapy experience (including CBT) and psychotropic medication.
Time Frame
Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Title
Change in Administrative databases records
Description
Data will be obtained from provincial administrative databases for medical and biopsychosocial services, hospitalization's registry, and medication data.
Time Frame
Starting 12 months prior to participant enrolment up to the 24-month post-randomization follow-up
Other Pre-specified Outcome Measures:
Title
Gross Cohesion Scale
Time Frame
During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants)
Title
Working Alliance Inventory
Time Frame
During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(1) aged 18 and over,
(2) fluent in spoken and written French,
(3) meeting DSM-5 diagnostic criteria for at least one of the following anxiety disorders: Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Social Anxiety Disorder. The clinical assessment is based on a customized version of the Mini International Neuropsychiatric Interview (M.I.N.I.).
(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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pasquale Roberge, Ph.D.
Phone
1-819-821-8000
Ext
70540
Email
pasquale.roberge@usherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Annie Benoit, M.Sc.
Phone
1-819-821-8000
Ext
74599
Email
annie.c.benoit@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasquale Roberge, Ph.D.
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janie Houle, Ph.D.
Organizational Affiliation
Université du Québec a Montréal
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35189848
Citation
Roberge P, Houle J, Provost JR, Coulombe S, Beaudin A, Bower P, Lemyre FC, Drapeau M, Drouin MS, Hudon C, Provencher MD, Vasiliadis HM. A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol. BMC Psychiatry. 2022 Feb 21;22(1):135. doi: 10.1186/s12888-021-03675-4.
Results Reference
derived
Links:
URL
https://proberge.recherche.usherbrooke.ca
Description
Nominated principal investigator's [PR] laboratory website.
Learn more about this trial
Clinical Trial of a Group Self-management Support Program for Anxiety Disorders
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