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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
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 27, 2021
    Last Updated
    December 9, 2021
    Sponsor
    Université de Sherbrooke
    Collaborators
    Canadian Institutes of Health Research (CIHR), Relief
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    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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