Panic DisorderNCT05124639
Clinical Trial of a Group Self-management Support Program for Anxiety Disorders
A study testing Group self-management support program for anxiety disorders in people with Panic Disorder and Agoraphobia, run by Université de Sherbrooke at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic Disorder, Agoraphobia, Social Anxiety Disorder
- What is being tested?
- Group self-management support program for anxiety disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteCanada
- Study dates
- 6 Oct 2022to 21 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Group self-management support program for anxiety disorders
- Keywords
- Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder, Anxiety disorders, Self-management support
- Medical subject headings
- Panic Disorder, Agoraphobia, Phobia, Social, Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group self-management support program for anxiety disordersBehavioural
Also called SMS+TAU
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.
| Study group | Role | What they receive |
|---|---|---|
| Group self-management support | Experimental | Group self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/). Receives: Behavioral: Group self-management support program for anxiety disorders |
| Treatment-as-usual | No intervention | Treatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck Anxiety Inventory (BAI)
Measured: Baseline and post-treatment (4-month post-randomization)
Secondary outcomes (8)
Change in Beck Anxiety Inventory
Measured: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Change in Generalised Anxiety Disorder-7
Measured: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Change in Patient Health Questionnaire-9
Measured: Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Change in Recovery Assessment Scale - Revised
Measured: Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Change in Mental Health Self-Management Questionnaire
Measured: Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Change in Assessment of Quality of Life - 6 Dimensions
Measured: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
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.
Measured: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Change in Administrative databases records
Data will be obtained from provincial administrative databases for medical and biopsychosocial services, hospitalization's registry, and medication data.
Measured: Starting 12 months prior to participant enrolment up to the 24-month post-randomization follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start6 Oct 2022
- Primary completion16 Mar 2024
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Relief
- Responsible party
- Sponsor
- Investigators
- Pasquale Roberge, Ph.D., Principal investigator, Université de SherbrookeJanie Houle, Ph.D., Principal investigator, Université du Québec a Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124639
- Sponsor's protocol ID
- PJT-169163
- Status last verified
- May 2024
- First submitted
- 27 Oct 2021
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35189848
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial of a Group Self-management Support Program Versus Treatment-as-usual for Anxiety Disorders
- ClinicalTrials.gov ID
- NCT05124639
- Acronym / sponsor ID
- PJT-169163
- Keywords
- Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder, Anxiety disorders, Self-management support
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Relief
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group self-management support | Experimental | Behavioral: Group self-management support program for anxiety disordersGroup self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/). |
| Treatment-as-usual | No intervention | –Treatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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
Key exclusion criteria (5 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group self-management support program for anxiety disordersAlso: SMS+TAUThe 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. | Behavioural | Group self-management support |
Primary outcome
Change in Beck Anxiety Inventory (BAI)
Time frame: Baseline and post-treatment (4-month post-randomization)
8 secondary outcomes
Change in Beck Anxiety Inventory
Time frame: 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
Change in Patient Health Questionnaire-9
Time frame: 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
Change in Mental Health Self-Management Questionnaire
Time frame: 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
Change in Health care use and indirect costs
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 35189848Roberge 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.
- Developper of the SMS-A programLink provided by the sponsor.
- Nominated principal investigator's \[PR\] laboratory website.Link provided by the sponsor.
- Published study protocol in BMC PsychiatryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasquale Roberge, Ph.D. principal investigator
Université de Sherbrooke
Janie Houle, Ph.D. principal investigator
Université du Québec a Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group self-management support program for anxiety disorders in people with Panic Disorder and Agoraphobia, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Beck Anxiety Inventory (BAI) (time frame: Baseline and post-treatment (4-month post-randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05124639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.