Group Self-Management Support for Anxiety Disorders

Recruiting in Sherbrooke (>99 mi)

Overseen By Annie Benoit, M.Sc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Suicidal intentions, Severe depression, Substance disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 10 weeks

414 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications. It seems to be an add-on to your usual treatment, so you may not need to stop them.

What data supports the effectiveness of the treatment Group self-management support program for anxiety disorders?

Research shows that self-management support can help people with anxiety disorders by educating them about their condition and improving their ability to manage symptoms. Additionally, group cognitive behavioral therapy, which shares some elements with self-management support, has been shown to reduce anxiety symptoms in participants. ^{1 2 3 4 5}

Is group self-management support for anxiety disorders safe for humans?

Group interventions for anxiety disorders can sometimes have negative effects, such as increased anxiety due to the group setting or interactions. However, these effects are often considered a normal part of therapy and not always documented as adverse events. ^{5 6 7 8 9}

How is the group self-management support program for anxiety disorders different from other treatments?

This treatment is unique because it combines self-help strategies with professional support, focusing on educating patients about their anxiety, improving their self-management skills, and empowering them to manage symptoms and prevent relapse. Unlike traditional treatments, it emphasizes group support and personal recovery, which is not commonly structured for anxiety disorders. ^{3 6 10 11 12}

Research Team

Pasquale Roberge, Ph.D.

Principal Investigator

Université de Sherbrooke

Janie Houle, Ph.D.

Principal Investigator

Université du Québec a Montréal

Eligibility Criteria

This trial is for adults over 18 in Quebec who speak French and have been diagnosed with anxiety disorders like Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, or Social Anxiety Disorder. They must have internet access and a device with a microphone and camera to participate.

Inclusion Criteria

Access to a computer or tablet connected to the internet with microphone and video camera

I have symptoms of anxiety as confirmed by assessments and an interview.

I am 18 years old or older.

Exclusion Criteria

Previous enrolment in the SMS intervention provided by Relief

Active suicidal intentions

Active substance-related and addictive disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 10-week virtual group self-management support program for anxiety disorders in addition to treatment-as-usual

10 weeks

Virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-ups at 4, 8, 12, and 24 months post-randomization

Treatment Details

Interventions

• Group self-management support program for anxiety disorders

Trial Overview The study tests a virtual group self-management support program as an addition to usual care for managing anxiety. It's compared against the standard treatment without this program. The effectiveness will be measured at different intervals up to two years after starting.

Participant Groups

Group I: Group self-management support Experimental Treatment 1 Intervention

Group self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/).

Group II: Treatment-as-usual Active Control 1 Intervention

Treatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Relief

Collaborator

Trials

1

Recruited

410+

Findings from Research

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

References

1. England pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy for heterogeneous anxiety disorders. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Getting better my way: Feasibility study of a self-management support tool for people with mood and anxiety disorders. [2019]

3. England pubmed.ncbi.nlm.nih.gov

A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Self-Management and Its Influential Factors Among Individuals With Anxiety Disorders: A Cross-Sectional Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of psychological outcomes following the intervention 'teaching group': study on predialysis patients. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Linking professional and self-help resources for anxiety management: a community project. [2018]

7. Croatia pubmed.ncbi.nlm.nih.gov

Unwanted Effects within a Cognitive Behavioral Therapy Group in Comparison with a Recreational Group - a Cluster-Randomized Controlled Trial. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

9. England pubmed.ncbi.nlm.nih.gov

Group psychoeducative cognitive-behaviour therapy for mixed anxiety and depression with older adults. [2018]

10. Canada pubmed.ncbi.nlm.nih.gov

[Perspective of peer helpers regarding their experience animating a self-treatment program for panic disorders]. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Relationship between self-management of patients with anxiety disorders and their anxiety level and quality of life: A cross-sectional study. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

[Self-management support in chronic illness: history, concept and challenges]. [2007]