Healthy Minds Online Group Intervention for Mood Disorders

Recruiting at 1 trial location

Overseen By Marc Corbière, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Université du Québec a Montréal

Disqualifiers: Organic disorder, Non-French speakers, others

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

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how an online group program, Healthy Minds, assists individuals with mood disorders such as depression or anxiety in returning to work and maintaining employment. Participants will determine if this program enhances their work life and reduces symptoms more effectively than no program. The trial compares participants receiving the program to those who do not, using online surveys over a year. Individuals who have recently returned to work or are about to, and have not previously undergone similar therapy, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore new methods for enhancing work life and managing mood disorders.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, but you should confirm with the trial organizers.

What prior data suggests that the Healthy Minds online group intervention is safe for individuals with mood disorders?

Research on the Healthy Minds online group program appears promising for people with mood disorders. Early results from studies on similar online mental health programs, such as MoodGYM, have shown that these programs are generally well-received. Most participants do not report serious side effects and often find the strategies helpful for managing their mood and improving mental well-being.

The Healthy Minds program employs cognitive-behavioral techniques, which change thinking patterns, to assist people in returning to work. Although specific safety data for Healthy Minds is not yet available, the absence of reported negative effects in similar programs suggests it is safe for most people to try.

Prospective participants in this trial can expect a supportive experience aimed at improving mood and work outcomes without the concern of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The "Healthy Minds" online group intervention is unique because it leverages digital technology to deliver mental health support, making it accessible to people who might not have easy access to traditional in-person therapy sessions. This approach is particularly exciting because it could help overcome barriers like geographical distance and scheduling conflicts, which are common issues with standard therapies for mood disorders, such as cognitive-behavioral therapy (CBT) and medication. Additionally, the program includes a comprehensive set of assessments that track not just mood symptoms, but also cognitive distortions and work-related functioning, offering a more holistic view of the participant's mental health over time. Researchers are hopeful that this trial will demonstrate the effectiveness of digital interventions, potentially leading to more flexible and personalized treatment options for mood disorders.

What evidence suggests that the Healthy Minds online group intervention is effective for mood disorders?

Research has shown that the Healthy Minds online group program, which participants in this trial may receive, can help individuals with mood disorders return to work more successfully. One study found that participants in this program experienced better mental health and job performance compared to those who did not participate. These benefits persisted over a year. The program employs cognitive-behavioral techniques, helping individuals change their thinking and behavior to manage their mood more effectively. While additional research is always beneficial, these early findings suggest that the Healthy Minds program could be a promising option for those dealing with mood disorders. ^{1 3 5 6 7}

Who Is on the Research Team?

Marc Corbière, PhD

Principal Investigator

Université du Québec a Montréal

Are You a Good Fit for This Trial?

This trial is for individuals currently on sick leave or who have recently returned to work (less than a month) due to mood disorders such as depression or adjustment disorder. Participants must be in the process of returning to work and not have received CBT-type interventions before. They should also be able to communicate in French.

Inclusion Criteria

I am returning to work after treatment for depression or anxiety.

I returned less than a month ago.

Exclusion Criteria

I have a diagnosed organic disorder.

I have undergone cognitive behavioral therapy.

I cannot communicate in French.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental group receive the 2-month online Healthy Minds group intervention, consisting of 8 weekly sessions

8 weeks

8 sessions (online)

First Follow-up

Participants complete online questionnaires to assess various health and work-related outcomes

2 months after baseline

1 visit (online)

Second Follow-up

Participants complete online questionnaires to assess various health and work-related outcomes

6 months after baseline

1 visit (online)

Third Follow-up

Participants complete online questionnaires to assess various health and work-related outcomes

12 months after baseline

1 visit (online)

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Minds

Trial Overview

The Healthy Minds online group intervention is being tested, which aims at helping people with mood disorders return to work sustainably. The study compares outcomes like mental health and job performance between those who receive this intervention and those who do not over one year.

How Is the Trial Designed?

Group I: Online group intervention "Healthy Minds" Experimental Treatment 1 Intervention

Group II: Control group Active Control 1 Intervention

Like the intervention group, the control group will complete an online set of questionnaires at the following time points: * Baseline * First follow-up (2 months after baseline) * Second follow-up (6 months after baseline) * Third follow-up (12 months after baseline) The questionnaires will cover the following domains: * Sociodemographic and biopsychosocial factors * Symptoms associated with the primary mood disorder * Cognitive difficulties and distortions * Self-efficacy in relation to returning to work * Work accommodations and natural supports * Relationship with immediate supervisor * Work functioning * Return-to-work time (number of days away from work)

Who Is Running the Clinical Trial?

Université du Québec a Montréal

Lead Sponsor

Trials

28

Recruited

5,600+

Ciusss de L'Est de l'Île de Montréal

Collaborator

Trials

81

Recruited

6,400+

PhysioExtra

Collaborator

Trials

1

Recruited

80+

Energir

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

E-health strategies, especially online psychotherapy and symptom documentation tools, have shown promise in effectively supporting individuals with mood disorders, although only these two have been rigorously evaluated for efficacy.

While social media and blogs are popular for reducing stigma and providing peer support, they lack sufficient research to confirm their effectiveness in managing mood disorders, highlighting a need for further studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-health: an overview of the uses of the Internet, social media, apps, and websites for mood disorders. Parikh, SV., Huniewicz, P.[2022]

A systematic review of 23 studies on online interventions for perinatal mood and anxiety disorders (PMADs) found that psychoeducation and cognitive-behavioral therapies (CBTs) were effective in significantly reducing symptoms of depression and anxiety.

Despite the effectiveness of these interventions, no study achieved a high-quality rating, and there was a notable lack of engagement with diverse populations, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Online Interventions to Reduce Perinatal Mood and Anxiety Disorders in Underserved Populations. Canfield, SM., Canada, KE.[2023]

This trial will compare the effectiveness of structured group psychoeducation versus unstructured peer support in adults with bipolar disorder, involving 21 sessions over 96 weeks, to see which approach better prevents future episodes.

The study aims to provide insights into not only the clinical outcomes but also the cost-effectiveness of these interventions, contributing to mental health practices in routine public settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder. Morriss, RK., Lobban, F., Jones, S., et al.[2022]

MoodSwings 2.0 is an enhanced online intervention for bipolar disorder that builds on the previous version, incorporating updates based on DSM-5 changes and technological improvements, making it more relevant and effective.

The ongoing randomized controlled trial (RCT) is evaluating the efficacy of MoodSwings 2.0 with a focus on changes in depressive and manic symptoms, utilizing a robust methodology that includes an attention control condition and safety measures for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressing MoodSwings. The upgrade and evaluation of MoodSwings 2.0: An online intervention for bipolar disorder. Lauder, S., Cosgrove, VE., Gliddon, E., et al.[2023]

This study will evaluate the effectiveness of a collaborative care model for mood disorders, involving 344 patients with unipolar depression or bipolar disorder, compared to usual care over a 12-month period.

The primary focus is on improving mood symptoms and mental health-related quality of life, while also assessing secondary outcomes like rehospitalization rates and adherence to treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a health plan-level mood disorders psychosocial intervention for solo or small practices. Kilbourne, AM., Nord, KM., Kyle, J., et al.[2018]

Participants in a study of 37 individuals (mostly female, average age 33) reported that weekly telephonic mood monitoring was generally helpful for managing mood and anxiety disorders, providing support and insights into their conditions.

While many found the monitoring beneficial, some participants also noted it could be burdensome and time-consuming, suggesting that researchers need to consider participant experiences and perceptions when designing future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participants' perspectives of weekly telephonic mood monitoring in South Africa: a feasibility study. Van der Watt, ASJ., Roos, T., Beyer, C., et al.[2022]

Feedback from nearly 10,000 patients indicated that the Mood Assessment Program (MAP) is easy to complete, highlighting its acceptability among users.

The MAP has been found to enhance communication between clinicians and patients, improve diagnostic processes, and increase efficiency in assessing mood disorders, according to the limited feedback from professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the utility of the Black Dog Institute's online Mood Assessment Program in clinical practice. Parker, G., Orman, J.[2019]

The MoodSwings online intervention for bipolar disorder was developed from a validated face-to-face program and has been well-received, with an average of 1.5 million hits annually and 7400 unique visitors each year.

A randomized controlled trial has shown that many individuals with bipolar disorder are open to using the Internet for treatment, demonstrating good retention rates and suggesting that online self-help strategies are a viable option for managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online intervention for bipolar disorder. www.moodswings.net.au. Lauder, S., Chester, A., Castle, D., et al.[2019]

Participants using the MoodGYM website are likely to experience better mental health outcomes, such as reduced depression and anxiety, if they complete more modules, indicating that engagement with the material is crucial for improvement.

The updated MoodGYM Mark II site, which requires users to complete core assessments, significantly increased the completion rates of questionnaires compared to the original site, suggesting that mandatory elements can enhance user compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free range users and one hit wonders: community users of an Internet-based cognitive behaviour therapy program. Christensen, H., Griffiths, K., Groves, C., et al.[2022]

Out of 1271 participants who provided depression symptom data, 65% screened positive for a current major depressive episode, indicating that the 'Healthy Mood' website primarily attracted individuals already experiencing significant depressive symptoms.

Only 30% of participants were suitable for prevention interventions, suggesting that such websites should also guide users with current depression towards professional help while offering appropriate self-help resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who comes to a self-help depression prevention website? Characteristics of Spanish- and English-speaking visitors. Muñoz, RF., Leykin, Y., Barrera, AZ., et al.[2022]

A study involving 19 adolescents with mood disorders and their 22 parents showed that Multi-Family Psychoeducational Psychotherapy (MF-PEP) significantly improved depressive symptoms and quality of life for the adolescents.

Parents reported increased understanding of mood disorders and overall satisfaction with the treatment, highlighting the effectiveness of MF-PEP as a group psychotherapy approach for addressing adolescent mood disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of Multi-Family Psychoeducational Psychotherapy (MF-PEP) for Adolescents with Mood Disorders: Preliminary Findings. Fristad, MA., Ackerman, JP., Nick, EA.[2020]

Patients using the online telemental health platform (Brightside) showed a significantly higher rate of improvement in depression symptoms, with nearly 80% experiencing a reduction of 5 or more points on the PHQ-9 scale, compared to 52% in the treatment as usual (TAU) group.

The average reduction in PHQ-9 scores was greater for the Brightside group (-11.5) than for the TAU group (-10.1), indicating that the telemental health approach may be more effective in managing depression symptoms in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Evaluation of Measurement-Based Psychiatric Care Delivered via Specialized Telemental Health Platform Versus Treatment As Usual: A Retrospective Analysis. Chokshi, S., Senathirajah, Y., Yadav, V., et al.[2022]

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