Healthy Minds Online Group Intervention for Mood Disorders

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: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to evaluate the impact of an online group intervention called Healthy Minds in facilitating a sustainable return to work for individuals with a mood disorder. The study aims to answer the following key questions : * Does receiving the Healthy Minds online intervention lead to a more sustainable return to work compared to not receiving the intervention? * Are the health outcomes (e.g., depressive symptoms) and work-related outcomes (e.g., work functioning) of individuals who receive the Healthy Minds online intervention better than those who do not receive the intervention in the year following the intervention? Both experimental and control participants will be recruited at baseline while on sick leave (expected to return to work in less than one month) or recently returned to work (less than one month). Participants will complete a series of online 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 areas : * Sociodemographic and biopsychosocial factors * Symptoms associated with the primary mood disorder * Cognitive difficulties and biaises * Self-efficacy related to return to work * Work accommodations and natural supports * Relationship with immediate supervisor * Work functioning * Return to work time (number of days away from work) Experimental participants will participate in the 2-month online Healthy Minds group intervention (cohort of 5 participants) between the baseline assessment and the first follow-up. The intervention consists of 8 sessions (one per week for 8 weeks), with each session focusing on a specific aspect of the return-to-work process from a cognitive-behavioral perspective.

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 data supports the idea that Healthy Minds Online Group Intervention for Mood Disorders is an effective treatment?

The available research does not provide specific data on the effectiveness of the Healthy Minds Online Group Intervention for Mood Disorders. However, it does mention other online interventions like MoodSwings, which is a self-help program for bipolar disorder. MoodSwings has shown that many people with bipolar disorder accept the Internet as a source of treatment and maintain engagement with the program. This suggests that online interventions can be a viable way to deliver mental health support. While this doesn't directly support the effectiveness of Healthy Minds, it indicates that similar online treatments can be beneficial. ^{1 2 3 4 5}

What safety data exists for the Healthy Minds Online Group Intervention for Mood Disorders?

The provided research does not directly address safety data for the Healthy Minds Online Group Intervention for Mood Disorders. The studies focus on other online mental health interventions, such as MoodGYM and a telemental health platform, but do not provide specific safety data for the Healthy Minds intervention. ^{6 7 8 9 10}

Is the Healthy Minds Online Group Intervention a promising treatment for mood disorders?

Yes, the Healthy Minds Online Group Intervention is a promising treatment for mood disorders because online health interventions are effective for treating mental health issues and increase access to care. ^{2 4 10 11 12}

Research Team

Marc Corbière, PhD

Principal Investigator

Université du Québec a Montréal

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

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

Participants' perspectives of weekly telephonic mood monitoring in South Africa: a feasibility study. [2022]

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

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

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

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

4. England pubmed.ncbi.nlm.nih.gov

Development of an online intervention for bipolar disorder. www.moodswings.net.au. [2019]

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

Progressing MoodSwings. The upgrade and evaluation of MoodSwings 2.0: An online intervention for bipolar disorder. [2023]

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

Free range users and one hit wonders: community users of an Internet-based cognitive behaviour therapy program. [2022]

7. United States 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a health plan-level mood disorders psychosocial intervention for solo or small practices. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Who comes to a self-help depression prevention website? Characteristics of Spanish- and English-speaking visitors. [2022]

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

Systematic Review of Online Interventions to Reduce Perinatal Mood and Anxiety Disorders in Underserved Populations. [2023]

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

Adaptation of Multi-Family Psychoeducational Psychotherapy (MF-PEP) for Adolescents with Mood Disorders: Preliminary Findings. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder. [2022]