Well-Being Resources for Depression

(Cares Trial)

Overseen By Lily Smith

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Severe aggression, Suicidality, Psychosis, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how learning about well-being can improve thoughts and feelings in romantic relationships. Participants will explore various resources, such as a mobile app or a curated list of well-being materials, to determine if these tools make a positive impact. The trial aims to understand whether gaining such knowledge benefits individuals and their partners. It suits those experiencing symptoms of depression, who have been in a relationship for at least a year, and who use a smartphone. As an unphased trial, this study offers a unique opportunity to explore innovative well-being tools that could enhance relationships and personal mental health.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Healthy Minds Program (HMP) mobile app has been tested for its impact on mental health. Studies found that users experienced moderate to large decreases in depression symptoms. This indicates that the app is generally safe and free from major safety issues.

The well-being resources, such as brochures, online communities, and educational content, are also safe. They provide information and support without any risks.

Both options in this trial are non-invasive and aim to enhance mental well-being, indicating safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Well-Being Resources for Depression trial because it explores innovative approaches to mental health care. The trial includes two experimental interventions: the Healthy Minds Program (HMP) mobile application and a curated list of well-being resources. Unlike traditional treatments for depression, such as medication and in-person therapy, the HMP app offers a digital, self-guided 4-week intervention, making it accessible and convenient for users to engage with mental health support on their own time. Additionally, the curated list of well-being resources provides personalized guidance, potentially enhancing the effectiveness of self-help strategies. This trial aims to discover if these digital, flexible options can provide effective support for individuals with depression.

What evidence suggests that this trial's treatments could be effective for depression?

Research shows that the Healthy Minds Program (HMP) mobile app, a treatment in this trial, reduces stress and improves well-being. Studies have found that using the app leads to moderate to large decreases in depression symptoms. One study highlighted a significant drop in both depression and anxiety symptoms. Another treatment arm in this trial uses a curated list of well-being resources. While many recommend these resources for learning about depression, limited data exists on their direct impact compared to the HMP app. Overall, the HMP app effectively helps people manage depression and improve mental health. ^{6 7 8 9 10}

Who Is on the Research Team?

Simon Goldberg, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for romantic couples where at least one partner may be experiencing depression. Participants must have access to the internet and be willing to complete online surveys about their thoughts and feelings.

Inclusion Criteria

Proficiency in English

US citizen or permanent resident

I have been in a relationship for at least 12 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Primary participants complete a 4-week meditation-based mobile intervention through the Healthy Minds Program app or use a curated list of well-being resources.

4 weeks

Online participation

Follow-up

Participants are monitored for changes in depression, relationship satisfaction, and other psychological measures.

2 years

Online surveys at 3 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• List of well-being resources

Trial Overview The study is testing if a well-being app or a list of well-being resources can positively affect individuals in romantic relationships. Couples will use these tools and report on their mental state through surveys.

How Is the Trial Designed?

Group I: The Healthy Minds Program (HMP) mobile application Experimental Treatment 1 Intervention

Primary participants in the HMP group will be instructed to complete a 4-week intervention through the app.

Group II: List of well-being resources Experimental Treatment 1 Intervention

Primary participants will be instructed to use a curated list of well-being resources.

Group III: Partner - Surveys only Active Control 1 Intervention

Partner participants will complete surveys their thoughts and feelings.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

The study successfully translated and validated the 'Global Trigger Tool-Psychiatry' (GTT-P) for identifying iatrogenic adverse events in psychiatric care in Norway, incorporating insights from both health professionals and service users to enhance its effectiveness.

Implementing the GTT-P can help mental health nurses in Norway and Sweden to better identify potential triggers for adverse events, ultimately improving patient safety and reducing the risk of harm in psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. Okkenhaug, A., Tritter, JQ., Landstad, BJ.[2023]

The paper emphasizes the importance of continuously evaluating safety data for medical products after they are approved, highlighting that safety profiles evolve as more data is collected.

It discusses the use of advanced statistical and graphical methods for analyzing large postmarketing surveillance databases, which have grown significantly due to improved reporting practices, to effectively detect safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance. Izem, R., Sanchez-Kam, M., Ma, H., et al.[2020]

A review of 10 clinical trials on esketamine for resistant depression found that 90% of the trials had low-quality reporting of adverse events (AEs), indicating significant gaps in safety data.

The study revealed that 41.5% of serious AEs and 39% of non-serious AEs were not reported in published articles, particularly psychiatric and cardiovascular events, suggesting that the assessment of esketamine's risk-benefit balance may be inaccurate due to incomplete harm reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of harms in clinical trials of esketamine in depression: a systematic review. Taillefer de Laportalière, T., Jullien, A., Yrondi, A., et al.[2023]

The pilot Patient Safety Presentation process, implemented in a psychiatry residency program, significantly improved residents' knowledge and engagement in patient safety practices, as evidenced by pre- and post-presentation surveys involving 32 residents.

All participating residents expressed satisfaction with the presentation, highlighting its effectiveness as a model for enhancing patient safety education in residency programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Pilot of a Process for Regularly Sharing Summary Patient Safety Data. Kim, B., Grech, SM., Rembisz, AE., et al.[2023]

The chapter emphasizes the importance of assessing patient outcomes in mental health and substance abuse to improve treatment effectiveness and patient care.

It provides recommendations for advancing assessment methods, which could lead to better understanding and management of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the science of mental health and substance abuse patient outcomes assessment. Smith, GR.[2019]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7732708/

Testing the Efficacy of a Multicomponent, Self-Guided ... This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/06/NCT05229406/SAP_001.pdf

Healthy Minds Program (HMP) App Dosage Study Moderate to large reductions in depression symptoms have been reported in several mobile health MBI studies with depressed samples (d = 1.09 in Dimidjian et al ...

3. mental.jmir.org mental.jmir.org/2020/11/e23825/

Three-Armed Randomized Controlled Trial - JMIR Mental Health This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social ...

4. centerhealthyminds.org centerhealthyminds.org/assets/files-publications/Creswell-meditation-app-revolution.pdf

Creswell-meditation-app-revolution. ... receiving the app showed significantly reduced depressive and anxiety symptoms (ds = 0.32 to 0.23, respectively) and improved insomnia ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0005796723000414

The efficacy of self-guided internet and mobile-based ... Self-guided internet and mobile based interventions appear to be effective at preventing incidence of depression.

6. cdc.gov cdc.gov/mental-health/about-data/mental-health-data-sources.html

Mental Health Data Sources Mental health data cover mental illness, depression, and service use. National Violent Death Reporting System (NVDRS) collects data from ...

7. hhs.gov hhs.gov/surgeongeneral/reports-and-publications/workplace-well-being/resources/index.html

Workplace Well‑Being Resources Visit our Workplace Mental Health and Well-Being resources page to find more information about how to implement positive changes in your ...

8. wellbeingtrust.org wellbeingtrust.org/mental-health-resources/

Resources Everyone deserves access to free mental health resources. This list of resources is a reflection of our commitment to advancing the mental, social, and ...

9. nimh.nih.gov nimh.nih.gov/health/publications

Brochures and Fact Sheets - National Institute of Mental Health Download, read, and order free NIMH brochures and fact sheets about mental disorders and related topics. Publications are also available in Spanish.

10. mentalhealthfirstaid.org mentalhealthfirstaid.org/mental-health-resources/

Mental Health Resources The Anxiety and Depression Association of America (ADAA) has free online peer-to-peer communities for people experiencing mental health challenges.