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

2000 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment List of well-being resources for depression?

Research shows that improvements in well-being and functioning in depressed patients are linked to having social support, active coping styles, and physical activity. These elements are often part of well-being resources, suggesting they could help improve mental health in depression. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

There is limited information on the safety of well-being resources for depression, as behavioral health trials often do not fully monitor adverse events. It's important to note that potential side effects, like temporary increases in anxiety, may not always be documented. ^{6 7 8 9 10}

How is the 'Well-Being Resources for Depression' treatment different from other treatments for depression?

This treatment is unique because it focuses on enhancing well-being and strengthening health-seeking resources, which can improve adaptive functioning in depressed individuals. Unlike traditional treatments that may rely on medication, this approach emphasizes non-drug strategies like internet-based interventions and complementary therapies to promote mental fitness and prevent depression. ^{11 12 13 14 15}

What is the purpose of this trial?

The goal of this clinical trial is to find out whether learning about well-being impacts the thoughts and feelings of romantic couples. The main question it aims to answer is: * Does gaining knowledge about well-being positively impact individuals and their romantic relationships? Participants will complete online surveys about their thoughts and feelings.

Research Team

Simon Goldberg, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Mental health and well-being in a 6-year follow-up of patients with depression: assessments of patients and clinicians. [2022]

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

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

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

Invariance Testing of the Disablement in the Physically Active Scale. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Patients' perspective on self-management during recovery from depression]. [2012]

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

Personal and psychosocial risk factors for physical and mental health outcomes and course of depression among depressed patients. [2022]

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

Development and Pilot of a Process for Regularly Sharing Summary Patient Safety Data. [2023]

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

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

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

Reporting of harms in clinical trials of esketamine in depression: a systematic review. [2023]

9. England 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. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance. [2020]

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

Health-seeking resources and adaptive functioning in depressed and nondepressed adults. [2019]

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

Sites for depression on the web: a comparison of consumer, professional and commercial sites. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Complementary medicine for depression. [2015]

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

Treating depression: what works besides meds? [2018]

15. Canada pubmed.ncbi.nlm.nih.gov

An Internet-based intervention to promote mental fitness for mildly depressed adults: randomized controlled trial. [2022]