Examining the impact of digital wellness modules on quality of life
Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life Via a Randomized Control Trial
This study is testing if using a smartphone app with mindfulness and exercise can help healthy adults feel better and reduce stress, anxiety, and depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05810259 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of digital wellness modules, which include mindfulness practices and light to moderate physical exercise, delivered via a smartphone application. The primary goal is to assess whether these interventions can enhance quality of life and reduce stress, anxiety, and depression in a healthy adult population. The study will also explore the motivations behind health behavior changes and the implementation of sustained changes through qualitative analysis. Conducted virtually by researchers at Yale University, this longitudinal study aims to provide insights into the role of digital wellness in mental health.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults residing in the United States who are interested in improving their mental well-being.
Not a fit: Patients with significant health issues or conditions that prevent them from engaging in light to moderate physical exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mental health and quality of life for participants through accessible digital wellness interventions.
How similar studies have performed: Other studies have shown promising results with digital wellness interventions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Resides in United States Exclusion Criteria: * Any individual who endorses any of the following criteria will be excluded from participation in this study: * Positive Health Screening Questions, as measured by the Health Screening Questionnaire (HSQ): * Pain, discomfort or pressure in the chest, difficulty breathing or shortness of breath, dizziness, fainting, or blackout, blood pressure with systolic greater than 140 or diastolic greater than 90, diagnosed or treated for any heart disease, heart murmur, chest pain (angina), palpitations (irregular beat), or heart attack, heart surgery, angioplasty, or a pacemaker, valve replacement, or heart transplant, resting pulse greater than 100 beats per minute, any arthritis, back trouble, hip /knee/joint /pain, or any other bone or joint condition, personal experience or doctor's advice of any other medical or physical reason that would prohibit the participant from doing light to moderate physical exercise, personal physician's recommendation against participating in light to moderate physical exercise because of asthma, diabetes, epilepsy or elevated cholesterol or a hernia. * Positive Psychiatric Disorders Screening Questions: * Positive screen for depression, excluding suicide (PHQ-8) cutoff score \> 6 * Positive screen for panic (SMPD) cutoff score \> 2 * Positive screen for generalized anxiety (GAD-7) cutoff score \> 10 * Positive screen psychosis (PDSQ) via psychosis section, cutoff score \> 3 * Positive screen mania via the Altman Self-Rating Mania Scale (ASRM) cutoff score \> 6
Where this trial is running
New Haven, Connecticut
- Yale University — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: David Klemanski, Psy.D., MPH — Yale University
- Study coordinator: David Klemanski, Psy.D., MPH
- Email: david.klemanski@yale.edu
- Phone: 203.214.5426
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.