The Effects of the Be Mindful Intervention in Previously Depressed Individuals Experiencing Subcl… (NCT04740879) | Clinical Trial Compass
CompletedNot Applicable
The Effects of the Be Mindful Intervention in Previously Depressed Individuals Experiencing Subclinical Symptoms
United States137 participantsStarted 2021-03-30
Plain-language summary
This study is designed to help individuals cope with their current depressive symptoms by providing them access to a 4-week online Mindfulness-Based Cognitive Therapy: Be Mindful. Research has shown that completion of the Be Mindful intervention can reduce depressive symptoms in a community sample, and this study aims to evaluate if it can also help reduce depressive symptoms in individuals with a confirmed history of depression. Participants will either receive the intervention at the start of the study or four months after the start of the study (i.e., at 3-month follow-up), which will allow research staff to assess if reductions in depression are due to the intervention or something else. Research staff will also evaluate if the reduction in depressive symptoms lasts over the three months following intervention, and will investigate possible reasons for the change in depression (i.e., why the intervention produces change).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* currently experiencing mild to moderate depressive symptoms (Patient Health Questionnaire 9 Current scores between 5 and 14)
* meet Diagnostic and Statistical Manual of Mental Disorders (fifth edition; DSM-5) criteria for Past Major Depressive Disorder (determined by clinical interview)
Exclusion Criteria:
* responses suggest they have never experienced a Major Depressive Episode
* responses suggest they are not currently experiencing sub-threshold symptoms of depression
* they state they are not open to learning mindfulness or meditation techniques
* they indicate they are currently receiving therapeutic treatment for depression or stress management elsewhere
* they indicate their age is not between 18 and 65
* they state they do not currently live in New York State
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 Post-Intervention
Timeframe: weekly during intervention, approximately 1-2 months
2
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 at 3-Month Follow-Up
Timeframe: at regular intervals until 3-month follow-up (approximately 4-5 months after the start of the study)