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Behavioural Intervention
Healthy Minds Program for Depression (BeWell Trial)
Verified Trial
N/A
Recruiting
Led By Richard Davidson
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Proficient in English
Able to provide informed consent
Must not have
Elevated PHQ-8 or PHQ-9 ≥ 5 at screening and pre-baseline interview
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, week 2, week 3, week 4, and 3 month follow up
Awards & highlights
BeWell Trial Summary
This trial will test if the Healthy Minds Program app can help promote well-being in adults with depression symptoms.
Who is the study for?
This trial is for US adults who feel sad or can't enjoy daily activities, can consent to participate, speak English, and have a smartphone. It's not for those with a history of psychosis or mania or high depression scores (PHQ-8/9 ≥ 5).Check my eligibility
What is being tested?
The study tests the Healthy Minds Program app against an active control without meditation and a waitlist group. The aim is to see if the app improves well-being in people with depression over four weeks.See study design
What are the potential side effects?
Since this trial involves using an app designed for improving mental health, side effects may include discomfort from confronting personal issues during use but are generally expected to be minimal.
BeWell Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You must be able to speak and understand English well.
Select...
You understand the study and agree to participate in it.
Select...
You need to have a smartphone that can download apps from Google Play or the Apple App Store.
Select...
You must be either a citizen of the United States or have permanent residency in the United States in order to receive payment.
Select...
You have never experienced episodes of severe mental illness, such as psychosis or mania.
Select...
I feel sad and don't enjoy daily activities anymore.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
You have reported symptoms of depression with a score of 5 or higher on the PHQ-8 or PHQ-9 questionnaire.
BeWell Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, week 2, week 3, week 4, and 3-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 2, week 3, week 4, and 3-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Secondary outcome measures
Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
Change in Awareness Measured by Five Facet Mindfulness Questionnaire Acting with Awareness Subscale Score
Change in Climate Change Anxiety Scale
+16 moreOther outcome measures
Change in Digital Working Alliance Inventory
Change in Facial Behavior
Change in Inclusion of Nature in Self
+10 moreBeWell Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Healthy Minds Program (HMP) appExperimental Treatment1 Intervention
Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Group II: Psychoeducation appActive Control1 Intervention
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Group III: Usual CareActive Control1 Intervention
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Healthy Minds Program
2022
N/A
~300
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,186 Previous Clinical Trials
3,168,347 Total Patients Enrolled
22 Trials studying Depression
9,185 Patients Enrolled for Depression
Hope for Depression Research FoundationOTHER
3 Previous Clinical Trials
345 Total Patients Enrolled
3 Trials studying Depression
345 Patients Enrolled for Depression
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
667,834 Total Patients Enrolled
61 Trials studying Depression
31,810 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You understand the study and agree to participate in it.You must be able to speak and understand English well.You have never experienced episodes of severe mental illness, such as psychosis or mania.You need to have a smartphone that can download apps from Google Play or the Apple App Store.I feel sad and don't enjoy daily activities anymore.You must be either a citizen of the United States or have permanent residency in the United States in order to receive payment.You have reported symptoms of depression with a score of 5 or higher on the PHQ-8 or PHQ-9 questionnaire.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Minds Program (HMP) app
- Group 2: Psychoeducation app
- Group 3: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05183867 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who has the prerequisites to join this scientific experiment?
"This study is recruiting roughly 1500 participants who are aged 18 to 65 years old and have depression. Qualified individuals should consider applying for this trial."
Answered by AI
Does this clinical experiment have an age restriction, and if so can those over 50 apply?
"This clinical trial is open to adults between the age of 18 and 65."
Answered by AI
Are there any opportunities for new participants to join this experiment?
"Indeed, the information available on clinicaltrials.gov confirms that this study is still actively seeking participants as of August 8th 2022. Initially posted in March 24th 2021, it requires 1500 patients to be recruited from a single medical centre."
Answered by AI
How many individuals have signed up to participate in this experiment?
"Affirmative. According to data on clinicaltrials.gov, this clinical trial is currently recruiting participants; first posted on March 24th 2022, and last updated August 8th 2022. To be successful, the study requires 1500 volunteers from a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Indiana
California
Other
How old are they?
18 - 65
What site did they apply to?
University of Wisconsin
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
0
3+
What questions have other patients asked about this trial?
Any sites in my area? Is this ok to do online? However long they need to? Are travel expenses covered?
PatientReceived 1 prior treatment
Do you pay for transportation?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I need someone to talk to. Currently in very depressed condition. Looking for anything that might help me.
PatientReceived 2+ prior treatments
I want to feel better and make money doing it. I take Prozac and I still struggle with depression.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Email
Average response time
- < 2 Days
Most responsive sites:
- University of Wisconsin: < 24 hours
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