The Lucida Project
ConditionDepression Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorUniversity of Wisconsin, Madison
About this trial
The purpose of this clinical trial is to learn about the impact of the Healthy Minds Program (HMP) on measurements of well-being. The main question it aims to answer is:
* Does use of HMP reduce symptoms of depression?
Participants will complete a 4-week well-being program.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 to 84
Elevated depressive symptoms: PHQ-9 ≥ 10; Healthy controls: PHQ-9 <5
Proficient in English to try to unsure understanding of study requirement, consent forms and questionnaires that can often us medical terms not routinely used in general conversation.
Able to provide informed consent
Disqualifiers
Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
Previous use of Healthy Minds Program app
Current suicidal intent and/or high self-injury risk (determined by PHQ-9 item 9 and BDI item 9)
Trial design
Design model
Parallel
Treatments tested in this trial
Healthy Minds Program
DeviceA mobile health meditation training program.
Healthy Minds Brian Games
BehavioralTypescript-based games installed as a web application
Care as usual
BehavioralCare as usual
Treatment groups
1,500 Participants
are divided into 3 treatment groupsGroup A: Healthy Minds Program (HMP)Experimental treatment 1 intervention
Group B: Active control groupActive comparator 1 intervention
Group C: Usual care groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Physical Health Questionnaire depression scale (PHQ-9)
The PHQ-9 is a 9-question screening tool used to assess depression severity. Each of the 9 items evaluates symptoms over the last 2 weeks and is scored from 0 (not at all) to 3 (nearly every day), resulting in a total possible score ranging from 0 to 27. Higher scores indicate higher depression severity.
Time frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 monthsSecondary outcomes
1
Change in Generalized Anxiety Disorder (GAD-7) score
The GAD-7 is a 7-item tool used to screen for Generalized Anxiety Disorder and assess symptom severity. Respondents rate how often they've been bothered by anxiety symptoms over the past two weeks on a scale of 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, where higher scores indicate greater levels of anxiety.
Time frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months2
Change in Flourishing Measure
This is a 12-item questionnaire used to assess various domains of flourishing, or human well-being. It is scored on a 0- to 10-point Likert scale where 0 = poor and 10 = excellent. Mean scores are reported for a range from 0 to 120 where higher scores indicate greater human well-being.
Time frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months3
Change in PROMIS Sleep Disturbance
Sleep disturbance will be assessed using the computer adaptive version of the PROMIS Sleep Disturbance measure. This measure produces scores a T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate greater sleep disturbance.
Time frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months4
Change in performance on the behavioral Self-Referential Encoding Task (SRET)
The SRET is a cognitive-behavioral paradigm used to measure how individuals process and recall information relating to themselves.
Time frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: