The Advancing Dynamic And Personalized Training Study
ConditionWell-Being, Psychological
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
This study aims to enhance the Healthy Minds Program (HMP) app by developing and testing a personalized, data-driven approach to optimize long-term well-being. 1100 participants will be enrolled and on study for up to 4 months (4 week intervention plus 3 month follow-up).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Elevated symptoms of depression (PHQ-9 greater than or equal to 5)
proficiency in English
access to a smartphone and internet
ability to receive text messages
Disqualifiers
Prior experience with meditation
Prior use of the Healthy Minds Program app
History of psychosis or mania
Plans to travel in the next six weeks
Trial design
Design model
Factorial
Treatments tested in this trial
Healthy Minds Program (HMP) app
Other interventionAll participants will complete baseline surveys, weekly questionnaires (for 4 weeks) through the HMP app intervention, and will be surveyed again at 3-months post-intervention. Participants are randomized to each of the following binary conditions. 1. Introduction video for the app (yes / no) 2. Introduction video for the training modules (yes / no) 3. Module order based on ACIP score (highest-first / lowest-first) 4. Practice-nudging text messages (yes / no) 5. Microsupport messages during the intervention period (yes / no) 6. Microsupport messages during the follow-up period (yes / no
Treatment groups
1,553 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Introduction Video to HMP appExperimental treatment 1 intervention
Group B: Introduction Video to Training ModulesExperimental treatment 1 intervention
Group C: Module Order based on ACIP ScoreExperimental treatment 1 intervention
Group D: Practice-Nudging Test MessagesExperimental treatment 1 intervention
Group E: Microsupport Messages During InterventionExperimental treatment 1 intervention
Group F: Microsupport Messages During Follow-UpExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in PHQ-9
PHQ-9 is a 9 item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale, where 0=not at all and 4=nearly every day. Scores range from 0-36, where higher scores indicate more depressive symptoms.
Time frame
Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)Secondary outcomes
1
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression
A computer-adaptive measure of feelings of depression scored from 1 to 5 where higher numbers indicate increased feelings of depression. It provides t-scores with a mean of 50 and SD of 10.
Time frame
Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)2
Change in PROMIS Anxiety Score
The PROMIS Anxiety Score is a computer adaptive measure of feelings of anxiety in the past 7 days. This is a computer-adaptive survey scored on a 5-point Likert scale from 1 (never) to 5 (always) with higher scores indicating increased anxiety. It provides t-scores with a mean of 50 and SD of 10. Higher t-scores indicate higher levels of anxiety.
Time frame
Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)3
Acceptability of Intervention Measure
The Acceptability of Intervention Measure is a 4-item self-report measure scored on a 5-point Likert scale. Scores range from 1 (completely disagree) to 5 (completely agree), with higher scores indicating more acceptability of the intervention.
Time frame
week 4 (of intervention period)4
Change in Growth Mindset Scale for Well-Being
A measure of fixed versus incremental mindset regarding well-being. The average across items for a possible range in scores from 1-6 will be measured, with higher scores indicating greater levels of incremental views on well-being (i.e., it can be learned).
Time frame
Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)Other outcomes
1
Change in Beck Depression Inventory Item 9 Score
Item 9 on the Beck Depression Inventory (BDI) assesses suicidal thoughts or wishes. The possible scores for this item are 0, 1, 2, or 3, corresponding to different levels of severity. A score of 0 indicates no suicidal thoughts, while higher scores indicate increasing severity of suicidal ideation.
Time frame
Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)2
Change in Mindfulness-Based Program - Meditation-Related Adverse Effects Scale (MBP-MRAES)
MBP-MRAES is an 11-item questionnaire which measures distressing experiences associated with meditation practice. The first ten items use a frequency-based scale with the following response options: Never, A few days to 1 week, 1 week to 1 month, 1 month to 1 year, and 1 year or longer. If a participant selects any response other than Never, they are prompted with a follow-up question asking them to rate the experience on a scale from Very distressing to Very positive. The eleventh item is an open-ended question that invites participants to describe any other significant symptoms they may have experienced.
Time frame
week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)3
Lasting Effects Questionnaire
An item about lasting bad effects from the HMP app will be scored on a 5-point scale from 1 = strongly disagree to 5 = strongly agree.
Time frame
3-month follow-up (up to 4 months on study)4
Medication and Therapy Questionnaire
The 3-item Medication and Therapy Questionnaire collects information on whether participants received medication or therapy for mental health concerns in the past month. Each item is a yes/no question.
Time frame
Baseline, week 4 (of intervention period), and 3-month follow-up (up to 4 months on study)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
Templeton World Charity Foundation
Collaborator
Source ClinicalTrials.gov