Behavior, Biology and Well-Being Study

Not Applicable

Completed

Conditions: Depression
Psychological Distress

Registration Number: NCT05183867

Lead Sponsor: University of Wisconsin, Madison

Brief Summary: The central aim of this study is to test the efficacy of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. The investigators plan to conduct a randomized controlled trial (RCT) involving 1100 participants comparing 4-weeks of the HMP app with an active control (Psychoeducation \[HMP without meditation practice\]), and a waitlist control in a sample of United States adults with elevated depression symptoms.

Detailed Description: Depression is highly prevalent and associated with extreme personal and societal costs. Meditation training reduces depression symptoms and psychological distress, but access to in-person programs is limited due to associated cost and lack of available services. Research on neurocognitive and biological mechanisms of meditation training in alleviating depression is at a preliminary stage, and an obstacle limiting research progress is over-reliance on retrospective self-report measures, which are vulnerable to a host of biases. This project will use gold-standard behavioral measures and explore novel measures of relevant neurocognitive and behavioral processes, namely pattern separation, self-referential thought, and video-based assessment of emotional well-being. Furthermore, the project will investigate effects on the gut microbiome (with fecal samples) and inflammation (with dried blood spots), which reflect biological systems hypothesized to be mechanistically related to benefits of meditation and well-being training.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1157

Inclusion Criteria

Elevated PHQ-8 or PHQ-9 ≥ 5 at screening
Proficient in English
Able to provide informed consent
Have access to a smartphone that can download apps from Google Play or the Apple App Store
For payment purposes, must be a US citizen or a permanent US resident

Exclusion Criteria

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 from the interview)
Self-reported history of psychosis
Self-reported history of mania
Current psychopathology that interferes with study participation as assessed by interview
Living or traveling outside the US during the whole study participation period (trips outside US after the interview phase is not an exclusion)
Alcohol Use Disorders Identification Test (AUDIT) score ≥ 13 for women and AUDIT score ≥ 15 for men
Drug Use Disorders Identification Test (DUDIT) score ≥ 8 for women and men

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up	The PHQ-8 is an 8-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 to 3 = nearly every day. The total possible range of scores is 0-24 where higher scores indicate more depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up	The GAD-7 is a 7-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 to 3 = nearly every day. The total possible range of scores is 0-21 where higher scores indicate more anxious symptoms.
Climate Change Anxiety Scale	Baseline, week 4, and 3 month follow up	The Climate Change Anxiety Scale is a 13-item scale where participants report their anxiety regarding climate change (e.g., "I have nightmares about climate change"). It is scored on a 5-point Likert scale where 1 = "never" to 5 = "almost always." Total scores range from 13 to 65 where higher scores indicate greater climate change anxiety.
Wellbeing Growth Mindset	Baseline, week 4, and 3 month follow up	The Wellbeing Growth Mindset scale is a 3-item scale where participants report whether they believe wellbeing is malleable (e.g., "Your well-being is something about you that you can't change very much."). It is scored on a 6-point Likert scale where 1 = "strongly disagree" to 6 = "strongly agree." Total scores range from 3 to 18 where higher scores indicate greater wellbeing growth mindset.
Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up	The PROMIS Sleep Disturbance scale is a computer-adaptive measure where participants report how often in the past 7 days they had various sleep-related experiences (e.g., "my sleep was restful"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, standard deviation (SD) = 10) where higher scores indicate more sleep disturbance.
Flourishing Measured by the Flourishing Index Score	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up	The Flourishing Index is a 10-item questionnaire where participants report their general level of flourishing (e.g., well-being, health, etc.). It is scored on a 0 to 10-point scale, with anchors varying across items. The total score ranges from 0 to 100 with higher scores indicating higher flourishing.
Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up	The Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is a 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus.
Connection Measured by NIH Toolbox Loneliness Score	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up	The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness.
Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up	The Decentering subscale of the Experience Questionnaire is an 11-item questionnaire where participants report on their ability to decenter from their experience. It is scored on a 5-point Likert scale where 1 = never to 5 = all the time. The total possible range of scores is 11-55 where higher scores indicate a greater ability to decenter from experience.
Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up	The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., "I understand my life's meaning"). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life.
Pain Intensity Measured by PROMIS Pain Intensity Score	Baseline, week 4 (of intervention period), and 3 month follow-up	The single-item PROMIS Pain Intensity scale is a 1-item scale where participants report on their pain intensity in the past 7 days. It is scored on an 11-point Likert-scale where 0 = no pain and 10 = worst pain imaginable. Scores range from 0 to 10, with higher scores indicating higher pain intensity
Pain Interference Measured by PROMIS Pain Inference Scale Score	Baseline, week 4 (of intervention period), and 3 month follow-up	The PROMIS Pain Interference scale is a computer-adaptive measure where participants report how often in the past 7 days they had pain-related interference in their life (e.g., "how much did pain interfere with your enjoyment of life"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more pain interference.
Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up	The Five Facet Mindfulness Questionnaire Nonjudgment Subscale is a 8-item subscale where participants report on their nonjudgment of experience in daily life. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater nonjudgment of experience.
Healthy Minds Index (HM Index) - Purpose	Baseline, week 4, and 3 month follow up	The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Purpose subscale range from 0 to 16, where higher scores indicate more purpose.
Healthy Minds Index (HM Index) - Awareness	Baseline, week 4, and 3 month follow up	The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Awareness subscale is 0 to 16 where higher scores indicate more awareness.
Healthy Minds Index (HM Index) - Connection	Baseline, week 4, and 3 month follow up	The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Connection subscale range from 0 to 24, where higher scores indicate more connection.
Healthy Minds Index (HM Index) - Insight	Baseline, week 4, and 3 month follow up	The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Insight subscale range from 0 to 12, where higher scores indicate more insight.
Life Orientation Test - Revised	Baseline, week 4, and 3 month follow up	The Life Orientation Test - Revised is a 6-item scale where participants report their level of optimism (e.g., "In uncertain times, I usually expect the best"). It is scored on a 5-point Likert scale where 0 = "strongly disagree" to 4 = "strongly agree." Total scores range from 0 to 24 where higher scores indicate greater optimism.
Perceived Stress Scale	Baseline, week 4, and 3 month follow up	The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., "In the last month, how often have you felt nervous and 'stressed'?"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "very often." Total scores range from 0 to 40 where higher scores indicate greater perceived stress.
Perseverative Thinking Questionnaire	Baseline, week 4, and 3 month follow up	The Perseverative Thinking Questionnaire is a 15-item scale where participants report their level of repetitive negative thinking (e.g., "My thoughts repeat themselves"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "almost always." Total scores range from 0 to 60 where higher scores indicate greater perseverative thinking.
Satisfaction With Life Scale	Baseline, week 4, and 3 month follow up	The Satisfaction with Life Scale is a 5-item scale where participants report their level of satisfaction with life (e.g., "In most ways my life is close to ideal"). It is scored on a 7-point Likert scale where 1 = "strongly disagree" to 7 = "strongly agree." Total scores range from 5 to 35 where higher scores indicate greater satisfaction with life.
Problematic and Risky Internet Use Screening Scale (PRIUSS-3)	Baseline, week 4, and 3 month follow up	The PRIUSS-3 is a 3-item scale where participants report their level of problematic internet use. It is scored on a 4-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 12, where higher scores indicate more problematic internet use.
Subjective Happiness Scale	Baseline, week 4, and 3 month follow up	The Subjective Happiness Scale is a 4-item scale where participants report their level of subjective happiness (e.g., "In general, I consider myself \[not a very happy person, a very happy person\]"). It is scored on a 7-point Likert scale where 1 = less happy to 7 = more happy. Total scores range from 4 to 28 where higher scores indicate greater subjective happiness.