Behavior, Biology and Well-Being Study

Depression Clinical Trial

— BeWell  

Official title:

Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05183867
• Other study ID #: 2021-0991
• Secondary ID: Protocol Version
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 24, 2022
• Est. completion date: July 2024

Study information

• Verified date: June 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 mediation 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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1170
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Elevated PHQ-8 or PHQ-9 = 5 at screening and pre-baseline interview

• 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

Related Conditions & MeSH terms

• Depression
• Psychological Distress

Intervention

Device:
• Healthy Minds Program
HMP is a 4-week mobile health (mHealth) meditation training program.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Hope for Depression Research Foundation, National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Inflammatory Biomarkers	Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from ~200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1).	Baseline and 3 month follow-up
Other	Change in Microbiome Alpha Diversity	Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. DNA extraction of the fecal community of microorganisms will provide the sequencing data to do alpha and beta diversity analysis and phenotypic cluster assessments.	Baseline and 3 month follow-up
Other	Change in Facial Behavior	Participants provide video recordings of their face while responding to a prompt watching brief videos of positive valence (e.g., baby giggling).	Baseline, week 4 (of intervention period), and 3 month follow-up
Other	Change in Pattern Separation Task	Meditation training has the capacity to normalize the overgeneralized inflexible cognition endemic to depression, which is hypothesized to relate to alterations in the hippocampal-dependent process of pattern separation. The investigators will use a pattern separation task to evaluate hippocampal function.	Baseline, week 4 (of intervention period), and 3 month follow-up
Other	Change in Self-Referential Pronoun Use	Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore indicators of self-referent, inflexible, & over-generalized thinking within natural language.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Other	Change in Negative Affect Word Use	Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Other	Change in Digital Working Alliance Inventory	The Digital Working Alliance Inventory is a 6-item scale where participants report their working alliance with the HMP app (e.g., "The HMP app supports me to overcome challenges"). It is scored on a 7-point Likert scale where 1 = "strongly disagree" to 7 = "strongly agree." Total scores range from 6 to 42 where higher scores indicate greater working alliance.	week 1, week 2, week 3, week 4, and 3-month follow-up
Other	Change in Inclusion of Nature in Self	The Inclusion of Nature in Self is a single item measure assessing the degree to which someone views nature as a part of their sense of self. Participants indicate which of a series of overlapping circles most closely resembles nature and their self. More overlapping circles indicate greater inclusion of nature in self.	Baseline, week 4 (of intervention period), and 3 month follow-up
Other	Mindfulness Adherence Questionnaire	The Mindfulness Adherence Questionnaire informal practice items are 6-items assessing the application of mindfulness during daily life (e.g., "In your daily life, how much of the time were you practicing being gentle and compassionate toward yourself?"). It is scored on a 7-point Likert scale where 0 = "never" to 6 = "always." Total scores range from 0 to 42 where higher scores indicate greater informal mindfulness practice.	week 1, week 2, week 3, week 4, and 3 month follow up
Other	Change in pre- and post-practice positive affect	Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.	Before and after HMP activities between baseline and post-test (week 4)
Other	Change in pre- and post-practice negative affect	Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.	Before and after HMP activities between baseline and post-test (week 4)
Other	Change in post-practice focus	A single item assessing focus during HMP activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time.	Before and after Before and after HMP activities between baseline and post-test (week 4)
Other	Treatment Expectancies	The Treatment Expectancies is a 6-item scale assessing how much participants believed the training program was helpful to them. Items assess how participants think (e.g., "At this point, how logical does the program offered to you seem?") and feel (e.g., "At this point, how much do you really feel that the program helped you to reduce your stress symptoms?"). Items are scored on either a 9-point Likert scale (e.g., 1 = "not at all logical" to 9 = "very logical") or on a percentage ("At the end of the program, how much improvement in your symptoms do you really feel occurred?", 0% to 100%). Higher scores reflect higher treatment expectancies.	week 4
Primary	Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score	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.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Secondary	Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score	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.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Secondary	Change in Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score	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.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Secondary	Change in Flourishing Measured by the Flourishing Index Score	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.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Secondary	Change in Awareness Measured by Five Facet Mindfulness Questionnaire Acting with Awareness Subscale Score	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.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Secondary	Change in Connection Measured by NIH Toolbox Loneliness Score	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.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Secondary	Change in Decentering Measured by Decentering Subscale of Experiencing Questionnaire scale score	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.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Secondary	Change in Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score	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.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Secondary	Change in Pain Intensity measured by PROMIS Pain Intensity score	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	Baseline, week 4 (of intervention period), and 3 month follow-up
Secondary	Change in Pain Interference measured by PROMIS Pain Inference Scale Score	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.	Baseline, week 4 (of intervention period), and 3 month follow-up
Secondary	Change in Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score	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.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Secondary	Change in Climate Change Anxiety Scale	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.	Baseline, week 4, and 3 month follow up
Secondary	Change in Wellbeing Growth Mindset	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.	Baseline, week 4, and 3 month follow up
Secondary	Change in Healthy Minds Index (HM Index)	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 four subscales range as follows: Awareness (0 to 16), Connection (0 to 24), Insight (0 to 12), Purpose (0 to 16) where higher scores indicate more of each quality.	Baseline, week 4, and 3 month follow up
Secondary	Change in Life Orientation Test - Revised	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.	Baseline, week 4, and 3 month follow up
Secondary	Change in Perceived Stress Scale	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.	Baseline, week 4, and 3 month follow up
Secondary	Change in Perseverative Thinking Questionnaire	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.	Baseline, week 4, and 3 month follow up
Secondary	Change in Satisfaction with Life Scale	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.	Baseline, week 4, and 3 month follow up
Secondary	Change in Subjective Happiness Scale	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.	Baseline, week 4, and 3 month follow up
Secondary	Change in Problematic and Risky Internet Use Screening Scale (PRIUSS-3)	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.	Baseline, week 4, and 3 month follow up