Depression Disorder
Conditions
Brief summary
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.
Interventions
DEVICEHealthy Minds Program
A mobile health meditation training program.
BEHAVIORALHealthy Minds Brian Games
Typescript-based games installed as a web application
BEHAVIORALCare as usual
Care as usual
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
- all participants: * Age 18 to 84 * Elevated depressive symptoms: PHQ-9 ≥ 10; Healthy controls: PHQ-9 \<5 Inclusion Criteria - randomized participants: * 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 * Have access to a smartphone that can download apps from Google Play or the Apple App Store * Ability to receive text messages * Indicate interest in participation after being informed of restrictions to payment
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 by PHQ-9 item 9 and BDI item 9) * Self-reported history of psychosis * Self-reported history of mania * Living or traveling outside the US during the whole study participation period (trips outside US after the interview phase is not an exclusion) * Hearing impairments * Prior participation * Self report pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Health Questionnaire depression scale (PHQ-9) | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Generalized Anxiety Disorder (GAD-7) score | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months | 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. |
| Change in Flourishing Measure | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months | 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. |
| Change in PROMIS Sleep Disturbance | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months | 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. |
| Change in performance on the behavioral Self-Referential Encoding Task (SRET) | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months | The SRET is a cognitive-behavioral paradigm used to measure how individuals process and recall information relating to themselves. |
| Change in self-referential thought | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months | Measured using a video recording task |
| Inflammatory Biomarkers: C-reactive Protein (CRP) | Baseline and 3 month follow-up | 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). |
| Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | Baseline and 3 month follow-up | 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). |
| Microbiome Alpha Diversity: Species Richness | Baseline and 3 month follow-up | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Reported here are the observed (total number of distinct taxa) and calculated (Chao1 = N + S2 / (2 D), where N is the number of observed OTUs (Operational Taxonomic Units), S is the number of singleton OTUs, and D is the number of doublet OTUs) number of species represented in the sample. Chao1 is a species richness calculator that accounts for rare species. |
Contacts
CONTACTSarah Effertz
PRINCIPAL_INVESTIGATORJo Handelsman, PhD
University of Wisconsin, Madison
Outcome results
None listed