Healthy Mind Healthy You: A Study of Mindfulness

Study Overview
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Brief Summary
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Most people experience stress at some point in their lives. Stress, especially when severe, can not only make you feel bad, it can also worsen existing health problems like heart disease, type 2 diabetes, obesity, high blood pressure, depression, and even cancer. Healthy Mind, Healthy You is a new study about how mindfulness can help people cope with stress. Funded by the Patient Centered Outcome Research Institute (PCORI) and involving 19 Patient Powered Research Networks (PPRNs), Healthy Mind Healthy You will be able to study the effects of mindfulness on a wide variety of populations and conditions.

Official Title
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Healthy Mind Healthy You: A Study of Mindfulness

Conditions
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Stress

Intervention / Treatment
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* Behavioral: Mindfulness-Based Cognitive Therapy
* Behavioral: Brief Mindfulness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be a member (patient/member of special population or caregiver) of one of the 19 PCORI Patient-Powered Research Networks (PPRN) Must be age 18 or older Exclusion Criteria: Under the age of 18 years Unable to read, understand, and/or participate in mindfulness exercises

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Cognitive Therapy<br>8 sessions of online mindfulness-based cognitive therapy | Behavioral: Mindfulness-Based Cognitive Therapy<br>* 8 sessions of online mindfulness-based cognitive therapy<br>|
| Experimental: Brief Mindfulness<br>3 sessions of online mindfulness therapy | Behavioral: Brief Mindfulness<br>* 3 sessions of online mindfulness therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Weekly Change on World Health Organization-5 (WHO-5) | The WHO-5 is a 5-item questionnaire that assesses well-being over the prior two weeks. Scores range 0-100 with higher scores reflecting greater well-being. We used linear mixed effects models to examine the effect of the interventions on weekly WHO-5 scores. Change = estimated average weekly change during time frame. | Baseline to 8 Weeks, Baseline to 20 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Weekly Change on Perceived Stress Scale (PSS) | The PSS is a 10-item questionnaire that evaluates an individual's experiences of stress in the previous month. Scores range 0-40, with higher scores representing greater perceived stress. Change = estimated average weekly change during time frame. | Baseline to 8 Weeks, Baseline to 20 Weeks | 
| Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form | The PROMIS: Emotional Distress-Depression Short Form is an 8-item questionnaire that measures perceived depressive symptoms over the past week. Scores range 8-40, with higher scores representing more severe depressive symptoms. Change = estimated average weekly change during time frame. | Baseline to 8 Weeks, Baseline to 20 Weeks | 
| Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form | The PROMIS: Emotional Distress-Anxiety Short Form is a 4-item questionnaire that measures self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal in the past seven days. Scores range 4-20, with higher scores representing more severe anxiety symptoms. Change = estimated average weekly change during time frame. | Baseline to 8 Weeks, Baseline to 20 Weeks | 
| Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form | The PROMIS: Ability to Participate in Social Roles and Activities Short Form is a 4-item questionnaire that measures the perceived ability to perform one's everyday social roles and activities. Scores range 4-20 with higher scores representing fewer limitations (greater abilities). Change = estimated average weekly change during time frame. | Baseline to 8 Weeks, Baseline to 20 Weeks | 
| Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated | The FFMQ is a 39-item questionnaire that examines five aspects of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Only the questions related to non-judging of inner experience and non-reactivity were administered (15 items total). The total score on these 15 items was used (range: 15-75). Higher scores represent greater mindfulness. Change = estimated average weekly change during time frame. | Baseline to 8 Weeks, Baseline to 20 Weeks |