Healthy Mind Healthy You: A Study of Mindfulness

Not Applicable

Completed

Conditions: Stress

Interventions: Behavioral: Mindfulness-Based Cognitive Therapy
Behavioral: Brief Mindfulness

Registration Number: NCT03844321

Lead Sponsor: Massachusetts General Hospital

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 4412

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Cognitive Therapy	Mindfulness-Based Cognitive Therapy	8 sessions of online mindfulness-based cognitive therapy
Brief Mindfulness	Brief Mindfulness	3 sessions of online mindfulness therapy

Primary Outcome Measures

Name	Time	Method
Estimated Weekly Change on World Health Organization-5 (WHO-5)	Baseline to 8 Weeks, Baseline to 20 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Estimated Weekly Change on Perceived Stress Scale (PSS)	Baseline to 8 Weeks, Baseline to 20 Weeks	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.
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form	Baseline to 8 Weeks, Baseline to 20 Weeks	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.
Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated	Baseline to 8 Weeks, Baseline to 20 Weeks	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.
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form	Baseline to 8 Weeks, Baseline to 20 Weeks	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.
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form	Baseline to 8 Weeks, Baseline to 20 Weeks	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.