Healthy Mind Healthy You: A Study of Mindfulness

Stress Clinical Trial

Official title:

Healthy Mind Healthy You: A Study of Mindfulness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844321
• Other study ID #: 2017P001648
• Status: Completed
• Phase: N/A
• Start date: February 27, 2019
• Est. completion date: February 19, 2020

Study information

• Verified date: April 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4412
• Est. completion date: February 19, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Mindfulness-Based Cognitive Therapy
8 sessions of online mindfulness-based cognitive therapy
• Brief Mindfulness
3 sessions of online mindfulness therapy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (17)

Lead Sponsor

Collaborator

Massachusetts General Hospital

Accelerated Cure Project for Multiple Sclerosis, Brigham and Women's Hospital, Children's Hospital Medical Center, Cincinnati, COPD Foundation, Genetic Alliance, Global Healthy Living Foundation, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Immune Deficiency Foundation, Mayo Clinic, Phelan-McDermid Syndrome Foundation, The Duchenne Registry, University of California, Los Angeles, University of California, San Francisco, University of North Carolina, University of Pennsylvania, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age	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. Age was self-reported.	Baseline to 8 Weeks, Baseline to 20 Weeks
Other	Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS)	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. 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.	Baseline to 8 Weeks, Baseline to 20 Weeks
Other	Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form (PROMIS: EDD)	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. The PROMIS: EDD 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.	Baseline to 8 Weeks, Baseline to 20 Weeks
Other	Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form (PROMIS: EDA)	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. The PROMIS: EDA 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.	Baseline to 8 Weeks, Baseline to 20 Weeks
Other	Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form (PROMIS: APRA)	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. The PROMIS: APRA 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).	Baseline to 8 Weeks, Baseline to 20 Weeks
Other	Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated	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. 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.	Baseline to 8 Weeks, Baseline to 20 Weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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