Arts & Health Education to Improve Health, Resilience, and Well-Being

NCT04154579 | Terminated

• 1 other identifier: IRB#19-854
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is an 8-week randomized controlled trial to help address health, resilience, and well-being. Participants are randomized into either a health education group or an arts-based health education group. Both groups will attend for 8 weeks and various study assessments will be conducted in order to measure the experience and impact of the program. Anyone 18 years and older with a chronic health condition (for example, diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disorder, asthma, weight, anxiety, depression, cardiac, arthritis, multiple sclerosis, and many more) are eligible to participate.

Conditions

Hypertension; Diabetes; Obesity; COPD; CHF; High Cholesterol; Asthma; Chronic Pain; Multiple Sclerosis; Depression; Anxiety; Heart Diseases; Stroke

Keywords

Chronic health conditions; Arts-based program; Health education program; Health; Resilience; Well-being

Outcome Measures

Primary Outcomes (24)

• Change in Short Depression-Happiness Scale from Week 1 to Week 8

  Means of assessing change in mood. Contains 6 items, 3 negative \& 3 positive. Participants think about how they felt in the past 7 days \& rate the frequency of each item on a 4-point scale. Scale ranges include scores between 0 and 18. Higher scores indicate higher levels of happiness.

  Weeks 1 and 8

• Change in Short Depression-Happiness Scale from Week 8 to Week 16

  Means of assessing change in mood. Contains 6 items, 3 negative \& 3 positive. Participants think about how they felt in the past 7 days \& rate the frequency of each item on a 4-point scale. Scale ranges include scores between 0 and 18. Higher scores indicate higher levels of happiness.

  Weeks 8 and 16

• Change in Short Depression-Happiness Scale from Week 1 to Week 16

  Means of assessing change in mood. Contains 6 items, 3 negative \& 3 positive. Participants think about how they felt in the past 7 days \& rate the frequency of each item on a 4-point scale. Scale ranges include scores between 0 and 18. Higher scores indicate higher levels of happiness.

  Weeks 1 and 16

• Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 1 to Week 8

  Participants answer 7 questions by choosing the answer that best describes their experience over the last 2 weeks. Designed to measure the feeling and functioning aspects of positive mental well-being. Scores range from 7 to 35. Higher scores represent higher positive mental well-being.

  Weeks 1 and 8

• Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 8 to Week 16

  Participants answer 7 questions by choosing the answer that best describes their experience over the last 2 weeks. Designed to measure the feeling and functioning aspects of positive mental well-being. Scores range from 7 to 35. Higher scores represent higher positive mental well-being.

  Weeks 8 and 16

• Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 1 to Week 16

  Participants answer 7 questions by choosing the answer that best describes their experience over the last 2 weeks. Designed to measure the feeling and functioning aspects of positive mental well-being. Scores range from 7 to 35. Higher scores represent higher positive mental well-being.

  Weeks 1 and 16

• Change in Brief Resilient Coping Scale from Week 1 to Week 8

  A 4-item measure designed to identify participants' abilities to cope with stress. It may be helpful for recognizing those who may need to learn techniques to help improve their coping skills and resilience. Scores range from 4-20. Scores of 4-13 represent low resilient copers, those of 14-16 represent medium resilient copers, and those of 17-20 represent high resilient copers.

  Weeks 1 and 8

• Change in Brief Resilient Coping Scale from Week 8 to Week 16

  A 4-item measure designed to identify participants' abilities to cope with stress. It may be helpful for recognizing those who may need to learn techniques to help improve their coping skills \& resilience. Scores range from 4-20. Scores of 4-13 represent low resilient copers, those of 14-16 represent medium resilient copers, and those of 17-20 represent high resilient copers.

  Weeks 8 and 16

• Change in Brief Resilient Coping Scale from Week 1 to Week 16

  A 4-item measure designed to identify participants' abilities to cope with stress. It may be helpful for recognizing those who may need to learn techniques to help improve their coping skills \& resilience. Scores range from 4-20. Scores of 4-13 represent low resilient copers, those of 14-16 represent medium resilient copers, and those of 17-20 represent high resilient copers.

  Weeks 1 and 16

• Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 1 to Week 8

  Measures amount of physical activity. Asks participants how many times on average, over a 7-day period, they engage in strenuous, moderate, or mild exercise for more than 15 minutes, and the average frequency of activity that leads to increased heart rate. Scores range from 0-24. Higher scores indicate higher levels of physical activity.

  Weeks 1 and 8

• Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 8 to Week 16

  Measures amount of physical activity. Asks participants how many times on average, over a 7-day period, they engage in strenuous, moderate, or mild exercise for more than 15 minutes, and the average frequency of activity that leads to increased heart rate. Scores range from 0-24. Higher scores indicate higher levels of physical activity.

  Weeks 8 and 16

• Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 1 to Week 16

  Measures amount of physical activity. Asks participants how many times on average, over a 7-day period, they engage in strenuous, moderate, or mild exercise for more than 15 minutes, and the average frequency of activity that leads to increased heart rate. Scores range from 0-24. Higher scores indicate higher levels of physical activity.

  Weeks 1 and 16

• Change in PROMIS Scale v1.2 - Global Health from Week 1 to Week 8

  A self-report measure to identify symptoms, feelings, behaviors, \& functions in the areas of physical, mental, \& social health. Raw scores for mental health and for physical health are translated into T-scores. The mean for the T-score is 50 and there is a standard deviation of 10. Therefore, a higher T-score represents higher physical health or higher mental health.

  Weeks 1 and 8

• Change in PROMIS Scale v1.2 - Global Health from Week 8 to Week 16

  A self-report measure to identify symptoms, feelings, behaviors, \& functions in the areas of physical, mental, \& social health. Raw scores for mental health and for physical health are translated into T-scores. The mean for the T-score is 50 and there is a standard deviation of 10. Therefore, a higher T-score represents higher physical health or higher mental health.

  Weeks 8 and 16

• Change in PROMIS Scale v1.2 - Global Health from Week 1 to Week 16

  A self-report measure to identify symptoms, feelings, behaviors, \& functions in the areas of physical, mental, \& social health. Raw scores for mental health and for physical health are translated into T-scores. The mean for the T-score is 50 and there is a standard deviation of 10. Therefore, a higher T-score represents higher physical health or higher mental health.

  Weeks 1 and 16

• Change in Systolic and Diastolic Blood Pressure from Week 1 to Week 8

  At the start of each session an investigator will take and document each participants' systolic and diastolic blood pressure.

  Weeks 1 and 8

• Change in Systolic and Diastolic Blood Pressure from Week 8 to Week 16

  At the start of each session an investigator will take and document each participants' systolic and diastolic blood pressure.

  Weeks 8 and 16

• Change in Systolic and Diastolic Blood Pressure from Week 1 to Week 16

  At the start of each session an investigator will take and document each participants' systolic and diastolic blood pressure.

  Weeks 1 and 16

• Change in Heart Rate from Week 1 to Week 8

  At the start of each session an investigator will take and document each participant's heart rate.

  Weeks 1 and 8

• Change in Heart Rate from Week 8 to Week 16

  At the start of each session an investigator will take and document each participant's heart rate.

  Weeks 8 and 16

• Change in Heart Rate from Week 1 to Week 16

  At the start of each session an investigator will take and document each participant's heart rate.

  Weeks 1 and 16

• Change in Pulse Oximetry from Week 1 to Week 8

  At the start of each session an investigator will take and document each participant's pulse oximetry.

  Weeks 1 and 8

• Change in Pulse Oximetry from Week 8 to Week 16

  At the start of each session an investigator will take and document each participant's pulse oximetry.

  Weeks 8 and 16

• Change in Pulse Oximetry from Week 1 to Week 16

  At the start of each session an investigator will take and document each participant's pulse oximetry.

  Weeks 1 and 16

Secondary Outcomes (3)

• Change in HeRe We Arts Survey from Week 1 to Week 8

  Weeks 1 and 8

• Change in HeRe We Ed Survey from Week 1 to Week 8

  Weeks 1 and 8

• Weekly Post-Session Survey

  Weeks 1-8

Other Outcomes (4)

• Weekly Take-Away Goals

  Weeks 1-8

• Phone Interview

  Week 9

• HeRe We Arts Week 16 Survey

  Week 16

Study Arms (2)

HeRe We Arts

EXPERIMENTAL

This is an 8 week, arts-based session that includes educational \& experiential components. Topics include: Introduction to Arts \& Health; Music, Well-Being, \& Resilience; Movement \& Physical Activity; Art \& Well-Being; Writing \& Communication/Self-Expression; Theater \& Socialization; Art Appreciation \& a Healthy Brain; \& Summary/Integration of the Arts into Daily Lives.

Behavioral: HeRe We Arts

HeRe We Ed (Health Education Group)

ACTIVE COMPARATOR

This is an 8 week, non-arts-based health education session that includes educational \& some experiential components. Topics include: Introduction to Health, Resilience, \& Well-Being; Nutrition \& Healthy Eating; Exercise, Chair Yoga, \& Sleep; Mental Health, Stress Management, \& Life Satisfaction; Holistic Approaches: Wellness, Integrative Medicine, \& Complementary \& Alternative Medicine; Chronic Illnesses \& Chronic Pain; Health \& Behaviors; Summary \& Navigating the Healthcare System.

Behavioral: HeRe We Ed

Interventions

HeRe We Arts BEHAVIORAL

Art Therapy interventions to promote health, resilience \& well-being will discussed; \& experiences such as key chain making, collaging on journal covers, creating sculpture garden will be utilized. Music therapy interventions such as lyric discussion, singing, instrument playing, \& music-assisted relaxation techniques will be utilized; \& discussion of use of music to elicit positive physical \& emotional responses will be held. Drums Alive (drumming \& movement) will be used to promote physical activity. Art appreciation will include discussion of public art forms. Journaling will include different techniques for journaling, writing poetry, etc. Theater games such as Password, Press Conference, Props Only, \& Draw What You Hear will be utilized. Chair yoga will be introduced as a form of exercise. Education will be provided on the various topics.

Also known as: Music Therapy, Drums Alive, Art Appreciation, Journaling, Theater Games, Art Therapy

HeRe We Arts

HeRe We Ed BEHAVIORAL

Educational components and some experiential components will be utilized to educate the participants on health, resilience, well-being, nutrition, healthy eating, weight management, eating disorders, obesity, exercise, physical activity, sleep hygiene and the importance of sleep, mental health, stress management, the importance of improving life satisfaction, holistic approaches, wellness, integrative medicine, complementary and alternative medicine, chronic illness, chronic pain, methods for dealing with chronic versus acute illnesses, changing behaviors and/or maintaining healthy behaviors in order to promote health and stay out of the hospital, and navigating the healthcare system. Specific experiential components will include Chair Yoga and Stress Management Techniques.

Also known as: Health Education, Chair Yoga, Stress Management Techniques

HeRe We Ed (Health Education Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Diagnosed with at least one chronic health condition (as reported by the participant)
• Able to participate safely in all program sessions
• Proficient in English
• Cognitively able to consent to participate

You may not qualify if:

• Severe visual or auditory impairment
• Severe and/or uncontrolled comorbidity precluding safe participation in the program

Sponsors & Collaborators

• Lisa Gallagher: lead
• National Endowment for the Arts, United States: collaborator
• Cuyahoga Arts and Culture: collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic Euclid Hospital

Euclid, Ohio, 44119, United States

Location

Related Publications (35)

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MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Obesity; Pulmonary Disease, Chronic Obstructive; Hypercholesterolemia; Asthma; Chronic Pain; Multiple Sclerosis; Depression; Anxiety Disorders; Heart Diseases; Stroke

Interventions

Music Therapy; Art Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pain; Neurologic Manifestations; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lisa M Gallagher, MA

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized controlled trial utilizing a mixed methods, pre-post intervention, and parallel group analysis.

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: November 6, 2019
• Study Start: July 1, 2019
• Primary Completion: June 23, 2020
• Study Completion: June 23, 2020
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)