HypertensionNCT04154579
Arts & Health Education to Improve Health, Resilience, and Well-Being
A study testing HeRe We Arts and HeRe We Ed in people with Hypertension and Diabetes, run by Lisa Gallagher at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes, Obesity
- What is being tested?
- HeRe We Arts and HeRe We Ed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 23 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe visual or auditory impairment
- Severe and/or uncontrolled comorbidity precluding safe participation in the program
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Euclid Hospital
Euclid, Ohio, 44119
About this study
Official title: A Randomized Controlled Trial Utilizing the Arts to Improve Health, Resilience, and Well-Being in Individuals With Chronic Health Conditions in Underserved Neighborhoods
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.
Read the detailed description
Within the healthcare field today there is an increased concern with public health, population health, wellness, and prevention, all of which include focusing on physical health, obesity, chronic health conditions, unhealthy lifestyles, aging, and mental health issues. As healthcare professionals attempt to improve individuals' health outcomes, quality of life, well-being, coping skills, and health indicators, they also must try to promote behavior change that helps keep patients out of the hospital. These are concerns faced by individuals of all ages, genders, ethnicities, cultural backgrounds, socioeconomic statuses, and diagnoses. Therefore, it is important to find multiple means of addressing these concerns with the various populations as it is likely that no one particular method would be effective for every individual.
Programs and interventions have been created to address health, resilience, and well-being at the individual and the social level. They demonstrate the importance of providing support, encouraging behavior changes, and reinforcing objectives determined by the healthcare system. Many of these programs have focused on improving resilience and increasing participants' ability to thrive or recover from the illnesses and challenges they face.
The broad problem to be addressed by this study is to assess if arts-based programs are superior to non-arts-based health education programs at improving individuals' physical and mental health outcomes, quality of life, well-being, resilience, coping skills, stress, and health indicators while promoting behavior change and keeping them out of the hospital. Previous programs have focused on improving resilience. Individual arts interventions such as music, art, craft, choir singing, writing, theater, and movement have been utilized and in many cases found to be helpful in addressing resilience, coping, health, and well-being; however, it is not known what effect a program utilizing multiple arts-based interventions would have on adults with chronic health conditions. The primary benefit of conducting research into the effectiveness of different arts-based programs is the identification of the specific benefits of programs aimed at influencing health, resilience, and well-being in individuals with a variety of chronic health conditions.
The purpose of this randomized controlled study is to determine the outcomes of an 8-week arts-based program on the health, resilience, and well-being of individuals with chronic health conditions in an outpatient underserved community setting as compared to outcomes from individuals participating in a separate 8-week-non-arts-based health education program in the same setting. The purpose of including a variety of arts experiences is so that individuals will hopefully find at least one art form to which they can relate and will utilize in their lives to assist with their health, resilience, and well-being. The non-arts-based program will include educational topics related to health, resilience, and well-being.
- Conditions
- Hypertension, Diabetes, Obesity, COPD, CHF, High Cholesterol
- Being tested
- HeRe We Arts, HeRe We Ed
- Keywords
- Chronic health conditions, Arts-based program, Health education program, Health, Resilience, Well-being
- Medical subject headings
- Hypertension, Diabetes Mellitus, Obesity, Pulmonary Disease, Chronic Obstructive, Hypercholesterolemia, Asthma, Chronic Pain, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeRe We ArtsBehavioural
Also called Music Therapy, Drums Alive, Art Appreciation, Journaling
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.
HeRe We EdBehavioural
Also called Health Education, Chair Yoga, Stress Management Techniques
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: HeRe We Ed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 1 and 16
Secondary outcomes (3)
Change in HeRe We Arts Survey from Week 1 to Week 8
A pre-test/post-survey utilized to test knowledge on arts and well-being, as well as satisfaction at endpoints. This is not a standardized measure and does not include a scale. It involves changes in knowledge and use of arts techniques, as well as satisfaction with the program via the use of open-ended and multiple choice questions.
Measured: Weeks 1 and 8
Change in HeRe We Ed Survey from Week 1 to Week 8
A pre-test/post-test utilized to test knowledge on health education \& well-being, as well as satisfaction, at endpoints. This is not a standardized measure and does not include a scale. It involves changes in knowledge and use of arts techniques, as well as satisfaction with the program via the use of open-ended and multiple choice questions.
Measured: Weeks 1 and 8
Weekly Post-Session Survey
Completed by participants at the end of each session in order to obtain information on learning and satisfaction. This is not a standardized measure and does not include a scale. It involves changes in knowledge and use of arts techniques, as well as satisfaction with the program via the use of open-ended and multiple choice questions.
Measured: Weeks 1-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Jul 2019
- Primary completion23 Jun 2020
- Study completion23 Jun 2020
Why it stopped: COVID-19 pandemic. Unable to restart as had hoped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial utilizing a mixed methods, pre-post intervention, and parallel group analysis.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa Gallagher
- Sponsor type
- University, hospital or other
- Collaborators
- National Endowment for the Arts, United States, Cuyahoga Arts and Culture, The Cleveland Clinic
- Responsible party
- Sponsor-investigator, Lisa Gallagher, The Cleveland Clinic
- Investigators
- Lisa M Gallagher, MA, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154579
- Sponsor's protocol ID
- IRB#19-854
- Status last verified
- Sep 2022
- First submitted
- 2 Oct 2019
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahern NR, Kiehl EM, Sole ML, Byers J. A review of instruments measuring resilience. Issues Compr Pediatr Nurs. 2006 Apr-Jun;29(2):103-25. doi: 10.1080/01460860600677643.
PubMed 16772239Beesley K, White JH, Alston MK, Sweetapple AL, Pollack M. Art after stroke: the qualitative experience of community dwelling stroke survivors in a group art programme. Disabil Rehabil. 2011;33(23-24):2346-55. doi: 10.3109/09638288.2011.571333. Epub 2011 Apr 18.
PubMed 21501042Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
PubMed 12964174Davydov DM, Stewart R, Ritchie K, Chaudieu I. Resilience and mental health. Clin Psychol Rev. 2010 Jul;30(5):479-95. doi: 10.1016/j.cpr.2010.03.003. Epub 2010 Mar 25.
PubMed 20395025Deshields TL, Heiland MF, Kracen AC, Dua P. Resilience in adults with cancer: development of a conceptual model. Psychooncology. 2016 Jan;25(1):11-8. doi: 10.1002/pon.3800. Epub 2015 Mar 18.
PubMed 25787828Dingle GA, Williams E, Jetten J, Welch J. Choir singing and creative writing enhance emotion regulation in adults with chronic mental health conditions. Br J Clin Psychol. 2017 Nov;56(4):443-457. doi: 10.1111/bjc.12149. Epub 2017 Jul 18.
PubMed 28722166Fancourt D, Perkins R, Ascenso S, Carvalho LA, Steptoe A, Williamon A. Effects of Group Drumming Interventions on Anxiety, Depression, Social Resilience and Inflammatory Immune Response among Mental Health Service Users. PLoS One. 2016 Mar 14;11(3):e0151136. doi: 10.1371/journal.pone.0151136. eCollection 2016.
PubMed 26974430Gallagher LM, Lagman R, Bates D, Edsall M, Eden P, Janaitis J, Rybicki L. Perceptions of family members of palliative medicine and hospice patients who experienced music therapy. Support Care Cancer. 2017 Jun;25(6):1769-1778. doi: 10.1007/s00520-017-3578-y. Epub 2017 Jan 19.
PubMed 28105524Gallagher LM, Lagman R, Rybicki L. Outcomes of Music Therapy Interventions on Symptom Management in Palliative Medicine Patients. Am J Hosp Palliat Care. 2018 Feb;35(2):250-257. doi: 10.1177/1049909117696723. Epub 2017 Mar 9.
PubMed 28274132Gloria CT, Steinhardt MA. Relationships Among Positive Emotions, Coping, Resilience and Mental Health. Stress Health. 2016 Apr;32(2):145-56. doi: 10.1002/smi.2589. Epub 2014 Jun 24.
PubMed 24962138Goubert L, Trompetter H. Towards a science and practice of resilience in the face of pain. Eur J Pain. 2017 Sep;21(8):1301-1315. doi: 10.1002/ejp.1062. Epub 2017 Jun 2.
PubMed 28573783Khan WU, Moss H. Increasing Public Health Awareness of and Capacity for Arts-Based Therapy in Medicine. JAMA Neurol. 2017 Sep 1;74(9):1029-1030. doi: 10.1001/jamaneurol.2017.1639. No abstract available.
PubMed 28783804Lesiuk T. The Effect of Mindfulness-Based Music Therapy on Attention and Mood in Women Receiving Adjuvant Chemotherapy for Breast Cancer: A Pilot Study. Oncol Nurs Forum. 2015 May;42(3):276-82. doi: 10.1188/15.ONF.276-282.
PubMed 25901379Orjasaeter KB, Ness O. Acting Out: Enabling Meaningful Participation Among People With Long-Term Mental Health Problems in a Music and Theater Workshop. Qual Health Res. 2017 Sep;27(11):1600-1613. doi: 10.1177/1049732316679954. Epub 2016 Nov 28.
PubMed 27899473Petriwskyj A, Parker D, O'Dwyer S, Moyle W, Nucifora N. Interventions to build resilience in family caregivers of people living with dementia: a comprehensive systematic review. JBI Database System Rev Implement Rep. 2016 Jun;14(6):238-73. doi: 10.11124/JBISRIR-2016-002555.
PubMed 27532659
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Utilizing the Arts to Improve Health, Resilience, and Well-Being in Individuals With Chronic Health Conditions in Underserved Neighborhoods
- ClinicalTrials.gov ID
- NCT04154579
- Acronym / sponsor ID
- IRB#19-854
- Conditions
- Hypertension, Diabetes, Obesity, COPD, CHF, High Cholesterol
- Keywords
- Chronic health conditions, Arts-based program, Health education program, Health, Resilience, Well-being
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic. Unable to restart as had hoped.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lisa GallagherUniversity, hospital or other
- Collaborators
- National Endowment for the Arts, United States, Cuyahoga Arts and Culture, The Cleveland Clinic
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Within the healthcare field today there is an increased concern with public health, population health, wellness, and prevention, all of which include focusing on physical health, obesity, chronic health conditions, unhealthy lifestyles, aging, and mental health issues. As healthcare professionals attempt to improve individuals' health outcomes, quality of life, well-being, coping skills, and health indicators, they also must try to promote behavior change that helps keep patients out of the hospital. These are concerns faced by individuals of all ages, genders, ethnicities, cultural backgrounds, socioeconomic statuses, and diagnoses. Therefore, it is important to find multiple means of addressing these concerns with the various populations as it is likely that no one particular method would be effective for every individual.
Programs and interventions have been created to address health, resilience, and well-being at the individual and the social level. They demonstrate the importance of providing support, encouraging behavior changes, and reinforcing objectives determined by the healthcare system. Many of these programs have focused on improving resilience and increasing participants' ability to thrive or recover from the illnesses and challenges they face.
The broad problem to be addressed by this study is to assess if arts-based programs are superior to non-arts-based health education programs at improving individuals' physical and mental health outcomes, quality of life, well-being, resilience, coping skills, stress, and health indicators while promoting behavior change and keeping them out of the hospital. Previous programs have focused on improving resilience. Individual arts interventions such as music, art, craft, choir singing, writing, theater, and movement have been utilized and in many cases found to be helpful in addressing resilience, coping, health, and well-being; however, it is not known what effect a program utilizing multiple arts-based interventions would have on adults with chronic health conditions. The primary benefit of conducting research into the effectiveness of different arts-based programs is the identification of the specific benefits of programs aimed at influencing health, resilience, and well-being in individuals with a variety of chronic health conditions.
The purpose of this randomized controlled study is to determine the outcomes of an 8-week arts-based program on the health, resilience, and well-being of individuals with chronic health conditions in an outpatient underserved community setting as compared to outcomes from individuals participating in a separate 8-week-non-arts-based health education program in the same setting. The purpose of including a variety of arts experiences is so that individuals will hopefully find at least one art form to which they can relate and will utilize in their lives to assist with their health, resilience, and well-being. The non-arts-based program will include educational topics related to health, resilience, and well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial utilizing a mixed methods, pre-post intervention, and parallel group analysis.
| Arm | Type | Receives |
|---|---|---|
| HeRe We Arts | Experimental | Behavioral: HeRe We ArtsThis 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. |
| HeRe We Ed (Health Education Group) | Active comparator | Behavioral: HeRe We EdThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Severe visual or auditory impairment
- Severe and/or uncontrolled comorbidity precluding safe participation in the program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeRe We ArtsAlso: Music Therapy, Drums Alive, Art Appreciation, JournalingArt 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. | Behavioural | HeRe We Arts |
| HeRe We EdAlso: Health Education, Chair Yoga, Stress Management TechniquesEducational 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. | Behavioural | HeRe We Ed (Health Education Group) |
Primary outcome
Change in Short Depression-Happiness Scale from Week 1 to Week 8
Time frame: Weeks 1 and 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.
Change in Short Depression-Happiness Scale from Week 8 to Week 16
Time frame: Weeks 8 and 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.
Change in Short Depression-Happiness Scale from Week 1 to Week 16
Time frame: Weeks 1 and 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.
Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 1 to Week 8
Time frame: Weeks 1 and 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.
Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 8 to Week 16
Time frame: Weeks 8 and 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.
Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 1 to Week 16
Time frame: Weeks 1 and 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.
Change in Brief Resilient Coping Scale from Week 1 to Week 8
Time frame: Weeks 1 and 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.
Change in Brief Resilient Coping Scale from Week 8 to Week 16
Time frame: Weeks 8 and 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.
Change in Brief Resilient Coping Scale from Week 1 to Week 16
Time frame: Weeks 1 and 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.
Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 1 to Week 8
Time frame: Weeks 1 and 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.
Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 8 to Week 16
Time frame: Weeks 8 and 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.
Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 1 to Week 16
Time frame: Weeks 1 and 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.
Change in PROMIS Scale v1.2 - Global Health from Week 1 to Week 8
Time frame: Weeks 1 and 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.
Change in PROMIS Scale v1.2 - Global Health from Week 8 to Week 16
Time frame: Weeks 8 and 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.
Change in PROMIS Scale v1.2 - Global Health from Week 1 to Week 16
Time frame: Weeks 1 and 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.
Change in Systolic and Diastolic Blood Pressure from Week 1 to Week 8
Time frame: Weeks 1 and 8
At the start of each session an investigator will take and document each participants' systolic and diastolic blood pressure.
Change in Systolic and Diastolic Blood Pressure from Week 8 to Week 16
Time frame: Weeks 8 and 16
At the start of each session an investigator will take and document each participants' systolic and diastolic blood pressure.
Change in Systolic and Diastolic Blood Pressure from Week 1 to Week 16
Time frame: Weeks 1 and 16
At the start of each session an investigator will take and document each participants' systolic and diastolic blood pressure.
Change in Heart Rate from Week 1 to Week 8
Time frame: Weeks 1 and 8
At the start of each session an investigator will take and document each participant's heart rate.
Change in Heart Rate from Week 8 to Week 16
Time frame: Weeks 8 and 16
At the start of each session an investigator will take and document each participant's heart rate.
Change in Heart Rate from Week 1 to Week 16
Time frame: Weeks 1 and 16
At the start of each session an investigator will take and document each participant's heart rate.
Change in Pulse Oximetry from Week 1 to Week 8
Time frame: Weeks 1 and 8
At the start of each session an investigator will take and document each participant's pulse oximetry.
Change in Pulse Oximetry from Week 8 to Week 16
Time frame: Weeks 8 and 16
At the start of each session an investigator will take and document each participant's pulse oximetry.
Change in Pulse Oximetry from Week 1 to Week 16
Time frame: Weeks 1 and 16
At the start of each session an investigator will take and document each participant's pulse oximetry.
3 secondary outcomes
Change in HeRe We Arts Survey from Week 1 to Week 8
Time frame: Weeks 1 and 8
Change in HeRe We Ed Survey from Week 1 to Week 8
Time frame: Weeks 1 and 8
Weekly Post-Session Survey
Time frame: Weeks 1-8
Results and safety
The study was stopped early (reason given: COVID-19 pandemic. Unable to restart as had hoped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Background: PubMed 16772239Ahern NR, Kiehl EM, Sole ML, Byers J. A review of instruments measuring resilience. Issues Compr Pediatr Nurs. 2006 Apr-Jun;29(2):103-25. doi: 10.1080/01460860600677643.
- Background: PubMed 21501042Beesley K, White JH, Alston MK, Sweetapple AL, Pollack M. Art after stroke: the qualitative experience of community dwelling stroke survivors in a group art programme. Disabil Rehabil. 2011;33(23-24):2346-55. doi: 10.3109/09638288.2011.571333. Epub 2011 Apr 18.
- Background: PubMed 12964174Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
- Background: PubMed 20395025Davydov DM, Stewart R, Ritchie K, Chaudieu I. Resilience and mental health. Clin Psychol Rev. 2010 Jul;30(5):479-95. doi: 10.1016/j.cpr.2010.03.003. Epub 2010 Mar 25.
- Background: PubMed 25787828Deshields TL, Heiland MF, Kracen AC, Dua P. Resilience in adults with cancer: development of a conceptual model. Psychooncology. 2016 Jan;25(1):11-8. doi: 10.1002/pon.3800. Epub 2015 Mar 18.
- Background: PubMed 28722166Dingle GA, Williams E, Jetten J, Welch J. Choir singing and creative writing enhance emotion regulation in adults with chronic mental health conditions. Br J Clin Psychol. 2017 Nov;56(4):443-457. doi: 10.1111/bjc.12149. Epub 2017 Jul 18.
- Background: PubMed 26974430Fancourt D, Perkins R, Ascenso S, Carvalho LA, Steptoe A, Williamon A. Effects of Group Drumming Interventions on Anxiety, Depression, Social Resilience and Inflammatory Immune Response among Mental Health Service Users. PLoS One. 2016 Mar 14;11(3):e0151136. doi: 10.1371/journal.pone.0151136. eCollection 2016.
- Background: PubMed 28105524Gallagher LM, Lagman R, Bates D, Edsall M, Eden P, Janaitis J, Rybicki L. Perceptions of family members of palliative medicine and hospice patients who experienced music therapy. Support Care Cancer. 2017 Jun;25(6):1769-1778. doi: 10.1007/s00520-017-3578-y. Epub 2017 Jan 19.
- Background: PubMed 28274132Gallagher LM, Lagman R, Rybicki L. Outcomes of Music Therapy Interventions on Symptom Management in Palliative Medicine Patients. Am J Hosp Palliat Care. 2018 Feb;35(2):250-257. doi: 10.1177/1049909117696723. Epub 2017 Mar 9.
- Background: PubMed 24962138Gloria CT, Steinhardt MA. Relationships Among Positive Emotions, Coping, Resilience and Mental Health. Stress Health. 2016 Apr;32(2):145-56. doi: 10.1002/smi.2589. Epub 2014 Jun 24.
- Background: PubMed 28573783Goubert L, Trompetter H. Towards a science and practice of resilience in the face of pain. Eur J Pain. 2017 Sep;21(8):1301-1315. doi: 10.1002/ejp.1062. Epub 2017 Jun 2.
- Background: PubMed 28783804Khan WU, Moss H. Increasing Public Health Awareness of and Capacity for Arts-Based Therapy in Medicine. JAMA Neurol. 2017 Sep 1;74(9):1029-1030. doi: 10.1001/jamaneurol.2017.1639. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Gallagher, MA principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeRe We Arts and HeRe We Ed in people with Hypertension and Diabetes, run by Lisa Gallagher at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 pandemic. Unable to restart as had hoped.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short Depression-Happiness Scale from Week 1 to Week 8 (time frame: Weeks 1 and 8). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154579, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.