EpilepsyNCT03994718
Creative Arts II Study
A study testing Music intervention, Visual arts intervention and Creative writing intervention in people with Epilepsy, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact of music, visual art, or creative writing on quality of life measures for epilepsy patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Music intervention, Visual arts intervention and Creative writing intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 1 Apr 2021
- 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
- Age > 18 years old
- Scheduled for admission to the Dartmouth-Hitchcock Medical Center Epilepsy Monitoring Unit for diagnostic Video/EEG monitoring
- Capable of giving informed consent.
- Able to follow instructions
Who cannot join
- Active psychiatric illness that would interfere with participation with the artist.
- Active general medical condition that would impair the participant's consciousness or ability to participate.
- Any other reason that, in the opinion of the investigator, would exclude the participant from successful participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Creative Arts Interventions for Improved Epilepsy Patient Quality of Life
The purpose of this study is to determine the impact of music, visual art, or creative writing on quality of life measures for epilepsy patients.
Read the detailed description
Qualifying patients admitted to Epilepsy Monitoring Unit will be approached for participation in the study. Patients who consent will be randomly assigned to work with one of three creative artists (visual artist, creative writer, or therapeutic musician. The assigned artist will provide 1 intervention while the patient is admitted and 4 follow-up interventions after discharge from the hospital. Follow-up sessions will be conducted remotely, either by phone or over the internet.
Subjects will be asked to complete study questionnaires before and after the first art intervention, and again after the last follow-up session. The study seeks to measure the impact of arts interventions on quality of life. Secondary objectives include the effects of the interventions on seizure frequency and EEG spike generation, as well as the impact of creative arts interventions on patients diagnosed with non-epileptic events during hospitalization.*
- Conditions
- Epilepsy
- Being tested
- Music intervention, Visual arts intervention, Creative writing intervention
- Keywords
- art, music, visual art, writing, epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
The music therapist will work with subjects for up to 60 minutes each session.
Visual arts interventionOther
The visual artist will work with subjects for up to 60 minutes each session.
Creative writing interventionOther
The creative writer will work with subjects for up to 60 minutes each session.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | The musician will either offer music that can either be played for the participant or an instrument so they can experience playing themselves. The duration of the intervention will be determined by participant interest and tolerance, but not to exceed 60 minutes. The outpatient music intervention will consist of providing a recording of similar music for the participant to listen to for at least 30 minutes per week, along a with telephone call session with the music therapist. Receives: Other: Music intervention |
| Visual art | Experimental | The creative visual artist will assess interest in spending time using the materials provided. Participants will be offered watercolor painting, drawing, or adult coloring. There will be a guided activity based on their art making preference. A standardized prompt will be utilized for both writing and visual art sessions. The duration of the intervention will be determined by participant interest and tolerance, but not to exceed 60 minutes. For remote follow-up sessions, participants will be supplied with a small art kit to use at home. Receives: Other: Visual arts intervention |
| Creative writing | Experimental | The writer will ask the participant about their interests and experiences in writing or storytelling. The following options are offered; introduction to journaling, storytelling or writing exercises with prompts to get started, interactive writing or storytelling activities. For participants who are unable to write or prefer not to, the writer can scribe their words on a laptop and print them out. The duration of the intervention will be determined by participant interest and tolerance, but not to exceed 60 minutes. For follow-up sessions, participants will be supplied with a journal. Receives: Other: Creative writing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant Quality of Life (QOLIE-10) scores before and after the interventions.
Change in quality of life will be calculated using the QOLIE-10 questionnaire responses.The QOLIE-10 includes 10 questions with a total score range of 10 - 51. The score will be calculated by the sum of scores for all questions divided by the number of items answered. Thus, if a patient skipped an item, it is not reflected in the total score. A lower score indicates a higher quality of life, and a higher score indicates a lower quality of life.
Measured: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Change in participant Distress scores before and after the interventions.
Change in distress will be calculated using the Distress scale. The Distress scale asks patients to rate their distress on a scale from 0 - 10, with 0 meaning "no distress" and 10 meaning "extreme distress." Lower scores indicate less distress.
Measured: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Secondary outcomes (6)
Change in participant Patient Health Questionnaire (PHQ-9) scores before and after interventions.
Change in health status will be calculated using the PHQ-9 questionnaire. The PHQ-9 is a 9-item questionnaire with scores ranging from 0 to 27. Lower scores indicate better health scores and higher scores represent worse health status. Scores of 5, 10, 15, and 20 represent cutoffs for mild, moderate, moderately severe and severe depression, respectively.
Measured: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Change in participant Generalized Anxiety Disorder (GAD-7) scores before and after interventions.
Change in anxiety level will be calculated using the GAD-7 questionnaire responses. The GAD-7 is a 7-items questionnaire with scores ranging from 0 to 21. Scores of 5, 10, and 15 represent cut-offs for mild, moderate, and severe anxiety, respectively.
Measured: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Change in EEG spike frequency before, during, and after the intervention while participant is admitted to the DHMC epilepsy inpatient service.
EEG spike frequency will be determined by automated spike detection software
Measured: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Change in seizure frequency from baseline to end of follow-up
Comparison of seizure data at baseline and post-interventions based on patient report of baseline and seizure calendar reporting
Measured: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Qualitative analysis to identify themes in the creative writing and visual art subject matter.
Participants assigned to either the creative writer or to the visual artist will supply their creations for analysis. The creative writing subject matter will be analyzed using N-Vivo software. Visual art subject matter will be coded for thematic content manually.
Measured: After the inpatient intervention (approximately Day 3 - 21) and after each follow-up remote intervention (approximately 8 weeks after discharge).
Change in quality of life measures for participants ultimately diagnosed with non-epileptic seizures compared to those diagnosed with epileptic seizures.
Change in quality of life for patients with non-epileptic seizures will be calculated using the QOLIE-10 questionnaire responses.The QOLIE-10 includes 10 questions. The score is calculated by the sum of scores for all questions divided by the number of items answered. Thus, if a patient skipped an item, it is not reflected in the total score. A lower score indicates a higher quality of life, and a higher score indicates a lower quality of life.
Measured: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start30 Sep 2019
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994718
- Sponsor's protocol ID
- D19124
- Status last verified
- Jun 2021
- First submitted
- 19 Jun 2019
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creative Arts Interventions for Improved Epilepsy Patient Quality of Life
- ClinicalTrials.gov ID
- NCT03994718
- Acronym / sponsor ID
- D19124
- Conditions
- Epilepsy
- Keywords
- art, music, visual art, writing, epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 21 Jun 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.
The purpose of this study is to determine the impact of music, visual art, or creative writing on quality of life measures for epilepsy patients.
Detailed description
Qualifying patients admitted to Epilepsy Monitoring Unit will be approached for participation in the study. Patients who consent will be randomly assigned to work with one of three creative artists (visual artist, creative writer, or therapeutic musician. The assigned artist will provide 1 intervention while the patient is admitted and 4 follow-up interventions after discharge from the hospital. Follow-up sessions will be conducted remotely, either by phone or over the internet.
Subjects will be asked to complete study questionnaires before and after the first art intervention, and again after the last follow-up session. The study seeks to measure the impact of arts interventions on quality of life. Secondary objectives include the effects of the interventions on seizure frequency and EEG spike generation, as well as the impact of creative arts interventions on patients diagnosed with non-epileptic events during hospitalization.*
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: Music interventionThe musician will either offer music that can either be played for the participant or an instrument so they can experience playing themselves. The duration of the intervention will be determined by participant interest and tolerance, but not to exceed 60 minutes. The outpatient music intervention will consist of providing a recording of similar music for the participant to listen to for at least 30 minutes per week, along a with telephone call session with the music therapist. |
| Visual art | Experimental | Other: Visual arts interventionThe creative visual artist will assess interest in spending time using the materials provided. Participants will be offered watercolor painting, drawing, or adult coloring. There will be a guided activity based on their art making preference. A standardized prompt will be utilized for both writing and visual art sessions. The duration of the intervention will be determined by participant interest and tolerance, but not to exceed 60 minutes. For remote follow-up sessions, participants will be supplied with a small art kit to use at home. |
| Creative writing | Experimental | Other: Creative writing interventionThe writer will ask the participant about their interests and experiences in writing or storytelling. The following options are offered; introduction to journaling, storytelling or writing exercises with prompts to get started, interactive writing or storytelling activities. For participants who are unable to write or prefer not to, the writer can scribe their words on a laptop and print them out. The duration of the intervention will be determined by participant interest and tolerance, but not to exceed 60 minutes. For follow-up sessions, participants will be supplied with a journal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Scheduled for admission to the Dartmouth-Hitchcock Medical Center Epilepsy Monitoring Unit for diagnostic Video/EEG monitoring
- Capable of giving informed consent.
- Able to follow instructions
Key exclusion criteria (3 listed)
- Active psychiatric illness that would interfere with participation with the artist.
- Active general medical condition that would impair the participant's consciousness or ability to participate.
- Any other reason that, in the opinion of the investigator, would exclude the participant from successful participation in the study.
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 |
|---|---|---|
| Music interventionThe music therapist will work with subjects for up to 60 minutes each session. | Other | Music |
| Visual arts interventionThe visual artist will work with subjects for up to 60 minutes each session. | Other | Visual art |
| Creative writing interventionThe creative writer will work with subjects for up to 60 minutes each session. | Other | Creative writing |
Primary outcome
Change in participant Quality of Life (QOLIE-10) scores before and after the interventions.
Time frame: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Change in quality of life will be calculated using the QOLIE-10 questionnaire responses.The QOLIE-10 includes 10 questions with a total score range of 10 - 51. The score will be calculated by the sum of scores for all questions divided by the number of items answered. Thus, if a patient skipped an item, it is not reflected in the total score. A lower score indicates a higher quality of life, and a higher score indicates a lower quality of life.
Change in participant Distress scores before and after the interventions.
Time frame: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Change in distress will be calculated using the Distress scale. The Distress scale asks patients to rate their distress on a scale from 0 - 10, with 0 meaning "no distress" and 10 meaning "extreme distress." Lower scores indicate less distress.
6 secondary outcomes
Change in participant Patient Health Questionnaire (PHQ-9) scores before and after interventions.
Time frame: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Change in participant Generalized Anxiety Disorder (GAD-7) scores before and after interventions.
Time frame: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Change in EEG spike frequency before, during, and after the intervention while participant is admitted to the DHMC epilepsy inpatient service.
Time frame: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Change in seizure frequency from baseline to end of follow-up
Time frame: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Qualitative analysis to identify themes in the creative writing and visual art subject matter.
Time frame: After the inpatient intervention (approximately Day 3 - 21) and after each follow-up remote intervention (approximately 8 weeks after discharge).
Change in quality of life measures for participants ultimately diagnosed with non-epileptic seizures compared to those diagnosed with epileptic seizures.
Time frame: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention, Visual arts intervention and Creative writing intervention in people with Epilepsy, run by Dartmouth-Hitchcock Medical Center 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jun 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 participant Quality of Life (QOLIE-10) scores before and after the interventions. (time frame: Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2021.