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Creative Arts II Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994718
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2019
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
National Endowment for the Arts
Information provided by (Responsible Party):
Lara K. Ronan, Dartmouth-Hitchcock Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Epilepsy Other: Music intervention Other: Visual arts intervention Other: Creative writing intervention Not Applicable

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.*

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Creative Arts Interventions for Improved Epilepsy Patient Quality of Life
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Music
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.
Other: Music intervention
The music therapist will work with subjects for up to 60 minutes each session.

Experimental: Visual art
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.
Other: Visual arts intervention
The visual artist will work with subjects for up to 60 minutes each session.

Experimental: Creative writing
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.
Other: Creative writing intervention
The creative writer will work with subjects for up to 60 minutes each session.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 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.

  2. 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 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.

  3. 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). ]
    EEG spike frequency will be determined by automated spike detection software

  4. 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). ]
    Comparison of seizure data at baseline and post-interventions based on patient report of baseline and seizure calendar reporting

  5. 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). ]
    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.

  6. 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). ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years old
  2. Scheduled for admission to the Dartmouth-Hitchcock Medical Center Epilepsy Monitoring Unit for diagnostic Video/EEG monitoring
  3. Capable of giving informed consent.
  4. Able to follow instructions

Exclusion Criteria:

  1. Active psychiatric illness that would interfere with participation with the artist.
  2. Active general medical condition that would impair the participant's consciousness or ability to participate.
  3. Any other reason that, in the opinion of the investigator, would exclude the participant from successful participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994718


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Endowment for the Arts
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Responsible Party: Lara K. Ronan, Principal Investigator, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03994718    
Other Study ID Numbers: D19124
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lara K. Ronan, Dartmouth-Hitchcock Medical Center:
art
music
visual art
writing
epilepsy
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases