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Creative Arts II Study

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music intervention
Visual arts intervention
Creative writing intervention
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring art, music, visual art, writing, epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Music

Visual art

Creative writing

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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
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
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.
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.

Full Information

First Posted
June 19, 2019
Last Updated
June 23, 2021
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Endowment for the Arts, United States
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1. Study Identification

Unique Protocol Identification Number
NCT03994718
Brief Title
Creative Arts II Study
Official Title
Creative Arts Interventions for Improved Epilepsy Patient Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Endowment for the Arts, United States

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.*

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
art, music, visual art, writing, epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music
Arm Type
Experimental
Arm Description
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.
Arm Title
Visual art
Arm Type
Experimental
Arm Description
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.
Arm Title
Creative writing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Music intervention
Intervention Description
The music therapist will work with subjects for up to 60 minutes each session.
Intervention Type
Other
Intervention Name(s)
Visual arts intervention
Intervention Description
The visual artist will work with subjects for up to 60 minutes each session.
Intervention Type
Other
Intervention Name(s)
Creative writing intervention
Intervention Description
The creative writer will work with subjects for up to 60 minutes each session.
Primary Outcome Measure Information:
Title
Change in participant Quality of Life (QOLIE-10) scores before and after the interventions.
Description
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.
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).
Title
Change in participant Distress scores before and after the interventions.
Description
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.
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).
Secondary Outcome Measure Information:
Title
Change in participant Patient Health Questionnaire (PHQ-9) scores before and after interventions.
Description
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.
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).
Title
Change in participant Generalized Anxiety Disorder (GAD-7) scores before and after interventions.
Description
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.
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).
Title
Change in EEG spike frequency before, during, and after the intervention while participant is admitted to the DHMC epilepsy inpatient service.
Description
EEG spike frequency will be determined by automated spike detection software
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).
Title
Change in seizure frequency from baseline to end of follow-up
Description
Comparison of seizure data at baseline and post-interventions based on patient report of baseline and seizure calendar reporting
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).
Title
Qualitative analysis to identify themes in the creative writing and visual art subject matter.
Description
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.
Time Frame
After the inpatient intervention (approximately Day 3 - 21) and after each follow-up remote intervention (approximately 8 weeks after discharge).
Title
Change in quality of life measures for participants ultimately diagnosed with non-epileptic seizures compared to those diagnosed with epileptic seizures.
Description
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

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Creative Arts II Study

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