Creative Arts II Study

Epilepsy Clinical Trial

Official title:

Creative Arts Interventions for Improved Epilepsy Patient Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03994718
• Other study ID #: D19124
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: June 2021
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.*

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Music intervention
The music therapist will work with subjects for up to 60 minutes each session.
• Visual arts intervention
The visual artist will work with subjects for up to 60 minutes each session.
• Creative writing intervention
The creative writer will work with subjects for up to 60 minutes each session.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Endowment for the Arts, United States

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).
Primary	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.	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	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.	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	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.	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	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	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	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	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	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.	After the inpatient intervention (approximately Day 3 - 21) and after each follow-up remote intervention (approximately 8 weeks after discharge).
Secondary	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.	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).