Project UPLIFT for Psychogenic Non-Epileptic Seizures (PNES)
Primary Purpose
Psychogenic Non-Epileptic Seizure, Depression, Non-Epileptic Seizure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project UPLIFT
Sponsored by
About this trial
This is an interventional treatment trial for Psychogenic Non-Epileptic Seizure focused on measuring PNES, UPLIFT, Depression, Mindfulness, CBT, Managing Epilepsy Well (MEW) Network, Psychogenic Seizures, Non-Epileptic Seizures
Eligibility Criteria
Inclusion Criteria:
- History of psychogenic non-epileptic seizures, confirmed by study investigator.
- Literate
- Reliable telephone access
Exclusion Criteria:
- Dual diagnosis of PNES with epilepsy.
- Presence of serious mental illness that will impair ability to participate.
- Presence of active suicidal ideation at baseline with intention to act.
- Severe mental disability or estimated intelligent quotient (IQ) less than 70.
- No reliable telephone access.
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate-Treatment
Waitlist Control
Arm Description
This group will receive Project UPLIFT immediately after completing surveys.
This group will receive Project UPLIFT after waiting approximately 3 months to begin the intervention.
Outcomes
Primary Outcome Measures
80% of participants who begin Session 1 of UPLIFT will complete 80% of the sessions.
To test the feasibility of giving Project UPLIFT to patients with PNES
Secondary Outcome Measures
Change in depression (Patient Health Questionnaire-9) before and after intervention.
Change from baseline in depression scores, as reported in the Patient Health Questionnaire-9. The PHQ-9 provides a total depression score ranging from 0-27, with higher score indicating more severe depression symptoms.
Change in seizure frequency as assessed by self-report seizure questionnaire.
Change from baseline in seizure frequency on the self-report seizure questionnaire. The self-report seizure questionnaire asks participants to report the number of seizures they have had in the previous week, month, and year. There is no upper limit of the scale, and is not a standardized survey.
Change in anxiety (Generalized Anxiety Disorder-7) before and after the intervention.
Change from baseline in anxiety scores, as reported on the Generalized Anxiety Disorder -7 survey. The GAD-7 provides a total score ranging from 0-21, with a higher score indicating more severe anxiety symptoms.
Change in symptoms of Post-Traumatic Stress Disorder (PTSD Checklist-Civilian Version, PCL-C) before and after the intervention.
Change from baseline in Post-Traumatic Stress Disorder scores as measured by the Post-Traumatic Stress Disorder Checklist - Civilian Version. The PCL-C provides a total score of PTSD severity that ranges from 17-85, with higher score indicating higher symptom severity.
Full Information
NCT ID
NCT03329703
First Posted
October 20, 2017
Last Updated
September 24, 2021
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03329703
Brief Title
Project UPLIFT for Psychogenic Non-Epileptic Seizures
Acronym
PNES
Official Title
The Feasibility of Project UPLIFT for the Treatment of Psychogenic Non-Epileptic Seizures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
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
Developed by researchers from the Centers for Disease Control and Prevention (CDC), Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a group telephone program designed to improve depression for people with epilepsy. Project UPLIFT uses evidence-based approaches of cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy to help people manage and prevent symptoms of depression.
For people with psychogenic non-epileptic seizures, there are few treatment options for depression that address the relationship between mood and seizures. There is evidence that mindfulness-based therapy and cognitive therapy are both effective for people with non-epileptic seizures, both in treating depression and reducing seizure frequency. In this study, Project UPLIFT will be offered to patients with psychogenic non-epileptic seizures.
Project UPLIFT is facilitated by a trained clinician to groups of 4-8 patients over the telephone. The group will meet at a regular time, once a week, for 8 consecutive weeks. Participants will be assigned to one of two groups: an immediate-treatment or a waitlist control group which will begin Project UPLIFT 3 months after enrolling in the study.
Detailed Description
Upon enrollment in the study, participants will be randomly assigned to one of two groups: an immediate-treatment group, or a 3-month waitlist control group. Both groups will be given surveys to complete online, and a seizure calendar to keep track of auras, seizures, and events. The immediate-treatment group will be scheduled to start Project UPLIFT with their trained facilitator. Each of the eight weekly sessions will take place at the same day of the week and at the same time, and will last approximately one hour. Participants will have the option of using a fake-name during the telephone calls to conceal their identity during the group telephone calls.
After the 8 weekly sessions, both groups will be given a second set of online surveys to complete individually. At this time, the waitlist control group will be scheduled to start Project UPLIFT with the trained facilitator. After the waitlist group completes the final session of Project UPLIFT, both groups will complete a third and final set of online surveys, thus concluding all study procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychogenic Non-Epileptic Seizure, Depression, Non-Epileptic Seizure, Psychogenic Seizure
Keywords
PNES, UPLIFT, Depression, Mindfulness, CBT, Managing Epilepsy Well (MEW) Network, Psychogenic Seizures, Non-Epileptic Seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate-Treatment
Arm Type
Experimental
Arm Description
This group will receive Project UPLIFT immediately after completing surveys.
Arm Title
Waitlist Control
Arm Type
Active Comparator
Arm Description
This group will receive Project UPLIFT after waiting approximately 3 months to begin the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Project UPLIFT
Intervention Description
A group, telephone-based intervention for depression that uses techniques from mindfulness-based therapy and cognitive therapy. The intervention consists of 8 sessions occurring at the same time and day every week.
Primary Outcome Measure Information:
Title
80% of participants who begin Session 1 of UPLIFT will complete 80% of the sessions.
Description
To test the feasibility of giving Project UPLIFT to patients with PNES
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in depression (Patient Health Questionnaire-9) before and after intervention.
Description
Change from baseline in depression scores, as reported in the Patient Health Questionnaire-9. The PHQ-9 provides a total depression score ranging from 0-27, with higher score indicating more severe depression symptoms.
Time Frame
6 months
Title
Change in seizure frequency as assessed by self-report seizure questionnaire.
Description
Change from baseline in seizure frequency on the self-report seizure questionnaire. The self-report seizure questionnaire asks participants to report the number of seizures they have had in the previous week, month, and year. There is no upper limit of the scale, and is not a standardized survey.
Time Frame
6 months
Title
Change in anxiety (Generalized Anxiety Disorder-7) before and after the intervention.
Description
Change from baseline in anxiety scores, as reported on the Generalized Anxiety Disorder -7 survey. The GAD-7 provides a total score ranging from 0-21, with a higher score indicating more severe anxiety symptoms.
Time Frame
6 months
Title
Change in symptoms of Post-Traumatic Stress Disorder (PTSD Checklist-Civilian Version, PCL-C) before and after the intervention.
Description
Change from baseline in Post-Traumatic Stress Disorder scores as measured by the Post-Traumatic Stress Disorder Checklist - Civilian Version. The PCL-C provides a total score of PTSD severity that ranges from 17-85, with higher score indicating higher symptom severity.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of psychogenic non-epileptic seizures, confirmed by study investigator.
Literate
Reliable telephone access
Exclusion Criteria:
Dual diagnosis of PNES with epilepsy.
Presence of serious mental illness that will impair ability to participate.
Presence of active suicidal ideation at baseline with intention to act.
Severe mental disability or estimated intelligent quotient (IQ) less than 70.
No reliable telephone access.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay Schommer, APRN
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
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
Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data (IPD) are not planned to be shared without outside researchers.
Learn more about this trial
Project UPLIFT for Psychogenic Non-Epileptic Seizures
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