Clinical trial NCT03329703: Project UPLIFT for Psychogenic Non-Epileptic Seizures
Official title: The Feasibility of Project UPLIFT for the Treatment of Psychogenic Non-Epileptic Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 80% of participants who begin Session 1 of UPLIFT will complete 80% of the sessions.
timeFrame: 6 months
Secondary outcomes:
measure: Change in depression (Patient Health Questionnaire-9) before and after intervention.
timeFrame: 6 months
measure: Change in seizure frequency as assessed by self-report seizure questionnaire.
timeFrame: 6 months
measure: Change in anxiety (Generalized Anxiety Disorder-7) before and after the intervention.
timeFrame: 6 months
measure: Change in symptoms of Post-Traumatic Stress Disorder (PTSD Checklist-Civilian Version, PCL-C) before and after the intervention.
timeFrame: 6 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Lindsay Schommer, APRN
role: PRINCIPAL_INVESTIGATOR
References: