Project UPLIFT for Psychogenic Non-Epileptic Seizures

NCT03329703 | Completed

• 1 other identifier: D17161
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (4)

• Change in depression (Patient Health Questionnaire-9) before and after intervention.

  6 months

• Change in seizure frequency as assessed by self-report seizure questionnaire.

  6 months

• Change in anxiety (Generalized Anxiety Disorder-7) before and after the intervention.

  6 months

• Change in symptoms of Post-Traumatic Stress Disorder (PTSD Checklist-Civilian Version, PCL-C) before and after the intervention.

  6 months

Study Arms (2)

Immediate-Treatment

EXPERIMENTAL

This group will receive Project UPLIFT immediately after completing surveys.

Behavioral: Project UPLIFT

Waitlist Control

ACTIVE COMPARATOR

This group will receive Project UPLIFT after waiting approximately 3 months to begin the intervention.

Behavioral: Project UPLIFT

Interventions

Project UPLIFT BEHAVIORAL

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.

Immediate-Treatment; Waitlist Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of psychogenic non-epileptic seizures, confirmed by study investigator.
• Literate
• Reliable telephone access

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Psychogenic Nonepileptic Seizures; Depression; Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Lindsay Schommer, APRN

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adv Prac Nrs, Neurology

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 6, 2017
• Study Start: July 23, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)