Project UPLIFT for Psychogenic Non-Epileptic Seizures

NCT ID: NCT03329703

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2020-12-31

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.

Conditions

Psychogenic Non-Epileptic Seizure; Depression; Non-Epileptic Seizure; Psychogenic Seizure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate-Treatment

This group will receive Project UPLIFT immediately after completing surveys.

Group Type: EXPERIMENTAL

Project UPLIFT

Intervention Type: 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.

Waitlist Control

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

Group Type: ACTIVE_COMPARATOR

Project UPLIFT

Intervention Type: 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.

Interventions

Project UPLIFT

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lindsay M. Schommer

Adv Prac Nrs, Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsay Schommer, APRN

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

D17161

Identifier Type: -

Identifier Source: org_study_id