Depression Clinical Trial
— PNESOfficial title:
The Feasibility of Project UPLIFT for the Treatment of Psychogenic Non-Epileptic Seizures
NCT number | NCT03329703 |
Other study ID # | D17161 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 23, 2018 |
Est. completion date | December 31, 2020 |
Verified date | September 2021 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | December 31, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months |
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