Psychogenic Non-Epileptic SeizurePNESNCT03329703
Project UPLIFT for Psychogenic Non-Epileptic Seizures
A study testing Project UPLIFT in people with Psychogenic Non-Epileptic Seizure and Depression, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychogenic Non-Epileptic Seizure, Depression, Non-Epileptic Seizure
- What is being tested?
- Project UPLIFT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of psychogenic non-epileptic seizures, confirmed by study investigator.
- Literate
- Reliable telephone access
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: The Feasibility of Project UPLIFT for the Treatment of Psychogenic Non-Epileptic Seizures
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.
Read the 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.
- Being tested
- Project UPLIFT
- Keywords
- PNES, UPLIFT, Depression, Mindfulness, CBT, Managing Epilepsy Well (MEW) Network, Psychogenic Seizures, Non-Epileptic Seizures
- Medical subject headings
- Psychogenic Nonepileptic Seizures, Depression, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project UPLIFTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate-Treatment | Experimental | This group will receive Project UPLIFT immediately after completing surveys. Receives: Behavioral: Project UPLIFT |
| Waitlist Control | Active comparator | This group will receive Project UPLIFT after waiting approximately 3 months to begin the intervention. Receives: Behavioral: Project UPLIFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start23 Jul 2018
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychogenic Non-Epileptic SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay M. Schommer, Dartmouth-Hitchcock Medical Center
- Investigators
- Lindsay Schommer, APRN, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329703
- Sponsor's protocol ID
- D17161
- Acronym
- PNES
- Status last verified
- Sep 2021
- First submitted
- 20 Oct 2017
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) are not planned to be shared without outside researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Project UPLIFT for the Treatment of Psychogenic Non-Epileptic Seizures
- ClinicalTrials.gov ID
- NCT03329703
- Acronym / sponsor ID
- PNES / D17161
- Keywords
- PNES, UPLIFT, Depression, Mindfulness, CBT, Managing Epilepsy Well (MEW) Network, Psychogenic Seizures, Non-Epileptic Seizures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate-Treatment | Experimental | Behavioral: Project UPLIFTThis group will receive Project UPLIFT immediately after completing surveys. |
| Waitlist Control | Active comparator | Behavioral: Project UPLIFTThis group will receive Project UPLIFT after waiting approximately 3 months to begin the intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of psychogenic non-epileptic seizures, confirmed by study investigator.
- Literate
- Reliable telephone access
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project UPLIFTA 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. | Behavioural | Immediate-Treatment, Waitlist Control |
Primary outcome
80% of participants who begin Session 1 of UPLIFT will complete 80% of the sessions.
Time frame: 6 months
To test the feasibility of giving Project UPLIFT to patients with PNES
4 secondary outcomes
Change in depression (Patient Health Questionnaire-9) before and after intervention.
Time frame: 6 months
Change in seizure frequency as assessed by self-report seizure questionnaire.
Time frame: 6 months
Change in anxiety (Generalized Anxiety Disorder-7) before and after the intervention.
Time frame: 6 months
Change in symptoms of Post-Traumatic Stress Disorder (PTSD Checklist-Civilian Version, PCL-C) before and after the intervention.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) are not planned to be shared without outside researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay Schommer, APRN principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project UPLIFT in people with Psychogenic Non-Epileptic Seizure and Depression, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
80% of participants who begin Session 1 of UPLIFT will complete 80% of the sessions. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.