Can a simple care program boost mood in epilepsy patients?
NCT ID NCT05559749
First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 5 times
Summary
This study tests whether a 24-week collaborative care program can improve quality of life for adults with epilepsy who also have anxiety or depression. The program includes regular check-in calls and expert recommendations from a psychiatrist and neurologist. Researchers will compare this approach to usual neurology care in 60 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- collaborative care program (behavioral intervention)
- What this could lead to
- If it works, this could point toward a practical way to improve emotional well-being and quality of life for people with epilepsy who also struggle with anxiety or depression.
- What could go wrong
- This is a small, early-stage trial with only 60 participants, so results may not apply to everyone. The intervention is behavioral and relies on participant engagement, which may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Provision of signed and dated Informed Consent Form * Stated willingness to comply with all study procedures * Males and Females; Age \>= 18 years * \* Diagnosis of epilepsy: Epilepsy diagnosis based on neurology clinician impression or EEG findings * Anxiety or Depression symptoms * Receiving clinical neurological care at Atrium Health Exclusion Criteria: * Current participation in another treatment of intervention study * Cognitive limitations precluding completion of Anxiety and Depression self-report instruments on paper, electronically, or by interview * Comorbid medical condition with life expectancy less than 6 months * Not a good candidate for collaborative care due to: * Active ongoing treatment by a psychiatrist * Active suicidal ideation * History of past suicide attempt and: * receiving ongoing psychotherapy OR * has seen a psychiatrist in the past year * History of suicide attempt in the past year and: * currently prescribed 2 or more psychotropic medications for psychiatric indication (not merely as a hypnotic) AND not felt to be a good candidate for collaborative care based on the judgement of the investigators * Unstable drug or alcohol abuse For the third Aim (sustainability supplement: intervention only care delivery exploratory study supplement) - the Participants meeting the following criteria may participate * individuals who meet the above INC-EXC criteria and have completed the Control Arm of a collaborative care research study - NCT05559749 - NCT05353452 or * individuals who meet the above INC-EXC criteria except rather than having a diagnosis of Epilepsy; they have a diagnosis of functional neurological disorder with seizures * individuals who meet the above INC-EXC criteria and receive clinical neurological care at Atrium Health Wake Forest Baptist
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
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