Can Phone-Based care ease anxiety in epilepsy patients?
NCT ID NCT05353452
First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times
Summary
This study tests whether a 24-week remote collaborative care program—involving care managers, a psychiatrist, and a psychologist—can improve quality of life for adults with posttraumatic epilepsy who also have anxiety or depression. About 56 participants will either receive this extra support or usual neurology care. The main goal is to see if the program leads to meaningful improvements in emotional well-being over six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- remote collaborative care program (behavioral intervention)
- What this could lead to
- If successful, this could provide an effective way to manage anxiety and depression in people with posttraumatic epilepsy, improving their daily quality of life.
- What could go wrong
- This is a small, early-stage trial with only 56 participants, so results may not apply to everyone. The intervention is behavioral, so benefits may vary and are not guaranteed.
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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40 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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May 2026
- 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 * Diagnosis of post-traumatic epilepsy, defined by the following: 1. Epilepsy diagnosis based on neurology clinician impression of diagnosis or electroencephalogram (EEG) findings (EEG findings: presence of interictal epileptiform discharges on EEG or ictal EEG recording of seizure definitively documenting epilepsy diagnosis) 2. History of at least mild traumatic brain injury based on the MIRECC (Mental Illness Research, Education, and Clinical Center) TBI (Traumatic Brain Injury) screening instrument or verified TBI history based on MIRECC research database 3. TBI pre-dated onset of epilepsy (NINDS post-traumatic epilepsy screening form) * Anxiety or depression symptoms--Generalized Anxiety Disorder scale (GAD-7) ≥8 or Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) \>13 * Receiving clinical neurological care at one of the study sites Exclusion Criteria: * Active ongoing treatment by a psychiatrist without the potential to benefit from additional collaborative care for anxiety or depression in the judgement of the investigators * Active suicidal ideation * History of past suicide attempt * Unstable drug or alcohol abuse * Unstable or progressive comorbid medical condition * Current participation in another treatment or intervention study * Cognitive limitations precluding completion of anxiety and depression self-report instruments on paper, electronically, or by interview.
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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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Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
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