NCT05559749 Collaborative Care for Anxiety and Depression in Epilepsy
| NCT ID | NCT05559749 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-05-04 |
| Primary Completion | 2026-02-19 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-05-04 with a primary completion date of 2026-02-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized effectiveness/implementation trial comparing a 24-week neurology-based collaborative care intervention to usual neurology care among 60 adults with epilepsy.
Eligibility Criteria
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
Contact & Investigator
Heidi M Munger Clary, MPH
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05559749 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05559749 currently recruiting?
Yes, NCT05559749 is actively recruiting participants. Contact the research team at Lauren.Richmond@Advocatehealth.org for enrollment information.
Where is the NCT05559749 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT05559749 clinical trial?
NCT05559749 is sponsored by Wake Forest University Health Sciences. The principal investigator is Heidi M Munger Clary, MPH at Wake Forest University Health Sciences. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.