Collaborative care for managing anxiety and depression in people with epilepsy
Collaborative Care to Improve Quality of Life for Anxiety and Depression in Epilepsy
This study tests a new team-based approach to help adults with epilepsy who also have anxiety or depression feel better compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05559749 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a 24-week collaborative care intervention designed for adults with epilepsy who also experience anxiety or depression. Participants will receive a structured care model that includes a care manager, social worker, and psychiatrist, working alongside their neurologist. The effectiveness of this collaborative approach will be compared to standard neurology care to determine its impact on patient outcomes. The study aims to enhance the quality of life for individuals managing these co-occurring conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with epilepsy who are experiencing symptoms of anxiety or depression.
Not a fit: Patients currently receiving ongoing psychiatric treatment or those with severe cognitive limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the mental health and overall quality of life for patients with epilepsy.
How similar studies have performed: Other studies have shown promising results with collaborative care models for mental health issues, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Heidi M Munger Clary, MPH — Wake Forest University Health Sciences
- Study coordinator: Lauren P Richmond
- Email: Lauren.Richmond@Advocatehealth.org
- Phone: 336.716.9632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.