NCT05559749 · Wake Forest University Health Sciences
Collaborative Care for Anxiety and Depression in Epilepsy
What this study is about
This is a randomly assigned effectiveness/implementation trial comparing a 24-week neurology-based collaborative care intervention to usual neurology care among 60 adults with epilepsy.
View original scientific description
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.
Interventions
BEHAVIORAL
collaborative care
a 24-week neurology based collaborative care program consisting of: 1. a series of every 2 weeks care management calls by the care manager to evaluate anxiety, depression, seizures and side effects and deliver brief therapy interventions to the participant, and 2. collaborative care conferences including a psychiatrist to generate expert recommendations for anxiety and depression management and communication of recommendations between the care manger, psychiatrist and neurologist.
BEHAVIORAL
usual neurology care
ongoing usual neurology care, without the addition of the collaborative care program
Primary outcome measures
change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups
Time frame: Month 6
adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Winston-Salem, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations