Collaborative Care for Anxiety and Depression in Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: collaborative care, usual neurology care.
- Who it may be relevant to
- Registry conditions: Epilepsy, Anxiety, Depression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Collaborative Care to Improve Quality of Life for Anxiety and Depression in Epilepsy
Overview
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.
Detailed description
The intervention is a 24-week, evidence-based collaborative care model initiated around the time of a neurology visit. The collaborative care team roles include the care manager/social worker and psychiatrist who interact with the patient participant and the patient's neurologist/neurology provider.
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]
Secondary outcome measures (4)
- Number of Participants adhering to Intervention [Time frame: Week 12]
- Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care [Time frame: Month 6]
- Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care [Time frame: Month 6]
- Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups [Time frame: Month 6]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT05559749 · IRB00088764