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NCT05559749 | Recruiting | Epilepsy

Collaborative Care for Anxiety and Depression in Epilepsy
Sponsor:

Wake Forest University Health Sciences

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.

Condition or disease

Epilepsy

Anxiety

Depression

Intervention/treatment

collaborative care

usual neurology care

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : Single
Masking Description : The randomization table will be prepared by the study statistician, uploaded by the developer, and concealed from the PI and coordinators in the REDCap data management system until after consent, enrollment and baseline data collection is complete, to minimize bias - once participants are randomized it is just outcome assessor who is truly blinded
Primary Purpose : Supportive Care
Official Title : Collaborative Care to Improve Quality of Life for Anxiety and Depression in Epilepsy
Actual Study Start Date : May 4, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025
Arm Intervention/treatment

Experimental: collaborative care

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.

Behavioral: collaborative care

Active Comparator: usual neurology care

Ongoing usual neurology care, without the addition of the collaborative care program - current standard care and is thus an ethically appropriate control condition for effectiveness and implementation trials.

Behavioral: usual neurology care
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 Wake Forest Baptist
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; Unstable drug or alcohol abuse; history of past suicide attempt and: currently prescribed 2 or more psychotropic medications for psychiatric indication OR receiving ongoing psychotherapy OR has seen a psychiatrist in the past year
Collaborative Care for Anxiety and Depression in Epilepsy

Location Details

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Collaborative Care for Anxiety and Depression in Epilepsy

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157