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Clinical Trials/NCT05559749
NCT05559749
Recruiting
Not Applicable

Collaborative Care to Improve Quality of Life for Anxiety and Depression in Epilepsy

Wake Forest University Health Sciences2 sites in 1 country60 target enrollmentMay 4, 2023

Overview

Phase
Not Applicable
Intervention
collaborative care
Conditions
Epilepsy
Sponsor
Wake Forest University Health Sciences
Enrollment
60
Locations
2
Primary Endpoint
change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups
Status
Recruiting
Last Updated
2 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 4, 2023
End Date
June 1, 2027
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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:

Arms & Interventions

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.

Intervention: collaborative care

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.

Intervention: usual neurology care

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care(Month 6)
  • Number of Participants adhering to Intervention(Week 12)
  • Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups(Month 6)
  • Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care(Month 6)

Study Sites (2)

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