Collaborative Care for Anxiety and Depression in Epilepsy

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05559749
Collaborator
(none)
60
1
2
24
2.5

Study Details

Study Description

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 Intervention/Treatment Phase
  • Behavioral: collaborative care
  • Behavioral: usual neurology care
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a randomized, single-blind hybrid effectiveness-implementation study of a neurology clinic-based 24-week collaborative care intervention versus usual neurology care among a total of 60 adults having epilepsy with anxiety and/or depression symptoms, during 6 months follow-up. Participants will be randomized in a 1:1 ratio to collaborative care intervention versus usual neurology care.This is a randomized, single-blind hybrid effectiveness-implementation study of a neurology clinic-based 24-week collaborative care intervention versus usual neurology care among a total of 60 adults having epilepsy with anxiety and/or depression symptoms, during 6 months follow-up. Participants will be randomized in a 1:1 ratio to collaborative care intervention versus usual neurology care.
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
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.
Primary Purpose:
Supportive Care
Official Title:
Collaborative Care to Improve Quality of Life for Anxiety and Depression in Epilepsy
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

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
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.

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
ongoing usual neurology care, without the addition of the collaborative care program

Outcome Measures

Primary Outcome Measures

  1. change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups [Month 6]

    adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state

Secondary Outcome Measures

  1. Number of Participants adhering to Intervention [Week 12]

    adherence of intervention participants to the majority of care management - proportion of intervention group participants meeting minimum adherence metric of 50% call participation at 12 weeks

  2. Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care [Month 6]

    adults with epilepsy and anxiety or depression symptoms - Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life

  3. Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care [Month 6]

    adults with epilepsy and anxiety or depression symptoms -- Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms

  4. Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups [Month 6]

    adults with epilepsy and anxiety or depression symptoms - The score was obtained by computing the sum of the scores obtained by items associated with it, from 0, "not at all", to 3, "nearly every day". The possible total score ranges from 0 to 54, with higher scores indicating worse anxiety symptoms

Other Outcome Measures

  1. Change in Generalized Anxiety Disorders- 7(GAD-7) Score between groups [Month 6]

    Questionnaire measuring anxiety symptoms-score ranges from 0 to 21, with higher score indicating increased anxiety symptoms - proportion achieving 50% symptom reduction or remission by 6 months

  2. Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) between groups [Months 3 and 6]

    Depression symptom questionnaire specifically for those with epilepsy-score ranges from 6 to 24, with a score >15 indicating presence of a likely major depressive episode.

  3. Change in Patient Health Questionnaire-9 (PHQ-9) Score between groups [Month 6]

    Score ranges from 0 to 27, with higher score indicating increased depression symptoms - proportion achieving 50% symptom reduction or remission by 6 months

  4. Emergency Department (ED)/Hospitalization Visits [Month 6]

    Number of hospitalizations or visits to ED.

  5. Change in Liverpool Seizure Severity Scale (LSSS) between groups [Month 6]

    Seizure severity questionnaire- score ranges from 0 to 100, with higher score indicating increased seizure severity.

  6. Seizure Frequency [Month 6]

    Number of seizures experienced by participants - this will be change in seizure frequency and time since last seizure categories from baseline to 6 month follow-up: categorical rating scale developed by Epilepsy Learning Healthcare System & standardized in the American Academy of Neurology (AAN) seizure frequency quality measure

  7. Number of Seizure medication adjustments [Month 6]

    number of seizure medication adjustments to address side effects or lack of seizure control over 6 months

  8. Feasibility of Intervention Measure (FIM) Subject Perspective [Baseline and Month 3]

    Questionnaire to help determine feasibility of Collaborative Care from Participants' perspectives - score ranges from 5-20, with higher score indication greater feasibility

  9. Feasibility of Intervention Measure (FIM) Neurologist Perspective [Baseline and Month 3]

    Questionnaire to help determine feasibility of Collaborative Care from Neurologists' perspectives - score ranges from 5-20, with higher score indication greater feasibility

  10. Acceptability of Intervention Measure (AIM) Subject Perspective [Baseline and Month 3]

    Questionnaire to help determine feasibility of Collaborative Care from Participants' perspectives - score ranges from 5-20, with higher score indication greater acceptability

  11. Acceptability of Intervention Measure (AIM) Neurologist Perspective [Baseline and Month 3]

    Questionnaire to help determine feasibility of Collaborative Care from Neurologists' perspectives - score ranges from 5-20, with higher score indication greater acceptability

  12. Intervention Appropriateness Measure (IAM) Subject Perspective [Baseline and Month 3]

    Questionnaire to help determine appropriateness of Collaborative Care from participants' perspectives. Score ranges form 5-20 with higher score indication greater appropriateness

  13. Intervention Appropriateness Measure (IAM) Neurologist Perspective [Baseline and Month 3]

    Questionnaire to help determine appropriateness of Collaborative Care from Neurologists' perspectives. Score ranges form 5-20 with higher score indication greater appropriateness

  14. Individual Participant Collaborative Care Call Attendance Percentage [Weeks 12 and 24]

    Individual Participant Collaborative Care Call Attendance Percentage

  15. change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups [Month 3]

    adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state

  16. change in brEASI (Brief anxiety in epilepsy survey instrument) [Months 3 and 6]

    Scores of ≥7 on the Brief anxiety in epilepsy survey instrument (brEASI) indicate probable anxiety disorder. Scores range from 0 to 24, with higher scores indicting increased anxiety symptoms.

  17. Beck Depression Inventory (BDI) change [Month 6]

    proportion achieving 50% symptom reduction or remission by 6 months

  18. anxiety in epilepsy survey instrument (EASI) change [Month 6]

    proportion achieving 50% symptom reduction or remission by 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Heidi M Munger Clary, MPH, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT05559749
Other Study ID Numbers:
  • IRB00088764
First Posted:
Sep 29, 2022
Last Update Posted:
Jan 30, 2023
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2023