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Collaborative Care for Anxiety and Depression in Epilepsy

Primary Purpose

Epilepsy, Anxiety, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
collaborative care
usual neurology care
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring Quality of Life, Collaborative care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

collaborative care

usual neurology care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups
adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state

Secondary Outcome Measures

Number of Participants adhering to Intervention
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
Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care
adults with epilepsy and anxiety or depression symptoms - Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life
Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care
adults with epilepsy and anxiety or depression symptoms -- Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms
Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups
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

Full Information

First Posted
September 26, 2022
Last Updated
October 3, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05559749
Brief Title
Collaborative Care for Anxiety and Depression in Epilepsy
Official Title
Collaborative Care to Improve Quality of Life for Anxiety and Depression in Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Anxiety, Depression
Keywords
Quality of Life, Collaborative care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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 - once participants are randomized it is just outcome assessor who is truly blinded
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
collaborative care
Arm Type
Experimental
Arm Description
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.
Arm Title
usual neurology care
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
collaborative care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
usual neurology care
Intervention Description
ongoing usual neurology care, without the addition of the collaborative care program
Primary Outcome Measure Information:
Title
change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups
Description
adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Number of Participants adhering to Intervention
Description
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
Time Frame
Week 12
Title
Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care
Description
adults with epilepsy and anxiety or depression symptoms - Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life
Time Frame
Month 6
Title
Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care
Description
adults with epilepsy and anxiety or depression symptoms -- Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms
Time Frame
Month 6
Title
Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups
Description
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
Time Frame
Month 6
Other Pre-specified Outcome Measures:
Title
Change in Generalized Anxiety Disorders- 7(GAD-7) Score between groups
Description
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
Time Frame
Month 6
Title
Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) between groups
Description
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.
Time Frame
Months 3 and 6
Title
Change in Patient Health Questionnaire-9 (PHQ-9) Score between groups
Description
Score ranges from 0 to 27, with higher score indicating increased depression symptoms - proportion achieving 50% symptom reduction or remission by 6 months
Time Frame
Month 6
Title
Emergency Department (ED)/Hospitalization Visits
Description
Number of hospitalizations or visits to ED.
Time Frame
Month 6
Title
Change in Liverpool Seizure Severity Scale (LSSS) between groups
Description
Seizure severity questionnaire- score ranges from 0 to 100, with higher score indicating increased seizure severity.
Time Frame
Month 6
Title
Seizure Frequency
Description
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
Time Frame
Month 6
Title
Number of Seizure medication adjustments
Description
number of seizure medication adjustments to address side effects or lack of seizure control over 6 months
Time Frame
Month 6
Title
Feasibility of Intervention Measure (FIM) Subject Perspective
Description
Questionnaire to help determine feasibility of Collaborative Care from Participants' perspectives - score ranges from 5-20, with higher score indication greater feasibility
Time Frame
Baseline and Month 15
Title
Feasibility of Intervention Measure (FIM) Neurologist Perspective
Description
Questionnaire to help determine feasibility of Collaborative Care from Neurologists' perspectives - score ranges from 5-20, with higher score indication greater feasibility
Time Frame
Baseline and Month 15
Title
Acceptability of Intervention Measure (AIM) Subject Perspective
Description
Questionnaire to help determine feasibility of Collaborative Care from Participants' perspectives - score ranges from 5-20, with higher score indication greater acceptability
Time Frame
Baseline and Month 15
Title
Acceptability of Intervention Measure (AIM) Neurologist Perspective
Description
Questionnaire to help determine feasibility of Collaborative Care from Neurologists' perspectives - score ranges from 5-20, with higher score indication greater acceptability
Time Frame
Baseline and Month 15
Title
Intervention Appropriateness Measure (IAM) Subject Perspective
Description
Questionnaire to help determine appropriateness of Collaborative Care from participants' perspectives. Score ranges form 5-20 with higher score indication greater appropriateness
Time Frame
Baseline and Month 15
Title
Intervention Appropriateness Measure (IAM) Neurologist Perspective
Description
Questionnaire to help determine appropriateness of Collaborative Care from Neurologists' perspectives. Score ranges form 5-20 with higher score indication greater appropriateness
Time Frame
Baseline and Month 15
Title
Individual Participant Collaborative Care Call Attendance Percentage
Description
Individual Participant Collaborative Care Call Attendance Percentage
Time Frame
Weeks 12 and 24
Title
change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups
Description
adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state
Time Frame
Month 3
Title
change in brEASI (Brief anxiety in epilepsy survey instrument)
Description
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.
Time Frame
Months 3 and 6
Title
Beck Depression Inventory (BDI) change
Description
proportion achieving 50% symptom reduction or remission by 6 months
Time Frame
Month 6
Title
anxiety in epilepsy survey instrument (EASI) change
Description
proportion achieving 50% symptom reduction or remission by 6 months
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren P Richmond
Phone
336.716.9632
Email
lprichmo@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi M Munger Clary, MD, MPH
Phone
336-716-7110
Email
hmungerc@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi M Munger Clary, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren P Richmond
Phone
336-716-9632
Email
lprichmo@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Heidi M Munger Clary, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and results published by primary study team, de-identified, archived data will be stored for potential use if requested by other qualified researchers including those outside of the study.
IPD Sharing Time Frame
after results published by primary study team
IPD Sharing Access Criteria
Access to study data may be provided by the PI if requested by qualified investigators for individual participant data meta-analyses or potentially for other methodologically sound proposals.

Learn more about this trial

Collaborative Care for Anxiety and Depression in Epilepsy

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