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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05559749
Other study ID # IRB00088764
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 4, 2023
Est. completion date March 2025

Study information

Verified date September 2023
Source Wake Forest University Health Sciences
Contact Lauren P Richmond
Phone 336.716.9632
Email lprichmo@wakehealth.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Generalized Anxiety Disorders- 7(GAD-7) Score between groups 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 Month 6
Other Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) between groups 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. Months 3 and 6
Other Change in Patient Health Questionnaire-9 (PHQ-9) Score between groups Score ranges from 0 to 27, with higher score indicating increased depression symptoms - proportion achieving 50% symptom reduction or remission by 6 months Month 6
Other Emergency Department (ED)/Hospitalization Visits Number of hospitalizations or visits to ED. Month 6
Other Change in Liverpool Seizure Severity Scale (LSSS) between groups Seizure severity questionnaire- score ranges from 0 to 100, with higher score indicating increased seizure severity. Month 6
Other Seizure Frequency 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 Month 6
Other Number of Seizure medication adjustments number of seizure medication adjustments to address side effects or lack of seizure control over 6 months Month 6
Other Feasibility of Intervention Measure (FIM) Subject Perspective Questionnaire to help determine feasibility of Collaborative Care from Participants' perspectives - score ranges from 5-20, with higher score indication greater feasibility Baseline and Month 15
Other Feasibility of Intervention Measure (FIM) Neurologist Perspective Questionnaire to help determine feasibility of Collaborative Care from Neurologists' perspectives - score ranges from 5-20, with higher score indication greater feasibility Baseline and Month 15
Other Acceptability of Intervention Measure (AIM) Subject Perspective Questionnaire to help determine feasibility of Collaborative Care from Participants' perspectives - score ranges from 5-20, with higher score indication greater acceptability Baseline and Month 15
Other Acceptability of Intervention Measure (AIM) Neurologist Perspective Questionnaire to help determine feasibility of Collaborative Care from Neurologists' perspectives - score ranges from 5-20, with higher score indication greater acceptability Baseline and Month 15
Other Intervention Appropriateness Measure (IAM) Subject Perspective Questionnaire to help determine appropriateness of Collaborative Care from participants' perspectives. Score ranges form 5-20 with higher score indication greater appropriateness Baseline and Month 15
Other Intervention Appropriateness Measure (IAM) Neurologist Perspective Questionnaire to help determine appropriateness of Collaborative Care from Neurologists' perspectives. Score ranges form 5-20 with higher score indication greater appropriateness Baseline and Month 15
Other Individual Participant Collaborative Care Call Attendance Percentage Individual Participant Collaborative Care Call Attendance Percentage Weeks 12 and 24
Other 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 Month 3
Other change in brEASI (Brief anxiety in epilepsy survey instrument) 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. Months 3 and 6
Other Beck Depression Inventory (BDI) change proportion achieving 50% symptom reduction or remission by 6 months Month 6
Other anxiety in epilepsy survey instrument (EASI) change proportion achieving 50% symptom reduction or remission by 6 months Month 6
Primary 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 Month 6
Secondary 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 Week 12
Secondary 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 Month 6
Secondary 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 Month 6
Secondary 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 Month 6
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