Collaborative Care for Anxiety and Depression in Epilepsy

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05559749
• Other study ID #: IRB00088764
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Epilepsy

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