Collaborative Care for Anxiety and Depression in Epilepsy

NCT05559749 | Recruiting DMC

• 1 other identifier: IRB00088764
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Anxiety; Depression

Keywords

Quality of Life; Collaborative care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants adhering to Intervention

  Week 12

• Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care

  Month 6

• Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care

  Month 6

• Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups

  Month 6

Other Outcomes (20)

• Change in Generalized Anxiety Disorders- 7(GAD-7) Score between groups

  Month 6

• Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) between groups

  Months 3 and 6

• Change in Patient Health Questionnaire-9 (PHQ-9) Score between groups

  Month 6

Study Arms (2)

collaborative care

EXPERIMENTAL

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

usual neurology care

ACTIVE COMPARATOR

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

Interventions

collaborative care BEHAVIORAL

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.

collaborative care

usual neurology care BEHAVIORAL

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

usual neurology care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• currently prescribed 2 or more psychotropic medications for psychiatric indication (not merely as a hypnotic) AND not felt to be a good candidate for collaborative care based on the judgement of the investigators
• Unstable drug or alcohol abuse
• For the third Aim (sustainability supplement: intervention only care delivery exploratory study supplement) - the Participants meeting the following criteria may participate
• individuals who meet the above INC-EXC criteria and have completed the Control Arm of a collaborative care research study - NCT05559749 - NCT05353452 or
• individuals who meet the above INC-EXC criteria except rather than having a diagnosis of Epilepsy; they have a diagnosis of functional neurological disorder with seizures

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Heidi M Munger Clary, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren P Richmond

CONTACT

336.716.9632; Lauren.Richmond@Advocatehealth.org

Heidi M Munger Clary, MD, MPH

CONTACT

336-716-7110; hmungerc@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: May 4, 2023
• Primary Completion: February 19, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after results published by primary study team
• 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.

Locations

US (1)