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NCT Number: NCT05559749

Collaborative Care for Anxiety and Depression in Epilepsy

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.

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Key information

Conditions

Epilepsy Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Mental Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Heidi M Munger Clary, MD, MPH

PRINCIPAL_INVESTIGATOR

Lauren P Richmond

CONTACT

[email protected]

336-716-9632

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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
  • 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

Treatment and study plan

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.

usual neurology care

Behavioral

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

Primary outcomes

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

    Time frame: Month 6

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

Secondary outcomes

  1. Number of Participants adhering to Intervention

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Month 6

    Number of hospitalizations or visits to ED.

  5. Change in Liverpool Seizure Severity Scale (LSSS) between groups

    Time frame: Month 6

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

  6. Seizure Frequency

    Time frame: 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

    Time frame: 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

    Time frame: Baseline and Month 15

    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

    Time frame: Baseline and Month 15

    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

    Time frame: Baseline and Month 15

    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

    Time frame: Baseline and Month 15

    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

    Time frame: Baseline and Month 15

    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

    Time frame: Baseline and Month 15

    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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: Month 6

    proportion achieving 50% symptom reduction or remission by 6 months

  18. anxiety in epilepsy survey instrument (EASI) change

    Time frame: Month 6

    proportion achieving 50% symptom reduction or remission by 6 months

  19. Sustainability - insurance payment (quantity) for collaborative care billing codes

    Time frame: Month 6

    only measured in Aim 3 - sustainability supplement - intervention only clinical care delivery with insurance billing

  20. Sustainability - did insurance pay (yes/no) for collaborative care billing

    Time frame: Month 6

    only measured in Aim 3 - sustainability supplement - intervention only clinical care delivery with insurance billing

Study contacts

Contact information is provided by the study sponsor or research team.

Heidi M Munger Clary, MD, MPH

CONTACT

[email protected]

336-716-7110

Lauren P Richmond

CONTACT

[email protected]

336.716.9632

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2022
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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