Clinical trial NCT05559749: 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
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Anxiety
Depression
Keywords: Quality of Life
Collaborative care
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

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

Primary outcomes:
measure: change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups
timeFrame: Month 6
Secondary outcomes:
measure: Number of Participants adhering to Intervention
timeFrame: Week 12
measure: Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care
timeFrame: Month 6
measure: Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care
timeFrame: Month 6
measure: Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups
timeFrame: Month 6
Other outcomes:
measure: Change in Generalized Anxiety Disorders- 7(GAD-7) Score between groups
timeFrame: Month 6
measure: Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) between groups
timeFrame: Months 3 and 6
measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score between groups
timeFrame: Month 6
measure: Emergency Department (ED)/Hospitalization Visits
timeFrame: Month 6
measure: Change in Liverpool Seizure Severity Scale (LSSS) between groups
timeFrame: Month 6
measure: Seizure Frequency
timeFrame: Month 6
measure: Number of Seizure medication adjustments
timeFrame: Month 6
measure: Feasibility of Intervention Measure (FIM) Subject Perspective
timeFrame: Baseline and Month 15
measure: Feasibility of Intervention Measure (FIM) Neurologist Perspective
timeFrame: Baseline and Month 15
measure: Acceptability of Intervention Measure (AIM) Subject Perspective
timeFrame: Baseline and Month 15
measure: Acceptability of Intervention Measure (AIM) Neurologist Perspective
timeFrame: Baseline and Month 15
measure: Intervention Appropriateness Measure (IAM) Subject Perspective
timeFrame: Baseline and Month 15
measure: Intervention Appropriateness Measure (IAM) Neurologist Perspective
timeFrame: Baseline and Month 15
measure: Individual Participant Collaborative Care Call Attendance Percentage
timeFrame: Weeks 12 and 24
measure: change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups
timeFrame: Month 3
measure: change in brEASI (Brief anxiety in epilepsy survey instrument)
timeFrame: Months 3 and 6
measure: Beck Depression Inventory (BDI) change
timeFrame: Month 6
measure: anxiety in epilepsy survey instrument (EASI) change
timeFrame: Month 6
measure: Sustainability - insurance payment (quantity) for collaborative care billing codes
timeFrame: Month 6
measure: Sustainability - did insurance pay (yes/no) for collaborative care billing
timeFrame: Month 6
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Heidi M Munger Clary, MPH
role: PRINCIPAL_INVESTIGATOR
References: