Collaborative Care for Anxiety and Depression in Epilepsy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: collaborative care 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
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.
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Active Comparator: usual neurology care 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
ongoing usual neurology care, without the addition of the collaborative care program
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Outcome Measures
Primary Outcome Measures
- change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups [Month 6]
adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state
Secondary Outcome Measures
- Number of Participants adhering to Intervention [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
- Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care [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
- Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care [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
- Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups [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 Outcome Measures
- Change in Generalized Anxiety Disorders- 7(GAD-7) Score between groups [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
- Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) between groups [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.
- Change in Patient Health Questionnaire-9 (PHQ-9) Score between groups [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
- Emergency Department (ED)/Hospitalization Visits [Month 6]
Number of hospitalizations or visits to ED.
- Change in Liverpool Seizure Severity Scale (LSSS) between groups [Month 6]
Seizure severity questionnaire- score ranges from 0 to 100, with higher score indicating increased seizure severity.
- Seizure Frequency [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
- Number of Seizure medication adjustments [Month 6]
number of seizure medication adjustments to address side effects or lack of seizure control over 6 months
- Feasibility of Intervention Measure (FIM) Subject Perspective [Baseline and Month 3]
Questionnaire to help determine feasibility of Collaborative Care from Participants' perspectives - score ranges from 5-20, with higher score indication greater feasibility
- Feasibility of Intervention Measure (FIM) Neurologist Perspective [Baseline and Month 3]
Questionnaire to help determine feasibility of Collaborative Care from Neurologists' perspectives - score ranges from 5-20, with higher score indication greater feasibility
- Acceptability of Intervention Measure (AIM) Subject Perspective [Baseline and Month 3]
Questionnaire to help determine feasibility of Collaborative Care from Participants' perspectives - score ranges from 5-20, with higher score indication greater acceptability
- Acceptability of Intervention Measure (AIM) Neurologist Perspective [Baseline and Month 3]
Questionnaire to help determine feasibility of Collaborative Care from Neurologists' perspectives - score ranges from 5-20, with higher score indication greater acceptability
- Intervention Appropriateness Measure (IAM) Subject Perspective [Baseline and Month 3]
Questionnaire to help determine appropriateness of Collaborative Care from participants' perspectives. Score ranges form 5-20 with higher score indication greater appropriateness
- Intervention Appropriateness Measure (IAM) Neurologist Perspective [Baseline and Month 3]
Questionnaire to help determine appropriateness of Collaborative Care from Neurologists' perspectives. Score ranges form 5-20 with higher score indication greater appropriateness
- Individual Participant Collaborative Care Call Attendance Percentage [Weeks 12 and 24]
Individual Participant Collaborative Care Call Attendance Percentage
- change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups [Month 3]
adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state
- change in brEASI (Brief anxiety in epilepsy survey instrument) [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.
- Beck Depression Inventory (BDI) change [Month 6]
proportion achieving 50% symptom reduction or remission by 6 months
- anxiety in epilepsy survey instrument (EASI) change [Month 6]
proportion achieving 50% symptom reduction or remission by 6 months
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of signed and dated Informed Consent Form
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Stated willingness to comply with all study procedures
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Males and Females; Age >= 18 years
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Diagnosis of epilepsy: Epilepsy diagnosis based on neurology clinician impression or EEG findings
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Anxiety or Depression symptoms
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Receiving clinical neurological care at Atrium Health Wake Forest Baptist
Exclusion Criteria:
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Current participation in another treatment of intervention study
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Cognitive limitations precluding completion of Anxiety and Depression self-report instruments on paper, electronically, or by interview
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Comorbid medical condition with life expectancy less than 6 months
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Heidi M Munger Clary, MPH, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00088764