Anxiety, Depression, Epilepsy
Conditions
Keywords
Neurologic Disorders, Chronic Care, Management, Treatment, SSRI Medication, SNRI Medication, Learning Healthcare System
Brief summary
As a potential solution to address high rates of depression and anxiety seen in epilepsy patients and poor mental health care access, this randomized trial aims to study treatment for anxiety and depression in epilepsy taking place directly within the epilepsy clinic vs. psychiatry referral (typical care). Patients that meet eligibility criteria, including significant symptoms of depression and/or anxiety, will be randomized to the either the intervention group or the control group. Patients that do not meet eligibility requirement or decline the study intervention will have the option of participating in the survey arm of the study. The intervention will consist of an initial prescription for an FDA-approved medication to treat depression/anxiety and telephone-based chronic care management plan for repeated symptom measurement and side effect surveillance. The control group will receive usual care, which is a referral order to psychiatry placed by their treating neurologist. Participants in the survey arm of the study will complete a one time survey.
Detailed description
This trial is an innovative learning healthcare system approach to translate the concept of measurement-based depression care into a specialty clinic setting and extend the concept to treat depression and/or anxiety. The investigators' neurologist/APP-administered medication intervention utilizes FDA-approved drugs with advantageous features for use in epilepsy (escitalopram and venlafaxine) and a telephone-based chronic care management plan for repeated symptom measurement and side effect surveillance. The proposed intervention may overcome barriers to implementing mental health treatment interventions in generalized clinical settings by using healthcare providers commonly present in specialty clinics (physicians and APPs) along with a billable, best practices chronic care management intervention package and EMR-based clinical tools.To test this idea, the investigators seek to pilot a randomized trial of neurologist/APP medication management of depression and anxiety versus usual care with psychiatry referral in the epilepsy clinic, using epilepsy as a paradigm for chronic medical illness with high prevalence of psychiatric comorbidity. The optional survey arm is to help investigators understand the population that do not meet criteria or refuse intervention.
Interventions
Participants will be given escitalopram 10mg by mouth daily and will be followed up with at 2, 4, 6, 8, and 10 weeks. Medication will be adjusted if side effects occur. If unable to tolerate escitalopram, then venlafaxine XR (Effexor XR) 37.5mg will be substituted.
OTHERReferral to Psychiatry
Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance.
OTHERSurvey only
One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessment phone calls for gathering scaled instrument scores will be carried out by a second study coordinator, blinded to treatment assignment.
Intervention model description
Participants will be randomized to one of two groups. Those randomized to the intervention group will receive an epileptologist-driven medication treatment for anxiety and depression, carried out directly in the epilepsy clinic during a regularly scheduled visit and supported by advanced practice provider (APP). Those randomized to the control group will receive an referral order to psychiatry placed by their epileptologist.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Age 18 or older * Ability to take oral medication and the willing to adhere to the intervention regimen * Minimum of 1 prior clinic visit at the Comprehensive Epilepsy Center * Ability to complete questionnaires independently * Diagnosis of epilepsy: EEG with documented seizure or epileptiform discharges OR non-epileptiform EEG and seizure remission with antiseizure drug OR treating epileptologist's leading clinical impression is epilepsy * (Neurological Disorders Depression Inventory for epilepsy, NDDI-E score greater than 15 and/or Generalized Anxiety Disorder-7, GAD-7 score greater than or equal to 10
Exclusion criteria
* Pregnancy or lactation * Known allergic reactions to escitalopram or venlafaxine * Comorbid psychogenic nonepileptic seizures * Prior psychiatric hospitalization * Prior suicide attempt * History of manic or psychotic symptoms (past manic episode (SCID-I), or psychotic symptom screen positive) * Current treatment by a psychiatrist or counselor/therapist * Active suicidality at the time of screening * Current treatment with buspirone or an SSRI/SNRI/atypical antidepressant (specifically bupropion, fluoxetine, levomilnacipran, citalopram, milnacipran, desvenlafaxine, mirtazapine, duloxetine, paroxetine, escitalopram, sertraline, fluvoxamine, venlafaxine, vilazodone, vortioxetine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Intervention | 12 weeks | Percentage of participants who report taking the prescribed medication at 12 weeks and who have completed at least 2 of the chronic care management scheduled visits (telephone or clinic visit) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accrual | baseline | Percentage of patients screened for the trial who are eligible |
| Participants Eligible for Consent Into Treatment Arms | baseline | Percent eligible who consent to participate in treatment study |
| Retention | 12 weeks | Percentage of participants who complete the 12 week outcome assessment |
| Efficacy - Depression Symptoms | baseline | Using Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome. |
| Efficacy - Anxiety Symptoms | baseline | Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Epileptologist-Driven Treatment The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily). | 3 |
| Standard of Care A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.
Referral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance. | 3 |
| Survey Arm This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.
Survey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study. | 63 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Epileptologist-Driven Treatment | Standard of Care | Survey Arm | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 61 Participants | 67 Participants |
| Age, Continuous | 39.0 years STANDARD_DEVIATION 6.1 | 41.3 years STANDARD_DEVIATION 4 | 42.2 years STANDARD_DEVIATION 13.5 | 42.0 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 47 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 12 Participants | 12 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 9 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 48 Participants | 53 Participants |
| Region of Enrollment United States | 3 participants | 3 participants | 63 participants | 69 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 40 Participants | 42 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 23 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 1 / 63 |
| other Total, other adverse events | 3 / 3 | 1 / 3 | 0 / 63 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 1 / 63 |
Outcome results
Primary
Adherence to Intervention
Percentage of participants who report taking the prescribed medication at 12 weeks and who have completed at least 2 of the chronic care management scheduled visits (telephone or clinic visit)
Time frame: 12 weeks
Population: This outcome only pertains to the experimental arm. This was an intention-to treat analysis including all who were randomized to the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epileptologist-Driven Treatment | Adherence to Intervention | 2 Participants |
| Standard of Care | Adherence to Intervention | 0 Participants |
| Survey Arm | Adherence to Intervention | 0 Participants |
Secondary
Accrual
Percentage of patients screened for the trial who are eligible
Time frame: baseline
Population: Number of participants analyzed were not all consented or randomized. These were pre-screening numbers.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epileptologist-Driven Treatment | Accrual | 19 Participants |
Secondary
Efficacy - Anxiety Symptoms
Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes.
Time frame: 12 weeks
Population: This outcome does not apply to survey arm. 12 week measurements were done after subjects in each treatment arm were lost to follow up and withdrew consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epileptologist-Driven Treatment | Efficacy - Anxiety Symptoms | 9.5 score on a scale | Standard Deviation 9.2 |
| Standard of Care | Efficacy - Anxiety Symptoms | 11 score on a scale | — |
Secondary
Efficacy - Anxiety Symptoms
Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes.
Time frame: baseline
Population: This outcome does not apply to survey arm. Baseline measurements were done before subjects in each treatment arm were lost to follow up and withdrew consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epileptologist-Driven Treatment | Efficacy - Anxiety Symptoms | 18.0 score on a scale | Standard Deviation 9.6 |
| Standard of Care | Efficacy - Anxiety Symptoms | 10.5 score on a scale | Standard Deviation 2.1 |
Secondary
Efficacy - Depression Symptoms
Using Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome.
Time frame: baseline
Population: This outcome does not apply to survey arm. Baseline measurements were done before subjects in each treatment arm were lost to follow up and withdrew consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epileptologist-Driven Treatment | Efficacy - Depression Symptoms | 26.7 score on a scale | Standard Deviation 3.5 |
| Standard of Care | Efficacy - Depression Symptoms | 21.0 score on a scale | Standard Deviation 7.2 |
Secondary
Efficacy - Depression Symptoms
Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome.
Time frame: 12 weeks
Population: This outcome does not apply to survey arm. 12 week measurements were done after subjects in each treatment arm were lost to follow up and withdrew consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epileptologist-Driven Treatment | Efficacy - Depression Symptoms | 25.0 score on a scale | Standard Deviation 5.7 |
| Standard of Care | Efficacy - Depression Symptoms | 17.0 score on a scale | Standard Deviation 8.5 |
Secondary
Participants Eligible for Consent Into Treatment Arms
Percent eligible who consent to participate in treatment study
Time frame: baseline
Population: This is the number who were pre-screened and who were eligible to consent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epileptologist-Driven Treatment | Participants Eligible for Consent Into Treatment Arms | 6 Participants |
Secondary
Retention
Percentage of participants who complete the 12 week outcome assessment
Time frame: 12 weeks
Population: This was an intention-to treat analysis including all who were randomized to the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epileptologist-Driven Treatment | Retention | 2 Participants |
| Standard of Care | Retention | 2 Participants |
| Survey Arm | Retention | 0 Participants |