Telephone-Based Support Programs for People With Epilepsy

Study Overview
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Brief Summary
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This is a two-arm randomized controlled trial to compare telephone-based depression self-management (UPLIFT) to telephone-based support groups (BOOST). A sample of 120 English- and Spanish-speaking people with epilepsy (PWE) with elevated depressive symptoms will be enrolled. Both interventions are 8-week programs delivered in one-hour weekly sessions to groups of about 6 participants. Changes in depressive symptoms, quality of life and seizures will be assessed over 12 months. The trial will also examine mediators and moderators of treatment effects.

Detailed Description
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The objectives of the trial are: To test effects of UPLIFT versus BOOST on changes in depressive symptoms (primary outcome) in PWE over 12 months. To test effects of UPLIFT versus BOOST on changes in quality of life and seizures (secondary outcomes) in PWE over 12 months. To test whether intervention effects are mediated by increases in mindfulness and decreases in rumination. To test whether intervention effects are moderated by participant characteristics and facilitator characteristics.

Official Title
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NYU Managing Epilepsy Well (MEW) Study: A Randomized Controlled Trial of Telephone-Based Support for People With Epilepsy

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)
* Behavioral: BOOST (Bringing Out Our Strength Together)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult (≥18 years of age); diagnosed with epilepsy for at least one year; fluent in English or Spanish; elevated depressive symptoms (PHQ-9 score ≥10); willing to participate in audiotaped group telephone sessions Exclusion Criteria: severe depressive symptoms (PHQ-9 ≥20); active suicidal ideation (PHQ-9 item #9 ≥1 or otherwise reported during screening); active psychotic disorder (psychiatric diagnosis or antipsychotic medications in the EHR); significant cognitive impairment (indicated in EHR or evident during screening)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)<br>UPLIFT is a telephone-based depression self-management program for people with epilepsy. | Behavioral: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)<br>* UPLIFT is an 8-week program that combines cognitive behavioral therapy (CBT) and mindfulness techniques and is delivered to small groups of participants by phone. Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise, and a home practice assignment. CBT-related skills include thought monitoring, identifying cognitive distortions, problem identification, goal setting, and identifying supports. Relaxation exercises are also used for coping and to facilitate awareness of the body. Mindfulness activities include attention to breath, sights and sounds and other meditations. Audio guides are provided for home practice of mindfulness exercises.<br>|
| Active Comparator: Arm 2: BOOST (Bringing Out Our Strength Together)<br>BOOST is a telephone-based support program for people with epilepsy. | Behavioral: BOOST (Bringing Out Our Strength Together)<br>* BOOST is a telephone-based support program delivered in 8 weekly group sessions. Each weekly session is 1 hour long and is comprised of a check-in period, introduction of the week's topic, and group discussion. Weekly BOOST session topics include: (1) personal experience of epilepsy; (2) personal experience of mood problems (depression, anxiety, stress); (3) seizure triggers; (4) concerns related to epilepsy treatment (e.g., medication adherence, side effects); (5) changes in seizures over time; (6) the impact of behavior (e.g., sleep, substance use) on seizures; (7) social relationships and epilepsy; and (8) review of the BOOST experience.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of clinically significant depressive symptoms | The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of <5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms. | Baseline Visit | 
| Presence of clinically significant depressive symptoms | The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of <5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms. | 3 month visit | 
| Presence of clinically significant depressive symptoms | The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of <5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms. | 6 month visit | 
| Presence of clinically significant depressive symptoms | The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of <5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms. | 12 month visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptom severity | Continuous PHQ-9 scores will be used to evaluate the magnitude of change in depressive symptoms. The PHQ-9 consists of nine questions that ask respondents how often they've been bothered by any of the following problems in the past two weeks. The questions address sleep, energy, appetite, and other possible symptoms of depression. Scores are calculated based on how frequently a person experiences these feelings. Score of 1-4 is considered minimal depression; score of 5-9 is considered mild depression; score of 10-14 is considered moderate depression; score of 15-19 is considered moderately severe depression; score of 20-27 is considered severe depression. | Baseline Visit, 3 month visit, 6 month visit, 12 month visit | 
| Change in seizure frequency | This will be assessed by self-reported 30-day seizure counts. | Baseline Visit, 3 month visit, 6 month visit, 12 month visit | 
| Change in seizure severity | This will be assessed by a 12-item version of the Liverpool Seizure Severity Scale. The possible scoring ranges are between 7 and 32 for the percept scale and between 10 and 48 for the ictal/postictal scale. The higher the score the more severe the seizures. | Baseline Visit, 3 month visit, 6 month visit, 12 month visit | 
| Change in disease-specific quality of life | This will be assessed by the Quality of Life in Epilepsy-10 (QOLIE-10) questionnaire, a 10-item measure of epilepsy-specific aspects of qualify of life. The QOLIE-10-P is a brief survey of health-related quality of life for adults with epilepsy. There are 10 questions about health and daily activities, one question about how much distress you feel about problems and worries related to epilepsy, and a review of what bothers you most. | Baseline Visit, 3 month visit, 6 month visit, 12 month visit | 
| Change in general health-related quality of life | This will be assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-10) questionnaire, a 10-item measure of global health (physical, mental and social functioning) developed by NIH as an indicator for Healthy People 2020. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the T-Score. The average T-Score for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. | Baseline Visit, 3 month visit, 6 month visit, 12 month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Depression, Seizures, Quality of life, Mindfulness, Telehealth