NYU Managing Epilepsy Well (MEW) Study: A Randomized Controlled Trial of Telephone-Based Support for People With Epilepsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Presence of clinically significant depressive symptoms
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)
UPLIFT is a telephone-based depression self-management program for people with epilepsy.
Intervention: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) (Behavioral)
Arm 2: BOOST (Bringing Out Our Strength Together)
BOOST is a telephone-based support program for people with epilepsy.
Intervention: BOOST (Bringing Out Our Strength Together) (Behavioral)
Outcomes
Primary Outcomes
Presence of clinically significant depressive symptoms
Time Frame: 12 month visit
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.
Presence of clinically significant depressive symptoms
Time Frame: Baseline Visit
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.
Presence of clinically significant depressive symptoms
Time Frame: 3 month visit
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.
Presence of clinically significant depressive symptoms
Time Frame: 6 month visit
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.
Secondary Outcomes
- Change in seizure frequency(Baseline Visit, 3 month visit, 6 month visit, 12 month visit)
- Change in depressive symptom severity(Baseline Visit, 3 month visit, 6 month visit, 12 month visit)
- Change in seizure severity(Baseline Visit, 3 month visit, 6 month visit, 12 month visit)
- Change in general health-related quality of life(Baseline Visit, 3 month visit, 6 month visit, 12 month visit)
- Change in disease-specific quality of life(Baseline Visit, 3 month visit, 6 month visit, 12 month visit)