Telephone-Based Support Programs for People With Epilepsy

NYU Langone Health

Status: Enrolling

Conditions: Epilepsy

Treatments: Behavioral: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts); Behavioral: BOOST (Bringing Out Our Strength Together)

Study type: Interventional

Funder types: Other

Identifiers

NCT05082181

21-00446

Details and patient eligibility

About

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.

Full description

The objectives of the trial are:

1. To test effects of UPLIFT versus BOOST on changes in depressive symptoms (primary outcome) in PWE over 12 months.
2. To test effects of UPLIFT versus BOOST on changes in quality of life and seizures (secondary outcomes) in PWE over 12 months.
3. To test whether intervention effects are mediated by increases in mindfulness and decreases in rumination.
4. To test whether intervention effects are moderated by participant characteristics and facilitator characteristics.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)

Experimental group

Description:

UPLIFT is a telephone-based depression self-management program for people with epilepsy.

Treatment:

Behavioral: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)

Arm 2: BOOST (Bringing Out Our Strength Together)

Active Comparator group

Description:

BOOST is a telephone-based support program for people with epilepsy.

Treatment:

Behavioral: BOOST (Bringing Out Our Strength Together)