NCT05082181

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Nov 2021Aug 2027

First Submitted

Initial submission to the registry

September 30, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

November 9, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

5.8 years

First QC Date

September 30, 2021

Last Update Submit

February 13, 2026

Conditions

Epilepsy

Keywords

EpilepsyDepressionSeizuresQuality of lifeMindfulnessTelehealth

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • Change in depressive symptom severity

    Baseline Visit, 3 month visit, 6 month visit, 12 month visit

  • Change in seizure frequency

    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 disease-specific quality of life

    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

Other Outcomes (8)

  • Change in perceived social support

    Baseline Visit, 3 month visit, 6 month visit, 12 month visit

  • Change in mindfulness

    Baseline Visit, 3 month visit, 6 month visit, 12 month visit

  • Change in rumination

    Baseline Visit, 3 month visit, 6 month visit, 12 month visit

  • +5 more other outcomes

Study Arms (2)

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

EXPERIMENTAL

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

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

Arm 2: BOOST (Bringing Out Our Strength Together)

ACTIVE COMPARATOR

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

Behavioral: BOOST (Bringing Out Our Strength Together)

Interventions

UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)BEHAVIORAL

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.

Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)
BOOST (Bringing Out Our Strength Together)BEHAVIORAL

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.

Arm 2: BOOST (Bringing Out Our Strength Together)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

EpilepsyDepressionSeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Friedman, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

  • Tanya Spruill, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanya Spruill, PhD

CONTACT

646-501-3429Tanya.Spruill@nyulangone.org

Alexis Bartelloni, MSPH

CONTACT

Alexis.Bartelloni@nyulangone.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 18, 2021

Study Start

November 9, 2021

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Tanya.Spruill@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)