MedTrace Logo

Emotional Awareness and SElf-regulation for Depression in Patients With Hypertension (EASE) Study

NCT03013907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2019-11-13

No results posted yet for this study

Summary

The purpose of this study is to adapt and then evaluate the feasibility, acceptability, and efficacy of a telephone-based intervention (UPLIFT: Using Practice and Learning to Increase Favorable Thoughts) for individuals with elevated depressive symptoms and hypertension. UPLIFT is a group-based intervention that is delivered over 8 weekly sessions for 1 hour/week by phone.

Aim 1 of this study is to adapt UPLIFT using qualitative focus groups and individual interviews and to test the adapted UPLIFT program in a single-arm design. Aim 2 of this study is a randomized controlled trial (RCT) that will compare the effects of the adapted UPLIFT program to usual care (UC) and to test mediators and moderators of the effects of UPLIFT.

Conditions

Interventions

BEHAVIORAL

UPLIFT

Session 1: Introduction to UPLIFT/Noticing Thoughts Session 2: Checking and Changing Thoughts Session 3: Coping \& Relaxing Session 4: Attention \& Mindfulness Session 5: The Present as a Calm Place Session 6: Thoughts as Changeable, Thoughts as Not Fixed Session 7: Focus on Pleasure \& the Importance of Reinforcement Session 8: Preventing Lapses and Giving Thanks

BEHAVIORAL

Usual care

Subjects randomized to UC will be advised to seek help from their primary care physician (PCP) or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study

Sponsors & Collaborators

Principal Investigators

  • Amanda Shallcross, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2018-10-12
Completion
2018-10-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03013907 on ClinicalTrials.gov