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

Completed · Not applicable

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT03013907

Run by

NYU Langone Health

People needed

81

Starts

2017-04-01

Expected to finish

2018-10-12

Last updated by the study team

2019-11-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of hypertension based on the criteria in the ICD-9/-10
• Mild to moderate depressive symptoms (PHQ-9 ≥ 5)
• English-speaking
• If taking depression medications, medications must stable for the past 6 weeks (no change to type or dose)
• Willing to provide informed consent, be audio-recorded, and comply with all other aspects of protocol

You may not qualify if…

• Moderate to severe depressive symptoms (PHQ-9 ≥ 15)
• Current substance abuse
• Current eating disorder
• Self-harm within the past 3 months
• Current obsessive-compulsive disorder
• Current anxiety disorder (e.g., PTSD, panic disorder)
• Active suicidal ideation
• History of or current diagnosis of psychosis
• Significant cognitive impairment (mini mental state examination score ≤ 20)
• History of previous training in mindfulness
• History of more than 8 sessions of cognitive behavioral therapy
• Counseling more frequently than once per month

Where it is running

• New York University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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