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

NYU Langone Health

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: UPLIFT; Behavioral: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03013907

16-01350

Details and patient eligibility

About

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.

Full description

Once 16 participants are enrolled (to form 2 groups of 8 patients each), an independent study staff member will determine participants' group assignments. The randomization sequence will be created a priori by Dr. Keith Goldfeld (biostatistician) by using a computer-generated list of random numbers with stratification by antidepressant medication use and baseline levels of depressive symptoms (PHQ scores <10 and ≥10).

UPLIFT: Eligible participants will complete 8 weekly group sessions by phone. The intervention builds cognitive-behavioral and mindfulness skills to help reduce depressive symptoms. Each hour-long weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment.

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. All treatments received over the course of the study for the UC group and outside of the study (for the intervention group) will be assessed at each time point.

Enrollment: 81 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 2 patient groups

UPLIFT

Experimental group

Description:

Eligible participants will complete 8 weekly group sessions by phone. The intervention builds cognitive-behavioral and mindfulness skills to help reduce depressive symptoms. Each hour-long weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment.

Treatment:

Behavioral: UPLIFT

Usual Care

Active Comparator group

Description:

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. All treatments received over the course of the study for the UC group and outside of the study (for the intervention group) will be assessed at each time point.

Treatment:

Behavioral: Usual care