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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: UPLIFT; Behavioral: Usual care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility measured by the number of weekly sessions attended	Determined by the number of weekly sessions attended and number of days of home-based practice completed each week	6 Months
Acceptability	8-item Client Satisfaction Questionnaire (CSQ-8)	6 Months
PHQ-9	validated measure of depressive symptoms. Items rate symptom severity during the prior 2 weeks based on DSM-IV diagnostic criteria for major depression. Scores range from 0-27; scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. The PHQ-9 will be completed at screening and at all study visits (continuous scores).	6 Months
Quick Inventory of Depressive Symptomatology (QIDS-SR 16)	Standardized depression instrument that has treatment sensitivity advantages over the PHQ-9 and will be administered at pre- and post-treatment. Total scores on the QIDS-SR16 range from 0 to 27 and reflect depression severity across 9 domains of the DSM-IV MDD criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes.	6 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Amanda Shallcross, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): October 12, 2018
• Study Completion (Actual): October 12, 2018

Study Registration Dates

• First Submitted: January 5, 2017
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Hypertension; Coping; Relaxing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 16-01350

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No