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

NCT03013907 | Completed

• 1 other identifier: 16-01350
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension

Keywords

Hypertension; Coping; Relaxing

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

UPLIFT

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

UPLIFT BEHAVIORAL

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

UPLIFT

Usual care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Amanda Shallcross, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 9, 2017
• Study Start: April 1, 2017
• Primary Completion: October 12, 2018
• Study Completion: October 12, 2018
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

US (1)