Clinical trial NCT03013907: Emotional Awareness and SElf-regulation for Depression in Patients With Hypertension (EASE) Study
Official title: Emotional Awareness and SElf-regulation for Depression in Patients With Hypertension (EASE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Coping
Relaxing
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 81
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility measured by the number of weekly sessions attended
timeFrame: 6 Months
measure: Acceptability
timeFrame: 6 Months
measure: PHQ-9
timeFrame: 6 Months
measure: Quick Inventory of Depressive Symptomatology (QIDS-SR 16)
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Amanda Shallcross, MD
role: PRINCIPAL_INVESTIGATOR
References: