Emotional Awareness and SElf-regulation for Depression in Patients With Hypertension (EASE) Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/31/2018 |
| Start Date: | April 1, 2017 |
| End Date: | October 2019 |
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.
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.
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.
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.
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
We found this trial at
1
site
New York, New York 10021
Principal Investigator: Amanda Shallcross, MD
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