Stress Management to Support Women's Health
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|ClinicalTrials.gov Identifier: NCT03223545|
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : August 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Stress Cardiovascular Diseases||Behavioral: MBCT-T Behavioral: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Stress Management to Support Women's Health|
|Actual Study Start Date :||May 7, 2018|
|Actual Primary Completion Date :||July 17, 2020|
|Actual Study Completion Date :||July 17, 2020|
|Experimental: Mindfulness-based cognitive therapy delivered by telephone||
This 8-week program combines mindfulness training with cognitive therapy and is delivered to small groups of patients by telephone using a conference line. Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise, and a home-based practice assignment.
|Placebo Comparator: Usual Care (UC)||
Behavioral: Usual Care
Treatment guidelines recommend counseling patients with prehypertension on the importance of lifestyle modification to reduce BP. Because of variability in counseling across primary care practices, the study team will provide all participants with NHLBI print educational materials to ensure exposure to lifestyle recommendations: "Your Guide to Lowering Blood Pressure"; and "Facts about the DASH Eating Plan".
- Blood pressure [ Time Frame: 3 Months ]The mean of three BP readings taken by a trained RA with an automated and validated BP monitor (Microlife WatchBP Office) will be recorded at each visit. Participants will be seated comfortably for 5 minutes with feet flat on the ground prior to measurements. The device will take three readings at 2-minute intervals.
- Perceived stress [ Time Frame: 3 Months ]Items are rated on a 5-point scale, and higher total scores indicate greater perceived stress.
- Measure of Depressive Symptoms using the PHQ-8 [ Time Frame: 3 Months ]The PHQ-8 is a validated measure of depressive symptoms during the prior two weeks based on DSM-IV diagnostic criteria for major depression. The PHQ-8 will be completed at screening; patients with scores ≥10, suggestive of clinically significant depressive symptoms, will be excluded and provided with treatment referrals.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223545
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Tanya Spruill, MD||NYU Langone Health|