Neural Effects of Wellness Classes in Women With Vulnerability to Depression ("The Women's Wellness Study")
NCT04106375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2019-09-27
Summary
The primary objective of the study is to examine the efficacy of mindfulness based cognitive therapy (MBCT) on the prevention of relapse in women with a history of depression. Additionally, the investigators will explore how brain activity might be affected in several brain regions as a result of MBCT. This study consists of two groups, a patient group consisting of women with a history of depression and a control group consisting of healthy women. All participants within the patient group will receive an 8-week MBCT intervention program and will continue their normal medication treatment. Participants will undergo, both pre and post intervention, various behavioral and neuroimaging tasks to assess intervention effects of well-established psychological measurements related to cognitive and emotional function.
Conditions
- Recurrent Major Depression
Interventions
- BEHAVIORAL
-
Online mindfulness based cognitive therapy intervention
MBCT is based on Mindfulness-Based Stress Reduction (MBSR), combining principles of cognitive therapy (CT) with those of mindfulness meditation to prevent depression relapse. Both MBSR and MBCT use contemplative practices, including sitting meditation, body scan and walking meditation, as core methods to teach awareness of negative thoughts and emotions with the aim of disengaging from pervasive patterns of ruminative self-centered mentation. Participants will be given an initial orientation session and then complete an online 8-week MBCT program. Each week participants will take part in one 2-hour online group session and will complete homework assignments anticipated to take 15-30 minutes per day to complete. Additionally, weekly phone coaching will be offered based on the modified tele-coach manual developed by Mohr and colleagues (Duffecy et al. 2010).
Sponsors & Collaborators
-
Brain & Behavior Research Foundation
collaborator OTHER -
Mind and Life Institute, Hadley, Massachusetts
collaborator OTHER -
University of Arizona
collaborator OTHER -
University of Toronto
collaborator OTHER -
Children's Hospital Medical Center, Cincinnati
collaborator OTHER -
University of Colorado, Boulder
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-03-05
- Primary Completion
- 2018-02-19
- Completion
- 2018-02-19
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