Status:
COMPLETED
Neural Effects of Wellness Classes in Women With Vulnerability to Depression ("The Women's Wellness Study")
Lead Sponsor:
University of Colorado, Boulder
Collaborating Sponsors:
Brain & Behavior Research Foundation
Mind and Life Institute, Hadley, Massachusetts
Conditions:
Recurrent Major Depression
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief 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 invest...
Detailed Description
Overall, this study aims to characterize the neural and psychological effects of an eight-week mindfulness based cognitive therapy (MBCT) intervention (online group class) in preventing depressive rel...
Eligibility Criteria
Inclusion
- Women with past history of recurrent major depressive disorder
- Women who are not currently pregnant
- Meeting criteria for prior depression (at least two episodes) and showing residual symptoms of depression (PHQ-9 score of 5-12)
- Not meeting criteria for a current active depressive episode (SCID criteria)
- Having access to internet and a smartphone with data plan
- Receiving no antidepressant/anxiolytic medication or under a stable regime of antidepressants/anxiolytics
- Healthy control women
- Women that are not currently pregnant
- Do not meet criteria for prior or current depression
- Have access to internet and a smartphone with data plan
Exclusion
- Exclusion criteria for all participants include:
- Current diagnoses of: psychosis, bipolar disorder/maniac episodes, OCD, persistent antisocial behavior, severe developmental delay, or persistent self-injury needing clinical management or therapy, organic brain injury, substance misuse.
- Past diagnoses of psychosis, bipolar disorder/mania episodes or OCD.
- Use of marijuana equal or more than 4 days per week.
- Additional exclusion criteria related to Magnetic Resonance Imaging safety requirements:
- We will exclude participants who have metal or electrical equipment including:
- Non-removable metal piercing
- Tattoos on head or neck, an older tattoo with metal-containing inks, and/or permanent makeup (eyeliner).
- An implanted (internal) defibrillator or pacemaker
- Cochlear (ear) implant
- Some type of clips used on brain aneurysms
- An intrauterine device (IUD) that is not compatible with the MRI scanner
- An implanted infusion pump device like an insulin pump
- Implanted nerve stimulators
- Magnetic dental appliances or fillings
- Metal plates, screws, staples, joint replacement, and prosthetics.
- Additional exclusion criteria for all participants include the following:
- Clear claustrophobic symptoms.
- Abnormal capability of performing the experimental tasks as they are designed and implemented (e.g., unable to read, unable to cooperate during fMRI examination, showing visual processing impairments that cannot be corrected using lenses or any significant impairments in the processing of auditory stimulation).
Key Trial Info
Start Date :
March 5 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04106375
Start Date
March 5 2016
End Date
February 19 2018
Last Update
September 27 2019
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