Neural Effects of Wellness Classes in Women With Vulnerability to Depression ("The Women's Wellness Study")

NCT04106375 | Completed

• 1 other identifier: 13-0257
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 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

Keywords

major depression; Mindfulness based cognitive therapy; MBCT; fMRI; recurrent depression; brain

Outcome Measures

Primary Outcomes (12)

• Occurrence of mood episodes and post treatment relapse rate

  Assessed via clinical interview

  Throughout study (pre-intervention to 6 months post-intervention)

• Depression symptoms

  Assessed via Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, \& Williams, 2001)

  Throughout study (pre-intervention to 6 months post-intervention)

• Rumination

  Rumination score measured using the Ruminative Response Scale (RRS; Nolen-Hoeksema 1987;1999).

  Throughout study (pre-intervention to 6 months post-intervention)

• Cognitive Decentering

  Score in the Experiences Questionnaire (Fresco, Moore, Dulmen, Segal, Ma, Teasdale, \& Williams, 2007)

  Throughout study (pre-intervention to 6 months post-intervention)

• Self-Compassion

  Self-compassion scores measured using the Self-Compassion Scale (SCS: Neff, 2003).

  Throughout study (pre-intervention to 6 months post-intervention)

• Mindfulness

  Score on the Five-factor Mindfulness Scale (FFMQ; Baer, Smith, Hopkins, Krietemeyer \& Toney, 2006)

  Throughout study (pre-intervention to 6 months post-intervention)

• Autobiographical Memory

  Assessed via the Autobiographical Memory Test (Williams \& Broadbent, 1986)

  Throughout study (pre-intervention to 6 months post-intervention)

• Self concept

  Assessed via the Twenty Statements Test (Kuhn and McPartland, 1954)

  Throughout study (pre-intervention to 6 months post-intervention)

• Brain activity during autobiographical memory recall

  Measured using task-based fMRI bold sequence

  Up to 15 weeks

• Brain activity in the absence of a task

  Measured using fMRI resting-state bold sequence

  Up to 15 weeks

• Brain activity during processing of self-referential traits

  Measured using task-based fMRI bold sequence

  Up to 15 weeks

• Everyday thinking patterns

  Measured with experience sampling in daily life, questions developed for our study

  Up to 15 weeks

Secondary Outcomes (12)

• Mindfulness

  Up to 15 weeks

• Lexical Associations

  Up to 15 weeks

• Worry

  Throughout study (pre-intervention to 6 months post-intervention)

• Fatigue

  Throughout study (pre-intervention to 6 months post-intervention)

• Physical pain

  Throughout study (pre-intervention to 6 months post-intervention)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Women with a history of depression and no other mental health disorders undergoing Mindfulness Based Cognitive Therapy.

Behavioral: Online mindfulness based cognitive therapy intervention

Control

NO INTERVENTION

Healthy women with no prior history of depression or other mental health disorders as a control group for time-repetition effects on brain activity and task performance

Interventions

Online mindfulness based cognitive therapy intervention BEHAVIORAL

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).

Also known as: online MBCT, Mindful mood balance (MMB)

Intervention Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• Clear claustrophobic symptoms.

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• Brain & Behavior Research Foundation: collaborator
• Mind and Life Institute, Hadley, Massachusetts: collaborator
• University of Arizona: collaborator
• University of Toronto: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI of study (previously employed by CU)

Model Details: One group of 25 currently remitted recurrent major depression patients undergoing mindfulness based cognitive therapy for 8 weeks and one group of 25 matched healthy controls to control for time-repetition effects on brain activity and task performance

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: September 27, 2019
• Study Start: March 5, 2016
• Primary Completion: February 19, 2018
• Study Completion: February 19, 2018
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share