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

Primary Purpose

Recurrent Major Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Online mindfulness based cognitive therapy intervention
Sponsored by
University of Colorado, Boulder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Recurrent Major Depression focused on measuring major depression, Mindfulness based cognitive therapy, MBCT, fMRI, recurrent depression, brain

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion Criteria:

  1. Women with past history of recurrent major depressive disorder

    1. Women who are not currently pregnant
    2. Meeting criteria for prior depression (at least two episodes) and showing residual symptoms of depression (PHQ-9 score of 5-12)
    3. Not meeting criteria for a current active depressive episode (SCID criteria)
    4. Having access to internet and a smartphone with data plan
    5. Receiving no antidepressant/anxiolytic medication or under a stable regime of antidepressants/anxiolytics
  2. Healthy control women

    1. Women that are not currently pregnant
    2. Do not meet criteria for prior or current depression
    3. Have access to internet and a smartphone with data plan

Exclusion Criteria:

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Group

    Control

    Arm Description

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

    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

    Outcomes

    Primary Outcome Measures

    Occurrence of mood episodes and post treatment relapse rate
    Assessed via clinical interview
    Depression symptoms
    Assessed via Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
    Rumination
    Rumination score measured using the Ruminative Response Scale (RRS; Nolen-Hoeksema 1987;1999).
    Cognitive Decentering
    Score in the Experiences Questionnaire (Fresco, Moore, Dulmen, Segal, Ma, Teasdale, & Williams, 2007)
    Self-Compassion
    Self-compassion scores measured using the Self-Compassion Scale (SCS: Neff, 2003).
    Mindfulness
    Score on the Five-factor Mindfulness Scale (FFMQ; Baer, Smith, Hopkins, Krietemeyer & Toney, 2006)
    Autobiographical Memory
    Assessed via the Autobiographical Memory Test (Williams & Broadbent, 1986)
    Self concept
    Assessed via the Twenty Statements Test (Kuhn and McPartland, 1954)
    Brain activity during autobiographical memory recall
    Measured using task-based fMRI bold sequence
    Brain activity in the absence of a task
    Measured using fMRI resting-state bold sequence
    Brain activity during processing of self-referential traits
    Measured using task-based fMRI bold sequence
    Everyday thinking patterns
    Measured with experience sampling in daily life, questions developed for our study

    Secondary Outcome Measures

    Mindfulness
    Assessed using the previously validated breath counting task (Levinson et al., 2014)
    Lexical Associations
    Assessed using the Thought fluency task (Andrews-Hanna et al., in prep.)
    Worry
    Worry score using the Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990).
    Fatigue
    Assessed using the Multidimensional Fatigue Inventory (Smets et al. 1995).
    Physical pain
    Assessed using the Brief Pain Inventory-short form (Cleeland and Ryan, 1994).
    Expectations about treatment outcome
    Score in the Credibility/Expectancy Questionnaire (CEQ, Devilly, G. J., & Borkovec, T. D. 2000)
    Client satisfaction about treatment outcome
    Assessed using the Client Satisfaction Questionnaire (CSQ, Attkisson & Greenfield, 2009).
    Positive and negative emotion
    Assessed by measuring responses while watching emotional movies (based on Gruber et al, 2008)
    Positive and negative affect
    Assessed using the Positive and Negative Affect Scale (PANAS; Watson & Clark, 1994)
    Emotion-induced attentional bias
    Assessed using the dot-brobe task (Kruijt et al., 2016)
    Mind wandering
    Score on the Imaginal Process Inventory (IPI, Singer et al., 1963)
    Well-being
    Assessed via the Ryff Scales of Psychological Well-Being (RYFF; Ryff, 1989; Ryff & Keyes, 1995)

    Full Information

    First Posted
    July 9, 2019
    Last Updated
    September 24, 2019
    Sponsor
    University of Colorado, Boulder
    Collaborators
    Brain & Behavior Research Foundation, Mind and Life Institute, Hadley, Massachusetts, University of Arizona, University of Toronto, Children's Hospital Medical Center, Cincinnati
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04106375
    Brief Title
    Neural Effects of Wellness Classes in Women With Vulnerability to Depression ("The Women's Wellness Study")
    Acronym
    WWS
    Official Title
    Brain Mechanisms of Mindfulness Based Cognitive Therapy in Women at High Risk for Depressive Relapse ("The Women's Wellness Study")
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 5, 2016 (Actual)
    Primary Completion Date
    February 19, 2018 (Actual)
    Study Completion Date
    February 19, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Colorado, Boulder
    Collaborators
    Brain & Behavior Research Foundation, Mind and Life Institute, Hadley, Massachusetts, University of Arizona, University of Toronto, Children's Hospital Medical Center, Cincinnati

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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 relapse in women with past history of major depression when exposed to different forms of self-relevant and context-specific emotional challenge. The investigators also aim to establish psychological and neural mechanisms contributing to depressive symptoms prior to intervention. A key objective of the study is to assess baseline markers of depressive symptoms and possible change resulting from the MBCT intervention from interdisciplinary perspectives, including the psychological perspective (i.e. measured with computer-based tasks, self-report ratings, questionnaires, etc.) and the neural perspective (neural activity measured with functional MRI). In addition, a critical factor the investigators will be observing is the shift from more 'narrative' to 'experiential' forms of self-related awareness as a function of MBCT. Narrative self-focus refers to a concept of self that is extended in time, including past memories and intentions for the future, together with abstract self-representations in relation to socio-emotional values. In contrast, the "experiential self-focus" refers to a more immediate self-experience and is associated with greater awareness of external stimuli and internal somatic-visceral bodily states. MBSR has been shown to increase brain activity in regions relevant for conferring "experiential" self-focus (insula-opercula, dorsal anterior cingulate/supplementary motor area), while decreasing responses in rostral-medial, lateral frontal and hippocampal regions that support the "narrative" mode of self-focus. Such changes in brain activity are associated with increased well-being. Brain regions to be examined include: 1) insula-opercula and dorsal anterior cingulate brain regions responsible for mediating 'narrative' self-focus thinking styles; 2) rostral-medial and lateral frontal, and hippocampal brain regions responsible for mediating 'experiential' self-focus thinking styles; and 3) default mode and insular-paralimbic networks thought to be involved in the generation and maintenance of depressive episodes. Behavioral Tasks Breath Count Task - an objective behavioral measure of mindfulness; Dot-Probe Task - a measure of negative emotion attentional bias Autobiographical Memory Interview - a means to quantify the nature of participants' autobiographical memory recall in an ecologically-valid manner Free-Association Semantic Task - a measure of associative processing Emotional Movies - a measure of emotional reactivity N-Back Task - a measure of working memory. Neuroimaging Tasks Rest Task - a means to examine brain activity and thought content during an unconstrained task 'Narrative' vs 'Experiential' Task during Autobiographical Memory Recall vs. n-back - a means to examine brain activity during 'narrative' vs 'experiential' forms of self-focus during autobiographical memory recall, vs. a demanding working memory task. Self-Syllable Judgment Task - a means to examine brain activity during self-judgment vs non-self-judgment tasks. Thought Sampling Participants will undergo an experience sampling paradigm in which daily thought surveys will be administered multiple times per day over the course of 7-10 days. These thought sampling surveys are designed to estimate several factors characterizing the occurrence of spontaneous thoughts in real-world settings as well as the nature and content of individuals' thoughts in real-world settings.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Major Depression
    Keywords
    major depression, Mindfulness based cognitive therapy, MBCT, fMRI, recurrent depression, brain

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Women with a history of depression and no other mental health disorders undergoing Mindfulness Based Cognitive Therapy.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Online mindfulness based cognitive therapy intervention
    Other Intervention Name(s)
    online MBCT, Mindful mood balance (MMB)
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Occurrence of mood episodes and post treatment relapse rate
    Description
    Assessed via clinical interview
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Depression symptoms
    Description
    Assessed via Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Rumination
    Description
    Rumination score measured using the Ruminative Response Scale (RRS; Nolen-Hoeksema 1987;1999).
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Cognitive Decentering
    Description
    Score in the Experiences Questionnaire (Fresco, Moore, Dulmen, Segal, Ma, Teasdale, & Williams, 2007)
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Self-Compassion
    Description
    Self-compassion scores measured using the Self-Compassion Scale (SCS: Neff, 2003).
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Mindfulness
    Description
    Score on the Five-factor Mindfulness Scale (FFMQ; Baer, Smith, Hopkins, Krietemeyer & Toney, 2006)
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Autobiographical Memory
    Description
    Assessed via the Autobiographical Memory Test (Williams & Broadbent, 1986)
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Self concept
    Description
    Assessed via the Twenty Statements Test (Kuhn and McPartland, 1954)
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Brain activity during autobiographical memory recall
    Description
    Measured using task-based fMRI bold sequence
    Time Frame
    Up to 15 weeks
    Title
    Brain activity in the absence of a task
    Description
    Measured using fMRI resting-state bold sequence
    Time Frame
    Up to 15 weeks
    Title
    Brain activity during processing of self-referential traits
    Description
    Measured using task-based fMRI bold sequence
    Time Frame
    Up to 15 weeks
    Title
    Everyday thinking patterns
    Description
    Measured with experience sampling in daily life, questions developed for our study
    Time Frame
    Up to 15 weeks
    Secondary Outcome Measure Information:
    Title
    Mindfulness
    Description
    Assessed using the previously validated breath counting task (Levinson et al., 2014)
    Time Frame
    Up to 15 weeks
    Title
    Lexical Associations
    Description
    Assessed using the Thought fluency task (Andrews-Hanna et al., in prep.)
    Time Frame
    Up to 15 weeks
    Title
    Worry
    Description
    Worry score using the Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990).
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Fatigue
    Description
    Assessed using the Multidimensional Fatigue Inventory (Smets et al. 1995).
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Physical pain
    Description
    Assessed using the Brief Pain Inventory-short form (Cleeland and Ryan, 1994).
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Expectations about treatment outcome
    Description
    Score in the Credibility/Expectancy Questionnaire (CEQ, Devilly, G. J., & Borkovec, T. D. 2000)
    Time Frame
    Pre-intervention
    Title
    Client satisfaction about treatment outcome
    Description
    Assessed using the Client Satisfaction Questionnaire (CSQ, Attkisson & Greenfield, 2009).
    Time Frame
    Up to 15 weeks
    Title
    Positive and negative emotion
    Description
    Assessed by measuring responses while watching emotional movies (based on Gruber et al, 2008)
    Time Frame
    Up to 15 weeks
    Title
    Positive and negative affect
    Description
    Assessed using the Positive and Negative Affect Scale (PANAS; Watson & Clark, 1994)
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Emotion-induced attentional bias
    Description
    Assessed using the dot-brobe task (Kruijt et al., 2016)
    Time Frame
    Up to 15 weeks
    Title
    Mind wandering
    Description
    Score on the Imaginal Process Inventory (IPI, Singer et al., 1963)
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)
    Title
    Well-being
    Description
    Assessed via the Ryff Scales of Psychological Well-Being (RYFF; Ryff, 1989; Ryff & Keyes, 1995)
    Time Frame
    Throughout study (pre-intervention to 6 months post-intervention)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Inclusion Criteria: 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 Criteria: 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).

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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