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Completed

NCT Number: NCT04106375

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Other names: online MBCT, Mindful mood balance (MMB)

Primary outcomes

  1. Occurrence of mood episodes and post treatment relapse rate

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

    Assessed via clinical interview

  2. Depression symptoms

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

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

  3. Rumination

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

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

  4. Cognitive Decentering

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

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

  5. Self-Compassion

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

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

  6. Mindfulness

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

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

  7. Autobiographical Memory

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

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

  8. Self concept

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

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

  9. Brain activity during autobiographical memory recall

    Time frame: Up to 15 weeks

    Measured using task-based fMRI bold sequence

  10. Brain activity in the absence of a task

    Time frame: Up to 15 weeks

    Measured using fMRI resting-state bold sequence

  11. Brain activity during processing of self-referential traits

    Time frame: Up to 15 weeks

    Measured using task-based fMRI bold sequence

  12. Everyday thinking patterns

    Time frame: Up to 15 weeks

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

Secondary outcomes

  1. Mindfulness

    Time frame: Up to 15 weeks

    Assessed using the previously validated breath counting task (Levinson et al., 2014)

  2. Lexical Associations

    Time frame: Up to 15 weeks

    Assessed using the Thought fluency task (Andrews-Hanna et al., in prep.)

  3. Worry

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

    Worry score using the Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990).

  4. Fatigue

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

    Assessed using the Multidimensional Fatigue Inventory (Smets et al. 1995).

  5. Physical pain

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

    Assessed using the Brief Pain Inventory-short form (Cleeland and Ryan, 1994).

  6. Expectations about treatment outcome

    Time frame: Pre-intervention

    Score in the Credibility/Expectancy Questionnaire (CEQ, Devilly, G. J., & Borkovec, T. D. 2000)

  7. Client satisfaction about treatment outcome

    Time frame: Up to 15 weeks

    Assessed using the Client Satisfaction Questionnaire (CSQ, Attkisson & Greenfield, 2009).

  8. Positive and negative emotion

    Time frame: Up to 15 weeks

    Assessed by measuring responses while watching emotional movies (based on Gruber et al, 2008)

  9. Positive and negative affect

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

    Assessed using the Positive and Negative Affect Scale (PANAS; Watson & Clark, 1994)

  10. Emotion-induced attentional bias

    Time frame: Up to 15 weeks

    Assessed using the dot-brobe task (Kruijt et al., 2016)

  11. Mind wandering

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

    Score on the Imaginal Process Inventory (IPI, Singer et al., 1963)

  12. Well-being

    Time frame: Throughout study (pre-intervention to 6 months post-intervention)

    Assessed via the Ryff Scales of Psychological Well-Being (RYFF; Ryff, 1989; Ryff & Keyes, 1995)

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

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

Registry information

Official study title

Brain Mechanisms of Mindfulness Based Cognitive Therapy in Women at High Risk for Depressive Relapse ("The Women's Wellness Study")

Acronym: WWS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 27, 2019
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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