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

Not Applicable

Completed

• Conditions: Recurrent Major Depression
• Interventions: Behavioral: Online mindfulness based cognitive therapy intervention

• Registration Number: NCT04106375
• Lead Sponsor: University of Colorado, Boulder

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

1. Breath Count Task - an objective behavioral measure of mindfulness; Dot-Probe Task - a measure of negative emotion attentional bias

2. Autobiographical Memory Interview - a means to quantify the nature of participants' autobiographical memory recall in an ecologically-valid manner

3. Free-Association Semantic Task - a measure of associative processing

4. Emotional Movies - a measure of emotional reactivity

5. N-Back Task - a measure of working memory.

Neuroimaging Tasks

1. Rest Task - a means to examine brain activity and thought content during an unconstrained task

2. '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.

3. 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.

Study Timeline

• Study Start: 2016-03-05
• Primary Completion: 2018-02-19
• Study Completion: 2018-02-19
• Study First Submitted: 2019-07-09
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-24
• Last Update Submitted: 2019-09-24
• Study First Posted: 2019-09-27
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Online mindfulness based cognitive therapy intervention	Women with a history of depression and no other mental health disorders undergoing Mindfulness Based Cognitive Therapy.

Primary Outcome Measures

Name	Time	Method
Self concept	Throughout study (pre-intervention to 6 months post-intervention)	Assessed via the Twenty Statements Test (Kuhn and McPartland, 1954)
Brain activity in the absence of a task	Up to 15 weeks	Measured using fMRI resting-state bold sequence
Occurrence of mood episodes and post treatment relapse rate	Throughout study (pre-intervention to 6 months post-intervention)	Assessed via clinical interview
Cognitive Decentering	Throughout study (pre-intervention to 6 months post-intervention)	Score in the Experiences Questionnaire (Fresco, Moore, Dulmen, Segal, Ma, Teasdale, \& Williams, 2007)
Mindfulness	Throughout study (pre-intervention to 6 months post-intervention)	Score on the Five-factor Mindfulness Scale (FFMQ; Baer, Smith, Hopkins, Krietemeyer \& Toney, 2006)
Autobiographical Memory	Throughout study (pre-intervention to 6 months post-intervention)	Assessed via the Autobiographical Memory Test (Williams \& Broadbent, 1986)
Rumination	Throughout study (pre-intervention to 6 months post-intervention)	Rumination score measured using the Ruminative Response Scale (RRS; Nolen-Hoeksema 1987;1999).
Brain activity during processing of self-referential traits	Up to 15 weeks	Measured using task-based fMRI bold sequence
Depression symptoms	Throughout study (pre-intervention to 6 months post-intervention)	Assessed via Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, \& Williams, 2001)
Self-Compassion	Throughout study (pre-intervention to 6 months post-intervention)	Self-compassion scores measured using the Self-Compassion Scale (SCS: Neff, 2003).
Brain activity during autobiographical memory recall	Up to 15 weeks	Measured using task-based fMRI bold sequence
Everyday thinking patterns	Up to 15 weeks	Measured with experience sampling in daily life, questions developed for our study

Secondary Outcome Measures

Name	Time	Method
Lexical Associations	Up to 15 weeks	Assessed using the Thought fluency task (Andrews-Hanna et al., in prep.)
Fatigue	Throughout study (pre-intervention to 6 months post-intervention)	Assessed using the Multidimensional Fatigue Inventory (Smets et al. 1995).
Client satisfaction about treatment outcome	Up to 15 weeks	Assessed using the Client Satisfaction Questionnaire (CSQ, Attkisson \& Greenfield, 2009).
Mindfulness	Up to 15 weeks	Assessed using the previously validated breath counting task (Levinson et al., 2014)
Worry	Throughout study (pre-intervention to 6 months post-intervention)	Worry score using the Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, \& Borkovec, 1990).
Positive and negative emotion	Up to 15 weeks	Assessed by measuring responses while watching emotional movies (based on Gruber et al, 2008)
Emotion-induced attentional bias	Up to 15 weeks	Assessed using the dot-brobe task (Kruijt et al., 2016)
Physical pain	Throughout study (pre-intervention to 6 months post-intervention)	Assessed using the Brief Pain Inventory-short form (Cleeland and Ryan, 1994).
Expectations about treatment outcome	Pre-intervention	Score in the Credibility/Expectancy Questionnaire (CEQ, Devilly, G. J., \& Borkovec, T. D. 2000)
Well-being	Throughout study (pre-intervention to 6 months post-intervention)	Assessed via the Ryff Scales of Psychological Well-Being (RYFF; Ryff, 1989; Ryff \& Keyes, 1995)
Positive and negative affect	Throughout study (pre-intervention to 6 months post-intervention)	Assessed using the Positive and Negative Affect Scale (PANAS; Watson \& Clark, 1994)
Mind wandering	Throughout study (pre-intervention to 6 months post-intervention)	Score on the Imaginal Process Inventory (IPI, Singer et al., 1963)