Investigating Biological Markers, Targets, and Intervention for Mood Disorders

Study Overview
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Brief Summary
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This multi-modal methods study will investigate neurophysiological, endocrinological, cognitive, psycho-social-emotional markers of disease, and targets for integrative health treatments in mood disorders.

Detailed Description
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It is estimated that 16.2 million adults in the USA suffer at least one depressive episode any given year. Mood disorders are associated with decreased quality of life, attention, memory, and executive function deficits, and increased health care cost. Despite successful medication and psychotherapies, mood disorders rarely respond completely to common treatment options. MBI's offer a low-cost, non-pharmacological alternative with accruing efficacy. Developing robust and specific non-pharmacologic intervention programs, on par with pharmacological clinical outcomes without harmful side-effects is a crucial unmet clinical need and a research priority for the NCCIH. Understanding the mechanistic pathways of these interventions is key to their clinical development and implementation for treating depression in primary care. Mindfulness-Based Interventions (MBIs) show similar clinical efficacy for mood disorders as pharmacology, and co-morbid symptoms of depression and anxiety. There is substantial consistent and replicated empirical evidence across multiple clinical sites highlighting the clinical efficacy of MBI in decreasing risk of depressive relapse ascertained from randomized RCTs comparing MBI with treatment as usual. Meta-analysis including 183 patients with Multiple Sclerosis showed efficacy in psychosocial outcomes, quality of life, anxiety, depression, and select physical symptoms including fatigue, pain, and vestibular symptoms. The clinical efficacy of MBIs appears to extend mood disorders, as a systematic review including 13 studies in fibromyalgia, chronic fatigue, and irritable bowel syndrome showed significant effect sizes, reported as standardized mean difference (SMD), compared to control conditions in reducing depression (SMD= -.23), anxiety (SMD= -.20), symptom severity (SMD= -.40), and pain (SMD= -.21). Cognitively, MBIs appear to enhance executive control and self-regulatory processing, that has a beneficial effect upon emotion regulation, pain perception, and has shown to reduce rumination in depression. This overarching study aims to identify key phenotypic markers and treatment targets of mood disorders, and further understand MBI mechanism in its treatment.

Official Title
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Investigating Biological Markers, Targets, and Intervention for Mood Disorders

Conditions
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Stress, Major Depressive Disorder, Depression

Intervention / Treatment
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* Behavioral: Mindfulness Based Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Patients: Age range: 18-65 years Must possess English language skills sufficient for providing informed consent, completing questionnaires, and understanding instructions If currently taking maintenance anti-depressant and/or anti-anxiety medication, must have a stable regimen as indexed by no medication or dosage changes within the past month IDS score ≥18 Currently depressed patients will be defined as: PHQ-9 score range 15 - 27 (moderately severe/severe depressive severity) Remitted depressed patients will be defined as: number of depressive episodes must be ≥ 3 and a PHQ-9 score of < 5 (minimal depression) Blood Collection Inclusion: At least 110 pounds Generally healthy by self-report on day of collection (i.e., free of cold and flu symptoms on the day of collection, no infections within two weeks prior to collection, no known sickle cell disease) Including the study draw, blood donation for clinical or research purposes within the preceding eight weeks will not exceed 550 mL No more than one blood draw will have occurred during the preceding week Exclusion Criteria for Patients: Prior diagnosis of bipolar I, bipolar II, psychotic personality disorder, borderline personality disorder, and/or narcissistic personality disorder Current history (equal/less than 6 months) of substance abuse/dependence Current history (equal/less than 6 months) of regular meditation practice (>1 session/week; >10 min/session) History of medical illness associated with possible changes in cerebral tissue or cerebrovasculature (e.g., stroke) or with neurologic abnormality (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma, defined by loss of consciousness of ≥ 5 minutes) Current suicidal ideation Exclusion Criteria for Healthy Controls: Previous or current mental health history (depression) Current history (equal/less than 6 months) of substance abuse/dependence History of medical illness associated with possible changes in cerebral tissue or cerebrovasculature (e.g., stroke) or with neurologic abnormality (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma, defined by loss of consciousness of ≥ 5 minutes) Current suicidal ideation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Based Intervention (MBI)<br>Patients Active Intervention group | Behavioral: Mindfulness Based Intervention<br>* Standardized 8-week Cognitive and Behavioral Psychotherapy group with 26 hrs of in-class training and homework, along with 1 all-day retreat in which core mindfulness skills are developed<br>* Other names: MBI;|
| No Intervention: Wait-list Control (WL)<br>Patient Control receiving no treatment | |
| No Intervention: Healthy Control (HC)<br>Healthy Control receiving no treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalography (EEG) | Event-Related Potentials (ERPs) | 36 months | 
| Electroencephalography (EEG) | Oscillatory Activity | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endocrine Measures | Oxytocin, Cortisol | 36 months | 
| Cognitive Behavioral Measure | Executive Functioning | 36 months | 
| Cognitive Behavioral Measure | Working Memory | 36 months | 
| Cognitive Behavioral Measure | Social Emotional Processing | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG/ERP, Neurophysiology, Endocrine, Cognitive, Mindfulness, Mechanistic Clinical Trial