Investigating Biological Markers, Targets, and Intervention for Mood Disorders

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Stress; Major Depressive Disorder
• Intervention / Treatment: Behavioral: Mindfulness Based Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Based Intervention (MBI); Patients Active Intervention group	Behavioral: Mindfulness Based Intervention; 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; Other Names: MBI
No Intervention: Healthy Control (HC); Healthy Control receiving no treatment
No Intervention: Wait-list Control (WL); Patient Control receiving no treatment

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Measures	Depression Symptoms	36 months
Clinical Measures	Anxiety Symptoms	36 months
Five Facet Mindfulness Questionnaire (FFMQ)	A 39-item assessment of trait mindfulness (encompassing observing, describing, acting with awareness, non-judging, and non-reactivity).	36 months
Rumination Response Scale (RRS)	22-item assessment that reliably assesses rumination and not confounded by depression. The 22 items of the RRS measure two aspects of rumination, brooding and reflective pondering.	36 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Poppy LA Schoenberg, PhD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Actual): January 15, 2022
• Study Completion (Actual): April 3, 2024

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Mindfulness; Cognitive; EEG/ERP; Endocrine; Neurophysiology; Mechanistic Clinical Trial
• Additional Relevant MeSH Terms: Mental Disorders; Depressive Disorder; Mood Disorders; Depressive Disorder, Major
• Other Study ID Numbers: IRB #201645

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The PI will adhere to the NIH Sharing of Biomedical Research Resources: Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.

1. Quality-controlled raw data as well as processed data used in publications will be de-identified before sharing upon "reasonable request". As described in the proposal, workflows and structure will be exactly described in reports and documented to allow precisely reproduce results from raw data and replicate methodology. Final data (computerized datasets with raw data and derived variables) that have not yet been published will be shared in a timely manner.
2. Software programs (i.e. experimental paradigm scripts produced for this study) and documentation will be made available for research purposes to replicate findings upon "reasonable request", and any software/script sharing requirements by journals.

• IPD Sharing Time Frame: 36 months
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No