Investigating Biological Markers, Targets, and Intervention for Mood Disorders

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04632498

Collaborator

(none)

Enrollment

Location

Arms

20.5

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Depression Stress	Behavioral: Mindfulness Based Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Investigating Biological Markers, Targets, and Intervention for Mood Disorders

Actual Study Start Date :

Oct 26, 2021

Anticipated Primary Completion Date :

Jul 11, 2023

Anticipated Study Completion Date :

Jul 11, 2023

Arms and Interventions

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: Wait-list Control (WL) Patient Control receiving no treatment
No Intervention: Healthy Control (HC) Healthy Control receiving no treatment

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: Wait-list Control (WL)

Patient Control receiving no treatment

No Intervention: Healthy Control (HC)

Healthy Control receiving no treatment

Outcome Measures

Primary Outcome Measures

Electroencephalography (EEG) [36 months]
Event-Related Potentials (ERPs)
Electroencephalography (EEG) [36 months]
Oscillatory Activity

Secondary Outcome Measures

Endocrine Measures [36 months]
Oxytocin, Cortisol
Cognitive Behavioral Measure [36 months]
Executive Functioning
Cognitive Behavioral Measure [36 months]
Working Memory
Cognitive Behavioral Measure [36 months]
Social Emotional Processing

Other Outcome Measures

Clinical Measures [36 months]
Depression Symptoms
Clinical Measures [36 months]
Anxiety Symptoms
Five Facet Mindfulness Questionnaire (FFMQ) [36 months]
A 39-item assessment of trait mindfulness (encompassing observing, describing, acting with awareness, non-judging, and non-reactivity).
Rumination Response Scale (RRS) [36 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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