Investigating Biological Markers, Targets, and Intervention for Mood Disorders

NCT04632498 | Terminated

• 1 other identifier: IRB #201645
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Depression; Stress

Keywords

EEG/ERP; Neurophysiology; Endocrine; Cognitive; Mindfulness; Mechanistic Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Electroencephalography (EEG)

  Event-Related Potentials (ERPs)

  36 months

• Electroencephalography (EEG)

  Oscillatory Activity

  36 months

Secondary Outcomes (4)

• Endocrine Measures

  36 months

• Cognitive Behavioral Measure

  36 months

• Cognitive Behavioral Measure

  36 months

• Cognitive Behavioral Measure

  36 months

Other Outcomes (4)

• Clinical Measures

  36 months

• Clinical Measures

  36 months

• Five Facet Mindfulness Questionnaire (FFMQ)

  36 months

Study Arms (3)

Mindfulness Based Intervention (MBI)

EXPERIMENTAL

Patients Active Intervention group

Behavioral: Mindfulness Based Intervention

Wait-list Control (WL)

NO INTERVENTION

Patient Control receiving no treatment

Healthy Control (HC)

NO INTERVENTION

Healthy Control receiving no treatment

Interventions

Mindfulness Based Intervention BEHAVIORAL

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

Also known as: MBI

Mindfulness Based Intervention (MBI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Poppy LA Schoenberg, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Physical Medicine & Rehabilitation

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 17, 2020
• Study Start: October 26, 2021
• Primary Completion: January 15, 2022
• Study Completion: April 3, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 36 months

Locations

US (1)