Investigating Biological Markers, Targets, and Intervention for Mood Disorders

NCT ID: NCT04632498

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-26
• Study Completion Date: 2024-04-03

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.

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.

Conditions

Major Depressive Disorder; Depression; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Mindfulness Based Intervention (MBI)

Patients Active Intervention group

Group Type: EXPERIMENTAL

Mindfulness Based Intervention

Intervention Type: 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

Wait-list Control (WL)

Patient Control receiving no treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Control (HC)

Healthy Control receiving no treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

MBI

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David J. Kennedy

Professor and Chair, Department of Physical Medicine & Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Poppy LA Schoenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

IRB #201645

Identifier Type: -

Identifier Source: org_study_id