The Effects of Chiropractic on Adults With Depression (DEP)

The Effects of Chiropractic on Adults With Depression: a Pilot Study

The goal of this clinical trial is to evaluate the feasibility of the study design in preparation for a future clinical trial examining chiropractic care for adults with mild to moderate depression. We aim to determine whether the study procedures function as intended, including the ability to recruit, retain, and engage participants, as well as whether the intervention is implemented as planned.

The main questions it aims to answer is:

1. Can sufficient eligible participants be enrolled within the planned timeframe?
2. Is there any retention of participant throughout the study duration and the factors contributing to ongoing participation?
3. Can participants adhere to pre-treatment instructions and protocols before their first check-up?
4. Can participants attend and complete all assessments and chiropractic sessions?
5. Can participants fulfill all required study activities without excessive burden?
6. Can chiropractors strictly follow chiropractic adjustments only, without offering any additional treatments?

Researchers will compare adults with depression on the waitlist group to see if chiropractic care effects on adults with depression.

Participants will

• Perform resting state Electrocardiography (ECG)
• Perform resting state Electroencephalography (EEG)
• Perform Event-related potential (ERP) à Auditory and visual stimuli tests
• Complete Patient Reported Outcomes (PROs)
• COMPASS-31
• PROMIS-29
• PROMIS-Cog-8
• Perceived Stress Scale
• Depression Short Form 8a
• Complete Assessment of Acceptability
• Complete Columbia Suicide Severity Rating Scale (C-SSRS)
• Receive 6 weeks of chiropractic care treatment

Study Overview

• Status: Suspended
• Conditions: Depression Disorder
• Intervention / Treatment: Other: Chiropractic Care

Detailed Description

The investigators shall recruit 20 participants for each group, who are currently aged between 18 and 65 years and have mild to moderate depression which is measured by T score.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Marietta, Georgia, United States, 30067
      • Center for Chiropractic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-65 years of age
• Mild (T-score 55-59) to moderate (T-score 60-69) depression, as measured by the PROMIS® Depression - Short Form 8a, an 8-question survey that assesses symptoms like sadness and hopelessness.

Exclusion Criteria:

• Severe suicidal risk
• Diagnosed with any untreated or uncontrolled externalizing disorders (like substance use or antisocial disorder) or thought disorders (like schizophrenia, paranoid personality, or bipolar).
• Diagnosis of rheumatoid arthritis, osteoporosis, or cervical spine instability
• Has hearing impairments (task involves auditory stimuli)
• Currently pregnant (if applicable)
• Chiropractic adjustment within the past 2 weeks
• Scalp injuries or surgeries within the past 3 months
• Prescribed short-acting benzodiazepines, which include midazolam & triazolam
• Current litigation related to a physical, health-related injury.
• Diagnosed heart conditions, including pacemakers.
• Living with and/or caring for someone with a diagnosed neuropsychiatric disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Waitlist Group (WL); After the 6-week lab assessments, the participants in the waitlist (WL) group will be offered 6 weeks of chiropractic care.	Other: Chiropractic Care; Participants of the treatment group will be randomly assigned to chiropractic care for 6 weeks. Participants will have their upper cervical spine (C1/C2) assessed for the presence of vertebral subluxations per the chiropractor's normal and customary procedures.
Experimental: Intervention Group; Within the 6-week lab assessments, the participants in the intervention group will receive 6 weeks of chiropractic care.	Other: Chiropractic Care; Participants of the treatment group will be randomly assigned to chiropractic care for 6 weeks. Participants will have their upper cervical spine (C1/C2) assessed for the presence of vertebral subluxations per the chiropractor's normal and customary procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Sufficient Eligible Participants Enrolled	The proportion of screened participants enrolled within the recruitment timeframe. This assesses recruitment	1 year
Number of Enrolled Control Group Participants	Proportion of enrolled control group participants who complete the final onsite assessment. This assesses retention.	1 year
Number of Participants Who Adhere to Study	Proportion of enrolled participants who adhere to the pre-baseline assessment lifestyle restrictions as instructed. This assesses compliance	1 year
Number of Participants Who Chiropractic Sessions	Proportion of participants attending 90% of chiropractic sessions within 7 weeks. This assesses adherence to treatment	1 year
Number of Participants That Can Fulfill Study Activities	Proportion of participants that can fulfill all required study activities without excessive burden. This assesses tolerability	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Activity (ECG/HRV)	Change from bassline in differences in heart rate variability (HRV)	1 year
Brain Activity (Resting EEG)	Changes in baseline of resting-state brain wave patterns (alpha, beta, theta, delta, gamma).	1 year
Event-Related Potentials (ERP)	Changes from bassline in brain responses to auditory oddball stimuli (e.g., P300 and MMN components), visual oddball stimuli (e.g., N100, N200, P300 ERP components), load-picture stimuli (e.g., N100, N200, P300 ERP components) using EEG.	1 year
Change in Brain-Heart Interplay	Changes in baseline of brain and heart activity to understand potential mechanisms of change utilizing EEG and HRV test such as postural challenge and EEG brain wave recordings.	1 year
Assessment of Acceptability	Participant ratings of acceptability from the participant's perspective, including their experiences with care, interaction with providers, and overall satisfaction with study participation.	1 year
Changes in Columbia Suicide Severity Scale	Change from baseline in suicide risk level measured using the Columbia-Suicide Severity Rating Scale (C-SSRS). This tool assesses the presence and severity of suicidal ideation and behavior using six standardized yes/no items. The outcome is the highest level of suicide risk endorsed. Higher scores indicate greater suicide risk.	1 year
Changes in COMPASS-31	Changes from baseline of self-reported outcomes of neurodegenerative system symptoms utilizing the Composite Autonomic Symptom Score-3 scale. Score range from 0-100. A higher score would indicate worse autonomic symptom severity.	1 year
Changes in PROMIS-29	Changes from baseline of self-reported outcomes of a comprehensive overview of a patient's physical, mental, and social health utilizing the PROMIS-29 scale. T scores range from 20-80 with a higher score indicating better health.	1 year
Changes in Perceived Stress Scale (PSS)	Change from baseline of self-reported symptoms of stress utilizing the Perceived Stress Scale 10. Score ranges from 0-40. A lower score indicates less stress, and a higher score indicates high stress.	1 year
Changes in PROMIS-Cog 8	Changes from baseline of self-reported cognitive abilities, such as memory, attention, and decision-making utilizing the PROMIS-Cog 8 scale. T scores range from 20-80. A higher T score range indicates better cognitive functioning.	1 year
Change in PROMIS Depression 8a	Change from baseline in depressive symptoms measured using the PROMIS Depression Short Form 8a. This questionnaire assesses negative mood, sadness, loss of interest, hopelessness, and related depressive symptoms over the past 7 days. Raw scores from the 8 items are converted into a single PROMIS T-score 20-80, representing overall depression severity. Higher T-scores indicate greater depressive symptom severity.	1 year

Collaborators and Investigators

• Sponsor: Life University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: October 9, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Waitlist; Chiropractic Care
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: I-0035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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