The Effects of Chiropractic on Adults With Depression

NCT07260045 | Suspended

• 1 other identifier: I-0035
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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

Conditions

Depression Disorder

Keywords

Depression; Waitlist; Chiropractic Care

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (11)

• Changes in Columbia Suicide Severity Scale

  1 year

• Changes in COMPASS-31

  1 year

• Changes in PROMIS-29

  1 year

• Changes in Perceived Stress Scale (PSS)

  1 year

• Changes in PROMIS-Cog 8

  1 year

Study Arms (2)

Waitlist Group (WL)

OTHER

After the 6-week lab assessments, the participants in the waitlist (WL) group will be offered 6 weeks of chiropractic care.

Other: Chiropractic Care

Intervention Group

EXPERIMENTAL

Within the 6-week lab assessments, the participants in the intervention group will receive 6 weeks of chiropractic care.

Other: Chiropractic Care

Interventions

Chiropractic Care OTHER

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.

Intervention Group; Waitlist Group (WL)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Life University: lead

Study Sites (1)

Center for Chiropractic Research

Marietta, Georgia, 30067, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: December 2, 2025
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)