The Effects of Chiropractic on Adults With Depression (DEP)

Life University

Status: Begins enrollment this month

Conditions: Depression Disorder

Treatments: Other: Chiropractic Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07260045

I-0035

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Waitlist Group (WL)

Other group

Description:

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

Treatment:

Other: Chiropractic Care

Intervention Group

Experimental group

Description:

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

Treatment:

Other: Chiropractic Care