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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
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.
Center for Chiropractic Research
Marietta, Georgia, United States
Number of Sufficient Eligible Participants Enrolled
The proportion of screened participants enrolled within the recruitment timeframe. This assesses recruitment
Time frame: 1 year
Number of Enrolled Control Group Participants
Proportion of enrolled control group participants who complete the final onsite assessment. This assesses retention.
Time frame: 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
Time frame: 1 year
Number of Participants Who Chiropractic Sessions
Proportion of participants attending 90% of chiropractic sessions within 7 weeks. This assesses adherence to treatment
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Heart Activity (ECG/HRV)
Change from bassline in differences in heart rate variability (HRV)
Time frame: 1 year
Brain Activity (Resting EEG)
Changes in baseline of resting-state brain wave patterns (alpha, beta, theta, delta, gamma).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
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