Depression Disorder
Conditions
Keywords
Depression, Waitlist, Chiropractic Care
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: 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
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.
Interventions
OTHERChiropractic 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.
Sponsors
Life University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sufficient Eligible Participants Enrolled | 1 year | The proportion of screened participants enrolled within the recruitment timeframe. This assesses recruitment |
| Number of Enrolled Control Group Participants | 1 year | Proportion of enrolled control group participants who complete the final onsite assessment. This assesses retention. |
| Number of Participants Who Adhere to Study | 1 year | Proportion of enrolled participants who adhere to the pre-baseline assessment lifestyle restrictions as instructed. This assesses compliance |
| Number of Participants Who Chiropractic Sessions | 1 year | Proportion of participants attending 90% of chiropractic sessions within 7 weeks. This assesses adherence to treatment |
| Number of Participants That Can Fulfill Study Activities | 1 year | Proportion of participants that can fulfill all required study activities without excessive burden. This assesses tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Activity (ECG/HRV) | 1 year | Change from bassline in differences in heart rate variability (HRV) |
| Brain Activity (Resting EEG) | 1 year | Changes in baseline of resting-state brain wave patterns (alpha, beta, theta, delta, gamma). |
| Event-Related Potentials (ERP) | 1 year | 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. |
| Changes in Columbia Suicide Severity Scale | 1 year | 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. |
| Assessment of Acceptability | 1 year | Participant ratings of acceptability from the participant's perspective, including their experiences with care, interaction with providers, and overall satisfaction with study participation. |
| Change in PROMIS Depression 8a | 1 year | 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. |
| Change in Brain-Heart Interplay | 1 year | 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. |
| Changes in COMPASS-31 | 1 year | 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. |
| Changes in PROMIS-29 | 1 year | 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. |
| Changes in Perceived Stress Scale (PSS) | 1 year | 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. |
| Changes in PROMIS-Cog 8 | 1 year | 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. |
Countries
United States
Contacts
Primary ContactDaekiara Smith-Ireland, MPH, DrPH
Backup ContactTahamina Principal Investigator, MBBS, PhD
Outcome results
None listed