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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:
Researchers will compare adults with depression on the waitlist group to see if chiropractic care effects on adults with depression.
Participants will
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Intervention Group | Experimental | Within the 6-week lab assessments, the participants in the intervention group will receive 6 weeks of chiropractic care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Chiropractic Research | Marietta | Georgia | 30067 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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 |
| 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 |
| 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 |