Depression DisorderDEPNCT07260045
The Effects of Chiropractic on Adults With Depression
A study testing Chiropractic Care in people with Depression Disorder, run by Life University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression Disorder
- What is being tested?
- Chiropractic Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Center for Chiropractic Research
Marietta, Georgia, 30067
About this study
Official title: The Effects of Chiropractic on Adults With Depression: a Pilot Study
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:
Read more
- Can sufficient eligible participants be enrolled within the planned timeframe?
- Is there any retention of participant throughout the study duration and the factors contributing to ongoing participation?
- Can participants adhere to pre-treatment instructions and protocols before their first check-up?
- Can participants attend and complete all assessments and chiropractic sessions?
- Can participants fulfill all required study activities without excessive burden?
- 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
Read the 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.
- Conditions
- Depression Disorder
- Being tested
- Chiropractic Care
- Keywords
- Depression, Waitlist, Chiropractic Care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Chiropractic Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Sufficient Eligible Participants Enrolled
The proportion of screened participants enrolled within the recruitment timeframe. This assesses recruitment
Measured: 1 year
Number of Enrolled Control Group Participants
Proportion of enrolled control group participants who complete the final onsite assessment. This assesses retention.
Measured: 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
Measured: 1 year
Number of Participants Who Chiropractic Sessions
Proportion of participants attending 90% of chiropractic sessions within 7 weeks. This assesses adherence to treatment
Measured: 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
Measured: 1 year
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Heart Activity (ECG/HRV)
Change from bassline in differences in heart rate variability (HRV)
Measured: 1 year
Brain Activity (Resting EEG)
Changes in baseline of resting-state brain wave patterns (alpha, beta, theta, delta, gamma).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Mar 2027 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyson Perez, DC, PhD, Life University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260045
- Sponsor's protocol ID
- I-0035
- Acronym
- DEP
- Status last verified
- May 2026
- First submitted
- 9 Oct 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Chiropractic on Adults With Depression: a Pilot Study
- ClinicalTrials.gov ID
- NCT07260045
- Acronym / sponsor ID
- DEP / I-0035
- Conditions
- Depression Disorder
- Keywords
- Depression, Waitlist, Chiropractic Care
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of funding
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can sufficient eligible participants be enrolled within the planned timeframe?
- Is there any retention of participant throughout the study duration and the factors contributing to ongoing participation?
- Can participants adhere to pre-treatment instructions and protocols before their first check-up?
- Can participants attend and complete all assessments and chiropractic sessions?
- Can participants fulfill all required study activities without excessive burden?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist Group (WL) | Other | Other: Chiropractic CareAfter the 6-week lab assessments, the participants in the waitlist (WL) group will be offered 6 weeks of chiropractic care. |
| Intervention Group | Experimental | Other: Chiropractic CareWithin the 6-week lab assessments, the participants in the intervention group will receive 6 weeks of chiropractic care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic CareParticipants 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. | Other | Intervention Group, Waitlist Group (WL) |
Primary outcome
Number of Sufficient Eligible Participants Enrolled
Time frame: 1 year
The proportion of screened participants enrolled within the recruitment timeframe. This assesses recruitment
Number of Enrolled Control Group Participants
Time frame: 1 year
Proportion of enrolled control group participants who complete the final onsite assessment. This assesses retention.
Number of Participants Who Adhere to Study
Time frame: 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
Time frame: 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
Time frame: 1 year
Proportion of participants that can fulfill all required study activities without excessive burden. This assesses tolerability
11 secondary outcomes
Changes in Columbia Suicide Severity Scale
Time frame: 1 year
Changes in COMPASS-31
Time frame: 1 year
Changes in PROMIS-29
Time frame: 1 year
Changes in Perceived Stress Scale (PSS)
Time frame: 1 year
Changes in PROMIS-Cog 8
Time frame: 1 year
Heart Activity (ECG/HRV)
Time frame: 1 year
Brain Activity (Resting EEG)
Time frame: 1 year
Event-Related Potentials (ERP)
Time frame: 1 year
Change in Brain-Heart Interplay
Time frame: 1 year
Assessment of Acceptability
Time frame: 1 year
Change in PROMIS Depression 8a
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic Care in people with Depression Disorder, run by Life University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Sufficient Eligible Participants Enrolled (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.