OMT as an Adjunctive Treatment in MDD

NCT05065580 | Completed

• 1 other identifier: EGME#05-2021
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

participants will be receiving OMT 1x/week for 8 weeks. Each appointment with be a duration of 30 minutes. Patients will be required to fill out PHQ-9 and SSS-8 questionnaires before beginning the study and following the conclusion of the study.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• PHQ-9 (Patient Health Questionnaire) results post treatment

  compare PHQ-9 results in the two groups based on SSS-8 (Somatic Symptom Score) score before and after treatment. PHQ-9 is a depression score ranging from 0 through 27. No depression 0-4, mild 5-9, moderate 10-14, moderately severe 15-19, severe 20-27. The SSS-8 ranges from 0 through 32. No to minimal symptoms range from 0 through 3, low from 4-7, medium 8-11\\, high 12-15, very high 16-32.

  8 weeks

Study Arms (2)

Low Somatic Symptom Score

ACTIVE COMPARATOR

Patients meeting PHQ-9 (Patient health Questionnaire)-9 with score greater than 10 with Somatic Symptom Score less than 7. These patients will receive the OMT treatment protocol and PHQ-9 and SSS scales will be recorded at 0, 4, and 8 weeks.

Procedure: Osteopathic Manipulative Treatment

High Somatic Symptom Score

ACTIVE COMPARATOR

Patients meeting PHQ-9 (Patient health Questionnaire)-9 with score greater than 10 with Somatic Symptom Score 8 or greater These patients will receive the OMT treatment protocol and PHQ-9 and SSS scales will be recorded at 0, 4, and 8 weeks.

Procedure: Osteopathic Manipulative Treatment

Interventions

Osteopathic Manipulative Treatment PROCEDURE

Individuals will receive the following techniques during weekly OMT (osteopathic manipulative techniques) for a duration of 8 weeks: 1. Suboccipital release 2. Vault hold. 3. Soft tissue techniques at the cervical and shoulder region 4.There will be NO high velocity low amplitude (HVLA) techniques

High Somatic Symptom Score; Low Somatic Symptom Score

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients 18-65, patients with diagnosis of MDD, PHQ-9 score \> 10 at screening and baseline

You may not qualify if:

• history of mania, hypomania, or psychosis as defined in DSM V
• current substance abuse, including abuse within the previous 6 months
• patients with a cognitive disorder or dementia
• patients with other axis I diagnosis (anxiety disorders, dissociative disorders, etc.) that was primary in the past 6 months
• receiving other forms of manual therapy during study
• authors belief that there was significant suicidal risk
• changes in medication or psychotherapy within 6 weeks of starting study or during study period
• history of migraines
• presence of any other significant organic disease (infectious, cardiac, pulmonary, gastrointestinal, renal, etc.)
• other absolute contraindications to OMT (malignancy, infection, myelopathy, severe osteoporosis, increased ICP, intracranial bleeding, fractures, etc.)

Sponsors & Collaborators

• Corewell Health South: lead

Study Sites (1)

Lakeland Regional Healthcare

Saint Joseph, Michigan, 49085, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: March 12, 2021
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)