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OMT as an Adjunctive Treatment in MDD

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment
Sponsored by
Spectrum Health - Lakeland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.)

Sites / Locations

  • Lakeland Regional Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low Somatic Symptom Score

High Somatic Symptom Score

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2021
Last Updated
June 8, 2023
Sponsor
Spectrum Health - Lakeland
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1. Study Identification

Unique Protocol Identification Number
NCT05065580
Brief Title
OMT as an Adjunctive Treatment in MDD
Official Title
Osteopathic Manipulative Treatment as an Adjunctive Treatment in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Health - Lakeland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Individuals will receive weekly OMT for a duration of 8 weeks. Primary assessment will be performed on initial visit, making note of the most severe somatic restrictions, but highest priority will be given to cervical and shoulder regions (most tension is noted here in patients with MDD). Focusing on only the cranial, cervical, and shoulder regions will allow for a more standardized approach to treatment. Osteopathic manipulative treatment (OMT) is the manipulation of tissues (muscles, joints, fascia, etc.) that is used to help restore movement and function throughout the body by a combination of stretching, gentle pressure, and resistance. The techniques we have chosen to use will focus primarily on muscle and fascia in the cranial, cervical, and shoulder regions. Cranial techniques used include: Suboccipital release - this helps to relieve muscle and fascial tension surrounding the head and neck, patient is supine, physician places finger pads below occipital protuberance at the base of the occiput as patient's relaxes head and lets it rest on physician's finger pads, position is held until softening of musculature is felt Vault hold - helps to restore cranial motion, patient is supine, physician places index finger on greater wing of sphenoid, middle finger on squamous portion of temporal bone, ring finger on mastoid process of temporal bone, and pinky finger on squamous portion of occipital bone, hands remain in this position to monitor cranial motion and determine if there is a dysfunction They will NOT be performing any high velocity low amplitude (HVLA) techniques, which requires a rapid, therapeutic force within the motion of the joint (this is the technique that is often responsible for the "cracking" or "popping")

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Somatic Symptom Score
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High Somatic Symptom Score
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulative Treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
PHQ-9 (Patient Health Questionnaire) results post treatment
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients 18-65, patients with diagnosis of MDD, PHQ-9 score > 10 at screening and baseline Exclusion Criteria: 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.)
Facility Information:
Facility Name
Lakeland Regional Healthcare
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

OMT as an Adjunctive Treatment in MDD

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