NCT05423405

Brief Summary

A new nursing intervention with non-invasive acupressure protocol for activation of parasympathetic nervous system to reduce stress related depression symptoms.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

June 9, 2022

Last Update Submit

June 14, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from baseline self reported Depression Severity

    Beck Depression Inventory BDI (Max score \>40 High depression, Min score \< 10 Normal)

    with 2 month

  • Change from Baseline Depression Severity

    Hamilton Depression Rating Scale HDRS (Max score \>18 Severe (moderate) depression, Min \< 7 no depression)

    with 2 month

Secondary Outcomes (2)

  • Change from baseline heart rate

    with 2 month

  • Change from baseline blood pressure

    with 2 month

Study Arms (3)

control

NO INTERVENTION

Treatment as usual with pharmacotherapy and other complementary therapies

Sham

SHAM COMPARATOR

No actual acupoint pressed but same settings as in acupressure therapy

Other: Acupressure

Intervention

EXPERIMENTAL

Treatment as usual plus acupressure intervention with selected acupoints pressure

Other: Acupressure

Interventions

selected acupoint pressure

Also known as: TCM
InterventionSham

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80
  • Primary diagnosis of MDD with a current moderate-to-severe episode (HAM-D score \> 16) 55
  • Treatment as usual for depression
  • Able to read and understand study procedures and participant's information
  • Agree to receive acupressure therapy

You may not qualify if:

  • Suicidal ideation
  • Antipsychotic medication
  • Primary diagnosis other than MDD
  • Contradiction for acupressure (skin diseases, pregnancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive DisorderDepressive Disorder, MajorDepression

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patients population with depression (mild, moderate, or severe)
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 21, 2022

Study Start

August 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

June 21, 2022

Record last verified: 2022-06