NCT07482358

Brief Summary

The goal of this hybrid implementation-effectiveness study is to learn about the effectiveness and appropriateness of "Trauma-Informed and Culturally-Responsive Integrated Massage Therapy" (TCI-Massage) for torture and war trauma survivors. The study aims are: • Examine the uptake of TCI-Massage within CVT by assessing key implementation science outcomes of acceptability and appropriateness among refugees and asylum seekers from diverse cultural backgrounds. • Examine the integration of massage therapy into the current psychosocial care model used at CVT. • Examine the effectiveness of TCI-Massage for torture and war trauma survivors to reduce distress (mental health symptoms, chronic pain, and HRV) and improve coping (interoceptive awareness and social functioning). Treatment group participants will participate in psychosocial care services + TCI-Massage, which the control group will only participate in psychosocial care services

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Feb 2024Jan 2027

Study Start

First participant enrolled

February 1, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

March 16, 2026

Last Update Submit

March 16, 2026

Conditions

PTSDChronic PainDepressionAnxiety DisordersSocial Functioning

Outcome Measures

Primary Outcomes (1)

  • Chronic Pain

    The Graded Chronic Pain Scale-Revised (GCPS-R) is a validated, self-report measure that classifies chronic pain severity into four grades based on pain intensity and interference with daily activities: Grade I (low disability, low intensity), Grade II (low disability, high intensity), Grade III (high disability, moderately limiting), and Grade IV (high disability, severely limiting).35 The GCPS allows for the calculation of the Pain, Enjoyment of Life and General Activity (PEG) Scale, which assesses pain intensity and its impact on general activity and enjoyment of life. The PEG consists of three items rated on a 0-10 scale; the total score is the average of these ratings, with higher scores indicating greater pain severity and interference.

    0, 3, and 6 months

Secondary Outcomes (6)

  • PTSD

    0, 3, and 6 months

  • Anxiety

    0, 3, and 6 months

  • Depression

    0, 3, and 6 months

  • Introception

    0, 3, and 6 months

  • Blood Pressure

    0, 3, and 6 months

  • +1 more secondary outcomes

Study Arms (2)

TG

EXPERIMENTAL
Other: TCI-Massage

CAU

ACTIVE COMPARATOR
Other: TCI-Massage

Interventions

TCI-MassageOTHER

Intervention Condition: Trauma-informed and Culturally-responsive Integrated model of massage therapy (TCI-Massage). Massage therapy, over clothes, is provided for one hour once a week for eight weeks.

CAUTG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Refugee or asylum seeker who has experienced torture or war related trauma
  • Receiving care at one of the CVT clinics offering the study
  • Moderate to high levels of pain as assessed through the Graded Chronic Pain Scale (Grade I or higher)
  • Age between 18 and 70 years

You may not qualify if:

  • Currently receiving massage therapy services
  • Presence of high risk medical condition(s) requiring referral to more intensive services or hospitalization such as inpatient psychiatric care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CVT

Centennial, Colorado, 80121, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticChronic PainDepressionAnxiety DisordersSocial Adjustment

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 19, 2026

Study Start

February 1, 2024

Primary Completion

March 30, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

US(1)