Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 4:08 AM
Study NCT ID:
NCT07482358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TCI-Massage Clinical Trial
Sponsor:
The Center for Victims of Torture, United States
Organization:
Study Overview
Official Title:
Trauma-Informed and Culturally-Responsive Integrated Massage Therapy (TCI-Massage): An Implementation and Effectiveness Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TCI-MT
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
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
Detailed Description:
The proposed project is a hybrid implementation effectiveness study. To examine effectiveness, the investigators will use a two group wait list randomized trial with repeated measures.
Aim 1: Implementation Science Aim. 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.
Aim 2: Implementation Science Aim. Examine the integration of massage therapy into the current psychosocial care model used at CVT. This aim involves examination of system level information including scheduling, session duration, care consultation, implementation costs, and in depth interviews with key clinical staff.
Aim 3: Health Outcome Aim. 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).
Research Strategy and Design.
Design. This study is a hybrid implementation effectiveness study. The implementation study involves surveys and focus groups with clinical staff and examination of system level outcomes such as cost, administrative burden, and scheduling. The effectiveness study involves a two group randomized controlled trial using a wait list control and repeated measures. Fifty patients will be recruited for participation and randomly assigned to a treatment group receiving TCI Massage plus usual care or to a control group receiving usual care only and placement on a wait list for TCI Massage. The wait list control group will receive TCI Massage after a three month wait period. Assessments will be administered at baseline, three months, and six months.
Inclusion criteria:
1. Refugee or asylum seeker who has experienced torture or war related trauma
2. Currently receiving care at one of the CVT clinics offering the study
3. Moderate to high levels of pain assessed through the Graded Chronic Pain Scale
e) Age between 18 and 70 years
Exclusion criteria:
1. Currently receiving massage therapy services
2. Presence of high risk medical condition(s) requiring referral to more intensive services or hospitalization such as inpatient psychiatric care
Usual Care Condition. All patients will engage in a multimodal psychosocial care approach including psychotherapy, social work, and medical services. Clients receive weekly or biweekly psychotherapy and social work services. Clients also have access to primary care services through the Healing Hearts program and to nursing and physician services.
Intervention Condition. Trauma informed and culturally responsive integrated model of massage therapy (TCI Massage).
Massage therapy over clothes will be provided for one hour once per week for eight weeks. The protocol for TCI Massage includes several defining elements described below.
Intake. The initial fifteen minutes of each session involve an intake to assess participant well being, symptoms, and trauma related information that may inform session orientation. Torture and war survivors often demonstrate heightened sensitivity to physical touch and extensive histories of physical and interpersonal trauma and pain. Additional time supports the establishment of safety and trust, agreement on boundaries regarding acceptable types of touch and intensity, and collaboration in cultural adaptation.
Massage. A forty five minute massage therapy session will be provided based on an established massage protocol used in previous massage therapy research. Participants will also receive weekly training in self massage from the massage therapist to extend and enhance the benefits of massage therapy interventions.
Data Collection Procedures and Measures or Methods presented below specific to aim.
Implementation Science Aim 1.
Data Collection Procedures. A trained facilitator will conduct in depth interviews with study participants at the close of treatment. Interviews will address acceptability and appropriateness of the intervention provided within the CVT clinical context. A trained facilitator will also conduct quarterly focus groups with CVT clinical staff including massage therapists, psychotherapists, social workers, and medical providers. Focus groups will address perceived acceptability and appropriateness.
Implementation Science Aim 2.
Data Collection Procedures. Monthly staff surveys addressing feasibility and fidelity will be administered. At the conclusion of the study, analysis of administrative data will assess the level of penetration of the intervention within the organization. After completion of the intervention, a financial review will assess implementation costs associated with the intervention rather than study costs.
Health Outcome Aim 3.
Data Collection Procedures. A research coordinator will administer all assessments. Assessments will include standardized measures of mental health symptoms, pain, and coping including interoceptive awareness and social functioning at baseline, three months, and six months. Objective physiological measures of cardiovascular health will also be collected at each time point. Trained professional interpreters will provide language support for measure administration.
Measures. The following measures will be administered. Pain will be assessed using the Graded Chronic Pain Scale designed to evaluate pain severity and the extent to which pain interferes with daily life.
Mental health conditions assessed will include Major Depressive Disorder, Generalized Anxiety, and Posttraumatic Stress Disorder (PTSD). Generalized anxiety will be measured using the Hopkins Symptom Checklist 25 (HSCL 25), composed of twenty five items with ten items assessing anxiety symptoms and fifteen items assessing depression symptoms. Each item includes four response options: Not at all, A little, Quite a bit, and Extremely. PTSD symptoms will be assessed using the Posttraumatic Diagnostic Scale 5, a self report measure of PTSD aligned with the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders.
Social functioning will be measured using the Center for Victims of Torture Social Circumstances and Functioning Inventory (CVT SCFI). The inventory was developed by the Center for Victims of Torture to define and measure social functioning domains among torture survivors living in the United States. The instrument was developed through scientific test construction methods and normed among torture survivors receiving services at CVT.
Interoceptive awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness (MAIA), a thirty two item instrument rated on a five point scale.
Cardiovascular health will be assessed using three indicators: blood pressure (BP), heart rate (HR), and heart rate variability (HRV).
DATA ANALYSIS PLAN presented below specific to aim.
Aim 1. Implementation Science Aim. Explore uptake of TCI Massage within CVT by examining key implementation science outcomes of acceptability and appropriateness among refugees and asylum seekers from diverse cultural backgrounds.
Analytic Method. Descriptive statistics derived from CVT electronic health records will describe trends in demographics and health characteristics among study participants as well as the number of patients referred, enrolled, and massage sessions attended. For analysis of in depth interviews and focus groups, a combination of a priori and inductive coding will be applied. A priori codes will address dimensions of acceptability and appropriateness with particular attention to trauma, cultural considerations, and language capacity. An emergent and iterative coding approach will also identify unanticipated themes and support increasingly granular analyses. Interview data, focus group data, and electronic health record data will be triangulated to assess the acceptability and appropriateness of the intervention.
Aim 2. Implementation Science Aim. Examine the integration of TCI Massage into the current psychosocial care model used at CVT.
Analytic Method. Descriptive statistics on feasibility and fidelity will identify trends and patterns in ongoing intervention implementation. Descriptive statistics will specify the number of participants referred, enrolled, and massage sessions received. A cost analysis framework will describe the overall costs of providing massage therapy within the clinic including salaries, local between clinic travel, equipment, and supplies. These costs will inform the overall assessment of implementation success and considerations for sustainability.
Aim 3. Health Outcome Aim. Examine the effectiveness of TCI Massage for torture and war trauma survivors to reduce distress including mental health symptoms, pain, and heart rate variability and improve coping including interoceptive awareness and social functioning.
Analytic Method.
Preliminary analyses. Standard statistical tests will assess key analytic assumptions. Baseline equivalence between treatment and control groups will be examined on demographic characteristics such as age and cultural background and baseline clinical characteristics such as PTSD symptoms and chronic pain levels using t tests and chi square tests. Variables demonstrating baseline imbalance will be included as covariates in subsequent analyses.
Main analysis. Treatment effects will be assessed using multilevel modeling approaches. Analyses will follow an intent to treat framework.
Aim 1: Implementation Science Aim. 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.
Aim 2: Implementation Science Aim. Examine the integration of massage therapy into the current psychosocial care model used at CVT. This aim involves examination of system level information including scheduling, session duration, care consultation, implementation costs, and in depth interviews with key clinical staff.
Aim 3: Health Outcome Aim. 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).
Research Strategy and Design.
Design. This study is a hybrid implementation effectiveness study. The implementation study involves surveys and focus groups with clinical staff and examination of system level outcomes such as cost, administrative burden, and scheduling. The effectiveness study involves a two group randomized controlled trial using a wait list control and repeated measures. Fifty patients will be recruited for participation and randomly assigned to a treatment group receiving TCI Massage plus usual care or to a control group receiving usual care only and placement on a wait list for TCI Massage. The wait list control group will receive TCI Massage after a three month wait period. Assessments will be administered at baseline, three months, and six months.
Inclusion criteria:
1. Refugee or asylum seeker who has experienced torture or war related trauma
2. Currently receiving care at one of the CVT clinics offering the study
3. Moderate to high levels of pain assessed through the Graded Chronic Pain Scale
e) Age between 18 and 70 years
Exclusion criteria:
1. Currently receiving massage therapy services
2. Presence of high risk medical condition(s) requiring referral to more intensive services or hospitalization such as inpatient psychiatric care
Usual Care Condition. All patients will engage in a multimodal psychosocial care approach including psychotherapy, social work, and medical services. Clients receive weekly or biweekly psychotherapy and social work services. Clients also have access to primary care services through the Healing Hearts program and to nursing and physician services.
Intervention Condition. Trauma informed and culturally responsive integrated model of massage therapy (TCI Massage).
Massage therapy over clothes will be provided for one hour once per week for eight weeks. The protocol for TCI Massage includes several defining elements described below.
Intake. The initial fifteen minutes of each session involve an intake to assess participant well being, symptoms, and trauma related information that may inform session orientation. Torture and war survivors often demonstrate heightened sensitivity to physical touch and extensive histories of physical and interpersonal trauma and pain. Additional time supports the establishment of safety and trust, agreement on boundaries regarding acceptable types of touch and intensity, and collaboration in cultural adaptation.
Massage. A forty five minute massage therapy session will be provided based on an established massage protocol used in previous massage therapy research. Participants will also receive weekly training in self massage from the massage therapist to extend and enhance the benefits of massage therapy interventions.
Data Collection Procedures and Measures or Methods presented below specific to aim.
Implementation Science Aim 1.
Data Collection Procedures. A trained facilitator will conduct in depth interviews with study participants at the close of treatment. Interviews will address acceptability and appropriateness of the intervention provided within the CVT clinical context. A trained facilitator will also conduct quarterly focus groups with CVT clinical staff including massage therapists, psychotherapists, social workers, and medical providers. Focus groups will address perceived acceptability and appropriateness.
Implementation Science Aim 2.
Data Collection Procedures. Monthly staff surveys addressing feasibility and fidelity will be administered. At the conclusion of the study, analysis of administrative data will assess the level of penetration of the intervention within the organization. After completion of the intervention, a financial review will assess implementation costs associated with the intervention rather than study costs.
Health Outcome Aim 3.
Data Collection Procedures. A research coordinator will administer all assessments. Assessments will include standardized measures of mental health symptoms, pain, and coping including interoceptive awareness and social functioning at baseline, three months, and six months. Objective physiological measures of cardiovascular health will also be collected at each time point. Trained professional interpreters will provide language support for measure administration.
Measures. The following measures will be administered. Pain will be assessed using the Graded Chronic Pain Scale designed to evaluate pain severity and the extent to which pain interferes with daily life.
Mental health conditions assessed will include Major Depressive Disorder, Generalized Anxiety, and Posttraumatic Stress Disorder (PTSD). Generalized anxiety will be measured using the Hopkins Symptom Checklist 25 (HSCL 25), composed of twenty five items with ten items assessing anxiety symptoms and fifteen items assessing depression symptoms. Each item includes four response options: Not at all, A little, Quite a bit, and Extremely. PTSD symptoms will be assessed using the Posttraumatic Diagnostic Scale 5, a self report measure of PTSD aligned with the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders.
Social functioning will be measured using the Center for Victims of Torture Social Circumstances and Functioning Inventory (CVT SCFI). The inventory was developed by the Center for Victims of Torture to define and measure social functioning domains among torture survivors living in the United States. The instrument was developed through scientific test construction methods and normed among torture survivors receiving services at CVT.
Interoceptive awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness (MAIA), a thirty two item instrument rated on a five point scale.
Cardiovascular health will be assessed using three indicators: blood pressure (BP), heart rate (HR), and heart rate variability (HRV).
DATA ANALYSIS PLAN presented below specific to aim.
Aim 1. Implementation Science Aim. Explore uptake of TCI Massage within CVT by examining key implementation science outcomes of acceptability and appropriateness among refugees and asylum seekers from diverse cultural backgrounds.
Analytic Method. Descriptive statistics derived from CVT electronic health records will describe trends in demographics and health characteristics among study participants as well as the number of patients referred, enrolled, and massage sessions attended. For analysis of in depth interviews and focus groups, a combination of a priori and inductive coding will be applied. A priori codes will address dimensions of acceptability and appropriateness with particular attention to trauma, cultural considerations, and language capacity. An emergent and iterative coding approach will also identify unanticipated themes and support increasingly granular analyses. Interview data, focus group data, and electronic health record data will be triangulated to assess the acceptability and appropriateness of the intervention.
Aim 2. Implementation Science Aim. Examine the integration of TCI Massage into the current psychosocial care model used at CVT.
Analytic Method. Descriptive statistics on feasibility and fidelity will identify trends and patterns in ongoing intervention implementation. Descriptive statistics will specify the number of participants referred, enrolled, and massage sessions received. A cost analysis framework will describe the overall costs of providing massage therapy within the clinic including salaries, local between clinic travel, equipment, and supplies. These costs will inform the overall assessment of implementation success and considerations for sustainability.
Aim 3. Health Outcome Aim. Examine the effectiveness of TCI Massage for torture and war trauma survivors to reduce distress including mental health symptoms, pain, and heart rate variability and improve coping including interoceptive awareness and social functioning.
Analytic Method.
Preliminary analyses. Standard statistical tests will assess key analytic assumptions. Baseline equivalence between treatment and control groups will be examined on demographic characteristics such as age and cultural background and baseline clinical characteristics such as PTSD symptoms and chronic pain levels using t tests and chi square tests. Variables demonstrating baseline imbalance will be included as covariates in subsequent analyses.
Main analysis. Treatment effects will be assessed using multilevel modeling approaches. Analyses will follow an intent to treat framework.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: