PainNCT04629963

Chronic Pain Diagnosis and Treatment in Torture Survivors

A study testing Pain Evaluation and BPISF and Surveys, a fingerstick blood sample, EMAs, and a digital wearable device in people with Pain and Pain, Chronic, run by Weill Medical College of Cornell University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Pain, Chronic
What is being tested?: Pain Evaluation and BPISF and Surveys, a fingerstick blood sample, EMAs, and a digital wearable device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 4 sitesUnited States
Study dates: 14 Jan 2021to 19 Jan 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 18 years old
Survived torture as defined by the World Medical Association
Consented to being contacted by our research team
≥ 18 years old
Survived torture as defined by the World Medical Association
Chronic pain as per Aim 1 findings

Who cannot join

Non-tortured refugees seeking asylum through T visas (trafficking), U visas (victims of violence in the US), Violence Against Women Act (VAMA), and Special Immigrant Juveniles (SIJ)
Pregnant women
(Aim 2)
Non-tortured refugees seeking asylum through T visas (trafficking), U visas (victims of violence in the US), Violence Against Women Act (VAMA), and Special Immigrant Juveniles (SIJ)
Pregnant women
(Aim 3): Inclusion Criteria

Show all 13Show fewer

≥ 18 years old
Survived torture as defined by the World Medical Association
Chronic pain as per Aim 1 findings
Personal smartphone
Non-tortured refugees seeking asylum through T visas (trafficking), U visas (victims of violence in the US), Violence Against Women Act (VAMA), and Special Immigrant Juveniles (SIJ)
Pregnant women
Planned move within 6 months

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Bellevue/New York University Program for Survivors of Torture
New York, New York, 10016
Mount Sinai Human Rights Program
New York, New York, 10029
Columbia University Human Rights Initiative and Asylum Clinic
New York, New York, 10032
Weill Cornell Medicine
New York, New York, 10065

Other trials in United States

About this study

The goal Aim 1 of this investigation is to characterize the diagnosis of chronic pain in torture survivors. The investigators hypothesize that using a validated pain screen to supplement the existing United Nations Istanbul Protocol can improve the ability to detect pain from 15% to 90% in this study population. Investigators will test this hypothesis by conducting a prospective, blind comparison to gold standard study. The goal of Aim 2 is to evaluate the acceptability of somatic pain treatment using qualitative interviews of torture survivors. The goal of Aim 3 is to assess the feasibility of recruiting and retaining participants in a digital pain program over six months.

Read the detailed description

The objective of this application is to improve the diagnosis and treatment of chronic pain in torture survivors. The central hypothesis, based on strong preliminary data from 25 subjects from the Weill Cornell Center for Human Rights, is that the novel application in torture survivors of a validated pain screen, the Brief Pain Inventory Short Form (BPISF), can supplement the United Nations Istanbul Protocol (UNIP) and improve its sensitivity for pain from 15% to 90%, as compared to the gold standard (a pain specialist). The rationale for the investigation is to improve the diagnosis of pain in torture survivors, leading to targeted treatment.

The objectives of this study are to improve the diagnosis of pain in torture survivors with the novel utilization in this population of a pain screen. The findings of this study also have implications for other populations that experience complex trauma such as veterans, prisoners of war, and sexual violence survivors.

The primary objective of the qualitative interview portion is to gain an understanding of how participants perceive, react to, and might utilize somatic pain treatment. We aim to qualitatively assess the challenges and acceptability of a proposed, evidence-based somatic pain treatment model, novel in its implementation in torture survivors: physical therapy and/or non-opioid analgesics and/or trigger point injections. We will use the Gelberg and Andersen Behavioral Model of Health Care Utilization for Vulnerable Populations as a conceptual framework to conduct qualitative interviews with 30 participants purposively sampled from Study Aim 1. Data with regard to acceptability and practicality from interviews will be used to adapt our proposed evidence-based somatic pain treatment for torture survivors.

The primary objective of Aim 3 is to answer critical questions on the feasibility of a subsequent clinical trial to treat somatic pain in torture survivors. As a secondary objective, we will analyze the prevalence of migration stress, pain, and cardiovascular disease, and their relationship over time, in refugee torture survivors. The primary objective of this sub-study is the recruitment, retention, and adherence of participants to the digital program over a six-month period. The secondary objectives of this sub-study are the assessment of pain, mental health status, trauma history, migration stress, and cardiovascular risk factors and diseases.

Conditions: Pain, Pain, Chronic
Being tested: Pain Evaluation and BPISF, Surveys, a fingerstick blood sample, EMAs, and a digital wearable device
Keywords: asylum, torture, refugee
Medical subject headings: Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pain Evaluation and BPISFOther
Current diagnostic approaches guide evaluators to use the United Nations Istanbul Protocol (UNIP) for the assessment of torture survivors. The proposed investigation offers a novel diagnostic paradigm by which participants are evaluated by the UNIP and a validated pain screen (Brief Pain Inventory Short Form).
Surveys, a fingerstick blood sample, EMAs, and a digital wearable deviceOther
The following surveys: BPI-SF, RHS-15, RTHC, SOIS-SF, RPMS, WHOAQ, QVSFS, a fingerstick blood sample, EMAs, and a digital wearable device

Study groups in NCT04629963
Study group	Role	What they receive
Aim 1: Pain Evaluation	Experimental	Participants will complete the validated pain questionnaire, the Brief Pain Inventory Short Form (BPISF). Participants will receive a non-invasive physical exam and pain assessment by a pain specialist. Receives: Other: Pain Evaluation and BPISF
Aim 2: Qualitative Interview	No intervention	Participants will complete individual interviews moderated by the research staff. Interviews will be based on the guide but will be minimally structured to facilitate exploration of novel topics as raised by participants and to ensure information-rich data on topics of interest. Individual interviews will be ~30-45 minutes in length, conducted in the subject's primary language with the use of an interpreter as appropriate. All interviews will be audio-recorded with participants' permission, transcribed, and translated into English for analysis.
Aim 3: Enrollment in a digital program assessing stress, pain, and cardiovascular health	Experimental	Continuous cardiovascular, stress, and pain data collection will occur for 6 months after enrollment. Biometric data including continuous heart rate, actigraphy, sleep, and derived physiological parameters will be collected using the wearable device. Pain and stress evaluations will be administered via a smartphone app as a survey of stress, pain, or cardiovascular symptoms. Participants will complete surveys assessing chronic pain, mental health, trauma history, migration stress, and cardiovascular risk factors and disease Total cholesterol, HDL, LDL, triglycerides, and glucose will be measured using a lipid analyzer with a fingerstick blood sample. Height, weight, and blood pressure will also be measured. Receives: Other: Surveys, a fingerstick blood sample, EMAs, and a digital wearable device

What is being measured

The primary outcome is the main question the study is designed to answer.

Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by the United Nations Istanbul Protocol (UNIP).
The UNIP results in a binary "yes" or "no" clinical pain diagnosis by the evaluator.
Measured: Day 1 (One-time Research Appointment)
Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by the United Nations Istanbul Protocol (UNIP) and the Brief Pain Inventory Short Form (BPISF).
As the UNIP results in a binary "yes" or "no" clinical pain diagnosis by the evaluator, the continuous BPISF will be converted into a binary "yes" or "no" for pain. Any participant who experiences interference as mild, moderate, or severe pain will be categorized as "yes" for pain; any participant who experiences pain as mild, moderate, or severe will be categorized as "yes" for pain. A score of 0 will be categorized as "no" for pain on the BPISF.
Measured: Day 1 (One-time Research Appointment)
Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by pain specialist evaluation.
The presence of pain detected by the pain specialist evaluation will be categorized as a binary "yes" or "no".
Measured: Day 1 (One-time Research Appointment)
Aim 2: Themes emerging across qualitative interview transcripts.
A thematic coding scheme will be created following the main points of the interview guide. Reports will be generated for each code and narratives will be analyzed for common themes related to acceptability of pain treatments and the relationship between stress and chronic pain. We will utilize the data gained from this Aim to adapt the design of our proposed evidence-based somatic pain treatment model.
Measured: Day 1 (One-time Research Appointment)
Aim 3: The recruitment as measured by the number of participants enrolled.
The investigators aim to recruit 20 participants.
Measured: 1.5 years
Aim 3: The retention as measured by the number of participants who complete the follow-up appointment 6 months after their baseline appointment.
Measured: 6 months
Aim 3: The adherence as measured by the number of participants who answer 1 or more Ecological Momentary Assessment (EMA) questions.
Participants are sent EMA questions each week to assess their levels of stress and pain, as well as their cardiovascular symptoms.
Measured: 6 months
Aim 3: The adherence as measured by the number of participants who wear their Fitbit for 1 or more days.
Measured: 6 months

Secondary outcomes (25)

Aim 3: Number of participants for whom "yes" is indicated for pain as assessed by the Brief Pain Inventory Short Form (BPISF).
The continuous BPISF will be converted into a binary "yes" or "no" for pain. Any participant who experiences mild, moderate, or severe pain or pain interference will be categorized as "yes" for pain; a score of 0 will be categorized as "no" for pain on the BPISF.
Measured: Baseline appointment
Aim 3: Number of participants for whom "yes" is indicated for pain as assessed by the Brief Pain Inventory Short Form (BPISF).
The continuous BPISF will be converted into a binary "yes" or "no" for pain. Any participant who experiences mild, moderate, or severe pain or pain interference will be categorized as "yes" for pain; a score of 0 will be categorized as "no" for pain on the BPISF.
Measured: 6-month follow-up appointment
Aim 3: The mean score for pain severity as assessed by the Brief Pain Inventory Short Form (BPISF).
Questions 3-6 on the BPISF assess mean pain severity score; these questions are scored on a scale of 0 to 10, with 0 indicating "no pain" and 10 indicating "pain as bad as you can imagine."
Measured: Baseline appointment
Aim 3: The mean score for pain severity as assessed by the Brief Pain Inventory Short Form (BPISF).
Questions 3-6 on the BPISF assess mean pain severity score; these questions are scored on a scale of 0 to 10, with 0 indicating "no pain" and 10 indicating "pain as bad as you can imagine."
Measured: 6-month follow-up appointment
Aim 3: The mean score for pain interference as assessed by the Brief Pain Inventory Short Form (BPISF).
Question 9 on the BPISF, comprised of 7 parts, assesses mean pain interference; these questions are scored on a scale of 0 to 10, with 0 indicating "does not interfere" and 10 indicating "completely interferes."
Measured: Baseline appointment
Aim 3: The mean score for pain interference as assessed by the Brief Pain Inventory Short Form (BPISF).
Question 9 on the BPISF, comprised of 7 parts, assesses mean pain interference; these questions are scored on a scale of 0 to 10, with 0 indicating "does not interfere" and 10 indicating "completely interferes."
Measured: 6-month follow-up appointment
Aim 3: Number of participants with positive scores on the Refugee Health Screener-15 (RHS-15).
Symptoms are scored from 0 to 4. A score of 0 indicates "not at all" and a score of 4 indicates "extremely." The survey also asks participants to rate their distress according to a distress thermometer; the thermometer scale ranges from 0 to 10, with 0 indicating "no distress" and 10 indicating "extreme distress." Screening is defined as positive with a total score greater than or equal to 12 on the first 14 items or a ranking greater than 5 on the distress thermometer.
Measured: Baseline appointment
Aim 3: Number of participants with positive scores on the Refugee Health Screener-15 (RHS-15).
Symptoms are scored from 0 to 4. A score of 0 indicates "not at all" and a score of 4 indicates "extremely." The survey also asks participants to rate their distress according to a distress thermometer; the thermometer scale ranges from 0 to 10, with 0 indicating "no distress" and 10 indicating "extreme distress." Screening is defined as positive with a total score greater than or equal to 12 on the first 14 items or a ranking greater than 5 on the distress thermometer.
Measured: 6-month follow-up appointment
Aim 3: Number of participants with positive scores on the Refugee Trauma History Checklist (RTHC).
The RTHC is comprised of binary "yes" and "no" questions. The RTHC is considered quantitatively positive if any item is marked as "yes."
Measured: Baseline appointment
Aim 3: Number of participants with positive scores on the Stress of Immigration - Short Form (SOIS-SF).
The SOIS-SF is considered positive if the participant answered a subscale score of more than 1 for any of the individual items in the survey. The subscale ranges from 1 to 5, with a score of 1 indicating "no stress" and a score of 5 indicating "severe stress."
Measured: Baseline appointment
Aim 3: Number of participants with positive scores on the Stress of Immigration - Short Form (SOIS-SF).
The SOIS-SF is considered positive if the individual answered a subscale score of more than 1 for any of the individual items in the survey. The subscale ranges from 1 to 5, with a score of 1 indicating "no stress" and a score of 5 indicating "severe stress."
Measured: 6-month follow-up appointment
Aim 3: The mean score on the Stress of Immigration - Short Form (SOIS-SF).
The SOIS-SF subscale ranges from 1 to 5, with a score of 1 indicating "no stress" and a score of 5 indicating "severe stress." The SOIS-SF is scored by averaging the scores of the 5-item survey. The mean of non-missing items results in a score of 1 to 5.
Measured: Baseline appointment
Aim 3: The mean score on the Stress of Immigration - Short Form (SOIS-SF).
The SOIS-SF subscale ranges from 1 to 5, with a score of 1 indicating "no stress" and a score of 5 indicating "severe stress." The SOIS-SF is scored by averaging the scores of the 5-item survey. The mean of non-missing items results in a score of 1 to 5.
Measured: 6-month follow-up appointment
Aim 3: Number of participants who say they would be willing to provide a saliva or hair sample to measure cortisol levels in a hypothetical future study.
Measured: Baseline appointment
Aim 3: Number of participants with positive scores on the Refugee Post Migration Stress Scale (RPMS).
The RPMS is considered positive if the individual answered a subscale score of more than 1 for any of the individual items in the survey. The subscale ranges from 1 to 5, with 1 indicating "never" and 5 indicating "very often." Items marked as a subscale score greater than 1 on the RPMS will be considered sources of stress.
Measured: Baseline appointment
Aim 3: Number of participants with positive scores on the Refugee Post Migration Stress Scale (RPMS).
The RPMS is considered positive if the individual answered a subscale score of more than 1 for any of the individual items in the survey. The subscale ranges from 1 to 5, with 1 indicating "never" and 5 indicating "very often." Items marked as a subscale score greater than 1 on the RPMS will be considered sources of stress.
Measured: 6-month appointment
Aim 3: Number of participants with positive scores on the Atherosclerotic Cardiovascular Disease Pooled Cohort Equation (ASCVD PCE).
Positive scores are indicated by ≥7.5% 10-year ASCVD risk (defined as first-occurrence nonfatal and fatal myocardial infarction (MI) and nonfatal and fatal stroke).
Measured: Baseline appointment
Aim 3: Number of participants with positive scores on the Atherosclerotic Cardiovascular Disease Pooled Cohort Equation (ASCVD PCE).
Positive scores are indicated by ≥7.5% 10-year ASCVD risk (defined as first-occurrence nonfatal and fatal myocardial infarction (MI) and nonfatal and fatal stroke).
Measured: 6-month follow-up appointment
Aim 3: Number of participants with positive scores on the World Health Organization Rose Angina Questionnaire (WHOAQ).
The WHOAQ is used to determine if a participant has experienced symptoms of a heart attack. The WHOAQ is positive if any symptoms are recorded.
Measured: Baseline appointment
Aim 3: Number of participants with positive scores on the World Health Organization Rose Angina Questionnaire (WHOAQ).
The WHOAQ is used to determine if a participant has experienced symptoms of a heart attack. The WHOAQ is positive if any symptoms are recorded.
Measured: 6-month follow-up appointment
Aim 3: Number of participants with positive scores on the Questionnaire Verifying Stroke Free Status (QVSFS).
The QVSFS is used to determine if a participant has experienced symptoms of a stroke. The QVSFS is positive if any questions are answered in the affirmative.
Measured: Baseline appointment
Aim 3: Number of participants with positive scores on the Questionnaire Verifying Stroke Free Status (QVSFS).
The QVSFS is used to determine if a participant has experienced symptoms of a stroke. The QVSFS is positive if any questions are answered in the affirmative.
Measured: 6-month follow-up appointment
Aim 3: Number of participants who have self-reports of Cardiovascular disease (CVD) symptoms and events.
Participants will be asked if they have experienced any of the following symptoms: anxiety, chest pain, depression, dizziness, dyspnea, fatigue.
Measured: Baseline appointment
Aim 3: Number of participants who have self-reports of Cardiovascular disease (CVD) symptoms and events.
Participants will be asked if they have experienced any of the following symptoms: anxiety, chest pain, depression, dizziness, dyspnea, fatigue.
Measured: 6-month follow-up appointment
Aim 3: Number of participants who have pain, stress, or CVD symptoms, as signalled by continuous biometric data.
Biometric data including continuous heart rate, actigraphy, sleep, and derived physiological parameters (e.g., resting heart rate and estimated energy expenditure) will be collected using the wrist-worn wearable device.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 202119 Jan 2026

First posted16 Nov 2020
Study start14 Jan 2021
Primary completion19 Jan 2026
Study completion19 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Single group
Model description: Investigators will enroll participants from human rights centers and compare the diagnostic ability of the United Nations Istanbul Protocol (UNIP) alone to the UNIP plus a validated pain screen (BPISF), both against the gold standard for pain assessment (pain specialist exam). Participants will complete individual interviews during which we will present our somatic pain treatment model and receive feedback on challenges, limitations, and acceptability of the interventions. A feasibility sub-study will be conducted with the primary outcome being recruitment and retention of participants over a 6-month period. Secondary outcomes include analysis of study visit data (i.e. migration stress, pain, cardiovascular) collected at enrollment and again after 6 months. Digital and biometric data will be collected continuously from a study-provided smartphone application and wearable fitness device for up to 6 months.
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04629963
Sponsor's protocol ID: 20-10022730
Other IDs: 1K23NS116114-01A1
Status last verified: Mar 2026
First submitted: 11 Nov 2020
Last updated: 31 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Chronic Pain Diagnosis and Treatment in Torture Survivors
ClinicalTrials.gov ID: NCT04629963
Acronym / sponsor ID: 20-10022730
Conditions: Pain, Pain, Chronic
Keywords: asylum, torture, refugee
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
Study start: 14 Jan 2021 (actual)
Primary completion: 19 Jan 2026 (actual)
Study completion: 19 Jan 2026 (actual)
First posted: 16 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3
Model description: Investigators will enroll participants from human rights centers and compare the diagnostic ability of the United Nations Istanbul Protocol (UNIP) alone to the UNIP plus a validated pain screen (BPISF), both against the gold standard for pain assessment (pain specialist exam). Participants will complete individual interviews during which we will present our somatic pain treatment model and receive feedback on challenges, limitations, and acceptability of the interventions. A feasibility sub-study will be conducted with the primary outcome being recruitment and retention of participants over a 6-month period. Secondary outcomes include analysis of study visit data (i.e. migration stress, pain, cardiovascular) collected at enrollment and again after 6 months. Digital and biometric data will be collected continuously from a study-provided smartphone application and wearable fitness device for up to 6 months.

Arm	Type	Receives
Aim 1: Pain Evaluation	Experimental	Other: Pain Evaluation and BPISFParticipants will complete the validated pain questionnaire, the Brief Pain Inventory Short Form (BPISF). Participants will receive a non-invasive physical exam and pain assessment by a pain specialist.
Aim 2: Qualitative Interview	No intervention	–Participants will complete individual interviews moderated by the research staff. Interviews will be based on the guide but will be minimally structured to facilitate exploration of novel topics as raised by participants and to ensure information-rich data on topics of interest. Individual interviews will be ~30-45 minutes in length, conducted in the subject's primary language with the use of an interpreter as appropriate. All interviews will be audio-recorded with participants' permission, transcribed, and translated into English for analysis.
Aim 3: Enrollment in a digital program assessing stress, pain, and cardiovascular health	Experimental	Other: Surveys, a fingerstick blood sample, EMAs, and a digital wearable deviceContinuous cardiovascular, stress, and pain data collection will occur for 6 months after enrollment. Biometric data including continuous heart rate, actigraphy, sleep, and derived physiological parameters will be collected using the wearable device. Pain and stress evaluations will be administered via a smartphone app as a survey of stress, pain, or cardiovascular symptoms. Participants will complete surveys assessing chronic pain, mental health, trauma history, migration stress, and cardiovascular risk factors and disease Total cholesterol, HDL, LDL, triglycerides, and glucose will be measured using a lipid analyzer with a fingerstick blood sample. Height, weight, and blood pressure will also be measured.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

≥ 18 years old
Survived torture as defined by the World Medical Association
Consented to being contacted by our research team
≥ 18 years old
Survived torture as defined by the World Medical Association

Key exclusion criteria (13 listed)

Non-tortured refugees seeking asylum through T visas (trafficking), U visas (victims of violence in the US), Violence Against Women Act (VAMA), and Special Immigrant Juveniles (SIJ)
Pregnant women
(Aim 2)
Non-tortured refugees seeking asylum through T visas (trafficking), U visas (victims of violence in the US), Violence Against Women Act (VAMA), and Special Immigrant Juveniles (SIJ)
Pregnant women

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pain Evaluation and BPISFCurrent diagnostic approaches guide evaluators to use the United Nations Istanbul Protocol (UNIP) for the assessment of torture survivors. The proposed investigation offers a novel diagnostic paradigm by which participants are evaluated by the UNIP and a validated pain screen (Brief Pain Inventory Short Form).	Other	Aim 1: Pain Evaluation
Surveys, a fingerstick blood sample, EMAs, and a digital wearable deviceThe following surveys: BPI-SF, RHS-15, RTHC, SOIS-SF, RPMS, WHOAQ, QVSFS, a fingerstick blood sample, EMAs, and a digital wearable device	Other	Aim 3: Enrollment in a digital program assessing stress, pain, and cardiovascular health

Primary outcome

Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by the United Nations Istanbul Protocol (UNIP).
Time frame: Day 1 (One-time Research Appointment)
The UNIP results in a binary "yes" or "no" clinical pain diagnosis by the evaluator.
Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by the United Nations Istanbul Protocol (UNIP) and the Brief Pain Inventory Short Form (BPISF).
Time frame: Day 1 (One-time Research Appointment)
As the UNIP results in a binary "yes" or "no" clinical pain diagnosis by the evaluator, the continuous BPISF will be converted into a binary "yes" or "no" for pain. Any participant who experiences interference as mild, moderate, or severe pain will be categorized as "yes" for pain; any participant who experiences pain as mild, moderate, or severe will be categorized as "yes" for pain. A score of 0 will be categorized as "no" for pain on the BPISF.
Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by pain specialist evaluation.
Time frame: Day 1 (One-time Research Appointment)
The presence of pain detected by the pain specialist evaluation will be categorized as a binary "yes" or "no".
Aim 2: Themes emerging across qualitative interview transcripts.
Time frame: Day 1 (One-time Research Appointment)
A thematic coding scheme will be created following the main points of the interview guide. Reports will be generated for each code and narratives will be analyzed for common themes related to acceptability of pain treatments and the relationship between stress and chronic pain. We will utilize the data gained from this Aim to adapt the design of our proposed evidence-based somatic pain treatment model.
Aim 3: The recruitment as measured by the number of participants enrolled.
Time frame: 1.5 years
The investigators aim to recruit 20 participants.
Aim 3: The retention as measured by the number of participants who complete the follow-up appointment 6 months after their baseline appointment.
Time frame: 6 months
Aim 3: The adherence as measured by the number of participants who answer 1 or more Ecological Momentary Assessment (EMA) questions.
Time frame: 6 months
Participants are sent EMA questions each week to assess their levels of stress and pain, as well as their cardiovascular symptoms.
Aim 3: The adherence as measured by the number of participants who wear their Fitbit for 1 or more days.
Time frame: 6 months

25 secondary outcomes

Aim 3: Number of participants for whom "yes" is indicated for pain as assessed by the Brief Pain Inventory Short Form (BPISF).
Time frame: Baseline appointment
Aim 3: Number of participants for whom "yes" is indicated for pain as assessed by the Brief Pain Inventory Short Form (BPISF).
Time frame: 6-month follow-up appointment
Aim 3: The mean score for pain severity as assessed by the Brief Pain Inventory Short Form (BPISF).
Time frame: Baseline appointment
Aim 3: The mean score for pain severity as assessed by the Brief Pain Inventory Short Form (BPISF).
Time frame: 6-month follow-up appointment
Aim 3: The mean score for pain interference as assessed by the Brief Pain Inventory Short Form (BPISF).
Time frame: Baseline appointment
Aim 3: The mean score for pain interference as assessed by the Brief Pain Inventory Short Form (BPISF).
Time frame: 6-month follow-up appointment
Aim 3: Number of participants with positive scores on the Refugee Health Screener-15 (RHS-15).
Time frame: Baseline appointment
Aim 3: Number of participants with positive scores on the Refugee Health Screener-15 (RHS-15).
Time frame: 6-month follow-up appointment
Aim 3: Number of participants with positive scores on the Refugee Trauma History Checklist (RTHC).
Time frame: Baseline appointment
Aim 3: Number of participants with positive scores on the Stress of Immigration - Short Form (SOIS-SF).
Time frame: Baseline appointment
Aim 3: Number of participants with positive scores on the Stress of Immigration - Short Form (SOIS-SF).
Time frame: 6-month follow-up appointment
Aim 3: The mean score on the Stress of Immigration - Short Form (SOIS-SF).
Time frame: Baseline appointment
Aim 3: The mean score on the Stress of Immigration - Short Form (SOIS-SF).
Time frame: 6-month follow-up appointment
Aim 3: Number of participants who say they would be willing to provide a saliva or hair sample to measure cortisol levels in a hypothetical future study.
Time frame: Baseline appointment
Aim 3: Number of participants with positive scores on the Refugee Post Migration Stress Scale (RPMS).
Time frame: Baseline appointment
Aim 3: Number of participants with positive scores on the Refugee Post Migration Stress Scale (RPMS).
Time frame: 6-month appointment
Aim 3: Number of participants with positive scores on the Atherosclerotic Cardiovascular Disease Pooled Cohort Equation (ASCVD PCE).
Time frame: Baseline appointment
Aim 3: Number of participants with positive scores on the Atherosclerotic Cardiovascular Disease Pooled Cohort Equation (ASCVD PCE).
Time frame: 6-month follow-up appointment
Aim 3: Number of participants with positive scores on the World Health Organization Rose Angina Questionnaire (WHOAQ).
Time frame: Baseline appointment
Aim 3: Number of participants with positive scores on the World Health Organization Rose Angina Questionnaire (WHOAQ).
Time frame: 6-month follow-up appointment
Aim 3: Number of participants with positive scores on the Questionnaire Verifying Stroke Free Status (QVSFS).
Time frame: Baseline appointment
Aim 3: Number of participants with positive scores on the Questionnaire Verifying Stroke Free Status (QVSFS).
Time frame: 6-month follow-up appointment
Aim 3: Number of participants who have self-reports of Cardiovascular disease (CVD) symptoms and events.
Time frame: Baseline appointment
Aim 3: Number of participants who have self-reports of Cardiovascular disease (CVD) symptoms and events.
Time frame: 6-month follow-up appointment
Aim 3: Number of participants who have pain, stress, or CVD symptoms, as signalled by continuous biometric data.
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gunisha Kaur, MA, MD principal investigator

Weill Medical College of Cornell University

Claudia Hatef, BS study director

Weill Medical College of Cornell University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by the United Nations Istanbul Protocol (UNIP). (time frame: Day 1 (One-time Research Appointment)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04629963.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.