Chronic Pain Diagnosis and Treatment in Torture Survivors

NCT04629963 | Completed

• 2 other identifiers: 20-100227301K23NS116114-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Pain; Pain, Chronic

Keywords

asylum; torture; refugee

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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".

  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.

  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.

  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.

  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.

  6 months

• Aim 3: The adherence as measured by the number of participants who wear their Fitbit for 1 or more days.

  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).

  Baseline appointment

• Aim 3: Number of participants for whom "yes" is indicated for pain as assessed by the Brief Pain Inventory Short Form (BPISF).

  6-month follow-up appointment

• Aim 3: The mean score for pain severity as assessed by the Brief Pain Inventory Short Form (BPISF).

  Baseline appointment

• Aim 3: The mean score for pain severity as assessed by the Brief Pain Inventory Short Form (BPISF).

  6-month follow-up appointment

• Aim 3: The mean score for pain interference as assessed by the Brief Pain Inventory Short Form (BPISF).

  Baseline appointment

Study Arms (3)

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.

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.

Other: Surveys, a fingerstick blood sample, EMAs, and a digital wearable device

Interventions

Surveys, a fingerstick blood sample, EMAs, and a digital wearable device OTHER

The following surveys: BPI-SF, RHS-15, RTHC, SOIS-SF, RPMS, WHOAQ, QVSFS, a fingerstick blood sample, EMAs, and a digital wearable device

Aim 3: Enrollment in a digital program assessing stress, pain, and cardiovascular health

Pain Evaluation and BPISF OTHER

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).

Aim 1: Pain Evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• ≥ 18 years old
• Survived torture as defined by the World Medical Association
• Chronic pain as per Aim 1 findings
• 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
• ≥ 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (4)

Bellevue/New York University Program for Survivors of Torture

New York, New York, 10016, United States

Location

Mount Sinai Human Rights Program

New York, New York, 10029, United States

Location

Columbia University Human Rights Initiative and Asylum Clinic

New York, New York, 10032, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Pain; Chronic Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gunisha Kaur, MA, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Claudia Hatef, BS

  Weill Medical College of Cornell University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 16, 2020
• Study Start: January 14, 2021
• Primary Completion: January 19, 2026
• Study Completion: January 19, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)