Trial Information

Immunologic Response to Negative Cognition in Persons With Chronic Pain

Methods: This prospective study examines the magnitude of biological stress and subsequent
immunologic changes in response to negative cognitive perseveration. Five physiological
measurement time points occur over the course of the 3 hour experiment.

Demographics and health characteristics of interest: gender, marital status, smoking status,
education level, race, height, weight, body mass index, medical comorbidity, psychological
comorbidity, medications (for inflammation, pain, or psychiatric conditions).

Inclusionary Criteria

- >18 years of age; <65 years of age

- Non-inflammatory musculoskeletal patients presenting for evaluation at Oregon Health &
Science University (OHSU) Comprehensive Pain Center (CPC)

Exclusionary Criteria

- Active or recent virus/infection

- Thought disorder, Suicidality,

- Substance Abuse

- Active corticosteroid regimen

- Pregnancy

- Limited venous access

- Former intravenous drug user

Enrollment: All persons presenting for evaluation at the CPC who meet study criteria will be
offered the option to participate in the study. Approximately 60 new pain patients are
evaluated by psychology monthly and we expect to obtain our goal of 40 participants within 6
months. Informed consent will be obtained in compliance with OHSU Institutional Review Board
protocol. Subjects will receive $100 gift certificate compensation, even if they fail to
complete the study. We anticipate a low completion failure rate as the study is completed in
one 3-hour time block. Study times will be standardized to account for circadian effects.
Participants will be told to arrive having eaten a light breakfast with minimal caffeine
consumption (e.g., less than 2 cups of coffee). They will be given a subject number and
their psychiatric diagnoses will be blinded to prevent bias. The study involves gathering 5
serum samples and thus participants will be catheterized by nursing staff to minimize
physiological stress.

Principal Investigator/Program Director (Last, First, Middle): Darnall, Beth APS Future
Leaders in Pain Small Research Grants Application Page 7 Continuation Format Page

Study site: The study will be conducted at the NIH-funded General Clinical Research Center
(GCRC). The GCRC provides state of the art resources including research space, specialized
research nurses to perform blood draws and gather biodata, biostatisticians, and
sophisticated laboratories to perform serum biomarker analysis. OHSU's GCRC is Oregon's
premier multidisciplinary patient-oriented research facility and is housed in the same
building as the CPC, thus minimizing travel burden on participants.

Active Stress Induction: Negative Cognitive Perseveration On their experiment day,
participants will interface with a licensed clinical psychologist who did not perform their
clinical interview and who is blinded to their diagnoses. The psychologist will instruct the
participant talk for 10 minutes about the worst aspects of their pain, to discuss their loss
of control over their situation, the negative impact pain has had on their life and others.
They will be guided to imagine that their situation will progressively worsen, and to focus
on how badly they will feel as a result. Two measures of induction efficacy will be given:
subjective verbal rating (0-10) and objective rating by attending psychologist (0-10). The
intervention ends at 10 minutes and the remainder of the study involves biodata measurement.

Study ends at 2.5 hrs post induction following the final blood draw. The psychologist will
debrief subjects and will assess their affective state. Their subjective units of distress
will be checked. Persons who are in a continued negative cognitive state will receive 30
minutes of Cognitive Behavioral Therapy (CBT) by the on-site psychologist. Care will be
taken not to allow participants to leave the study site in distress. Participants will
receive follow up psychology care at the CPC as indicated in their treatment plan.