Structured Treatment of Pain (STOP) Study

People with a history of traumatic brain injury (TBI) often have pain, such as headaches or
neck pain as well as pain from other injuries. Effective treatments that teach people how to
manage pain have been used to treat chronic pain in the general population. However, it is
often hard for people to access these treatments, as since they are usually only offered in
person. The investigators are interested in learning if these treatments can be effectively
delivered by telephone, and if the treatments are effective for Veterans with a history of
TBI. The purpose of this study is to compare two of these treatments to see if they can be
delivered by telephone, and see if they can help reduce pain in Veterans with a history of
TBI. Both of these methods are called "self-management" approaches to pain management. Both
of these treatments are commonly used in pain clinics and have been used to treat pain in
persons with TBI. The investigators are interested in comparing these two different
approaches to self-management delivered by phone. Additionally, the investigators want to
determine if these treatments can help reduce the negative consequences that pain often
causes, such as disruption in mood, daily activities, and enjoyment of life.

The sponsor of this study is the Department of Defense. The scientist in charge of this
project is at the University of Washington, as are many of the co-investigators and study
staff. However, all the people who participate in this study will be Operation Enduring
Freedom (OEF)/Operation Iraqi Freedom (OIF)/Operation New Dawn (OND) Veterans recruited from
VA Puget Sound Health Care System (VAPSHCS). Dr. Rhonda Williams is the scientist at the
VAPSHCS who will oversee the project activities at this site. The investigators enrolled 231
subjects into this study. The study will be funded through September 29, 2017.

Subjects will be asked to participate in the following:

1)Informed Consent 2)6 Six Assessments (including cognitive testing, interviews administered
by phone and in person) 3)Participate in a telephone-based 1:1 treatment intervention for
pain. Subjects will be randomly assigned (by chance, like flipping a coin) to one of the two
treatment interventions.

4)All of the activities included in the study are considered research and would not normally
be part of the treatment subjects receive at the VAPSHCS.

Details about the various study activities are included below:

Informed Consent A research staff member will review the details of the study with each
subject and answer any questions the subject may have, and see if the subject is interested
in participating. Subjects will then print their name, sign and date the study consent form
if they are interested in participating.

Assessments There are several assessments required as part of subjects' participation in this
study: cognitive tests, a baseline assessment interview, and four "assessment periods". The
"assessment periods" are weeks in which the researchers will call subjects four times, each
on a different day, to do a brief assessment interview. All of these assessments are
described in detail below.

Cognitive Testing Session

The first assessment is a short battery of cognitive tests. These tests will test memory and
information processing. These tests will take about 15-20 minutes to complete and need to be
completed in person. Subjects can complete them immediately following the consent process
today or at a later time. Subjects will be compensated $20 for completing this assessment.

Baseline Assessment Interview A research staff member will interview each subject for 20-30
minutes. Subjects will be asked a number of standard questions such as their age, gender,
race, ethnicity, education level, military service, and their pain problem(s). Research staff
members will also ask about personal habits and history, including alcohol and drug use, as
well as any problems subjects may experience related to stressful military experiences.
Subjects will also be asked two questions about whether or not they ever experienced military
sexual trauma. These questions will take about 20-30 minutes to answer all together, and can
be completed in person after the cognitive testing session, or over the telephone at a later
time. Subjects will not be paid to complete this interview.

Medical Record Review

Research staff members will collect some information about subjects from their medical
record, including the following:

Level of Service Connection Number of TBI-Related Events Where subjects were located when the
TBI-Related Events occurred (e.g., in combat, in the USA) Causes of TBI(s) Severity of TBI(s)

This information will be linked to the data subjects provide while participating in the
study. Subjects will not have to do anything other than enroll in the study in order for the
researchers to review their medical records.

Four Telephone Assessment Periods Research staff will call subjects to complete four sets of
telephone interviews during study participation. The first of these will occur at the
beginning of the study. The second will occur about half- way through treatment. The third
will occur at the end of treatment, and the fourth will occur about six months after the
subject began treatment. Each assessment period will include four telephone calls on
different days, all within the same week. Telephone calls may be as brief as 5 minutes, or
one of the 4 lasting as long as 30 minutes, depending on how subjects choose to space the
assessment questions over the four calls within a given assessment period week. The entire
assessment will take about 40-45 minutes to complete, spread over four telephone calls within
a week.

During each telephone call, research staff will ask subjects at the minimum to rate their
current, average, worst and least pain intensity over the past 24 hours, as well as the
frequency and severity of any headaches subjects may have had in the past 24 hours.

In addition, once during each of the four assessment period weeks the research staff will
also ask subjects an extra set of questions about how much pain has interfered with their
life, how they have been feeling recently, and thoughts or feelings they have had about their
pain problem. These extra questions take about 25 minutes in total to answer.

Subjects will have the option to:

1. complete the extra set of questions all at once, in one of the four telephone
interviews,

2. spread the set of questions across the four telephone interviews, so that each call is
about 10 minutes long, or

3. complete a bare minimum of questions over the telephone during any of the four phone
interviews, and then complete the remaining questions via a paper-and-pencil
questionnaire sent to the subject. Subjects will then return the completed questionnaire
in a postage-paid envelope provided by staff. Research staff will call subjects if they
have not received the completed questionnaire after a certain period of time.

The four telephone interviews must be completed within one week, and each of the assessment
calls will take place on different days during the one week. The pre-treatment assessments
must be completed in the week before the first treatment session. Otherwise, the first
treatment session will be postponed until all four of the assessments have been completed.

Treatment Once subjects are enrolled in the research study and have completed the cognitive
testing session and the baseline assessment, a research staff member will call each subject
to schedule the initial treatment session. The clinicians who will conduct the treatment
sessions are clinical psychologists or trained therapists who are supervised by clinical
psychologists.

Before the first treatment session, subjects will be randomly assigned (by chance, like
flipping a coin) to one of two treatment interventions. Both treatments involve eight
hour-long telephone calls with the assigned study therapist. Both treatments involve
educating subjects about pain, discussing the impact of pain, and discussing different ways
to manage it in hopes of decreasing subjects' pain and its impact on their lives. Subjects
will be encouraged to use what they learn in the telephone sessions outside of treatment to
help them with their pain.

Every participant will receive eight 60-minute sessions conducted by telephone by one of the
study's clinicians. Whenever possible, research staff will try to schedule the treatment
sessions an average of once a week, so that a subject's total time in treatment is eight
weeks. Research staff will send subjects a workbook by standard mail or electronically, with
materials to refer to and discuss during the telephone sessions, as well as additional
materials to review between sessions. Subjects may also receive audio recordings as part of
the material they will talk about in treatment.

The research staff members who are conducting the assessments will not know which treatment
intervention subjects have been assigned to, nor will they have access to any information
covered during the treatment sessions with study clinicians. All treatment is administered
over the phone.

Subjects will be asked to complete the follow-up assessments if they decide they no longer
want to participate in the study before they finish the treatment sessions.

The study clinician who conducted the treatment sessions will call each subject 2, 6, and 10
weeks after the last treatment session. The clinician will call to ask how subjects are doing
and answer questions they may have. These telephone calls are called "booster sessions" and
will take about up to 15 minutes to complete.

Inclusion Criteria:

- Veteran Status

- Diagnosis of TBI of any severity verified in VA medical records (e.g., VA TBI
Comprehensive Evaluation or other comparable neuropsychological or medical evaluation
in the record)

- Most recent TBI must have occurred after onset of OEF

- Military Service in OEF, OIF, and/or OND

- Average pain intensity in the past month of 4 or above on 0-10 numeric rating scale
(moderate pain and above)

- Pain of at least six months duration, with pain reportedly present greater than or
equal to half of the days in the past six months

- Able to read and speak English

- Able to communicate over the phone (i.e., must be verbal)

- Age 18 years or older

Exclusion Criteria:

- Hospitalization for psychiatric reasons involving psychosis other than suicidal
ideation, homicidal ideation, and/or PTSD

- Communication limitations that would prevent ability to participate in the
intervention or assessments

- Cognitive impairment that interferes with ability to engage in the intervention
despite modifications specifically for TBI. This will be defined as a score of 5/10 or
less indicating moderate or severe cognitive impairment on the Short Portable Mental
Status Questionnaire (SPMSQ)

- Diagnosis of primary psychotic or major thought disorder as listed in participant's
medical record or self-reported