Chronic Pain Skills Study

Cognitive Assessment

Following enrollment, research staff will administer a battery of five neuropsychological
measures assessing memory, information processing, and executive functioning. These measures
take approximately 20-30 minutes to complete.

Hypnotic and Relaxation Exercise

A research staff member will administer in person the Modified Stanford Hypnotic Clinical
Scale (SHCS) to assess hypnotizability for all participants following enrollment but prior to
randomization. This measure takes approximately 15-20 minutes to complete.

Baseline Data and Demographic Form

A research staff member will then ask the participant to provide demographic data (age, sex,
marital status, income, education level, employment status) and deployment history (number
and month of deployments, whether deployment involved hostile duty) for descriptive purposes.
Study investigators will also ask participants their history of receiving the study
treatments, and the presence of history of military sexual trauma.

The baseline data and demographic form will take approximately 20-30 minutes to complete, and
may be completed following enrollment either in person or over the telephone at a later time
if more convenient for the participant.

Brain Wave Activity (or EEG) Assessment

Brain wave activity will be assessed following enrollment by conducting a brain wave activity
or EEG assessment. The brain wave activity assessment will take place at the Integrated Brain
Imaging Center (IBIC) at the University of Washington main campus. The IBIC is a
research-dedicated technology center organized under the department of Radiology.

EEG will be sampled with an electrode array using an electrode net dipped in a saline
solution. The research staff member, an IBIC employee with a Without Compensation (WOC)
appointment at the VA, will collect the EEG activity data, and ask the participant to remain
as still as possible during portions of the assessment.

The EEG technician will collect from the participant data regarding medication used within 24
hours of assessment. He/she will also ask the participant to rate the intensity of his or her
pain just before the assessment (current pain), after a few minutes of the assessment
(current pain and worst, least, and average pain over the past few minutes), and at the end
of the EEG session (current pain, and worst, least, and average pain over the past few
minutes), using 0-10 Numerical Rating Scales.

The entire brain wave activity assessment will take approximately 45-60 minutes to complete.
Subjects will be asked to complete the same brain activity assessment following completion of
treatment following the same procedures above. Participants may still participate in the
study if they decline to participate in the EEG assessments.

Assessment: Pre-Treatment and General Overview

Subjective reports of pain intensity vary over time, and to most accurately measure pain
intensity (our primary outcome), it is most valid to assess multiple times and take an
average. Hence, study investigators have developed a method of assessment that will seek to
obtain up to four telephone assessments over a period of one week or 7 days with a minimum of
24 hours between each assessment. During each telephone contact, research staff will ask
participants, at minimum, to rate their current, average, worst and least pain intensity over
the past 24 hours, as well as their average pain intensity over the past 7 days. In addition,
if possible, research staff will ask the participant to rate their current, average, worst
and least pain intensity over the past week during the final telephone contact. These
assessments will be referred to as "short assessments." The primary outcome will be an
average of all of the 24-hour ratings (range=1-4 ratings) of average pain intensity obtained
over a period of one week during each assessment period.

In addition, sometime during this assessment period researchers will ask questions regarding
pain interference, depression, anxiety, sleep disturbance, post-traumatic stress disorder
(PTSD) symptoms, medication use, medical services utilization, thoughts about pain and
treatment motivation. This latter set of questions will only be asked once during the
assessment period, and will be referred to as "the long assessment." Research staff will give
participants the option to: 1) complete the long assessment during one of the four short
telephone assessments described above; or 2) spread the long assessment across several days
during the assessment period. The entire long assessment or portions thereof may fall up to
two days outside the 7-day period for the four short assessments.

The entire time required to answer questions during the assessment period is 45-60 minutes.

The assessment period described above will be completed prior to initiating treatment, and
then after completion of treatment sessions #2, 4 and 6 and 8 (i.e. post-treatment), and 3
and 6 months following the end of treatment for a total of seven times. These assessment
periods that occur following the start of treatment will also include questions about group
climate, therapeutic alliance with the group clinician, treatment satisfaction, and overall
improvement since the participant began the pain program.

Randomization

Enrolled participants who complete the required baseline components (cognitive assessment,
hypnotic and relaxation exercise, baseline data form, and pre-treatment assessment period)
will be randomized in stratified blocks to ensure that participants with each sex and pain
type (neuropathic, non-neuropathic, mixed or undetermined) have an equal chance of being
randomized to one of the 3 conditions.

Treatment Scheduling

Cohorts of study intervention groups will be offered beginning every four months. In each
4-month period, there will be two class options for each condition, one based in Seattle and
one at American Lake. Thus, there will be six classes offered per four month period, or a
total of 18 classes per year.

Up to 15 participants can be enrolled in each intervention class; 10 spots will be protected
for research participants, and the remaining 5 for Veterans who have completed the study and
wish to try another type of intervention, or who are non-research participants. If any
protected research spots are not filled at the start of a cohort, non-research participants
will be offered those spots and vice versa.

Treatment

In all three treatment conditions, intervention appointments will be scheduled in regular
group clinics at the VA facility (American Lake or Seattle). This means that treatment
sessions will appear on the Veterans' lists of regular clinical appointments. Although the
appointments are scheduled for 90 minutes, in practice they will last 60-80 minutes, with a
10 minute time cushion built in to allow for participants who may have mobility limitations
to arrive, settle, and then vacate the group rooms without hurrying.

The group sessions will be conducted by VAPSHCS providers who have undergone a formal two-day
training process that prepares clinicians to conduct each of the three treatment
interventions in a group setting.

In all conditions, home practice activities will be assigned to increase engagement in the
treatment. Participants will be asked to record the extent of engagement in these activities
using a form provided to them by the clinician. Study investigators realize that adherence to
interventions assigned outside of treatment sessions may influence study outcomes so will
utilize data collected by the clinicians about homework compliance. In addition, all
participants in all interventions will be given a treatment workbook with materials to refer
to and discuss during the group sessions as well as additional materials to read between
sessions.

Please see below for description of study treatment interventions.

Data Collected during Treatment Sessions

Participants will complete and hand in a form regarding their completion of tasks or
"homework" assigned by the clinician from the previous session.

In addition, participants will complete and hand in forms before and after each session that
include questions regarding pain intensity and comfort level, as well as questions about what
the participants have found helpful or non-helpful about the treatment. Finally, study
clinicians will complete a form each session that captures information regarding the
perceived engagement of each participant in that particular session. All of these forms will
be labeled with a subject's name.

Audio Recordings

The group treatment sessions will be audio recorded to make sure the study clinician is
following study procedures.

Optional Assessments

For the pre-treatment and post-treatment telephone assessment periods, research staff will
use a script to invite participants upon completing the assessment period to participate in
an optional assessment consisting of two measures developed by study researchers. The
optional assessment should take approximately 10-15 minutes to complete, and consists of
questions about how participants feel when they feel pain or think about their pain problem,
and how participants respond to their pain.

Open Label Phase

Following the completion of the 6-month telephone assessment period research staff will
invite participants to complete in one or both of the treatment groups they did not attend
during participation in the main phase. Participants would only participate in one treatment
group at a time. The open label phase does not include any screening procedures; all research
participants are welcome to participate. Research staff will schedule a consent session if
the participant is interested in participating in the 'open label phase' of the study.

Sleep Sub-Study

Subjects enrolled in the main study will be offered the opportunity to participate
concurrently in the sleep sub-study. All subjects enrolled in the main study are eligible to
participate in the sub-study. Interested subjects will participate in a separate informed
consent process before participating in sub-study procedures.

Telephone Assessments

A research staff member will ask each sub-study subject two questions about how much the
subject agrees with certain statements about his/her sleep, as well as two questions about
how confident the subject is about carrying our certain sleep behaviors. These questions will
be asked during the pre-treatment assessment period, 4-week assessment period, post-treatment
assessment period, and the assessment period that takes place 3 months following the end of
treatment.

Sleep Diary

Three times during his/her participation in the sub-study, study investigators will ask the
subject to keep a sleep diary: once following enrollment but prior to randomization, once
following the end of treatment, and once three months following the end of treatment. The
subject will complete a diary entry twice a day (morning and night) for seven days. In the
morning, the subject would answer basic questions about his/her sleep during the previous
night, including time the subject thinks s/he fell asleep, the quality of his/her sleep, and
any other experiences that might have affected his/her sleep. In the evening, the subject
will answer questions about how the subject felt that day, any problems s/he experienced such
as illness or discomfort, and basic activities s/he participated in like going to work,
napping, drinking caffeinated beverages, etc.

Also, the subject will be instructed to call a toll free number twice a day to report when
s/he woke up in the morning, and when s/he is going to sleep in the evening.

Actigraphy Device

Three times during his/her participation in the sub-study, study investigators will ask the
subject to wear a sleep monitor device called an Actigraph: once following enrollment but
prior to randomization, once following the end of treatment, and once three months following
the end of treatment. The subject would wear the actigraph (Actiwatch , Philips Respironics,
Bend, OR) like a wrist watch on his/her non-dominant arm. The device will measure how long
the subject sleeps, as well as the overall quality of his/her sleep. The subject will wear
the actigraph at all times during the same 7-day period s/he is completing the sleep diary
except for when the subjects is participating in activities that might get the actigraph wet
like swimming, showering, or bathing.

Inclusion Criteria:

1. 18 years of age or older;

2. Veteran eligible for services through Veteran Health Affairs;

3. experience moderate to severe chronic pain on a regular basis; and

4. able to read, speak and understand English.

Exclusion Criteria:

1. severe cognitive impairment;

2. current or history of psychiatric or behavioral issues that require immediate
attention and/or prevent the subject from participating effectively in the study;

3. reported use of a high dose of an opioid(s).