Clinical trial NCT02653664: Chronic Pain Skills Study
Official title: Hypnosis and Meditation for Pain Management in Veterans: Efficacy and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Sleep
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: VA Puget Sound Health Care System
name: Washington State University
First posted: 2016-01-12
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pain is a significant problem for many Veterans, including new Veterans returning from Iraq and Afghanistan. It is also associated with a number of other significant problems, such as post-traumatic stress disorder and sleep problems. All of these can have significant negative effects of the quality of life of Veterans

Three different types of treatment that have been used to treat chronic pain in the general population include self-hypnosis, education about chronic pain, and teaching individuals how to be more mindful. The purpose of this study is to see if these three treatments can help decrease pain in Veterans. Additionally, the researchers want to determine if each of these treatments can help reduce the negative consequences associated with pain, such as changes in mood, sleep, and enjoyment of life.

Different types of treatment that include self-hypnosis, education about chronic pain, and learning skills on how to change how a person perceives his/her pain have been used to treat chronic pain the general population.

The purpose of this study of this study is to see if these different treatments can help decrease pain and improve quality of life in Veterans with chronic pain, and determine how and why these treatments are effective. A subject must have a Veteran status, have chronic pain, speak English and be at least 18 years old to participate.

Sleep Sub-Study

Chronic pain and sleep problems are common among Veterans. Study researchers believe the treatment interventions provided as part of the main study will help improve pain and sleep. However, the main study does not include a "real time" measurement of sleep nor does it include any specific strategies for examining the relationship between sleep and pain.

Previous research has shown that adequate sleep has been linked to improvements in pain reports. Adversely, sleep deprivation has been found to increase pain perception since it decreases a person's ability to disengage from pain. Therefore, the purpose of this sub-study is to measure sleep in order to learn more about how it interacts with chronic pain.

All of the subjects in this sub-study will be Veterans recruited from VA Puget Sound who experience moderate-to-severe chronic pain on a regular basis and who have enrolled in the main study. Study investigators will enroll up to 135 subjects into the sub-study.

Detailed description: 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 Puget Sound Health Care System (VAPSHCS), 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale Immediately Following End of Treatment (Post-Treatment)
timeFrame: Change in Average Pain Intensity from Pre-Treatment to Immediately Following End of Approximately Eight Weeks of Treatment (Post-Treatment)
Secondary outcomes:
Other outcomes:
measure: Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale 3 Months Following End of Treatment
timeFrame: Change in Average Pain Intensity from Pre-Treatment to 3 Months Following End of Treatment
measure: Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale 6 Months Following End of Treatment
timeFrame: Change in Average Pain Intensity from Pre-Treatment to 6 Months Following End of Treatment
Locations:
city: Seattle
country: United States
facility: University of Washington, Ninth and Jefferson Building
state: Washington
city: Seattle
country: United States
facility: University of Washington- Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: VA Puget Sound Health Care System, Seattle Division
state: Washington
city: Seattle
country: United States
facility: University of Washington, Integrated Brain Imaging Center
state: Washington
city: Tacoma
country: United States
facility: VA Puget Sound Health Care System, American Lake
state: Washington
Study officials:
affiliation: University of Washington
name: Mark Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Healthcare System (VAPSHCS)
name: Rhonda Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams RM, Day MA, Ehde DM, Turner AP, Ciol MA, Gertz KJ, Patterson D, Hakimian S, Suri P, Jensen MP. Effects of hypnosis vs mindfulness meditation vs education on chronic pain intensity and secondary outcomes in veterans: a randomized clinical trial. Pain. 2022 Oct 1;163(10):1905-1918. doi: 10.1097/j.pain.0000000000002586. Epub 2022 Jan 25.
citation: Turner AP, Jensen MP, Day MA, Williams RM. Behavioral activation and behavioral inhibition: An examination of function in chronic pain. Rehabil Psychol. 2021 Feb;66(1):57-64. doi: 10.1037/rep0000316. Epub 2020 Mar 9.
citation: Williams RM, Ehde DM, Day M, Turner AP, Hakimian S, Gertz K, Ciol M, McCall A, Kincaid C, Pettet MW, Patterson D, Suri P, Jensen MP. The chronic pain skills study: Protocol for a randomized controlled trial comparing hypnosis, mindfulness meditation and pain education in Veterans. Contemp Clin Trials. 2020 Mar;90:105935. doi: 10.1016/j.cct.2020.105935. Epub 2020 Jan 9.