Chronic pain is a prevalent, disabling problem affecting as many as 50% of men and 75% of women Veterans. Cognitive Behavioral Therapy (CBT) is the current gold standard treatment for chronic pain. However, while some individuals do respond to CBT, many individuals do not obtain meaningful benefit. As a result, the average response to CBT treatment in groups of individuals with chronic pain is only modest. To address the need for effective treatments, the investigators have developed and adapted Complementary and Integrative Health (CIH) interventions such as Mindfulness-Based Cognitive Therapy (MBCT) and Hypnotic Cognitive Therapy (HYP-CT) for chronic pain management. Research shows these treatments are beneficial alternatives to CBT. However, as with CBT, response to these treatments varies, and the investigators' preliminary data suggests outcome variability is explained by a number of baseline patient factors. Research is now needed to advance knowledge regarding the pre-treatment patient factors (i.e., predictive markers) that moderate treatment outcome (i.e., patient factors that interact with treatment condition to predict outcome). The findings from this research will provide an empirical basis for developing patient-treatment matching algorithms to prospectively match a given individual to the evidence-based treatment most likely to be beneficial for them. The investigators have initiated a program of research to identify the factors that predict response to psychosocial pain treatments, including HYP-CT, MBCT, and CBT. Preliminary findings suggest that predictive markers such as brain activity (e.g., alpha and beta power, as measured by EEG), and the traits of mindfulness, hypnotizability, and catastrophizing, will predict who benefits most from different treatments. For example, post hoc analyses show that those who are "well-matched" to HYP-CT, based on the identified baseline moderators, achieve twice the amount of pain reduction with treatment, compared to those who are not well- matched. To confirm these findings, prospective research is now needed. The findings from this study will provide a foundation upon which to develop an assessment battery to identify critical values on which to base algorithms for a priori matching of individual patients to different treatments. This has the potential to substantially boost the typically modest average effect sizes that are achieved when using a more traditional "one size fits all" approach.
This study has a single overall aim: to identify patient predictive markers that determine who benefits most from two CIH treatments (hypnotic cognitive therapy \[HYP-CT\] and Mindfulness-Based Cognitive Therapy \[MBCT\]) and the current gold standard non-pharmacological treatment (CBT) vs. usual care (UC). This aim will be addressed in the context of a clinical trial in which participants with chronic pain will be randomized to one of the three active chronic pain treatments or UC. Based on findings from prior research, the investigators hypothesize that five primary predictive markers assessed at pre-treatment (alpha power, beta power, hypnotizability, nonreactivity \[a mindfulness domain\], and catastrophizing) will modify subsequent treatment-related changes in pain intensity following MBCT, HYP-CT, and CBT, relative to usual care. The primary clinical endpoint is reduction (change) in average pain intensity from pre- to post-treatment; the post-treatment assessment point is the primary endpoint. Average pain intensity will be measured using a composite of up to 4 separate pain ratings assessed within a 1-week period at each study assessment window. Although there are up to four ratings, each from a different day in a 7-day window, that are used to compute post-treatment average pain severity score, these variables will be used to compute a single score representing average pain during the post-treatment period; therefore, there is only a single primary post-treatment end point. The primary predictive markers are EEG-assessed alpha and beta power, researcher-measured hypnotizability, and self-reported-pain catastrophizing and non-reactivity mindfulness, all of which will be assessed at pre-treatment. The five primary study hypotheses are as follows: Hypotheses 1a, 1b, and 1c: Baseline alpha power will predict pre- to post-treatment change in pain intensity, such that, relative to UC, more alpha power predicts greater change (reduction) in pain intensity in response to HYP-CT (1a), and lower levels of alpha power predict greater pain intensity change (reduction) in response to both CBT (1b) and MBCT (1c). Hypothesis 2: Baseline beta power will predict pre- to post-treatment change in pain intensity, such that, relative to UC, more beta power predicts greater change (reduction) in pain intensity in response to CBT. Hypotheses 3a and 3b: Baseline hypnotizability will predict pre- to post-treatment change in pain intensity, such that, relative to UC, more hypnotizability predicts greater change (reduction) in pain intensity in response to HYP-CT (3a), and predicts less change (reduction) in pain intensity in response to CBT (3b), relative to UC. Hypothesis 4a and 4b: Baseline catastrophizing and the nonreactivity domain of mindfulness will predict pre- to post-treatment change in pain intensity, such that lower levels of baseline catastrophizing (4a) and greater levels of nonreactivity (4b) will predict greater pain intensity change (reduction) in response to MBCT, relative to UC. Hypothesis 5: Baseline mindfulness will predict pre- to post-treatment change in pain intensity, such that higher levels of baseline mindfulness will predict greater pain reduction in response to MBCT. Secondary study objectives include: * Understand the zero order associations between predictive markers and pre- to post-treatment pain reductions for participants in each treatment condition separately. * Understand the predictive role of the primary predictive markers on longer-term outcomes (i.e., 3 and 6-months post-treatment follow-ups) for the four treatment conditions. * Understand any differences in clinical outcomes between the three active treatments, relative to usual care. * Determine if there are any effects of "dose" of treatment on clinical outcomes. Tertiary/exploratory study objectives include: * Identify additional potential predictive markers of treatment-related improvements in pain. * Identify potential predictive markers of treatment effects on secondary outcomes. * Develop initial treatment matching algorithm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
331
The CBT intervention will be used to help participants learn about the role of cognitions (particularly pain catastrophizing), pain beliefs (including perceived control), and maladaptive or unhelpful coping behaviors in chronic pain. This technique will help participants: (1) identify and change or restructure unhelpful or negative thinking about pain; (2) utilize positive coping strategies including positive coping self-statements; relaxation techniques; behavioral activation (including setting goals for activation), activity pacing and scheduling; and (3) cope with pain flare-ups.
The HYP-CT intervention will be used to help participants learn about the role of hypnosis to reduce pain, increase comfort and well-being, and to instill and reinforce healthy, adaptive cognitions. This technique will help participants to use their ability to enter a state of focused attention to then increase their acceptance of new adaptive ideas about pain provided both by (1) clinicians during sessions and on audio recordings, as well as (2) the participants themselves during self-hypnosis practice.
The MBCT intervention will be used to help participants learn about the role of MBCT in training the mind to respond more adaptively to pain. This technique will help participants: (1) apply the skills they learn not only to pain but also to the problems pain causes for them, including sleep disturbance, depressed mood, stress, and other problems; (2) build on their strengths and their innate ability to focus their attention at will, and to use this ability to mindfully perceive experience in a non-judgmental, non-reactive way; and (3) notice their moment-to-moment experience and to shift their relationship to this experience. With enhanced mindful awareness comes the opportunity to then mindfully choose how to respond to the pain in a way that reduces stress and is most helpful or adaptive.
University of Washington, Ninth and Jefferson Building
Seattle, Washington, United States
VA Puget Sound Health Care System, Seattle Division
Seattle, Washington, United States
VA Puget Sound Health Care System, American Lake
Tacoma, Washington, United States
Change in Average Daily Pain Intensity
Change in pain intensity will be measured using a 0-10 numerical rating scale (NRS) of average pain in the past 24 hours, up to 4 times within a 7-day period. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity.
Time frame: Assessed online up to 4 times within a 7-day period at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.
Change in Depression
Change in depression will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form-8A. Responses from each item will be summed to form a total raw score ranging from 8-40. Higher scores indicate higher self-reported levels of depression.
Time frame: Assessed online at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.
Change in Anxiety
Change in anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form-8A. Responses from each item will be summed to form a total raw score ranging from 8-40. Higher scores indicate higher self-reported levels of anxiety.
Time frame: Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.
Change in Sleep Quality
Change in sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form-8A. Responses from each item will be summed to form a total raw score of 8-40. Higher scores indicate higher self-reported levels of sleep disturbance.
Time frame: Assessed online at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.
Change in Pain Interference
Change in pain interference with different daily activities and aspects of life will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form-6A. Responses from each item will be summed to form a total raw score of 6-30. Higher scores indicate higher self-reported levels of pain interference.
Time frame: Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.
Change in Fatigue
Change in fatigue will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form-8A. Responses from each item will be summed to form a total raw score of 8-40. Higher scores indicate higher self-reported levels of fatigue.
Time frame: Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.
Change in Social Role Participation
Change in perceived ability to perform one's usual social roles and activities will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Short Form-4A. Responses from each item will be summed to form a total raw score of 4-20. Higher scores indicate higher self-reported levels of ability to participate in social roles and activities.
Time frame: Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.
Change in General Health
Change in general health will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health V1.2. The participants will be asked to choose a number between 1-5 that best represents their general health. A higher score indicates higher self-reported levels of general health
Time frame: Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.
Change in Cognition
Change in cognitive function will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function - Abilities Short Form-6A. Responses from each item will be summed to form a total raw score of 6-30. Higher scores indicate higher self-reported levels of cognitive function.
Time frame: Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.
Change in Fear Avoidance Beliefs
Change in fear avoidance beliefs will be measured with the Fear-Avoidance Beliefs Questionnaire. The participants will be asked to choose a number between 0-6 that best represents how much physical activities affect or would affect their pain. Higher scores indicate higher self-reported levels of fear avoidance beliefs.
Time frame: Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.
Change in Pain Intensity without Medications
Change in pain intensity without medications will be measured using a numerical rating scale (NRS). Participants will be asked to choose a number from 0-10 that best represents what their pain intensity would have been, on average over the past 7 days, if they were not taking any pain medications. Higher scores indicate higher levels of self-reported pain intensity without any pain medications.
Time frame: Assessed online at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.
Change in Medication Use
Change in medication use will be measured by asking participants to report the number of days in the past 7 days they used opioid or narcotic pain medications, oral or topical NSAIDs, Acetaminophen, Aspirin, muscle relaxants, oral steroids or corticosteroids, Duloxetine, tricyclic antidepressants, or other pain-relieving medicines.
Time frame: Assessed online at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.
Change in Well-being
Change in well-being will be measured with the World Health Organization (WHO) Well-being Index. The participants will be asked to choose a number between 0-5 that best represents how they have been feeling over the past 2 weeks. The raw score ranging from 0 to 25 is multiplied by 4 to give a final score from 0-100. Higher scores indicate higher self-reported levels of well-being.
Time frame: Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.
Change in PTSD Symptoms
Change in PTSD symptoms and related aspects will be measured with the Short PTSD Rating Interview (SPRINT). The participants will be asked to choose a number between 0-4 that best represents how much they have been bothered by a specific problem in the last week. Responses from each item will be summed to form a total raw score of 0-32. Higher scores indicate higher self-reported levels of PTSD Symptoms.
Time frame: Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.
Change in Cannabis Use
Change in cannabis use will be measured with the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use (DFAQ-CU) Inventory. The participants will be asked to choose the responses that best describes their use of cannabis. Participants will be directed to note that the term cannabis is being used to refer to marijuana, cannabis concentrates, and cannabis-infused edibles. High scores indicate higher self-reported levels of cannabis use.
Time frame: Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.
Change in Alcohol Use
Change in alcohol use will be measured with the Alcohol Use Disorders Identification Test (AUDIT). Responses from each item will be summed to form a total score between 0-40. Higher scores indicate higher self-report levels of alcohol use.
Time frame: Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.
Global Impressions of Change
Global impressions of change will be measured with the Patient Global Impressions of Change (PGIC). The participants will be asked to choose a number from 1-7 to describe the change in pain intensity, their ability to manage pain, pain interference, medication and substance use, and overall well-being since the beginning of the study treatment. Lower scores indicate higher self-reported levels of global impressions of change.
Time frame: Assessed online at post-tx (8-week).
Global Assessment of Treatment Satisfaction
Global assessment of treatment satisfaction will be measured with the Patient Global Assessment of Treatment Satisfaction (PGATS). The participants will be asked to describe their level of satisfaction with the study treatment using a number from 0-4. A higher score indicates higher self-report treatment satisfaction.
Time frame: Assessed online at post-tx (8-week).
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