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Back on Track to Healthy Living Study (BOT)

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ClinicalTrials.gov Identifier: NCT03687762
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Collaborators:
Rush University
Medical University of South Carolina
The University of Queensland
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Mark Jensen, University of Washington

Brief Summary:

Chronic low back pain (CLBP) is a significant problem affecting millions of Americans. Research has shown that psychological treatments can help people with CLBP manage their pain and improve their quality of life. Three common psychological treatments for CLBP are Cognitive Therapy (CT), Mindfulness Meditation (MM), and Activation Skills (AS). While research has shown these treatments are helpful for people with CLBP, there is little research explaining why these treatments are helpful. The purpose of this study is to understand the specific ways these treatments work. Increasing our understanding of how these treatments work will help researchers and clinicians improve treatments for people with CLBP in the future.

Aim 1, Primary: Researchers will determine how much late-treatment improvement in pain interference related to the study's psychological treatments is predicted by early-treatment changes in the content of negative thoughts about pain (i.e., pain catastrophizing), thought processes (i.e., non-judgment), and/or activity level.

Hypothesis 1a: Early treatment changes in pain catastrophizing, non-judgment, and activity level are significantly related with late treatment improvements in pain interference.

Hypothesis 1b: If changes in pain catastrophizing, non-judgment, and activity level are mechanisms shared across the three treatments, then the actual treatment condition will have small and non-significant effects on early changes in the mechanism variables. This is known as the Shared Mechanisms Model.

Hypothesis 1c: If changes in pain catastrophizing, non-judgment, and activity level are mechanisms specific to CT, MM, and AS, respectively, then treatment condition will have a significant effect on early changes in the mechanism variables (i.e., the effects of the three treatments on the three mechanism variables will be different, with CT having the largest effects on early treatment decreases in catastrophizing, MM having the largest effects on early treatment increases in non-judgment, and AS having the largest effects on early treatment increases in activity level). In addition, later improvement in the primary outcome will be predicted by different mechanism variables as a function of treatment condition; that is, late treatment changes in pain interference will be substantially and uniquely predicted by early treatment changes in: (1) cognitive content (i.e., pain catastrophizing) in CT but not in MM or AS; (2) cognitive process (i.e., non-judgment) in MM but not in CT or AS; and (3) activity level in AS but not in CT or MM, in addition to each mechanism variable significantly predicting the primary outcome. This is known as the Specific Mechanisms Model.

Researchers also predict that change in the mechanism variables will precede and predict change in outcome, but not vice versa.

Secondary Objective: As a secondary aim, this study will also examine the post-treatment mechanisms that explain relapse, maintenance, and continued gains associated with these treatments [Aim 2; Secondary]. The Shared (Hypothesis 2a) and Specific (Hypothesis 2b) Mechanism models will also be applied to data collected via EMA and ActiGraph daily during the 4-weeks post-treatment to better understand the post-treatment mechanisms that underlie maintenance of gains and relapse.

Exploratory Objective: Researchers will test if (1) higher baseline levels of catastrophizing are associated with a positive response to the CT intervention, (2) lower baseline levels of activity are associated with a positive response to AS, and (3) higher baseline levels of non-judgment are associated with a positive response to MM.


Condition or disease Intervention/treatment Phase
Low Back Pain, Recurrent Behavioral: Cognitive Therapy (CT) Behavioral: Mindfulness Meditation (MM) Behavioral: Activation Skills (AS) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, 3-group parallel design, 240-subject clinical trial to test the mechanisms of cognitive therapy, mindfulness meditation, and activation skills on individuals with chronic low back pain.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanisms of Psychosocial Treatments for Chronic Low Back Pain
Actual Study Start Date : September 7, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Cognitive Therapy (CT) Condition
Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.
Behavioral: Cognitive Therapy (CT)
The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.

Active Comparator: Mindfulness Meditation (MM) Condition
Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events.
Behavioral: Mindfulness Meditation (MM)
Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.

Active Comparator: Activation Skills (AS) Condition
Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Behavioral: Activation Skills (AS)
Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.




Primary Outcome Measures :
  1. Change in Pain Interference [ Time Frame: Assessed via EMA twice daily during 2 wks before Session (Tx) 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 ]
    Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed for a total raw score from 5-25. Higher scores indicate more self-reported pain interference with different activities/aspects of life.


Secondary Outcome Measures :
  1. Change in Pain Intensity [ Time Frame: Assessed via EMA twice daily during 2 wks before Session (Tx) 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 ]
    Change in pain intensity of low back pain will be measured using a 0-10 numerical rating scale. 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.

  2. Change in Mood [ Time Frame: Assessed via EMA twice daily during 2 wks before Session (Tx) 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 ]
    Change in mood will be assessed using the Positive and Negative Affect Schedule (PANAS). When assessed via phone, responses from the positive affect items will be summed for a total positive score ranging from 5-25 while responses from the negative affect items will be separately summed for a total negative score ranging from 5-25. When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect.

  3. Change in Physical Function [ Time Frame: Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 ]
    Change in extent of physical function will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form-4A. Responses from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of physical function.

  4. Change in Sleep Quality [ Time Frame: Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 ]
    Change in sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form-4A. Responses from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of sleep disturbance.

  5. Change in Depression [ Time Frame: Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 ]
    Change in depression will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form-4A. Responses from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of depression.

  6. Change in Medication Use [ Time Frame: Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 ]
    Change in medication use will be assessed by asking participants to report use of antidepressant, sedative/hypnotic, anticonvulsant, NSAID, or opioid medications within the past 7 days. For NSAID and opioid medications, participants will be asked to report medication name, quantity per dose (e.g., 50 mg), and number of medication doses taken in the past week. For each antidepressant, sedative/hypnotic, or anticonvulsant medication, participants will report yes or no to having taken them in the past week. Researchers will calculate a morphine equivalent dose (MED) for opioid medications; a lower MED indicates less self-reported opioid medication use. For all other medication types, researchers will track medication counts (if medication was used or not) at each time point.


Other Outcome Measures:
  1. Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism) [ Time Frame: Assessed via EMA twice daily during 2 wks before Session (Tx) 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 ]

    Change in pain catastrophizing will be measured with items from the University of Washington (UW) Pain Appraisal Scale (PAS) item bank and the 2-item Coping Strategy Questionnaire (CSQ) Catastrophizing Scale. When assessed via phone, responses from the PAS will be summed for a total raw score from 6-30. The total raw score will then be converted to a IRT (Item Response Theory)-based T-score. Higher T scores indicate a higher level of pain catastrophizing. Similarly, the 2-item CSQ will be averaged for a mean score from 0-6. A higher mean CSQ score indicates a higher level of pain catastrophizing.

    The PAS is also assessed via EMA. When assessed via EMA, responses from the PAS will be summed for a total raw score from 4-20. The total raw score will then be converted to a IRT-based T-score. Higher T scores indicate a higher level of pain catastrophizing.


  2. Change in Non-Judgment (i.e., Cognitive Process Mechanism) [ Time Frame: Assessed via EMA twice daily during 2 wks before Session (Tx) 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 ]
    Change in non-judgment will be measured with items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. When assessed via phone, the full 6-item scale will be used while only four items are used in the EMA. Items will be averaged for a mean score from 0-4. Higher mean PCPQ scores indicate higher frequencies of using the adaptive cognitive process of non-judgment in responding to pain.

  3. Change in Activity Level (Actigraphy) [ Time Frame: Worn daily for 2 weeks before Session (Tx) 1, during 4-week treatment period, and during immediate 4 weeks after Tx 8 ]
    Change in activity level will be measured by an actigraphy device worn by the participant measuring activity level and sleep.

  4. Change in Activity Level (Exercise Self-Report) [ Time Frame: Assessed via EMA twice daily during 2 wks before Session (Tx) 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 ]

    Change in time spent exercising will be measured using the Godin Leisure-Time Exercise Questionnaire, a 3-item questionnaire assessing time spent in mild, moderate, and strenuous exercise. When assessed via phone, participants will report the number of times in the past week spent in each of the three intensity levels. The number of times at each intensity level will be multiplied by MET values of 3, 5, and 9, respectively, and these values are then summed to create a total weekly exercise score. Higher total weekly exercise scores indicate higher levels of physical activity.

    The Godin Leisure-Time Exercise Questionnaire is also assessed via EMA. When assessed via EMA, participants are asked to report the number of minutes they spent exercising at each of the three intensity levels for that day. More time reported at each of the three exercise intensity levels indicate higher levels of physical activity.


  5. Change in Activity Level (Hours Spent Sitting without Exercising Self-Report) [ Time Frame: Assessed via EMA twice daily during 2 wks before Session (Tx) 1, 4-week treatment period, and immediate 4 weeks after Tx 8 ]
    Change in hours spent sitting without exercising will be measured using a single self-report item. A higher number of hours spent sitting without exercising indicates a higher amount of sedentary time.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years;
  2. Diagnosis of low back pain;
  3. Location of primary (i.e., worst) pain source is the low back region;
  4. Chronic (≥3 months, with pain experienced on ≥50% of days) musculoskeletal pain of the lower back;
  5. Average intensity of low back pain ≥3 on a 10-point scale for most days of the previous 3 months;
  6. Low back pain interference for general activities ≥3 on a 10-point scale for the past 3 months;
  7. Able to read, speak, and understand English;
  8. If currently taking analgesic or psychotropic medication, medications must have been stabilized for ≥4 weeks prior to this study; and
  9. Availability of a telephone, webcam and microphone through computer or telephone, as well as daily internet access.

Exclusion Criteria:

  1. Severe cognitive impairment;
  2. Current alcohol or substance dependence;
  3. Active malignancy (e.g., cancer not in remission) or autoimmune disorders with a pain component (e.g., lupus);
  4. Another confounding chronic pain condition that interacts with or complicates one's low back pain, causing the low back pain to be qualitatively distinct from typical, non-specific low back pain;
  5. CLBP condition for which surgery is recommended and/or planned;
  6. Currently receiving other psychosocial treatments for any pain condition;
  7. Current or past participation in a UW Department of Rehabilitation Medicine research study with treatment components that may overlap those in the current study;
  8. Current or history of diagnosis of primary psychotic or major thought disorder within the past 5 years;
  9. Psychiatric hospitalization within the past 6 months;
  10. Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months;
  11. Any psychiatric or behavioral issues as noted in the medical record or disclosed/observed during self-report screening that would indicate participant may be inappropriate in a group setting; and
  12. Presenting symptoms at the time of screening that would interfere with participation, specifically active suicidal or homicidal ideation with intent to harm oneself or others or active delusional or psychotic thinking.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687762


Contacts
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Contact: Joy Chan, B.S. 206-744-3626 joychan@uw.edu
Contact: Sam Battalio, B.S. 206-616-8205 sbattali@uw.edu

Locations
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United States, Washington
University of Washington, Ninth and Jefferson Building Recruiting
Seattle, Washington, United States, 98104
Contact: Joy Chan, B.S.    206-744-3626    joychan@uw.edu   
Contact: Sam Battalio, B.S.    206-616-8205    sbattali@uw.edu   
Sponsors and Collaborators
University of Washington
Rush University
Medical University of South Carolina
The University of Queensland
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Mark Jensen, Ph.D. University of Washington
Principal Investigator: Melissa Day, Ph.D. The University of Queensland

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Responsible Party: Mark Jensen, Professor, School of Medicine: Rehabilitation Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT03687762     History of Changes
Other Study ID Numbers: STUDY00003841
R01AT008559 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mark Jensen, University of Washington:
chronic pain
mechanisms
cognitive therapy
mindfulness meditation
activation skills

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms