Chronic Pain
Conditions
Keywords
chronic pain, mechanisms, cognitive therapy, mindfulness meditation, behavioral activation
Brief summary
Chronic pain is a significant problem affecting millions of Americans. Research has shown that psychological treatments can help people with chronic pain manage their pain and improve their quality of life. Three common psychological treatments for chronic pain are Cognitive Therapy (CT), Mindfulness Meditation (MM), and Behavioral Activation (BA). While research has shown these treatments are helpful for people with chronic pain, 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 chronic pain in the future. As a secondary aim, this study will also examine the post-treatment mechanisms that explain relapse, maintenance, and continued gains associated with these treatments. Treatment moderators will also be explored.
Detailed description
The purpose of this randomized controlled trial is to evaluate the mechanisms of cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA) as treatments for individuals with chronic pain who endorse low back pain as a primary or secondary pain problem. Participants (240 individuals) will be randomly assigned to eight (8), 1.5 hour telehealth group sessions of (1) CT, (2) MM, or (3) BA. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. Follow-up macro-level assessments will be conducted at 3- and 6-months post-treatment. The study will address two aims. Primary Objective: The objective of the proposed research is to examine the mechanisms of cognitive therapy (CT), mindfulness meditation training (MM), and behavioral activation (BA) \[Aim 1; Primary\]. After ensuring that there is at least a small effect of time on early treatment changes in the three mechanism variables, researchers will determine the extent to which late-treatment improvement in primary outcome (pain interference) associated with CT, MM, and BA is predicted by early-treatment changes in cognitive content (i.e., pain catastrophizing), cognitive process (i.e., non-judgment), and/or activity level (i.e., ActiGraph activity counts). Hypothesis 1a: Early treatment changes in pain catastrophizing, non-judgment, and activity counts are significantly associated with late treatment improvements in pain interference. Hypothesis 1b: The Shared Mechanisms Model hypothesizes that if changes in cognitive content, cognitive process, and activity levels are shared mechanisms across the three treatments, then treatment condition will have small and non-significant effects on early changes in the mechanism variables (i.e., the effects of the three treatments on the three mechanism variables will be similar; Shared Mechanisms Model). Hypothesis 1c: The Specific Mechanisms Model hypothesizes that if changes in content, process, and activity level are mechanisms specific to CT, MM, and BA, 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 BA having the largest effects on early treatment increases in activity level). Further, 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 BA; (2) cognitive process (i.e., non-judgment) in MM but not in CT or BA; and (3) activity level in BA but not in CT or MM, in addition to each mechanism variable significantly predicting the primary outcome (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 evaluate 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: Test the Limit, Activate, and Enhance (LAE) moderation model. Specifically, to 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 BA, and (3) higher baseline levels of non-judgment are associated with a positive response to MM. Primary and Secondary Endpoint: The primary endpoint researchers propose for the primary study aim (Aim 1) is the post-treatment pain interference score, operationalized as an average of pain interference ratings made on the twice-daily diaries during the first four days after treatment (i.e., Days 43-46). The endpoint for the secondary study aim (Aim 2) is the post-treatment score at 28 days follow-up, as operationalized as the average of days 67-70 of pain interference ratings on the diaries. Design and Outcomes 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 pain who endorse low back pain as a primary or secondary pain problem. Interventions and Duration Participants will be randomly assigned to eight (8) telehealth group sessions of (1) cognitive therapy (CT), (2) mindfulness meditation (MM), or (3) behavioral activation (BA). Treatment groups will meet, on average, twice per week over the Zoom videoconferencing platform. Each session will last for a duration of about 90 minutes. Proposed mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. Macro-level assessments will be conducted at pre- and post-treatment and at 3- and 6-months post-treatment. The total time involved in the study (excluding between session skills practice) is approximately 35-40 hours over an 8 to 9-month period. Sample Size and Population Researchers plan to enroll 300 participants with moderate to severe chronic pain including low back pain as a primary or secondary pain problem to achieve a sample size of 240 completers, with 80 completers in each of the treatment groups. Enrolled participants who complete the required baseline components (baseline data and demographic questions, pre-treatment extended assessment period, technology training, re-assessment of pain interference for general activities with a score of ≥3 for the past 3 months, re-assessment of pain consistency with a response of ≥50% of the time in the past 6 months, and a minimum number of EMA surveys during one week of Baseline Monitoring (Days 1-7) will be randomized to one of the three conditions.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALMindfulness 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.
BEHAVIORALBehavioral Activation (BA)
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.
Sponsors
Rush University
Medical University of South Carolina
The University of Queensland
National Center for Complementary and Integrative Health (NCCIH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A randomized, 3-group parallel design, 240-subject clinical trial to test the mechanisms of cognitive therapy, mindfulness meditation, and behavioral activation on individuals with chronic pain who endorse low back pain as a primary or secondary pain problem.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years; 2. Endorse having low back pain as a primary or secondary pain problem in the past 6 months; 3. Meet criteria for having a chronic pain problem (≥3 months, with pain experienced on ≥50% of days in past 6 months); 4. Average intensity of chronic pain ≥3 on a 10-point scale for most days of the previous 3 months; 5. Chronic pain interference for general activities ≥3 on a 10-point scale for the past 3 months; 6. Able to read, speak, and understand English; 7. If currently taking analgesic or psychotropic medication, medications must have been stabilized for ≥4 weeks prior to this study; and 8. Availability of a telephone, webcam, and microphone through computer or telephone, as well as daily internet access.
Exclusion criteria
1. Primary pain condition is headache; 2. Severe cognitive impairment; 3. Current alcohol or substance dependence; 4. Active malignancy (e.g., cancer not in remission), terminal illnesses, or serious medical conditions that may interfere with either study participation or with receiving potential treatment benefits (e.g., severe lupus); 5. Inability to walk (defined as unable to walk at least 50 yards), which would limit the ability of participants to benefit from the activation skills intervention; 6. Significant pain from a recent surgery or injury; 7. Pain condition for which surgery has been recommended and is planned; 8. Any planned surgery, procedure, or hospitalization that may conflict with or otherwise influence participation in the study; 9. Currently receiving or had received other psychosocial treatments for any pain condition; 10. Current or past participation in a research study with treatment components that may overlap those in the current study; 11. Current or history of diagnosis of primary psychotic or major thought disorder within the past 5 years; 12. Psychiatric hospitalization within the past 6 months; 13. Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months; 14. 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 15. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Interference (Micro-level Change) | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported | 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. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. |
| Change in Pain Interference (Macro-level Change) | Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx | 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. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Quality | Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx | 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. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported sleep disturbance. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
| Change in Depression Severity | Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx | 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. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher self-reported levels of depression. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
| Change in Anxiety Severity | Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx | Change in anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form-4A. Responses from each item will be summed to form a total raw score ranging from 4-20. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher self-reported levels of anxiety. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
| Change in Medication Use | Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx | Change in opioid medication use will be assessed by asking participants to report use of opioid medications within the past 7 days. 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. Researchers will calculate a morphine equivalent dose (MED) for opioid medications. Due to violation of assumptions of normality, the MED data was transformed into a categorical variable (no prescription, increase, decrease, no change). |
| Change in Pain Intensity (Macro-level) | Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx | Change in pain intensity of chronic pain in general 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. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
| Change in Mood (Macro-level) | Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx | Change in mood will be assessed using the Positive and Negative Affect Schedule (PANAS). 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. 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. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
| Change in Pain Intensity (Micro-level) | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported | Change in pain intensity of chronic pain in general 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. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. |
| Change in Mood (Micro-level) | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported | Change in mood will be assessed using the Positive and Negative Affect Schedule (PANAS). 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. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. |
| Change in Physical Function | Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx | 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. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels (i.e., better) physical function. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) | Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx | Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
| Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) | Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx | 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. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
| Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Micro-level) | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported | Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. |
| Change in Non-Judgment (i.e., Cognitive Process Mechanism; Micro-level) | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported | 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. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. |
| Change in Activity Level (Actigraph, Vector Magnitude Average Counts) | Worn daily during 4-week treatment period, early treatment (baseline-2 weeks) and late treatment (2-4 weeks) reported | Change in activity level will be measured by an actigraphy device worn by the participant measuring activity level. In this study, we used the vector magnitude average counts variable, which is the average of all activity counts recorded per minute that the device was worn (i.e., it removes non-wear times from analysis). Higher activity counts indicate higher intensity activities that day; the minimum possible score (theoretically is zero, with no theoretical maximum score). Slopes were calculated by computing the linear regression slopes for the Actigraph collected activity counts. |
Countries
United States
Participant flow
Recruitment details
Potential participants were identified primarily via coding lists (i.e., sections of medical charts) of UW Medicine patients who had a low back pain diagnosis in their electronic medical record. Other recruitment strategies included the use of the UW Rehabilitation Medicine departmental research participant pool, posted flyers in pain and rehabilitation clinics, clinician referrals, news releases with the UW Newsroom, and a variety of national recruitment strategies.
Pre-assignment details
Of the 1081 participants screened for eligibility, 100 could not be contacted, 78 declined participation, 494 did not meet screening criteria, and 12 were not recruited as the recruitment period had concluded. A total of 397 were then enrolled and commenced the baseline assessments. Of those, 302 completed at least 10/14 EMA surveys and also returned the activity monitor with overall wear compliance at 70% of time or higher, and these participants were then randomized to condition.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 99 |
| 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. | 102 |
| Behavioral Activation (BA) 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. | 101 |
| Total | 302 |
Baseline characteristics
| Characteristic | Cognitive Therapy (CT) Condition | Mindfulness Meditation (MM) Condition | Behavioral Activation (BA) Condition | Total |
|---|---|---|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 14.7 | 49.4 years STANDARD_DEVIATION 14.7 | 51.0 years STANDARD_DEVIATION 12.2 | 49.1 years STANDARD_DEVIATION 14 |
| PROMIS Pain Interference | 66.6 T-score STANDARD_DEVIATION 5.2 | 64.9 T-score STANDARD_DEVIATION 5.4 | 66.4 T-score STANDARD_DEVIATION 5.9 | 65.98 T-score STANDARD_DEVIATION 5.5 |
| Race/Ethnicity, Customized Black/African American | 4 participants | 8 participants | 8 participants | 20 participants |
| Race/Ethnicity, Customized Latinx | 3 participants | 8 participants | 8 participants | 19 participants |
| Race/Ethnicity, Customized Other/Unspecified | 9 participants | 14 participants | 10 participants | 33 participants |
| Race/Ethnicity, Customized White | 83 participants | 72 participants | 75 participants | 230 participants |
| Region of Enrollment United States | 99 participants | 102 participants | 101 participants | 302 participants |
| Sex/Gender, Customized Man | 18 participants | 21 participants | 18 participants | 57 participants |
| Sex/Gender, Customized Non-binary | 2 participants | 1 participants | 1 participants | 4 participants |
| Sex/Gender, Customized Other/Unspecified | 1 participants | 3 participants | 4 participants | 8 participants |
| Sex/Gender, Customized Transgender | 0 participants | 1 participants | 0 participants | 1 participants |
| Sex/Gender, Customized Woman | 78 participants | 76 participants | 78 participants | 232 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 102 | 0 / 101 |
| other Total, other adverse events | 48 / 99 | 43 / 102 | 52 / 101 |
| serious Total, serious adverse events | 5 / 99 | 9 / 102 | 11 / 101 |
Outcome results
Primary
Change in Pain Interference (Macro-level Change)
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. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx
Population: Intent to treat sample.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Pain Interference (Macro-level Change) | Change from pre- to 3 months post-treatment (assessed over phone) | -4.7 change score on a scale | Standard Deviation 5.5 |
| Cognitive Therapy (CT) Condition | Change in Pain Interference (Macro-level Change) | Change from pre- to post-treatment (assessed over phone) | -5.0 change score on a scale | Standard Deviation 5 |
| Cognitive Therapy (CT) Condition | Change in Pain Interference (Macro-level Change) | Change from pre- to 6 months post-treatment (assessed over phone) | -4.1 change score on a scale | Standard Deviation 6 |
| Mindfulness Meditation (MM) Condition | Change in Pain Interference (Macro-level Change) | Change from pre- to 3 months post-treatment (assessed over phone) | -3.4 change score on a scale | Standard Deviation 6.2 |
| Mindfulness Meditation (MM) Condition | Change in Pain Interference (Macro-level Change) | Change from pre- to post-treatment (assessed over phone) | -4.5 change score on a scale | Standard Deviation 6.4 |
| Mindfulness Meditation (MM) Condition | Change in Pain Interference (Macro-level Change) | Change from pre- to 6 months post-treatment (assessed over phone) | -3.4 change score on a scale | Standard Deviation 6.2 |
| Behavioral Activation (BA) Condition | Change in Pain Interference (Macro-level Change) | Change from pre- to post-treatment (assessed over phone) | -5.6 change score on a scale | Standard Deviation 5.6 |
| Behavioral Activation (BA) Condition | Change in Pain Interference (Macro-level Change) | Change from pre- to 6 months post-treatment (assessed over phone) | -5.6 change score on a scale | Standard Deviation 7 |
| Behavioral Activation (BA) Condition | Change in Pain Interference (Macro-level Change) | Change from pre- to 3 months post-treatment (assessed over phone) | -5.6 change score on a scale | Standard Deviation 6.2 |
p-value: >0.05ANOVA
Primary
Change in Pain Interference (Micro-level Change)
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. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Population: Intent to treat sample.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Pain Interference (Micro-level Change) | Early treatment slope (assessed via EMA) | -1.34 scores on a scale | Standard Deviation 9.93 |
| Cognitive Therapy (CT) Condition | Change in Pain Interference (Micro-level Change) | Late treatment slope (assessed via EMA) | -0.73 scores on a scale | Standard Deviation 6.67 |
| Mindfulness Meditation (MM) Condition | Change in Pain Interference (Micro-level Change) | Early treatment slope (assessed via EMA) | -1.03 scores on a scale | Standard Deviation 5.68 |
| Mindfulness Meditation (MM) Condition | Change in Pain Interference (Micro-level Change) | Late treatment slope (assessed via EMA) | 0.01 scores on a scale | Standard Deviation 6.05 |
| Behavioral Activation (BA) Condition | Change in Pain Interference (Micro-level Change) | Early treatment slope (assessed via EMA) | -0.50 scores on a scale | Standard Deviation 4.73 |
| Behavioral Activation (BA) Condition | Change in Pain Interference (Micro-level Change) | Late treatment slope (assessed via EMA) | -0.73 scores on a scale | Standard Deviation 6.29 |
p-value: >0.05ANOVA
Secondary
Change in Anxiety Severity
Change in anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form-4A. Responses from each item will be summed to form a total raw score ranging from 4-20. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher self-reported levels of anxiety. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Anxiety Severity | Change from pre- to 3 months post-treatment (assessed over phone) | -1.4 change score on a scale | Standard Deviation 8.6 |
| Cognitive Therapy (CT) Condition | Change in Anxiety Severity | Change from pre- to post-treatment (assessed over phone) | -2.2 change score on a scale | Standard Deviation 7.1 |
| Cognitive Therapy (CT) Condition | Change in Anxiety Severity | Change from pre- to 6 months post-treatment (assessed over phone) | -1.8 change score on a scale | Standard Deviation 8.4 |
| Mindfulness Meditation (MM) Condition | Change in Anxiety Severity | Change from pre- to 3 months post-treatment (assessed over phone) | -2.2 change score on a scale | Standard Deviation 9 |
| Mindfulness Meditation (MM) Condition | Change in Anxiety Severity | Change from pre- to post-treatment (assessed over phone) | -2.1 change score on a scale | Standard Deviation 7.9 |
| Mindfulness Meditation (MM) Condition | Change in Anxiety Severity | Change from pre- to 6 months post-treatment (assessed over phone) | -1.4 change score on a scale | Standard Deviation 9.4 |
| Behavioral Activation (BA) Condition | Change in Anxiety Severity | Change from pre- to post-treatment (assessed over phone) | -1.5 change score on a scale | Standard Deviation 7.2 |
| Behavioral Activation (BA) Condition | Change in Anxiety Severity | Change from pre- to 6 months post-treatment (assessed over phone) | 0.1 change score on a scale | Standard Deviation 8.9 |
| Behavioral Activation (BA) Condition | Change in Anxiety Severity | Change from pre- to 3 months post-treatment (assessed over phone) | -0.4 change score on a scale | Standard Deviation 8.3 |
p-value: >0.05ANOVA
Secondary
Change in Depression Severity
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. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher self-reported levels of depression. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Depression Severity | Change from pre- to 3 months post-treatment (assessed over phone) | -2.4 change score on a scale | Standard Deviation 6.9 |
| Cognitive Therapy (CT) Condition | Change in Depression Severity | Change from pre- to post-treatment (assessed over phone) | -3.3 change score on a scale | Standard Deviation 7 |
| Cognitive Therapy (CT) Condition | Change in Depression Severity | Change from pre- to 6 months post-treatment (assessed over phone) | -2.3 change score on a scale | Standard Deviation 7.7 |
| Mindfulness Meditation (MM) Condition | Change in Depression Severity | Change from pre- to 3 months post-treatment (assessed over phone) | -2.3 change score on a scale | Standard Deviation 8.2 |
| Mindfulness Meditation (MM) Condition | Change in Depression Severity | Change from pre- to post-treatment (assessed over phone) | -2.6 change score on a scale | Standard Deviation 7.8 |
| Mindfulness Meditation (MM) Condition | Change in Depression Severity | Change from pre- to 6 months post-treatment (assessed over phone) | -2.2 change score on a scale | Standard Deviation 9.4 |
| Behavioral Activation (BA) Condition | Change in Depression Severity | Change from pre- to post-treatment (assessed over phone) | -2.6 change score on a scale | Standard Deviation 6.7 |
| Behavioral Activation (BA) Condition | Change in Depression Severity | Change from pre- to 6 months post-treatment (assessed over phone) | -1.9 change score on a scale | Standard Deviation 7.4 |
| Behavioral Activation (BA) Condition | Change in Depression Severity | Change from pre- to 3 months post-treatment (assessed over phone) | -2.0 change score on a scale | Standard Deviation 6.4 |
p-value: >0.05ANOVA
Secondary
Change in Medication Use
Change in opioid medication use will be assessed by asking participants to report use of opioid medications within the past 7 days. 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. Researchers will calculate a morphine equivalent dose (MED) for opioid medications. Due to violation of assumptions of normality, the MED data was transformed into a categorical variable (no prescription, increase, decrease, no change).
Time frame: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx
Population: Intent to treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Medication Use | No prescription pre or 6 months post-treatment | 50 Participants |
| Cognitive Therapy (CT) Condition | Change in Medication Use | No change from pre- to post-treatment | 12 Participants |
| Cognitive Therapy (CT) Condition | Change in Medication Use | No prescription pre or post-treatment | 58 Participants |
| Cognitive Therapy (CT) Condition | Change in Medication Use | No change from pre- to 3 months post-treatment | 7 Participants |
| Cognitive Therapy (CT) Condition | Change in Medication Use | Increase from pre- to post-treatment | 9 Participants |
| Cognitive Therapy (CT) Condition | Change in Medication Use | No change from pre- to 6 months post-treatment | 7 Participants |
| Cognitive Therapy (CT) Condition | Change in Medication Use | Increase from pre- to 3 months post-treatment | 13 Participants |
| Cognitive Therapy (CT) Condition | Change in Medication Use | No prescription pre or 3 months post-treatment | 53 Participants |
| Cognitive Therapy (CT) Condition | Change in Medication Use | Increase from pre- to 6 months post-treatment | 11 Participants |
| Cognitive Therapy (CT) Condition | Change in Medication Use | Decrease from pre- to post-treatment | 6 Participants |
| Cognitive Therapy (CT) Condition | Change in Medication Use | Decrease from pre- to 3 months post-treatment | 8 Participants |
| Cognitive Therapy (CT) Condition | Change in Medication Use | Decrease from pre- to 6 months post-treatment | 10 Participants |
| Mindfulness Meditation (MM) Condition | Change in Medication Use | Decrease from pre- to 3 months post-treatment | 10 Participants |
| Mindfulness Meditation (MM) Condition | Change in Medication Use | Decrease from pre- to 6 months post-treatment | 10 Participants |
| Mindfulness Meditation (MM) Condition | Change in Medication Use | No prescription pre or 6 months post-treatment | 48 Participants |
| Mindfulness Meditation (MM) Condition | Change in Medication Use | Increase from pre- to 3 months post-treatment | 12 Participants |
| Mindfulness Meditation (MM) Condition | Change in Medication Use | No change from pre- to post-treatment | 3 Participants |
| Mindfulness Meditation (MM) Condition | Change in Medication Use | Decrease from pre- to post-treatment | 13 Participants |
| Mindfulness Meditation (MM) Condition | Change in Medication Use | No prescription pre or post-treatment | 61 Participants |
| Mindfulness Meditation (MM) Condition | Change in Medication Use | No change from pre- to 3 months post-treatment | 3 Participants |
| Mindfulness Meditation (MM) Condition | Change in Medication Use | Increase from pre- to 6 months post-treatment | 13 Participants |
| Mindfulness Meditation (MM) Condition | Change in Medication Use | No prescription pre or 3 months post-treatment | 53 Participants |
| Mindfulness Meditation (MM) Condition | Change in Medication Use | No change from pre- to 6 months post-treatment | 1 Participants |
| Mindfulness Meditation (MM) Condition | Change in Medication Use | Increase from pre- to post-treatment | 10 Participants |
| Behavioral Activation (BA) Condition | Change in Medication Use | No change from pre- to 6 months post-treatment | 9 Participants |
| Behavioral Activation (BA) Condition | Change in Medication Use | No prescription pre or post-treatment | 58 Participants |
| Behavioral Activation (BA) Condition | Change in Medication Use | No prescription pre or 3 months post-treatment | 49 Participants |
| Behavioral Activation (BA) Condition | Change in Medication Use | No prescription pre or 6 months post-treatment | 51 Participants |
| Behavioral Activation (BA) Condition | Change in Medication Use | Increase from pre- to 3 months post-treatment | 9 Participants |
| Behavioral Activation (BA) Condition | Change in Medication Use | Increase from pre- to 6 months post-treatment | 10 Participants |
| Behavioral Activation (BA) Condition | Change in Medication Use | Decrease from pre- to post-treatment | 12 Participants |
| Behavioral Activation (BA) Condition | Change in Medication Use | Decrease from pre- to 3 months post-treatment | 14 Participants |
| Behavioral Activation (BA) Condition | Change in Medication Use | Decrease from pre- to 6 months post-treatment | 10 Participants |
| Behavioral Activation (BA) Condition | Change in Medication Use | No change from pre- to post-treatment | 13 Participants |
| Behavioral Activation (BA) Condition | Change in Medication Use | No change from pre- to 3 months post-treatment | 7 Participants |
| Behavioral Activation (BA) Condition | Change in Medication Use | Increase from pre- to post-treatment | 6 Participants |
p-value: >0.05Chi-squared
Secondary
Change in Mood (Macro-level)
Change in mood will be assessed using the Positive and Negative Affect Schedule (PANAS). 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. 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. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Mood (Macro-level) | Positive Affect, change from pre- to post-treatment (assessed over phone) | 1.5 change score on a scale | Standard Deviation 3.5 |
| Cognitive Therapy (CT) Condition | Change in Mood (Macro-level) | Negative Affect, change from pre- to post-treatment (assessed over phone) | -1.2 change score on a scale | Standard Deviation 3.2 |
| Cognitive Therapy (CT) Condition | Change in Mood (Macro-level) | Positive Affect, change from pre- to 3 months post-treatment (assessed over phone) | 1.4 change score on a scale | Standard Deviation 3.6 |
| Cognitive Therapy (CT) Condition | Change in Mood (Macro-level) | Negative Affect, change from pre- to 3 months post-treatment (assessed over phone) | -0.8 change score on a scale | Standard Deviation 3.4 |
| Cognitive Therapy (CT) Condition | Change in Mood (Macro-level) | Positive Affect, change from pre- to 6 months post-treatment (assessed over phone) | 0.7 change score on a scale | Standard Deviation 3.9 |
| Cognitive Therapy (CT) Condition | Change in Mood (Macro-level) | Negative Affect, change from pre- to 6 months post-treatment (assessed over phone) | -0.7 change score on a scale | Standard Deviation 3.8 |
| Mindfulness Meditation (MM) Condition | Change in Mood (Macro-level) | Negative Affect, change from pre- to 6 months post-treatment (assessed over phone) | -0.5 change score on a scale | Standard Deviation 4.2 |
| Mindfulness Meditation (MM) Condition | Change in Mood (Macro-level) | Positive Affect, change from pre- to post-treatment (assessed over phone) | 1.3 change score on a scale | Standard Deviation 3 |
| Mindfulness Meditation (MM) Condition | Change in Mood (Macro-level) | Negative Affect, change from pre- to 3 months post-treatment (assessed over phone) | -0.5 change score on a scale | Standard Deviation 3.6 |
| Mindfulness Meditation (MM) Condition | Change in Mood (Macro-level) | Positive Affect, change from pre- to 6 months post-treatment (assessed over phone) | 1.1 change score on a scale | Standard Deviation 3.2 |
| Mindfulness Meditation (MM) Condition | Change in Mood (Macro-level) | Negative Affect, change from pre- to post-treatment (assessed over phone) | -0.8 change score on a scale | Standard Deviation 4.1 |
| Mindfulness Meditation (MM) Condition | Change in Mood (Macro-level) | Positive Affect, change from pre- to 3 months post-treatment (assessed over phone) | 0.4 change score on a scale | Standard Deviation 3.4 |
| Behavioral Activation (BA) Condition | Change in Mood (Macro-level) | Negative Affect, change from pre- to post-treatment (assessed over phone) | -1.3 change score on a scale | Standard Deviation 3.3 |
| Behavioral Activation (BA) Condition | Change in Mood (Macro-level) | Positive Affect, change from pre- to 3 months post-treatment (assessed over phone) | 1.0 change score on a scale | Standard Deviation 4.1 |
| Behavioral Activation (BA) Condition | Change in Mood (Macro-level) | Negative Affect, change from pre- to 6 months post-treatment (assessed over phone) | -1.0 change score on a scale | Standard Deviation 3.9 |
| Behavioral Activation (BA) Condition | Change in Mood (Macro-level) | Negative Affect, change from pre- to 3 months post-treatment (assessed over phone) | -1.0 change score on a scale | Standard Deviation 3 |
| Behavioral Activation (BA) Condition | Change in Mood (Macro-level) | Positive Affect, change from pre- to post-treatment (assessed over phone) | 1.6 change score on a scale | Standard Deviation 3.9 |
| Behavioral Activation (BA) Condition | Change in Mood (Macro-level) | Positive Affect, change from pre- to 6 months post-treatment (assessed over phone) | 0.8 change score on a scale | Standard Deviation 4.2 |
p-value: >0.05ANOVA
Secondary
Change in Mood (Micro-level)
Change in mood will be assessed using the Positive and Negative Affect Schedule (PANAS). 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. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Mood (Micro-level) | Positive Affect, late treatment slope (assessed via EMA) | 0.08 scores on a scale | Standard Deviation 0.67 |
| Cognitive Therapy (CT) Condition | Change in Mood (Micro-level) | Positive Affect, early treatment slope (assessed via EMA) | 0.13 scores on a scale | Standard Deviation 1.01 |
| Cognitive Therapy (CT) Condition | Change in Mood (Micro-level) | Negative Affect, late treatment slope (assessed via EMA) | -0.14 scores on a scale | Standard Deviation 0.73 |
| Cognitive Therapy (CT) Condition | Change in Mood (Micro-level) | Negative Affect, early treatment slope (assessed via EMA) | -0.19 scores on a scale | Standard Deviation 0.82 |
| Mindfulness Meditation (MM) Condition | Change in Mood (Micro-level) | Positive Affect, late treatment slope (assessed via EMA) | 0.08 scores on a scale | Standard Deviation 0.6 |
| Mindfulness Meditation (MM) Condition | Change in Mood (Micro-level) | Negative Affect, early treatment slope (assessed via EMA) | -0.08 scores on a scale | Standard Deviation 0.96 |
| Mindfulness Meditation (MM) Condition | Change in Mood (Micro-level) | Positive Affect, early treatment slope (assessed via EMA) | 0.06 scores on a scale | Standard Deviation 0.89 |
| Mindfulness Meditation (MM) Condition | Change in Mood (Micro-level) | Negative Affect, late treatment slope (assessed via EMA) | 0.05 scores on a scale | Standard Deviation 0.7 |
| Behavioral Activation (BA) Condition | Change in Mood (Micro-level) | Negative Affect, early treatment slope (assessed via EMA) | -0.13 scores on a scale | Standard Deviation 0.73 |
| Behavioral Activation (BA) Condition | Change in Mood (Micro-level) | Positive Affect, early treatment slope (assessed via EMA) | 0.01 scores on a scale | Standard Deviation 0.71 |
| Behavioral Activation (BA) Condition | Change in Mood (Micro-level) | Negative Affect, late treatment slope (assessed via EMA) | 0.11 scores on a scale | Standard Deviation 0.75 |
| Behavioral Activation (BA) Condition | Change in Mood (Micro-level) | Positive Affect, late treatment slope (assessed via EMA) | 0.16 scores on a scale | Standard Deviation 0.62 |
p-value: >0.05ANOVA
Secondary
Change in Pain Intensity (Macro-level)
Change in pain intensity of chronic pain in general 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. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Pain Intensity (Macro-level) | Change from pre- to 3 months post-treatment (assessed over phone) | -0.9 change score on a scale | Standard Deviation 1.7 |
| Cognitive Therapy (CT) Condition | Change in Pain Intensity (Macro-level) | Change from pre- to post-treatment (assessed over phone) | -1.0 change score on a scale | Standard Deviation 1.8 |
| Cognitive Therapy (CT) Condition | Change in Pain Intensity (Macro-level) | Change from pre- to 6 months post-treatment (assessed over phone) | -1.0 change score on a scale | Standard Deviation 1.9 |
| Mindfulness Meditation (MM) Condition | Change in Pain Intensity (Macro-level) | Change from pre- to 3 months post-treatment (assessed over phone) | -0.8 change score on a scale | Standard Deviation 1.9 |
| Mindfulness Meditation (MM) Condition | Change in Pain Intensity (Macro-level) | Change from pre- to post-treatment (assessed over phone) | -1.2 change score on a scale | Standard Deviation 2.1 |
| Mindfulness Meditation (MM) Condition | Change in Pain Intensity (Macro-level) | Change from pre- to 6 months post-treatment (assessed over phone) | -1.0 change score on a scale | Standard Deviation 2 |
| Behavioral Activation (BA) Condition | Change in Pain Intensity (Macro-level) | Change from pre- to post-treatment (assessed over phone) | -1.3 change score on a scale | Standard Deviation 1.9 |
| Behavioral Activation (BA) Condition | Change in Pain Intensity (Macro-level) | Change from pre- to 6 months post-treatment (assessed over phone) | -1.1 change score on a scale | Standard Deviation 2 |
| Behavioral Activation (BA) Condition | Change in Pain Intensity (Macro-level) | Change from pre- to 3 months post-treatment (assessed over phone) | -1.4 change score on a scale | Standard Deviation 2.2 |
p-value: >0.05ANOVA
Secondary
Change in Pain Intensity (Micro-level)
Change in pain intensity of chronic pain in general 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. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Pain Intensity (Micro-level) | Early treatment slope (assessed via EMA) | -0.40 scores on a scale | Standard Deviation 2 |
| Cognitive Therapy (CT) Condition | Change in Pain Intensity (Micro-level) | Late treatment slope (assessed via EMA) | -0.17 scores on a scale | Standard Deviation 1.26 |
| Mindfulness Meditation (MM) Condition | Change in Pain Intensity (Micro-level) | Early treatment slope (assessed via EMA) | -0.26 scores on a scale | Standard Deviation 1.67 |
| Mindfulness Meditation (MM) Condition | Change in Pain Intensity (Micro-level) | Late treatment slope (assessed via EMA) | 0.09 scores on a scale | Standard Deviation 1.74 |
| Behavioral Activation (BA) Condition | Change in Pain Intensity (Micro-level) | Early treatment slope (assessed via EMA) | -0.23 scores on a scale | Standard Deviation 1.18 |
| Behavioral Activation (BA) Condition | Change in Pain Intensity (Micro-level) | Late treatment slope (assessed via EMA) | -0.04 scores on a scale | Standard Deviation 1.79 |
p-value: >0.05ANOVA
Secondary
Change in Physical Function
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. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels (i.e., better) physical function. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Physical Function | Change from pre- to 3 months post-treatment (assessed over phone) | 2.0 change score on a scale | Standard Deviation 4.3 |
| Cognitive Therapy (CT) Condition | Change in Physical Function | Change from pre- to post-treatment (assessed over phone) | 1.6 change score on a scale | Standard Deviation 3.6 |
| Cognitive Therapy (CT) Condition | Change in Physical Function | Change from pre- to 6 months post-treatment (assessed over phone) | 1.9 change score on a scale | Standard Deviation 5.6 |
| Mindfulness Meditation (MM) Condition | Change in Physical Function | Change from pre- to 3 months post-treatment (assessed over phone) | 1.2 change score on a scale | Standard Deviation 4 |
| Mindfulness Meditation (MM) Condition | Change in Physical Function | Change from pre- to post-treatment (assessed over phone) | 1.1 change score on a scale | Standard Deviation 3.4 |
| Mindfulness Meditation (MM) Condition | Change in Physical Function | Change from pre- to 6 months post-treatment (assessed over phone) | 1.3 change score on a scale | Standard Deviation 5.2 |
| Behavioral Activation (BA) Condition | Change in Physical Function | Change from pre- to post-treatment (assessed over phone) | 2.1 change score on a scale | Standard Deviation 3.8 |
| Behavioral Activation (BA) Condition | Change in Physical Function | Change from pre- to 6 months post-treatment (assessed over phone) | 2.5 change score on a scale | Standard Deviation 4.8 |
| Behavioral Activation (BA) Condition | Change in Physical Function | Change from pre- to 3 months post-treatment (assessed over phone) | 2.7 change score on a scale | Standard Deviation 4.2 |
p-value: >0.05ANOVA
Secondary
Change in Sleep Quality
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. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported sleep disturbance. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Sleep Quality | Change from pre- to 3 months post-treatment (assessed over phone) | -3.5 change score on a scale | Standard Deviation 6.6 |
| Cognitive Therapy (CT) Condition | Change in Sleep Quality | Change from pre- to post-treatment (assessed over phone) | -3.5 change score on a scale | Standard Deviation 7.1 |
| Cognitive Therapy (CT) Condition | Change in Sleep Quality | Change from pre- to 6 months post-treatment (assessed over phone) | -4.0 change score on a scale | Standard Deviation 7.3 |
| Mindfulness Meditation (MM) Condition | Change in Sleep Quality | Change from pre- to 3 months post-treatment (assessed over phone) | -2.1 change score on a scale | Standard Deviation 7.1 |
| Mindfulness Meditation (MM) Condition | Change in Sleep Quality | Change from pre- to post-treatment (assessed over phone) | -1.7 change score on a scale | Standard Deviation 6.2 |
| Mindfulness Meditation (MM) Condition | Change in Sleep Quality | Change from pre- to 6 months post-treatment (assessed over phone) | -3.4 change score on a scale | Standard Deviation 7.6 |
| Behavioral Activation (BA) Condition | Change in Sleep Quality | Change from pre- to post-treatment (assessed over phone) | -4.9 change score on a scale | Standard Deviation 6.8 |
| Behavioral Activation (BA) Condition | Change in Sleep Quality | Change from pre- to 6 months post-treatment (assessed over phone) | -4.9 change score on a scale | Standard Deviation 9.4 |
| Behavioral Activation (BA) Condition | Change in Sleep Quality | Change from pre- to 3 months post-treatment (assessed over phone) | -4.3 change score on a scale | Standard Deviation 8.3 |
p-value: 0.01ANOVA
Other Pre-specified
Change in Activity Level (Actigraph, Vector Magnitude Average Counts)
Change in activity level will be measured by an actigraphy device worn by the participant measuring activity level. In this study, we used the vector magnitude average counts variable, which is the average of all activity counts recorded per minute that the device was worn (i.e., it removes non-wear times from analysis). Higher activity counts indicate higher intensity activities that day; the minimum possible score (theoretically is zero, with no theoretical maximum score). Slopes were calculated by computing the linear regression slopes for the Actigraph collected activity counts.
Time frame: Worn daily during 4-week treatment period, early treatment (baseline-2 weeks) and late treatment (2-4 weeks) reported
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Activity Level (Actigraph, Vector Magnitude Average Counts) | Early Treatment (at baseline to 2 weeks) | -148064.01 activity counts | Standard Deviation 955190.23 |
| Cognitive Therapy (CT) Condition | Change in Activity Level (Actigraph, Vector Magnitude Average Counts) | Late Treatment (at 2 weeks to 4 weeks) | 26392.50 activity counts | Standard Deviation 962819.17 |
| Mindfulness Meditation (MM) Condition | Change in Activity Level (Actigraph, Vector Magnitude Average Counts) | Early Treatment (at baseline to 2 weeks) | -2380.15 activity counts | Standard Deviation 569389.47 |
| Mindfulness Meditation (MM) Condition | Change in Activity Level (Actigraph, Vector Magnitude Average Counts) | Late Treatment (at 2 weeks to 4 weeks) | -38711.02 activity counts | Standard Deviation 980492.69 |
| Behavioral Activation (BA) Condition | Change in Activity Level (Actigraph, Vector Magnitude Average Counts) | Early Treatment (at baseline to 2 weeks) | -82046.98 activity counts | Standard Deviation 430455.44 |
| Behavioral Activation (BA) Condition | Change in Activity Level (Actigraph, Vector Magnitude Average Counts) | Late Treatment (at 2 weeks to 4 weeks) | 64274.53 activity counts | Standard Deviation 573771.91 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level)
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. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) | Change from pre- to 3 months post-treatment (assessed over phone) | 0.39 change score on a scale | Standard Deviation 1.01 |
| Cognitive Therapy (CT) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) | Change from pre- to post-treatment (assessed over phone) | 0.43 change score on a scale | Standard Deviation 1.14 |
| Cognitive Therapy (CT) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) | Change from pre- to 6 months post-treatment (assessed over phone) | 0.36 change score on a scale | Standard Deviation 0.98 |
| Mindfulness Meditation (MM) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) | Change from pre- to 3 months post-treatment (assessed over phone) | 0.35 change score on a scale | Standard Deviation 1.34 |
| Mindfulness Meditation (MM) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) | Change from pre- to post-treatment (assessed over phone) | 0.45 change score on a scale | Standard Deviation 1.19 |
| Mindfulness Meditation (MM) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) | Change from pre- to 6 months post-treatment (assessed over phone) | 0.41 change score on a scale | Standard Deviation 1.24 |
| Behavioral Activation (BA) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) | Change from pre- to post-treatment (assessed over phone) | 0.48 change score on a scale | Standard Deviation 1.2 |
| Behavioral Activation (BA) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) | Change from pre- to 6 months post-treatment (assessed over phone) | 0.46 change score on a scale | Standard Deviation 1.2 |
| Behavioral Activation (BA) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) | Change from pre- to 3 months post-treatment (assessed over phone) | 0.57 change score on a scale | Standard Deviation 1.04 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Non-Judgment (i.e., Cognitive Process Mechanism; Micro-level)
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. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Micro-level) | Early treatment slope (assessed via EMA) | 0.31 scores on a scale | Standard Deviation 0.77 |
| Cognitive Therapy (CT) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Micro-level) | Late treatment slope (assessed via EMA) | 0.10 scores on a scale | Standard Deviation 0.73 |
| Mindfulness Meditation (MM) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Micro-level) | Early treatment slope (assessed via EMA) | 0.18 scores on a scale | Standard Deviation 0.84 |
| Mindfulness Meditation (MM) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Micro-level) | Late treatment slope (assessed via EMA) | 0.10 scores on a scale | Standard Deviation 0.79 |
| Behavioral Activation (BA) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Micro-level) | Early treatment slope (assessed via EMA) | 0.10 scores on a scale | Standard Deviation 0.72 |
| Behavioral Activation (BA) Condition | Change in Non-Judgment (i.e., Cognitive Process Mechanism; Micro-level) | Late treatment slope (assessed via EMA) | 0.05 scores on a scale | Standard Deviation 0.68 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level)
Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) | Change from pre- to 3 months post-treatment (assessed over phone) | -6.72 change score on a scale | Standard Deviation 9.32 |
| Cognitive Therapy (CT) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) | Change from pre- to post-treatment (assessed over phone) | -7.12 change score on a scale | Standard Deviation 8.45 |
| Cognitive Therapy (CT) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) | Change from pre- to 6 months post-treatment (assessed over phone) | -5.47 change score on a scale | Standard Deviation 10.29 |
| Mindfulness Meditation (MM) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) | Change from pre- to 3 months post-treatment (assessed over phone) | -4.70 change score on a scale | Standard Deviation 8.76 |
| Mindfulness Meditation (MM) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) | Change from pre- to post-treatment (assessed over phone) | -6.91 change score on a scale | Standard Deviation 9.85 |
| Mindfulness Meditation (MM) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) | Change from pre- to 6 months post-treatment (assessed over phone) | -5.82 change score on a scale | Standard Deviation 9.59 |
| Behavioral Activation (BA) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) | Change from pre- to post-treatment (assessed over phone) | -8.28 change score on a scale | Standard Deviation 8.12 |
| Behavioral Activation (BA) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) | Change from pre- to 6 months post-treatment (assessed over phone) | -6.56 change score on a scale | Standard Deviation 9.62 |
| Behavioral Activation (BA) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) | Change from pre- to 3 months post-treatment (assessed over phone) | -7.97 change score on a scale | Standard Deviation 9.48 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Micro-level)
Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Micro-level) | Early treatment slope (assessed via EMA) | -2.3 scores on a scale | Standard Deviation 7.96 |
| Cognitive Therapy (CT) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Micro-level) | Late treatment slope (assessed via EMA) | -1.55 scores on a scale | Standard Deviation 7.69 |
| Mindfulness Meditation (MM) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Micro-level) | Early treatment slope (assessed via EMA) | -1.30 scores on a scale | Standard Deviation 7.72 |
| Mindfulness Meditation (MM) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Micro-level) | Late treatment slope (assessed via EMA) | -0.27 scores on a scale | Standard Deviation 7.34 |
| Behavioral Activation (BA) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Micro-level) | Early treatment slope (assessed via EMA) | -0.71 scores on a scale | Standard Deviation 5.96 |
| Behavioral Activation (BA) Condition | Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Micro-level) | Late treatment slope (assessed via EMA) | -0.07 scores on a scale | Standard Deviation 5.65 |
p-value: >0.05ANOVA