Moderators and Nonspecific Predictors of Treatment Benefits in a Randomized Trial of Mindfulness-Based Stress Reduction vs Cognitive-Behavioral Therapy vs Usual Care for Chronic Low Back Pain

May combine two claims.

Strong evidence supports CBT for depression, anxiety, and pain-related disability.

“Substantial evidence supports the effectiveness of CBT for depression,17,21 anxiety,87 and pain and pain-related disability.93”

• cites [17] Cuijpers, 2019, Effectiveness and acceptability of cognitive behavior therapy delivery formats in adults with depression: A network meta-analysis, JAMA Psychiatry sourceNot checked — no full text of the source
• cites [21] Driessen, 2010, Cognitive behavioral therapy for mood disorders: Efficacy, moderators and mediators, Psychiatr Clin North Am sourceSupported
• cites [87] van Dis, 2020, Long-term outcomes of cognitive behavioral therapy for anxiety-related disorders: A systematic review and meta-analysis, JAMA Psychiatry sourceSupported

May combine two claims.

In the earlier MAP randomized trial, both CBT and MBSR improved pain and function in adults with chronic low back pain.

“In the Mind-body Approaches to Pain (MAP) randomized controlled trial (RCT), we found both CBT and mindfulness-based stress reduction (MBSR) to have benefits for pain and function among individuals with chronic low back pain (CLBP).13”

• cites [13] Cherkin, 2016, Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: a randomized clinical trial, JAMA sourceSupported

May combine two claims.

The evidence on such predictors is mixed and may depend on sample characteristics, follow-up length, and other design features.

“but the evidence is mixed5,6,55,81 and may be influenced by study sample characteristics, length of follow-up, and other study design features.28,56”

• cites [5] Broderick, 2016, Cognitive behavioral therapy for chronic pain is effective, but for whom?, PAIN sourceNot checked — no full text of the source
• cites [6] Brown, 2021, Do gender, anxiety, or sleep quality predict mindfulness-based stress reduction outcomes?, J Health Psychol sourcePartly supported

  The Gender differences in MBSR response section says predictor findings need replication across studies, populations, and outcomes. The Strengths, limitations, and future directions section identifies sample composition and design limitations. These passages support the possibility that findings vary with sample and design, but the paper does not link that variation to length of follow-up. No page numbers were provided in our copy. (LLM, conf=0.84)

  Experimental — accuracy not yet measured
• cites [55] Mascaro, 2021, Randomized, wait-list–controlled pilot study of app-delivered mindfulness for patients reporting chronic pain, PAIN Rep sourcePartly supported

  The Discussion (page unavailable) contrasts the study’s findings on demographic predictors of app use with prior research, supporting the idea that findings may vary with sample characteristics. The Limitations section also notes that subgroups may have benefited differently. The paper does not establish that length of follow-up or other study design features explain mixed evidence on predictors. (LLM, conf=0.79)

  Experimental — accuracy not yet measured

May combine two claims.

MBSR and CBT each reduce chronic low back pain.

“Both mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) are effective for chronic low back pain (CLBP)”

• Also stated in: § Introduction · plain

  “In the Mind-body Approaches to Pain (MAP) randomized controlled trial (RCT), we found both CBT and mindfulness-based stress reduction (MBSR) to have benefits for pain and function among individuals with chronic low back pain (CLBP).13”

• cites [13] Cherkin, 2016, Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: a randomized clinical trial, JAMA sourceSupported
• cites [8] Burns, 2022, Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for the treatment of chronic pain: randomized controlled trial, PAIN sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Among randomized participants, 56.6% attended at least six CBT sessions and 50.9% attended at least six MBSR sessions.

“session attendance rates (56.6% and 50.9% of randomized participants attended at least 6 sessions of CBT and MBSR, respectively)”

• cites [13] Cherkin, 2016, Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: a randomized clinical trial, JAMA sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

In a similar but not identical trial, participants with high mindful nonreactivity improved more in physical function with mindfulness-based cognitive therapy than with mindfulness meditation.

“In a trial of treatments for CLBP similar but not identical to those in our trial,19 participants reporting high levels of another dimension of mindfulness, mindful nonreactivity, showed greater improvement in physical function with mindfulness-based cognitive therapy than with mindfulness meditation.”

• cites [19] Day, 2020, Moderators of mindfulness meditation, cognitive therapy, and mindfulness-based cognitive therapy for chronic low back pain: A test of the limit, activate, and enhance model, J Pain sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Middle-aged and older adults are known to differ in pain-related variables.

“There are known differences between middle-aged and older adults in pain-related variables.58,59”

• cites [58] Molton, 2014, Overview of Persistent Pain in Older Adults, Am Psychol sourceNot checked — no full text of the source
• cites [59] Murray, 2021, Age differences in cognitive–affective processes in adults with chronic pain, Eur J Pain sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

In these data, the Bonferroni correction produced conclusions similar to those from other sequential methods.

“Although the Bonferroni method is conservative compared to other approaches, in our data it yielded conclusions similar to those of other (sequential) methods.92”

• cites [92] Wang, 2013, Detecting moderator effects using subgroup analyses, Prev Sci sourcePartly supported

  The Multiplicity Issue section (page unavailable) says Bonferroni is conservative and describes sequential methods designed to increase efficiency. It does not report a comparison showing that Bonferroni and those methods reached similar conclusions in the citing authors’ data; that is the citing authors’ own result. (LLM, conf=0.84)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

Twenty-six percent of participants randomized to MBSR attended the retreat.

“and retreat attendance rate (26% of participants randomized to MBSR),13”

• cites [13] Cherkin, 2016, Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: a randomized clinical trial, JAMA sourceSupported
  Experimental — accuracy not yet measured

May combine two claims.

In that prior trial, no moderating effect was found for the FFMQ-SF Observing scale, and nonjudging was not examined.

“Consistent with our results, a moderating effect was not found for the FFMQ-SF Observing scale.19 Nonjudging was not examined.”

• cites [19] Day, 2020, Moderators of mindfulness meditation, cognitive therapy, and mindfulness-based cognitive therapy for chronic low back pain: A test of the limit, activate, and enhance model, J Pain sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Prior studies have found pain self-efficacy and harm beliefs to predict pain outcomes.

“Prior studies have found both to predict pain outcomes.20,37”

• cites [20] de Rooij, 2013, Predictors of outcome of multidisciplinary treatment in chronic widespread pain: An observational study, BMC Musculoskelet Disord sourcePartly supported

  The Results and Discussion (page unavailable) associate beliefs about illness consequences with improvement in pain interference. But the Discussion says general self-efficacy did not predict treatment outcome; it also says fear-avoidance beliefs, if those are what the citing paper means by harm beliefs, did not predict that outcome. Thus this source does not establish that both beliefs predicted pain outcomes. (LLM, conf=0.84)

  Experimental — accuracy not yet measured
• cites [37] Jensen, 2007, Changes after multidisciplinary pain treatment in patient pain beliefs and coping are associated with concurrent changes in patient functioning, PAIN sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

A study of CBT for temporomandibular disorder pain also found greater benefits for those with higher pain self-efficacy.

“A study of CBT for temporomandibular disorder pain also found greater benefits for those with higher pain self-efficacy.51”

• cites [51] Litt, 2010, Brief cognitive-behavioral treatment for TMD pain: Long-term outcomes and moderators of treatment, PAIN sourceSupported

May combine two claims.

Subsequent research supports mindfulness interventions as a group for depression and anxiety, but not MBSR for mental health or long-term pain and function in back pain patients.

“Subsequent research has provided more support for the effectiveness of mindfulness interventions as a group for depression and anxiety,29 but not for benefits of MBSR for mental health or long-term benefits for pain and function among patients with back pain.1”

• cites [29] Goldberg, 2018, Mindfulness-based interventions for psychiatric disorders: A systematic review and meta-analysis, Clin Psychol Rev sourceSupported
• cites [1] Anheyer, 2017, Mindfulness-based stress reduction for treating low back pain: A systematic review and meta-analysis, Ann Intern Med sourceNot checked — no full text of the source

May combine two claims.

Consistent with the hypothesis and prior studies, college-educated participants showed greater improvement in pain bothersomeness than less educated participants, though not significant after correction.

“Consistent with our hypothesis and prior studies,16,84 college-educated participants showed greater improvement in pain bothersomeness than did those with less education, although this was not statistically significant after correction.”

• cites [16] Costa, 2009, Prognosis for patients with chronic low back pain: Inception cohort study, BMJ sourcePartly supported

  The Results report that participants with no education beyond secondary school were less likely to recover from low-back pain than those with more education. This supports the cited prior-study association in the same direction, but the paper measured recovery from pain, not improvement in pain bothersomeness. The citing authors’ finding and its significance after correction are not attributed to this source. (LLM, conf=0.85)

  Experimental — accuracy not yet measured
• cites [84] Turner, 2013, Optimizing prediction of back pain outcomes, PAIN sourceNot checked — no full text of the source

May combine two claims.

Multiple studies have reported similar findings for perceived control, supporting the importance of perceived control and the potential benefit of interventions that increase confidence in controlling pain.

“Multiple studies have reported similar findings for perceived control;11,20,38 as a group, these findings support the importance of perceived control and the potential benefit of interventions designed to increase patients’ confidence in their ability to control their pain.”

• cites [11] Chen, 2018, Trajectories and predictors of the long-term course of low back pain: cohort study with 5-year follow-up, PAIN sourceSupported
• cites [20] de Rooij, 2013, Predictors of outcome of multidisciplinary treatment in chronic widespread pain: An observational study, BMC Musculoskelet Disord sourceSupported
• cites [38] Jensen, 2001, Changes in beliefs, catastrophizing, and coping are associated with improvement in multidisciplinary pain treatment, J Consult Clin Psychol sourceNot checked — no full text of the source

May combine two claims.

For depressive symptoms, the largest subgroup differences were by baseline depressive symptom level, but no comparisons were significant after Bonferroni correction.

“When examining depressive symptoms as the outcome, we observed the largest differences for the baseline depressive symptom subgroups (see Table 4), but no comparisons were statistically significant after Bonferroni correction.”

May combine two claims.

For functional limitations, CBT vs UC benefit was larger among participants with higher baseline pain self-efficacy than among those with lower self-efficacy, but this difference was not significant after Bonferroni correction (P = 0.03).

“The effect of CBT vs. UC on function was greater among participants with higher pain self-efficacy (adjusted mean change: CBT −4.40 vs. UC −1.42; difference −2.98 [−4.76, −1.20]) than among those with lower self-efficacy (adjusted mean change: CBT −2.18 vs. UC −1.89; difference −0.29 [−1.87, 1.29]) (P = 0.03), but this difference was not statistically significant with Bonferroni correction.”

May combine two claims.

Using a PHQ-8 cut point of 10, CBT was better than UC for depressive symptoms among participants with moderate or severe baseline symptoms but not among those with mild or minimal symptoms (P = 0.04).

“When using a PHQ-8 cut point of 10 (moderate or greater level of symptoms), CBT had greater benefit than UC among participants with moderate or severe baseline depressive symptoms (adjusted mean change on the 0–24 depressive symptom scale: CBT −5.96 vs. UC −1.78; difference: −4.18 [−6.40, −1.97]) but not among those with mild or minimal symptoms at baseline (adjusted mean change: CBT −1.45 vs. UC”

May combine two claims.

Greater belief in personal control over pain and greater pain catastrophizing were associated with more improvement in functional limitations regardless of treatment group.

“Stronger beliefs in one’s personal control over pain (SOPA Control; P = 0.002) and greater endorsement of catastrophic thinking in response to pain (PCS; P = 0.005) were associated with greater improvement in functional limitations for participants regardless of assigned treatment group.”

May combine two claims.

For pain bothersomeness, CBT was better than MBSR among participants with mild or greater depressive symptoms, while MBSR was better than CBT among those with minimal or no depressive symptoms (P = 0.01).

“CBT had greater benefit than MBSR among those with mild or greater depressive symptom severity (adjusted mean change: CBT −1.30 vs. MBSR −0.81; difference: −0.49 [−1.19, 0.20]), but MBSR had greater benefit than CBT among those with minimal or no depressive symptoms (adjusted mean change: CBT −0.99 vs. MBSR −1.76; difference: 0.77 [0.03, 1.51]) (P = 0.01).”

May combine two claims.

SOPA Harm moderated CBT vs UC effects on pain bothersomeness: CBT was better than UC among participants with low harm conviction but not among those with greater harm conviction (P = 0.02).

“Conviction that pain is a sign of bodily damage and the need to avoid activity, as measured by the SOPA Harm scale, was a potential moderator of the effects of CBT vs. UC on pain bothersomeness. CBT was superior to UC among participants with low conviction that pain is a sign of physical harm (adjusted mean change: CBT −1.54 vs. UC −0.39; difference: −1.14 [−1.84, −0.45]) but not among those with”

May combine two claims.

For pain bothersomeness, MBSR was better than UC among women but not among men (P = 0.02).

“MBSR was superior to UC among women (adjusted mean change: MBSR −1.50 vs. UC −0.36; difference −1.13 [−1.74, −0.53]) but not men (adjusted mean change: MBSR −0.93 vs. UC −1.15; difference 0.21 [−0.71, 1.13]) (P = 0.02).”

May combine two claims.

For pain bothersomeness, MBSR was better than UC among participants with greater baseline pain self-efficacy but not among those with lower self-efficacy (P = 0.03).

“MBSR was more beneficial than UC among participants with greater pain self-efficacy at baseline (adjusted mean change: MBSR −1.63 vs. UC −0.28; difference: −1.35 [−2.14, −0.56]) but not among participants with lower pain self-efficacy at baseline (adjusted mean change: MBSR −1.02 vs. UC −0.77; difference: −0.25 [−0.90, 0.40]) (P = 0.03).”

May combine two claims.

Nonjudging moderated CBT vs MBSR effects on both function and pain, but the difference was significant after correction only for function.

“Although differences in effects of CBT vs. MBSR based on nonjudging were observed for both function and pain, the difference was statistically significant after correction only for function.”

May combine two claims.

After Bonferroni correction, only lower anxiety and greater belief in control over pain remained significant predictors of improvement in depressive symptoms; no predictors of function or pain remained significant.

“After Bonferroni correction for multiple comparisons, only anxiety and belief in one’s control over pain were statistically significant predictors of improvement in depression. No predictors of function or pain were statistically significant after correction.”

May combine two claims.

Among less nonjudging participants, CBT produced greater benefit; among more nonjudgmental participants, MBSR produced greater benefit.

“Among participants who reported being less nonjudging of their thoughts and feelings, benefits were greater from CBT; among those who reported being more nonjudging, benefits were greater from MBSR.”

May combine two claims.

As hypothesized, participants with greater baseline depressive symptoms improved more in depressive symptoms with CBT and MBSR vs UC, and with CBT vs MBSR, though no comparison was significant after correction.

“As hypothesized, participants with greater depressive symptoms at baseline showed greater improvement in depressive symptoms with CBT and MBSR vs. UC, and with CBT vs. MBSR, although no comparisons were statistically significant after correction.”

May combine two claims.

For pain bothersomeness, MBSR was better than UC among participants with minimal depressive symptoms but not among those with mild or greater depressive symptoms (P = 0.004).

“MBSR was superior to UC among those with minimal depressive symptoms (adjusted mean change: MBSR −1.76 vs. UC −0.31; difference: −1.45 [−2.16, −0.73]) but not among those with mild or greater depressive symptoms (adjusted mean change: MBSR −0.81 vs. UC −0.83; difference: 0.02 [−0.68, 0.72]) (P = 0.004).”

May combine two claims.

For pain bothersomeness, CBT was better than MBSR among men, while MBSR was better than CBT among women (P = 0.03).

“The effect of CBT vs. MBSR on pain bothersomeness was greater among men (adjusted mean change on the 0–10 rating: CBT −1.51 vs. MBSR −0.93; difference −0.58 [−1.38, 0.22]), whereas MBSR was superior to CBT among women (adjusted mean change: CBT −0.93 vs. MBSR −1.50; difference: 0.56 [−0.09, 1.22]) (P = 0.03).”

May combine two claims.

Predictors of greater improvement in depressive symptoms included older age, less widespread pain, lower anxiety, greater belief in control over pain, and greater FFMQ-SF Acting with Awareness and Nonjudging scores.

“Nonspecific baseline predictors of greater improvement in depressive symptoms were older age (P = 0.007), less widespread pain (P = 0.009), lower anxiety (GAD-2; P < 0.001), greater belief in one’s control over pain (SOPA Control; P < 0.001), and greater endorsement of mindfulness on the FFMQ-SF Acting with Awareness (P = 0.008) and Nonjudging (P = 0.008) scales.”

May combine two claims.

For pain bothersomeness, the largest subgroup differences were for gender, depression, SOPA Harm, pain self-efficacy, and FFMQ-SF nonjudging, but none were significant after Bonferroni correction.

“The largest differences observed were for gender, depression, conviction that pain is a sign of physical harm, pain self-efficacy, and the nonjudging mindfulness subscale. Although none of these comparisons were statistically significant after Bonferroni correction”

May combine two claims. The quote only partly states this claim.

For functional limitations, CBT was better than MBSR among less nonjudging participants, while MBSR was better than CBT among more nonjudgmental participants; the interaction was significant after Bonferroni correction (P = 0.001).

“Comparing the effects of CBT vs. MBSR on functional limitations, CBT was superior to MBSR among participants who reported being less nonjudging of their thoughts and feelings (adjusted mean change from baseline to 8 weeks on the 0–23 mRDQ −3.84 in CBT vs. −1.70 in MBSR; difference between treatments −2.14 [95% CI, −3.91, −0.37])”

May combine two claims.

FFMQ-SF nonjudging moderated CBT vs MBSR effects on pain bothersomeness: CBT was better among less nonjudging participants, while MBSR was better among more nonjudgmental participants (P = 0.04).

“Finally, the tendency to engage in a non-evaluative stance towards thoughts and feelings, as measured by the FFMQ-SF nonjudging subscale, was a potential moderator of the effects of CBT vs. MBSR on pain bothersomeness. The benefit of CBT was greater among participants who reported being less nonjudging of their thoughts and feelings (adjusted mean change: CBT −1.31 vs. MBSR −0.86; difference: −0.”

May combine two claims.

Greater belief in personal control over pain and college education were associated with more improvement in pain bothersomeness.

“Stronger belief in one’s personal control over pain (P = 0.03) was also associated with greater improvement in pain bothersomeness, as was college education (P = 0.049).”

May combine two claims.

Few baseline characteristics were significant after familywise error adjustment, and findings were inconsistent across outcomes.

“It can be seen that few characteristics were statistically significant after adjustment for the familywise error rate and there were inconsistencies in findings across outcomes examined.”

May combine two claims.

An exploratory demographic variable was identified as a potential moderator: CBT improved pain bothersomeness more than MBSR among men, while MBSR was more effective for pain than CBT among women.

“An exploratory demographic variable was identified as a potential moderator, although it was not statistically significant after correction: CBT improved pain bothersomeness more than did MBSR among men, whereas MBSR was more effective for pain than was CBT among women.”

May combine two claims.

Harm beliefs did not moderate any MBSR effects or any effects on functional limitations.

“Harm beliefs did not moderate any MBSR effects or any effects on functional limitations.”

May combine two claims.

Among other hypothesized nonspecific predictors, only less widespread pain predicted improvement, and this association was not significant after correction.

“Among our other hypothesized nonspecific predictors (widespread pain, pain bothersomeness, functional limitations, expectations of improvement), only less widespread pain predicted improvement, and this association was not statistically significant after correction.”

May combine two claims.

Treatment outcome did not vary substantially by other demographic characteristics examined, including age, which a prior study found to moderate CBT effects on function in CLBP.

“Treatment outcome did not vary substantially by other demographic characteristics examined, including age, which was found in a prior study to moderate effects of CBT for CLBP on function (greater response among younger patients).86”

• cites [86] Underwood, 2011, Predicting response to a cognitive-behavioral approach to treating low back pain: Secondary analysis of the BeST data set, Arthritis Care Res sourceNot checked — no full text of the source

May combine two claims.

Participants with low baseline belief that pain is a sign of physical harm improved more in pain bothersomeness from CBT vs UC, though the effect was not significant after correction.

“Participants with a low baseline belief that pain is a sign of physical harm improved more in pain bothersomeness from CBT vs. UC, although the effect was not statistically significant after correction.”

May combine two claims.

Participants with higher pain self-efficacy benefited more from CBT vs UC for functional limitations and from MBSR vs UC for pain bothersomeness, though neither finding remained significant after correction.

“Participants with higher pain self-efficacy benefited more from CBT vs. UC for functional limitations and from MBSR vs. UC for pain bothersomeness, although neither finding remained statistically significant after correction.”

May combine two claims.

Contrary to hypotheses and past research, higher expectations of improvement and lower baseline pain or disability did not predict better outcomes at 8 weeks.

“Contrary to our hypotheses and past research,52,56,81,84,91 we did not find that higher expectations of improvement or lower levels of pain or disability at baseline predicted better outcomes at 8 weeks.”

• cites [52] Mallen, 2007, Prognostic factors for musculoskeletal pain in primary care: A systematic review, Br J Gen PractNot checked — no full text of the source
• cites [56] McCracken, 2002, Behavioral and cognitive–behavioral treatment for chronic pain: Outcome, predictors of outcome, and treatment process, Spine sourceNot checked — no full text of the source
• cites [81] Turner, 2007, Mediators, moderators, and predictors of therapeutic change in cognitive–behavioral therapy for chronic pain, PAIN sourceNot checked — no full text of the source

May combine two claims.

Study participants volunteered for a mind-body treatment study, had generally high expectations of benefit, and had fairly low psychosocial distress.

“Study participants volunteered for a study of mind-body treatments for pain, had generally high expectations of benefitting, and had fairly low levels of psychosocial distress.”

May combine two claims.

The hypotheses that CBT and MBSR vs UC, and CBT vs MBSR, would be more effective among participants with higher baseline anxiety, pain, and disability were not confirmed.

“Our hypotheses that the effects of CBT and MBSR vs. UC, and of CBT vs. MBSR, would be greater among participants with higher baseline levels of anxiety, pain, and disability were not confirmed.”

May combine two claims.

The two treatments produced broadly similar benefits, which supports considering either as a reasonable option for adults with chronic low back pain.

“These two interventions had generally similar benefits, suggesting that both are reasonable options for adults with CLBP.”

• cites [8] Burns, 2022, Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for the treatment of chronic pain: randomized controlled trial, PAIN sourceNot checked — no full text of the source

Classified as probably not a substantial claim. May combine two claims.

Continuous baseline measures were dichotomized using pre-specified cut points, and all dichotomization decisions were made before analyses.

“To examine treatment effect modification, we dichotomized continuous baseline measures using pre-specified cut points based on clinically meaningful criteria because cut points are advantageous for future clinical decision-making.”

• Also stated in: § Measures · plain

  “All dichotomization decisions were made prior to conducting analyses.”

• AssumptionRests on an assumption: Using dichotomous cut points on baseline measures yields results more useful for clinical decision-making than using continuous measures would.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The Survey of Pain Attitudes scales show good stability over time, validity, and internal consistency.

“These scales have good test-retest stability, validity, and internal consistency.33,35,39,69”

• cites [33] Jensen, 1992, Pain-specific beliefs, perceived symptom severity, and adjustment to chronic pain, Clin J Pain United States; sourceNot checked — no full text of the source
• cites [35] Jensen, 1999, Patient beliefs predict patient functioning: Further support for a cognitive-behavioural model of chronic pain, PAIN sourceNot checked — no full text of the source
• cites [39] Jensen, 1994, Relationship of pain-specific beliefs to chronic pain adjustment, PAIN sourceNot checked — no full text of the source

Classified as probably not a substantial claim. May combine two claims.

The CBT and MBSR interventions were distinct: CBT did not include mindfulness, meditation, or yoga techniques, and MBSR did not include the CBT techniques.

“None of these techniques were included in the MBSR intervention, and mindfulness, meditation, and yoga techniques were not included in the CBT intervention.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The PHQ-8 is a widely used and validated measure of depressive symptom severity.

“Participants completed the 8-item Patient Health Questionnaire (PHQ-8), a widely-used, validated measure of depressive symptom severity (score range 0–24; higher scores indicate greater depressive symptom severity).49”

• cites [49] Kroenke, 2009, The PHQ-8 as a measure of current depression in the general population, J Affect Disord sourceNot checked — no full text of the source

May combine two claims.

Taken together, these results support the potential importance of mindfulness dimensions for selecting patients for mind-body interventions and for future moderator research.

“Although we did not find a moderating effect for nonreactivity, taken as a whole, these results support the potential importance of mindfulness dimensions in selecting patients for mind-body interventions and in future research regarding moderators and treatment mechanisms.”

Probably not a substantial claim: may not pass S3 (load-bearing).

More widespread pain has consistently been found to predict worse pain outcomes.

“Research has consistently demonstrated more widespread pain to predict worse pain outcomes.52,84”

• cites [52] Mallen, 2007, Prognostic factors for musculoskeletal pain in primary care: A systematic review, Br J Gen PractNot checked — no full text of the source
• cites [84] Turner, 2013, Optimizing prediction of back pain outcomes, PAIN sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

One item from the FFMQ-SF Nonjudging scale was inadvertently not administered.

“5-item scale, although inadvertently one question [‘I make judgments about whether my thoughts are good or bad’] was not asked”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The GAD-2 is a widely used and validated two-item anxiety measure with high sensitivity and specificity for anxiety disorders in primary care.

“Participants completed the Generalized Anxiety Disorder (GAD)-2, a widely-used, validated 2-item measure of anxiety with high sensitivity and specificity for detecting anxiety disorders in primary care (score range 0–6; higher scores indicate greater anxiety).47,48”

• cites [47] Kroenke, 2010, The Patient Health Questionnaire somatic, anxiety, and depressive symptom scales: A systematic review, Gen Hosp Psychiatry sourceNot checked — no full text of the source
• cites [48] Kroenke, 2007, Anxiety disorders in primary care: Prevalence, impairment, comorbidity, and detection, Ann Intern Med sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

Age, gender, education, and pain duration were chosen a priori as covariates.

“We decided a priori to control for these variables given their potential to affect participant response to treatment and likelihood of obtaining follow-up information.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The FFMQ-SF has been shown to be reliable, valid, and sensitive to change.

“The FFMQ-SF has been demonstrated to be reliable, valid, and sensitive to change.4”

• cites [4] Bohlmeijer, 2011, Psychometric properties of the Five Facet Mindfulness Questionnaire in depressed adults and development of a short form, Assessment sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

For nonspecific predictors, Bonferroni correction was applied across 22 comparisons, with significance set at P < 0.002.

“Using the Bonferroni method, we defined statistical significance for a given nonspecific predictor as a P-value < 0.002 (0.05/22 to adjust for family-wise error rate over 22 comparisons).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The Pain Self-efficacy Questionnaire has been shown to be valid, reliable, and sensitive to change.

“The questionnaire has been demonstrated to be valid, reliable, and sensitive to change.60”

• cites [60] Nicholas, 2007, The pain self-efficacy questionnaire: Taking pain into account, Eur J Pain sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Study measures were administered by trained survey staff who were masked to treatment assignment.

“Trained survey staff, masked to treatment group, administered study measures to participants in computer-assisted telephone interviews.”

Classified as probably not a substantial claim.

The reported analyses included 297 participants who completed both baseline and 8-week follow-up.

“For the analyses reported here, we include the 297 participants who completed both the baseline and 8-week follow-up assessments.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The MBSR instructors had formal training and extensive experience, and the CBT therapists were licensed psychologists with chronic pain CBT experience.

“all 8 MBSR instructors received formal training in teaching MBSR from the Center for Mindfulness at the University of Massachusetts or equivalent training and had extensive previous experience teaching MBSR.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The trial and its analysis plan were preregistered on ClinicalTrials.gov under NCT01467843.

“The trial and analysis plan were preregistered in ClinicalTrials.gov (Identifier: NCT01467843).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The CPAQ-8 has been shown to be reliable and valid.

“The Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), an 8-item version of the 20-item CPAQ, has been shown to be reliable and valid.25,26”

• cites [25] Fish, 2013, Willing and able: A closer look at pain willingness and activity engagement on the Chronic Pain Acceptance Questionnaire (CPAQ-8), J Pain sourceNot checked — no full text of the source
• cites [26] Fish, 2010, Validation of the Chronic Pain Acceptance Questionnaire (CPAQ) in an internet sample and development and preliminary validation of the CPAQ-8, Pain sourceNot checked — no full text of the source

May combine two claims.

The trial was not powered to detect treatment effect moderators, so the analyses were exploratory and focused on effect size.

“Given the exploratory nature of these analyses and the fact that the trial was not powered to detect treatment effect moderators, our primary focus is on effect size and results should be interpreted accordingly.”

Classified as probably not a substantial claim. May combine two claims.

The analysis used Bonferroni correction within each pairwise treatment comparison to control family-wise error across 23 moderator tests, with significance set at P < 0.002.

“We used the Bonferroni method57 within each pairwise treatment group comparison to control family-wise error rates due to testing for treatment interactions of 23 potential moderators. Specifically, we defined statistical significance for a given moderator as a P-value < 0.002 (0.05/23).”

• cites [57] Miller, 1981Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Randomization was stratified by baseline modified Roland Disability Questionnaire score, categorized as moderate versus high functional limitations.

“We stratified randomization based on the baseline value of the primary outcome, a modified version of the Roland Disability Questionnaire (mRDQ), which we categorized as moderate (mRDQ score ≤12 on the 0–23 scale) vs. high (mRDQ scores ≥13) back pain-related functional limitations.63”

• cites [63] Patrick, 1995, Assessing health-related quality of life in patients with sciatica, Spine sourceNot checked — no full text of the source

May combine two claims.

If individuals believe they can self-manage their pain, they may be more likely to engage in and benefit from treatment; this hypothesis is supported by the finding that higher pain self-efficacy predicted attending 6 or more classes.

“If individuals believe they can self-manage their pain, they may be more likely to engage in, and hence benefit from, treatment.72 This hypothesis is supported by our finding that participants with higher pain self-efficacy were significantly more likely to attend 6 or more classes of either intervention.”

• cites [72] Thompson, 2016, Do pain-related beliefs influence adherence to multidisciplinary rehabilitation?: A systematic review, Clin J Pain sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

It is unclear how far these findings generalize to more distressed and disabled patients or those less receptive to psychosocial pain treatments.

“The extent to which these findings would generalize to more highly distressed and disabled patients or those less receptive to psychosocial treatments for pain is unclear.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Another meta-analysis found MBSR was not effective for mental health among patients with back pain.

“Another meta-analysis found that MBSR was not effective for mental health among patients with back pain.1”

• cites [1] Anheyer, 2017, Mindfulness-based stress reduction for treating low back pain: A systematic review and meta-analysis, Ann Intern Med sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S2 (checkable).

Despite limitations, the study offers unique insights into potential moderators and nonspecific predictors of improvement with CBT and MBSR for chronic pain.

“Despite these limitations, our study, by leveraging data from a large RCT, offers unique insights into potential moderators and nonspecific predictors of improvement with two evidence-based treatments for chronic pain, CBT and MBSR.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Results could differ in studies with different numbers of sessions or treatment adherence rates.

“Results could differ in studies with different numbers of sessions or treatment adherence rates.”

May combine two claims.

Although only one moderator was significant after correction, other subgroup differences could indicate potentially clinically meaningful differences.

“Although only one potential moderator was statistically significant after applying a conservative correction for familywise error rate, other subgroup differences could indicate potentially clinically meaningful differences.”

Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

If confirmed, these findings could help patient-treatment matching, resource allocation, cost-effective care, and understanding of treatment mechanisms.

“If confirmed in future studies, such findings could have utility for patient-treatment matching, which could lead to improved allocation of limited resources and more cost-effective care, as well as to enhanced understanding of treatments mechanisms and potential ways to increase efficacy.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Differences in findings across studies may reflect differences in sampling, interventions, measures, and statistical power.

“Differences in findings may reflect differences in sampling, interventions, measures, and statistical power to detect effects.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

CBT was delivered in a group format, and results could differ for individual CBT.

“Finally, CBT was delivered in a group format in our study and results could differ for CBT delivered individually.”