Cognitive behavioral treatments for insomnia and pain in adults with comorbid chronic insomnia and fibromyalgia: clinical outcomes from the SPIN randomized controlled trial.

STUDY OBJECTIVES: To examine the effects of cognitive behavioral treatments for insomnia (CBT-I) and pain (CBT-P) in patients with comorbid fibromyalgia and insomnia. METHODS: One hundred thirteen patients (Mage = 53, SD = 10.9) were randomized to eight sessions of CBT-I (n = 39), CBT-P (n = 37), or a waitlist control (WLC, n = 37). Primary (self-reported sleep onset latency [SOL], wake after sleep onset [WASO], sleep efficiency [SE], sleep quality [SQ], and pain ratings) and secondary outcomes (dysfunctional beliefs and attitudes about sleep [DBAS]; actigraphy and polysomnography SOL, WASO, and SE; McGill Pain Questionnaire; Pain Disability Index; depression; and anxiety) were examined at posttreatment and 6 months. RESULTS: Mixed effects analyses revealed that both treatments improved self-reported WASO, SE, and SQ relative to control at posttreatment and follow-up, with generally larger effect sizes for CBT-I. DBAS improved in CBT-I only. Pain and mood improvements did not differ by group. Clinical significance analyses revealed the proportion of participants no longer reporting difficulties initiating and maintaining sleep was higher for CBT-I posttreatment and for both treatments at 6 months relative to control. Few participants achieved >50% pain reductions. Proportion achieving pain reductions of >30% (~1/3) was higher for both treatments posttreatment and for CBT-I at 6 months relative to control. CONCLUSIONS: CBT-I and CBT-P improved self-reported insomnia symptoms. CBT-I prompted improvements of larger magnitude that were maintained. Neither treatment improved pain or mood. However, both prompted clinically meaningful, immediate pain reductions in one third of patients. Improvements persisted for CBT-I, suggesting that CBT-I may provide better long-term pain reduction than CBT-P. Research identifying which patients benefit and mechanisms driving intervention effects is needed. CLINICAL TRIAL: Sleep and Pain Interventions in Fibromyalgia (SPIN), clinicaltrials.gov, NCT02001077.

A Comparison of Deceptive and Non-Deceptive Placebo Analgesia: Efficacy and Ethical Consequences.

BACKGROUND: Research has demonstrated the efficacy of analgesic placebos. The manner in which they are usually delivered deceptively raises questions about their impact on recipients. However, there has been little empirical investigation into the potential harms of analgesic placebo. Moreover, the role of deception in determining the magnitude of analgesic placebo response remains poorly understood. PURPOSE: This study aimed to investigate the consequences of deceptive placebo analgesia in terms of ethical/psychological effects and efficacy. METHODS: Healthy adults (N = 75) were randomized to a control group, deceptive placebo manipulation, or non-deceptive placebo manipulation. All participants underwent repeated pain testing using a thermal stimulus. Placebo manipulation groups underwent placebo conditioning involving a cream that was described as being either analgesic or inert. State-specific negative mood and attitudes toward research and pain treatment were assessed before and after placebo conditioning. RESULTS: Deceptive and non-deceptive placebo manipulations yielded pain ratings that did not differ significantly from one another but did differ from those of the control group, which experienced a pain sensitization response across trials. Results thus indicated that both deceptive and non-deceptive placebo manipulations prevented pain sensitization. Across groups, the participants reported improved depression, anxiety, frustration, and fear. The use of placebo did not negatively impact participants' attitudes and beliefs about research or pain treatments. The participants tended to rate several parameters related to research participation more positively after participating in our study. CONCLUSIONS: Our results indicate that the placebo manipulation groups experienced an anti-sensitization effect. The use of analgesic placebo did not result in any detrimental ethical or psychological effects.

Investigating patient expectations and treatment outcome in a chronic low back pain population.

OBJECTIVE: This study aimed to measure the outcomes that patients consider clinically meaningful across four treatment domains - (1) pain, (2) fatigue, (3) emotional distress, and (4) level of interference - and determine if patients met their own success criteria. Additionally, the role of expectations in treatment outcome was examined. This study also aimed to determine how change in levels of pain, fatigue, disability, and level of interference varied according to the type of treatment delivered to participants. PATIENTS: Forty-seven chronic low back pain patients were recruited from university-affiliated pain clinics. DESIGN: The study design was longitudinal, consisting of two randomly assigned treatment conditions. The first treatment condition used opioid medication only and the second used both opioid medication and brief cognitive behavioral therapy. Pre- and post-treatment assessments were conducted, which occurred approximately 3 months after the initiation of treatment. OUTCOME MEASURES: A patient-centered outcomes questionnaire was completed by participants at both pre- and post-treatment assessment. RESULTS: Results suggest that patients did not meet their own success criteria in treatment across any of the four domains. There was a significant main effect of time for level of pain indicating that both treatment groups had a decrease in their level of pain at post-treatment, F(1, 45) = 11.98, P < 0.001. There was a significant main effect of time for level of interference domain indicating that both groups experienced a reduction in the level of pain-related interference with daily activities, F(1, 45) = 5.46, P < 0.05. There were no significant effects of time for emotional distress or fatigue or any significant group by time interactions. Contrary to our hypothesis, no significant correlations were found between pretreatment expectations and usual level ratings at post-treatment across the four domains. CONCLUSION: Patients sought larger reductions in pain, fatigue, level of distress, and level of interference than they attained at post-treatment. Enhancing opioid treatment with brief cognitive behavioral therapy did not yield additional improvements for the four domains assessed in patients with chronic low back pain.

The role of psychological interventions in the management of patients with chronic pain.

Chronic pain can be best understood from a biopsychosocial perspective through which pain is viewed as a complex, multifaceted experience emerging from the dynamic interplay of a patient's physiological state, thoughts, emotions, behaviors, and sociocultural influences. A biopsychosocial perspective focuses on viewing chronic pain as an illness rather than disease, thus recognizing that it is a subjective experience and that treatment approaches are aimed at the management, rather than the cure, of chronic pain. Current psychological approaches to the management of chronic pain include interventions that aim to achieve increased self-management, behavioral change, and cognitive change rather than directly eliminate the locus of pain. Benefits of including psychological treatments in multidisciplinary approaches to the management of chronic pain include, but are not limited to, increased self-management of pain, improved pain-coping resources, reduced pain-related disability, and reduced emotional distress - improvements that are effected via a variety of effective self-regulatory, behavioral, and cognitive techniques. Through implementation of these changes, psychologists can effectively help patients feel more in command of their pain control and enable them to live as normal a life as possible despite pain. Moreover, the skills learned through psychological interventions empower and enable patients to become active participants in the management of their illness and instill valuable skills that patients can employ throughout their lives.

Factors affecting placebo acceptability: deception, outcome, and disease severity.

UNLABELLED: A burgeoning body of evidence supports the efficacy and elucidates the mechanisms of placebo analgesia. Debate persists, however, concerning their ethical use, with many of the present arguments being philosophically based. The present web-based study empirically investigated the acceptability of an analgesic placebo treatment. Participants (103) responded to vignettes depicting patients receiving a placebo analgesic. We experimentally manipulated: 1) placebo treatment instructions (level of deception); 2) treatment outcome; and 3) patients' pain severity. Participants rated vignettes on outcome measures of deception, physician-patient relationship, and patient mood. Participants then characterized a range of placebo acceptability through ratings of deceptiveness, effectiveness, and negative consequences. Results showed that placebos described as "medication shown to be a powerful analgesic in some people" were equally deceptive as those described as "standard drug treatment." Ratings of patient mood and physician approval were determined as much by treatment instruction as by treatment outcome and an analgesic response mitigated the negative consequences of deceptive administration. Participants tolerated moderate effectiveness and considerable negative consequences in an acceptable placebo, although results suggest lay individuals may not have a sophisticated conceptualization of placebo effectiveness. Studies altering individuals' understanding of placebo effectiveness and mechanisms are needed to identify additional factors determining placebo acceptability. PERSPECTIVE: This study represents an empirical examination of analgesic placebo acceptability among lay individuals. This article is the first to systematically manipulate deception, treatment outcome, and disease severity to determine how these factors interact to differentially determine placebo acceptability-a highly relevant finding that informs the clinical use of placebo.

Frequency and perceived effectiveness of coping define important subgroups of patients with chronic pain.

OBJECTIVES: Investigate the relationship between frequency and perceived effectiveness of coping strategies used to cope with chronic pain. Examine the association between these variables and pain-related negative mood. METHODS: Retrospective review of psychological measures completed by 122 adult chronic pain patients seen at a multidisciplinary pain clinic at the University of Florida. Empirical subgroups according to reported frequency and perceived effectiveness of coping strategies used were identified resulting in a 4-group solution based on combinations of high versus low effectiveness and high versus low frequency of use. RESULTS: Analysis of variance results revealed significantly higher levels of distress (depression and pain-related anxiety) for selected subgroups [F(2,99)=4.902, P<0.05, η2=0.09 and F(2,93)=3.504, P<0.05, η2=0.07, respectively]. Post-hoc analyses revealed significantly more depression (mean=20.20, SD=9.77) and more pain-related anxiety (mean=101.07, SD=35.78) in individuals frequently using ineffective coping as compared with those reporting frequent use of effective coping (Mean(depression)=14.88, SD(depression)=7.40; Mean(pain-related anxiety)=78.93, SD(pain-related anxiety)=32.26) and those reporting infrequent use of ineffective coping (Mean(depression)=13.89, SD(depression)=9.44). DISCUSSION: Perceived effectiveness and frequency of coping strategy use may influence pain-related negative mood. Maladaptive coping may be a risk factor associated with more emotional distress; it is also possible that more emotional distress predisposes maladaptive coping. Taking into account both the frequency of coping strategy use and the perceived effectiveness of strategy type is suggested for future studies.

Daily variations in objective nighttime sleep and subjective morning pain in older adults with insomnia: evidence of covariation over time.

OBJECTIVES: To examine the relationship between objectively measured nocturnal sleep and subjective report of morning pain in older adults with insomnia; to examine not only the difference between persons in the association between sleep and pain (mean level over 14 days), but also the within-person, day-to-day association. DESIGN: Cross-sectional. SETTING: North-central Florida. PARTICIPANTS: Fifty community-dwelling older adults (mean age+/-standard deviation 69.1+/-7.0, range 60-90) with insomnia. MEASUREMENTS: Daily home-based assessment using nightly actigraphic measurement of sleep and daily self-report of pain over 14 consecutive days. RESULTS: Between persons, average sleep over 14 days was not associated with average levels of rated pain, but after a night in which an older adult with insomnia experienced above-average total sleep time he or she subsequently reported below-average pain ratings. The model explained approximately 24% of the within-person and 8% of the between-person variance in pain ratings. CONCLUSIONS: Sleep and pain show day-to-day associations (i.e., covary over time) in older adults with insomnia. Such associations may suggest that common physiological systems underlie the experience of insomnia and pain. Future research should examine the crossover effects of sleep treatment on pain and of pain treatment on sleep.

Effects of coping statements on experimental pain in chronic pain patients.

The present study measured the effects of catastrophizing self-statements and positive coping self-statements on cold pressor-induced pain. Participants were 58 adult chronic pain patients with current facial pain. It was hypothesized that catastrophizing would lead to a decrease in pain endurance whereas positive coping would lead to an increase in pain endurance. It was also hypothesized that catastrophizing would lead to an increase in peak pain intensity whereas positive coping would lead to a decrease in peak pain intensity. At pretest, participants submerged their nondominant hand in the cold pressor. Pain sensitivity ranges (PSR) were subsequently determined by calculating the difference between tolerance and threshold times. Ratings of peak pain intensity were measured using a pressure sensitive bladder/transducer. Participants underwent random assignment to either a catastrophizing group or a positive coping self-statement group. ANCOVA results revealed that on average, participants employing catastrophizing statements as a coping strategy experienced significantly lower PSR (M = 35.53, SD = 39.71) compared to participants employing positive coping self-statements (M = 73.70, SD = 86.14) when controlling for pretest PSR. Group assignment had no significant influence on peak pain intensity ratings. Thus, our results reveal that manipulation of coping causes changes in pain endurance.