Suicidal thoughts and behaviors in patients with chronic pain, with and without co-occurring opioid use disorder.

BACKGROUND: Individuals with chronic pain and a co-occurring substance use disorder present higher risk of suicide, but the individual and joint impacts of chronic pain and substance use disorders on suicide risk are not well defined. The objective of this study was to exam the factors associated with suicidal thoughts and behaviors in a cohort of patients with chronic non-cancer pain (CNCP), with or without concomitant opioid use disorder (OUD). DESIGN: Cross sectional cohort design. SETTING: Primary care clinics, pain clinics, and substance abuse treatment facilities in Pennsylvania, Washington, and Utah. SUBJECTS: In total, 609 adults with CNCP treated with long-term opioid therapy (>/= 6 months) who either developed an OUD (cases, n = 175) or displayed no evidence of OUD (controls, n = 434). METHODS: The predicted outcome was elevated suicidal behavior in patients with CNCP as indicated by a Suicide Behavior Questionnaire-Revised (SBQ-R) score of 8 or above. The presence of CNCP and OUD were key predictors. Covariates included demographics, pain severity, psychiatric history, pain coping, social support, depression, pain catastrophizing and mental defeat. RESULTS: Participants with CNCP and co-occurring OUD had an increased odds ratio of 3.44 in reporting elevated suicide scores as compared to participants with chronic pain only. Multivariable modeling revealed that mental defeat, pain catastrophizing, depression, and having chronic pain, and co-occurring OUD significantly increased the odds of elevated suicide scores. CONCLUSIONS: Patients with CNCP and co-morbid OUD are associated with a 3-fold increase in risk of suicide.

Development and testing of an opioid tapering self-management intervention for chronic pain: I-WOTCH.

OBJECTIVES: To describe the design, development and pilot of a multicomponent intervention aimed at supporting withdrawal of opioids for people with chronic non-malignant pain for future evaluation in the Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial. DESIGN: The I-WOTCH intervention draws on previous literature and collaboration with stakeholders (patient and public involvement). Intervention mapping and development activities of Behaviour Change Taxonomy are described. SETTING: The intervention development was conducted by a multidisciplinary team with clinical, academic and service user perspectives. The team had expertise in the development and testing of complex health behaviour interventions, opioid tapering and pain management in primary and secondary care, I.T programming, and software development-to develop an opioid tapering App. PARTICIPANTS: The I-WOTCH trial participants are adults (18 years and over) with chronic non-malignant pain using strong opioids for at least 3 months and on most days in the preceding month. OUTCOMES: A multicomponent self-management support package to help people using opioids for chronic non-malignant pain reduce opioid use. INTERVENTIONS AND RESULTS: Receiving information on the impact of long-term opioid use, and potential adverse effects were highlighted as important facilitators in making the decision to reduce opioids. Case studies of those who have successfully stopped taking opioids were also favoured as a facilitator to reduce opioid use. Barriers included the need for a 'trade-off to fill the deficit of the effect of the drug'. The final I-WOTCH intervention consists of an 8-10 week programme incorporating: education; problem-solving; motivation; group and one to one tailored planning; reflection and monitoring. A detailed facilitator manual was developed to promote consistent delivery of the intervention across the UK. CONCLUSIONS: We describe the development of an opioid reduction intervention package suitable for testing in the I-WOTCH randomised controlled trial. TRIAL REGISTRATION NUMBER: ISRCTN49470934.

Testing a support programme for opioid reduction for people with chronic non-malignant pain: the I-WOTCH randomised controlled trial protocol.

INTRODUCTION: Chronic non-malignant pain has a major impact on the well-being, mood and productivity of those affected. Opioids are increasingly prescribed to manage this type of pain, but with a risk of other disabling symptoms, when their effectiveness has been questioned. This trial is designed to implement and evaluate a patient-centred intervention targeting withdrawal of strong opioids in people with chronic pain. METHODS AND ANALYSIS: A pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of a group-based multicomponent intervention combined with individualised clinical facilitator led support for the management of chronic non-malignant pain against the control intervention (self-help booklet and relaxation compact disc). An embedded process evaluation will examine fidelity of delivery and investigate experiences of the intervention. The two primary outcomes are activities of daily living (measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A)) and opioid use. The secondary outcomes are pain severity, quality of life, sleep quality, self-efficacy, adverse events and National Health Service (NHS) healthcare resource use. Participants are followed up at 4, 8 and 12 months, with a primary endpoint of 12 months. Between-group differences will indicate effectiveness; we are looking for a difference of 3.5 points on our pain interference outcome (scale 40 to 77). We will undertake an NHS perspective cost-effectiveness analysis using quality adjusted life years. ETHICS AND DISSEMINATION: Full approval was given by Yorkshire & The Humber - South Yorkshire Research Ethics Committee on 13 September, 2016 (16/YH/0325). Appropriate local approvals were sought for each area in which recruitment was undertaken. The current protocol version is 1.6 date 19 December 2018. Publication of results in peer- reviewed journals will inform the scientific and clinical community. We will disseminate results to patient participants and study facilitators in a study newsletter as well as a lay summary of results on the study website. TRIAL REGISTRATION NUMBER: ISRCTN49470934; Pre-results.

The effect of opioid therapy on sleep quality in patients with chronic non-malignant pain: A systematic review and exploratory meta-analysis.

Current guidelines recommend opioid therapy to chronic non-malignant pain (CNP) patients when the benefits for pain and function outweigh risks. This systematic review examined the effects of opioid therapy on sleep - a valued functional outcome- in CNP. Electronic and hand searches of relevant studies up through July 2017 identified 18 eligible studies providing data from 3,746 CNP patients for analysis. Twelve of these studies were randomised controlled trials of up to 12-month in duration. Morphine sulfate, oxycodone and transdermal fentanyl were the most tested therapies (n = 4 each). Only two studies used objective sleep measures in addition to self-report ratings, questionnaires or sleep diaries. Whilst calmer sleep with less body/leg movements and fewer awakenings could be achieved following opioid therapy, these might occur with increased sleep-disordered breathing and a much-shortened rapid eye movement (REM) sleep latency. Both the narrative synthesis and exploratory meta-analysis suggest that opioid therapy in CNP is associated with improved self-reported sleep quality. However, the effect is inconsistent, small (Standardised Mean Difference = 0.36), and may be accompanied by excessive daytime sleepiness. As a Cochrane-recommended assessment revealed "unclear" or "high" overall risk of bias for all studies, future opioid trials of stronger methodology and better reporting are needed to confirm and elucidate the effect.

Nonpharmacological Treatments of Insomnia for Long-Term Painful Conditions: A Systematic Review and Meta-analysis of Patient-Reported Outcomes in Randomized Controlled Trials.

STUDY OBJECTIVES: Insomnia is a debilitating comorbidity of chronic pain. This study evaluated the effect of nonpharmacological sleep treatments on patient-reported sleep quality, pain, and well-being in people with long-term cancer and non-cancer (e.g., back pain, arthritis, fibromyalgia) pain conditions. DESIGN: We systematically searched Cochrane CENTRAL, MEDLINE, Embase, and PsychINFO for relevant studies. Search period was set to inception of these databases to March 2014. Studies were included if they were: original randomized controlled trials (RCTs); testing a nonpharmacological intervention; that targets sleep; in adults; with painful health conditions; that has a control group; includes a measure of sleep quality; and at least one other health and well-being outcome. MEASUREMENT AND FINDINGS: Means and standard deviations of sleep quality, pain, fatigue, depression, anxiety, physical and psychological functioning were extracted for the sleep treatment and control groups at baseline, posttreatment and final follow-up. Methodological details concerning the treatment, participants, and study design were abstracted to guide heterogeneity and subgroup analyses. Eleven RCTs involving 1,066 participants (mean age 45-61 years) met the criteria for the meta-analysis. There was no systematic evidence of publication bias. Nonpharmacological sleep treatments in chronic pain patients were associated with a large improvement in sleep quality (standardized mean difference = 0.78, 95% Confidence Interval [0.42, 1.13]; P < 0.001), small reduction in pain (0.18 [0, 0.36] P < 0.05), and moderate improvement in fatigue (0.38 [0.08, 0.69]; P < 0.01) at posttreatment. The effects on sleep quality and fatigue were maintained at follow-up (up to 1 year) when a moderate reduction in depression (0.31, [0.09, 0.53]; P < 0.01) was also observed. Both cancer and non-cancer pain patients benefited from nonpharmacological sleep treatments. Face-to-face treatments achieved better outcomes than those delivered over the phone/internet. CONCLUSIONS: Although the body of evidence was small, nonpharmacological sleep interventions may represent a fruitful avenue for optimizing treatment outcomes in patients with chronic pain. REGISTRATION: PROSPERO registration: CRD42013004131.

Effects of mood on pain responses and pain tolerance: an experimental study in chronic back pain patients.

Although chronic pain and depression commonly co-occur, causal relationships have yet to be established. A reciprocal relationship, with depression increasing pain and vice versa, is most frequently suggested, but experimental evidence is needed to validate such a view. The most straightforward approach would be a demonstration that increasing or decreasing depressed mood predictably modifies pain responses. The current experiment tested whether experimentally induced depressed and happy mood have differential effects on pain ratings and tolerance in 55 patients suffering from chronic back pain. Participants were randomly assigned to depressed, neutral (control) or elated mood induction conditions. They completed a physically passive baseline task prior to receiving mood induction, then a clinically relevant physically active task (holding a heavy bag) to elicit pain responses and tolerance. Measures were taken immediately after the baseline task and immediately after the mood induction to assess the changes in mood, pain ratings and tolerance before and after the experimental manipulation. Results indicate that the induction of depressed mood resulted in significantly higher pain ratings at rest and lower pain tolerance, whilst induced happy mood resulted in significantly lower pain ratings at rest and greater pain tolerance. Correlations between changes in mood on the one hand and changes in pain response and pain tolerance on the other hand were consistent with these findings. It is concluded that, in chronic back pain patients, experimentally induced negative mood increases self-reported pain and decreases tolerance for a pain-relevant task, with positive mood having the opposite effect.

Increased use of safety-seeking behaviors in chronic back pain patients with high health anxiety.

Many patients with chronic pain also exhibit elevated levels of health anxiety. This study examined the effect of health anxiety on the use of safety-seeking behaviors (SSBs) in pain-provoking situations. Participants were 20 chronic back pain patients with high health anxiety (Group H), 20 with low health anxiety (Group L) and 20 pain-free controls (Group C). Two physical tasks were video recorded, and compared both for overt pain behavior (identified by blind observers following a standardized procedure) and for the occurrence of SSB (identified by showing the participants video playback and asking them to specify motivation for all actions/behaviors displayed during the tasks). While there were no differences in the display of overt pain behaviors, Group H deployed a greater number of SSBs than Groups L and C. This finding held true for both tasks and remained significant when concurrent pain and mood ratings were statistically controlled for. SSB was correlated with catastrophizing thoughts but not pain intensity; pain intensity was correlated with overt pain behavior but not catastrophizing. Taken together, these findings suggest that SSB is distinct from overt pain behavior and may be a defining characteristic of chronic pain patients reporting high levels of health anxiety.