Abstract
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.
Chronic pain constitutes a significant burden for the individuals affected, and is a frequent reason why patients seek health care services. While in-person psychosocial interventions can be of ...support to people living with chronic pain, such interventions are not always accessible. eHealth interventions may provide greater accessibility, but the evidence and use of digital self-management solutions for chronic pain are still limited and the lack of health care provider input in the development process of such solutions a concern. Therefore, the aim of the current study was to investigate health care providers' experiences of treating patients with chronic pain, their attitudes towards, and use of, digital solutions in pain management, and their suggestions for content and design elements for a potential digital pain self-management intervention.
Twelve health care providers representing a variety of health care disciplines participated in semi-structured interviews. The interviews were analyzed using thematic analysis.
The material was analyzed into three main themes: 1 Patients with chronic pain and their current use of the health care services, 2 Health care providers' own motivation and impression of patient prerequisites for use of digital self-management interventions, and 3 Suggestions for content and design elements in a digital self-management intervention for people living with chronic pain. The challenges faced by patients living with chronic pain were described as numerous. Despite interest and positive attitudes, few of the health care providers had used or recommended eHealth solutions to their patients. A range of potential content and functionality elements were identified, including aspects of motivation and engagement and providers also emphasized the importance of easy access and positive, personal content to support existing treatment.
This study offers insights into health care providers' considerations for the potential of digital self-management interventions supporting patients living with chronic pain. Findings indicate the need for change and a more comprehensive treatment approach to pain management. eHealth solutions may contribute to such change, and providers pointed to a need for health care provider involvement, timely support and follow-up as important factors for integrating digital pain self-management interventions into clinical care.
ClinicalTrials.gov : NCT03705104.
Background
Chronic pain conditions involve numerous physical and psychological challenges, and while psychosocial self-management interventions can be of benefit for people living with chronic pain, ...such in-person treatment is not always accessible. Digital self-management approaches could improve this disparity, potentially bolstering outreach and providing easy, relatively low-cost access to pain self-management interventions.
Objective
This randomized controlled trial aimed to evaluate the short-term efficacy of EPIO (ie, inspired by the Greek goddess for the soothing of pain, Epione), a digital self-management intervention, for people living with chronic pain.
Methods
Patients (N=266) were randomly assigned to either the EPIO intervention (n=132) or a care-as-usual control group (n=134). Outcome measures included pain interference (Brief Pain Inventory; primary outcome measure), anxiety and depression (Hospital Anxiety and Depression Scale), self-regulatory fatigue (Self-Regulatory Fatigue 18 scale), health-related quality of life (SF-36 Short Form Health Survey), pain catastrophizing (Pain Catastrophizing Scale), and pain acceptance (Chronic Pain Acceptance Questionnaire). Linear regression models used change scores as the dependent variables.
Results
The participants were primarily female (210/259, 81.1%), with a median age of 49 (range 22-78) years and a variety of pain conditions. Analyses (n=229) after 3 months revealed no statistically significant changes for the primary outcome of pain interference (P=.84), but significant reductions in the secondary outcomes of depression (mean difference −0.90; P=.03) and self-regulatory fatigue (mean difference −2.76; P=.008) in favor of the intervention group. No other statistically significant changes were observed at 3 months (all P>.05). Participants described EPIO as useful (ie, totally agree or agree; 95/109, 87.2%) and easy to use (101/109, 92.7%), with easily understandable exercises (106/109, 97.2%).
Conclusions
Evidence-informed, user-centered digital pain self-management interventions such as EPIO may have the potential to effectively support self-management and improve psychological functioning in the form of reduced symptoms of depression and improved capacity to regulate thoughts, feelings, and behavior for people living with chronic pain.
Trial Registration
ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104
Chronic pain conditions entail significant personal and societal burdens and improved outreach of evidence-based pain self-management programs are needed. Digital cognitive-behavioral self-management ...interventions have shown promise. However, evidence is still scarce and several challenges with such interventions for chronic pain exist. Exploring patients' experiences and engagement with digital interventions may be an essential step towards developing meaningful digital self-management interventions for those living with chronic pain.
This study aimed to gain insight into the experiences of people with chronic pain when engaging with EPIO, an application (app)-based cognitive-behavioral pain self-management intervention program.
Participants (N = 50) living with chronic pain received access to the EPIO intervention in a feasibility pilot-study for 3 months. During this time, all participants received a follow-up phone call at 2-3 weeks, and a subsample (n = 15) also participated in individual semi-structured interviews after 3 months. A qualitative design was used and thematic analysis was employed aiming to capture participants' experiences when engaging with the EPIO intervention program.
Findings identifying program-related experiences and engagement were organized into three main topics, each with three sub-themes: (1) Engaging with EPIO; motivation to learn, fostering joy and enthusiasm, and helpful reminders and personalization, (2) Coping with pain in everyday life; awareness, practice and using EPIO in everyday life, and (3) The value of engaging with the EPIO program; EPIO - a friend, making peace with the presence of pain, and fostering communication and social support.
This qualitative study explored participants' experiences and engagement with EPIO, a digital self-management intervention program for people living with chronic pain. Findings identified valued aspects related to motivation for engagement, and showed how such a program may be incorporated into daily life, and encourage a sense of acceptance, social support and relatedness. The findings highlight vital components for facilitating digital program engagement and use in support of self-management for people living with chronic pain.
ClinicalTrials.gov NCT03705104 .
Sleep disturbances and increased negative mood are common among chronic pain patients. Research suggests that sleep disruption can contribute to increased pain; however, the role of negative mood in ...this relationship is unclear. The present study investigated the relationship among sleep disturbance, negative mood, and pain within a large sample of chronic pain patients. It was hypothesized that negative mood would mediate the relationship between sleep and pain.
In all, 292 chronic pain patients (116 facial pain, 55 back pain, 121 fibromyalgia) between 18 and 65 years of age (M=46.67) were recruited from 3 chronic pain clinics at a large tertiary care hospital. Patients completed validated measures of pain, negative mood, and sleep during a routine clinical assessment. Structural equation modeling examined the relationship between sleep, negative mood, and pain.
All 3 groups of patients reported sleep disturbances, with these being highest among back pain and fibromyalgia patients. Structural equation modeling analyses revealed a significant direct relationship between poor sleep and pain, and further demonstrated that negative mood mediated the relationship between poor sleep and pain in this sample of chronic pain patients.
These findings suggest that addressing negative mood directly, or by addressing sleep disturbances in chronic pain patients, may have a beneficial impact on patients' pain. As sleep disturbance may be causing negative mood, treating the sleep disturbance may also be beneficial among chronic pain patients. Negative mood may perpetuate the impact of sleep disturbances on pain, possibly through increased arousal or disruptions in diurnal patterns.
A growing body of evidence supports the potential effectiveness of electronic health (eHealth) interventions in managing chronic pain. However, research on the needs and preferences of patients with ...chronic pain in relation to eHealth interventions is scarce. Eliciting user input in the development of eHealth interventions may be a crucial step toward developing meaningful interventions for patients for potentially improving treatment outcomes.
This study aimed to explore the experiences of patients with chronic pain with regard to information and communication technology, understand how an eHealth intervention can support the everyday needs and challenges of patients with chronic pain, and identify possible facilitators and barriers for patients' use of an eHealth pain management intervention.
Twenty patients living with chronic pain and five spouses participated in individual interviews. Semistructured interview guides were used to explore participants' needs, experiences, and challenges in daily life as well as their information and communication technology experiences and preferences for eHealth support interventions. Spouses were recruited and interviewed to gain additional insight into the patients' needs. The study used qualitative thematic analysis.
The participants were generally experienced technology users and reported using apps regularly. They were mainly in favor of using an eHealth self-management intervention for chronic pain and considered it a potentially acceptable way of gathering knowledge and support for pain management. The participants expressed the need for obtaining more information and knowledge, establishing a better balance in everyday life, and receiving support for improving communication and social participation. They provided suggestions for the eHealth intervention content and functionality to address these needs. Accessibility, personalization, and usability were emphasized as important elements for an eHealth support tool. The participants described an ideal eHealth intervention as one that could be used for support and distraction from pain, at any time or in any situation, regardless of varying pain intensity and concentration capacity.
This study provides insight into user preferences for eHealth interventions aiming to address self-management for chronic pain. Participants highlighted important factors to be considered when designing and developing eHealth interventions for self-management of chronic pain, illustrating the importance and benefit of including users in the development of eHealth interventions.
ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.
Objective: This study examined the association between pain catastrophizing with pain interference, depressive symptoms, and health-related quality of life (HRQoL) among National Football League ...(NFL) retirees. Method: Former NFL athletes from the Retired NFL Players Association (N = 90) were recruited from 2018 to 2019 via telephone and were administered measures of pain, substance use, depressive symptoms, and HRQoL. Multiple linear and binomial regression analyses examined the association of pain catastrophizing with pain interference, depressive symptoms, and HRQoL while controlling for covariates (i.e., pain intensity, concussions, opioid use, binge alcohol use, years since NFL retirement, and marital status). Results: Many retired NFL athletes reported moderate-severe depressive symptoms as well as poorer perceived physical health compared with general medical patients. Greater pain catastrophizing was associated with more severe pain interference, greater odds of reporting moderate-severe depressive symptoms, and lower odds of reporting average and above physical and mental HRQoL after adjusting for relevant covariates. Concussions were not associated with any of the study outcomes. Conclusions: Given the findings from this study, health care professionals should monitor symptoms of catastrophizing among current and retired NFL athletes. Assessment and requisite treatment of pain catastrophizing may assist these elite athletes in reducing depressive symptoms, while improving pain interference and HRQoL in this population.
Chronic pain conditions are complicated and challenging to live with. Electronic health (eHealth) interventions show promise in helping people cope with chronic illness, including pain. The success ...of these interventions depends not only on the technology and intervention content but also on the users' acceptance and adherence. Involving all stakeholders (eg, patients, spouses, health care providers, designers, software developers, and researchers) and exploring their input and preferences in the design and development process is an important step toward developing meaningful interventions and possibly strengthening treatment outcomes.
The aim of this study was to design and develop a user-centered, evidence-based eHealth self-management intervention for people with chronic pain.
The study employed a multidisciplinary and user-centered design approach. Overall, 20 stakeholders from the project team (ie, 7 researchers, 5 editors, 7 software developers, and 1 user representative), together with 33 external stakeholders (ie, 12 health care providers, 1 health care manger, 1 eHealth research psychologist, and 17 patients with chronic pain and 2 of their spouses) participated in a user-centered development process that included workshops, intervention content development, and usability testing. Intervention content was developed and finalized based on existing evidence, stakeholder input, and user testing. Stakeholder input was examined through qualitative analyses with rapid and in-depth analysis approaches.
Analyses from stakeholder input identified themes including a need for reliable, trustworthy, and evidence-based content, personalization, options for feedback, behavioral tracking, and self-assessment/registration as factors to include in the intervention. Evidence-based intervention content development resulted in one face-to-face introduction session and 9 app-based educational and exercise-based modules. Usability testing provided further insight into how to optimize the design of the intervention to the user group, identifying accessibility and a simple design to be essential.
The design and development process of eHealth interventions should strive to combine well-known evidence-based concepts with stakeholder input. This study, designing and developing the pain management intervention EPIO, illustrates how a stakeholder-centered design approach can provide essential input in the development of an eHealth self-management intervention for people with chronic pain.
ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.
Insomnia is an adverse cancer outcome impacting mood, pain, quality of life, and mortality in cancer patients. Cognitive Behavioral Therapy (CBT) is an evidence-based treatment for diverse ...psychophysiological disorders, including pain and insomnia. Primarily studied in breast cancer, there is limited research on CBT within gynecology oncology. This study examined CBT effects on subjective and behavioral sleep outcomes: Sleep Efficiency (SE), Sleep Quality (SQ), Total Wake Time (TWT), Sleep Onset Latency (SOL), and Wake After Sleep Onset (WASO). Thirty-five women with insomnia status/post-surgery for gynecologic cancer were randomized to CBT for insomnia and pain (CBTi.p., N = 18) or Psychoeducation (N = 17). Sleep was assessed via sleep diaries and wrist-worn actigraphy at baseline (T1), post-intervention (T2), and two-month follow-up (T3). Intent-to-treat analyses utilizing mixed linear modeling examined longitudinal group differences on sleep controlling for age and advanced cancer. All participants demonstrated improved (1) subjective SE (0.5, p < .01), SOL (−1.2, p < .01), TWT (−1.2, p < .01), and (2) behavioral SE (0.1, p = .02), TWT (−1.2, p = .03), WASO (−0.8, p < .01) across time. Group-level time trends were indicative of higher subjective SE (6.8, p = .02), lower TWT (−40.3, p = .01), and lower SOL (−13.0, p = .05) in CBTi.p. compared to Psychoeducation. Supplemental analyses examining clinical significance and acute treatment effects demonstrated clinical improvements in SE (T1), TWT (T2, T3), and SOL (T3). Remaining effects were not significant. Despite lacking power to detect interaction effects, CBTi.p. clinically improved sleep in women with gynecologic cancers and insomnia during the active treatment phase. Future research will focus on developing larger trials within underserved populations.
This article presents results of a systematic review of the literature (2000-2017) examining the prevalence and correlates of psychological distress among retired elite athletes. Forty articles were ...selected and included. Our review suggests the prevalence of psychological distress among retired athletes is similar to that found in the general population. However, subgroups reporting medical comorbidities, significant pain, a greater number of concussions, less social support, and adverse psychosocial factors were at greater risk for psychological distress. Additionally, athletes experiencing psychological distress in retirement often do not seek treatment for their distress. Based on the existing literature, there is a need for greater standardization and use of reliable measures, as well as use of diagnostic interviews in order to assess the most accurate prevalence of psychological distress among these athletes. Longitudinal designs, matched control groups, more heterogeneous samples, and use of multivariate analyses would also help to more accurately determine the prevalence and risk factors of psychological distress in this population. This review suggests a number of different clinical implications and highlights directions for future research to enhance our understanding of the long-term psychological health of former elite athletes.
PDF
