Meaning in life after cancer: Validation of the sources of meaning card method among participants in cancer rehabilitation.

Cancer survivors may be struggling to re-create meaning in life. Addressing their personal sources of meaning can support them in this process. The sources of meaning card method (SoMeCaM) aims to map and explore personal sources of meaning in a 1-h session. It includes 26 cards, each with a statement on a source of meaning. The purpose of this study was to validate the statements on the sources of meaning cards for use among participants in cancer rehabilitation by examining whether participants attribute the same meaning to the statements as intended. The three step test interview method was used to assess response processes to the sources of meaning cards among 12 participants in a 5-day cancer rehabilitation program in Denmark. The interviews were transcribed verbatim and analyzed using framework analysis. Nineteen of the 26 statements were interpreted congruently, that is, in line with the underlying theory, by all participants. Issues of incongruency, ambiguity and confusion were observed in participants' interpretations of the statements on religiosity (n = 6), spirituality (n = 10), and reason (n = 6). Minor issues were observed for the statements on practicality, achievement, knowledge, and attentiveness. In most statements, cancer survivors' interpretation aligned with the underlying theory. Problems were apparent regarding the sources of meaning religiosity, spirituality and reason, and a reconsideration of the wording of the statements is recommended. These problems may be due to cultural and linguistic interpretations rather than to being a cancer survivor. Future studies could focus on these issues in other target populations. Despite these minor issues, the SoMeCaM has proven useful in addressing the important topic of meaning in life in the cancer rehabilitation setting. Clinicians should pay attention to nuances in participants' understanding of the cards.

Content of clinicians' communication with patients suffering from spinal pain in assessment situations in a specialized spine center: A qualitative study evaluating psychologically informed pain assessments before and after clinicians' participation in an Acceptance and Commitment Therapy course.

INTRODUCTION: Assessment is an important part of chronic pain rehabilitation and should be conducted in line with the current biopsychosocial conceptualization of pain to capture the subjectivity and context of pain. However, pain assessment is commonly conducted from a biomedical framework. A course in Acceptance and Commitment Therapy (ACT) was provided to spinal pain clinicians as a framework to promote more person-centered and psychosocially focused assessments and related psychologically informed practices. The purpose of this qualitative study was to explore the verbal content of clinicians' communication with patients experiencing spinal pain in assessment situations before and after clinicians participated in an ACT course. METHODS: Pain assessments of patients with chronic low back pain conducted by six spinal pain clinicians from different professions were audio-recorded and transcribed. This was done before and after participation in an eight-day ACT course with four following supervisions. A thematic analysis was carried out by two authors across all material, and a comparison of the applied number of codes pre-course and post-course was carried out as an indicator of change. RESULTS: Data consisted of transcripts from the six clinicians across 23 different patients (12 before course participation). Through analysis, 11 codes were developed, which were clustered in three overarching themes: Psychological domains, Communication Techniques, and Intervention Elements. Overall, there was an increase in the application of many of the codes in the transcripts from pre-course to post-course, however with large differences across codes. Increases were primary related to the discussion of life values and value-based action and quality of life as well as the employment of mirroring, challenging beliefs and assumptions, and addressing coping and pacing. CONCLUSIONS: While not the case for all factors, the present findings indicate an increase in including psychological factors and employing interpersonal communication skills after a course in ACT. However, it remains unknown due to the design if the changes reported in this study reflect a clinically valuable change and whether they are due to the ACT training itself. Future research will improve our understanding of the effectiveness of this type of intervention in assessment practices.

Does the Danish version of the Spinal Cord Lesion-related Coping Strategies Questionnaire measure what we think it measures? A triangulated mixed-methods validation approach.

STUDY DESIGN: Triangulated mixed-methods validation study. OBJECTIVES: To validate the Danish version of the Spinal Cord Lesion-related Coping Strategies Questionnaire (SCL-CSQ). SETTING: Community in Denmark. METHODS: Participants were invited via a patient organization and its specialized hospital. Eligibility criteria were having a spinal cord injury (SCI), being 18 years or older, and able to understand and respond in Danish. Quantitative data were collected to determine internal consistency and criterion validity of the three subscales of SCL-CSQ, i.e., acceptance, fighting spirit, and social reliance. The Three-Step Test-Interview approach was employed to determine whether items measured what they were intended to measure (i.e., construct validity based on response processes). RESULTS: The quantitative sample consisted of 107 participants, and the interview sample comprised 11 participants. The acceptance and fighting spirit subscales showed adequate internal consistency (Cronbach's alpha of 0.72 and 0.76 respectively) and satisfactory criterion validity (expected correlations with quality of life and depression). The social reliance subscale showed inadequate internal consistency (Cronbach's alpha of 0.58) and criterion validity. All fighting spirit items and all but one acceptance items were interpreted congruently by most participants. Conversely, two social reliance items were only interpreted congruently by 9 and 27%. CONCLUSION: The acceptance and fighting spirit subscales of the Danish version of the SCL-CSQ showed good psychometric properties, while the social reliance subscale showed serious issues and should be revised. Researchers and clinicians are urged to reflect on these findings when revising the SCL-CSQ or adapting it to other languages, cultural contexts, and rehabilitation settings.

The Clinical Effectiveness of Blended Cognitive Behavioral Therapy Compared With Face-to-Face Cognitive Behavioral Therapy for Adult Depression: Randomized Controlled Noninferiority Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (FtF) consultations in a blended format may produce a new treatment format (B-CBT) with multiple benefits from both traditional CBT and iCBT, such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation. OBJECTIVE: The primary aim of this study is to compare directly the clinical effectiveness of B-CBT with FtF-CBT for adult major depressive disorder. METHODS: A 2-arm randomized controlled noninferiority trial compared B-CBT for adult depression with treatment as usual (TAU). The trial was researcher blinded (unblinded for participants and clinicians). B-CBT comprised 6 sessions of FtF-CBT alternated with 6-8 web-based CBT self-help modules. TAU comprised 12 sessions of FtF-CBT. All participants were aged 18 or older and met the diagnostic criteria for major depressive disorder and were recruited via a national iCBT clinic. The primary outcome was change in depression severity on the 9-item Patient Health Questionnaire (PHQ-9). Secondary analyses included client satisfaction (8-item Client Satisfaction Questionnaire [CSQ-8]), patient expectancy (Credibility and Expectancy Questionnaire [CEQ]), and working (Working Alliance Inventory [WAI] and Technical Alliance Inventory [TAI]). The primary outcome was analyzed by a mixed effects model including all available data from baseline, weekly measures, 3-, 6, and 12-month follow-up. RESULTS: A total of 76 individuals were randomized, with 38 allocated to each treatment group. Age ranged from 18 to 71 years (SD 13.96) with 56 (74%) females. Attrition rate was 20% (n=15), which was less in the FtF-CBT group (n=6, 16%) than in the B-CBT group (n=9, 24%). As many as 53 (70%) completed 9 or more sessions almost equally distributed between the groups (nFtF-CBT=27, 71%; nB-CBT=26, 68%). PHQ-9 reduced 11.38 points in the FtF-CBT group and 8.10 in the B-CBT group. At 6 months, the mean difference was a mere 0.17 points. The primary analyses confirmed large and significant within-group reductions in both groups (FtF-CBT: ß=-.03; standard error [SE] 0.00; P<.001 and B-CBT: ß=-.02; SE 0.00; P<.001). A small but significant interaction effect was observed between groups (ß=.01; SE 0.00; P=.03). Employment status influenced the outcome differently between groups, where the B-CBT group was seen to profit more from not being full-time employed than the FtF group. CONCLUSIONS: With large within-group effects in both treatment arms, the study demonstrated feasibility of B-CBT in Denmark. At 6 months' follow-up, there appeared to be no difference between the 2 treatment formats, with a small but nonsignificant difference at 12 months. The study seems to demonstrate that B-CBT is capable of producing treatment effects that are close to FtF-CBT and that completion rates and satisfaction rates were comparable between groups. However, the study was limited by small sample size and should be interpreted with caution. TRIAL REGISTRATION: ClinicalTrials.gov NCT02796573; https://clinicaltrials.gov/ct2/show/NCT02796573. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-016-1140-y.

Prevalence of long-term opioid therapy in spine center outpatients the spinal pain opioid cohort (SPOC).

PURPOSE: No reference material exists on the scope of long-term problems in novel spinal pain opioid users. In this study, we evaluate the prevalence and long-term use of prescribed opioids in patients of the Spinal Pain Opioid Cohort. METHODS: The setting was an outpatient healthcare entity (Spine Center). Prospective variables include demographics, clinical data collected in SpineData, and The Danish National Prescription Registry. Patients with a new spinal pain episode lasting for more than two months, aged between 18 and 65 years, who had their first outpatient visit. Based on the prescription of opioids from 4 years before the first spine center visit to 5 years after, six or more opioid prescriptions in a single 1-year interval fulfilled the main outcome criteria Long-Term Opioid Therapy (LTOT). RESULTS: Overall, of 8356 patients included in the cohort, 4409 (53%) had one or more opioid prescriptions in the registered nine years period. Of opioid users, 2261 (27%) were NaiveStarters receiving their first opioid prescription after a new acute pain episode; 2148(26%) PreStarters had previously received opioids. The prevalence of LTOT in PreStarters/NaiveStarters was 17.2%/11.2% in their first outpatient year. Similar differences between groups were seen in all follow-up intervals. In the last follow-up year, LTOT prevalence in Prestarters/NaiveStarters was 12.5%/7.0%. CONCLUSIONS: Previous opioid treatment-i.e., before a new acute spinal pain episode and referral to a Spine Center-doubled the risk of LTOT 5 years later. The results underscore clinicians' obligation to carefully and individually weigh the benefits against the risks of prescribing opioid therapy. LEVEL OF EVIDENCE I: Diagnostic: individual cross-sectional studies with consistently applied reference standard and blinding.

Adherence and characteristics of participants enrolled in a standardised programme of patient education and exercises for low back pain, GLA:D® Back - a prospective observational study.

BACKGROUND: Low back pain is often long-lasting, and implementation of low-cost interventions to improve care and minimise its burden is needed. GLA:D® Back is an evidence-based programme consisting of patient education and supervised exercises for people with low back pain, which was implemented nationwide in primary care clinics in Denmark. To assess how the intervention was received and factors influencing adherence to the program, we aimed to evaluate participants' adherence to the intervention and identified characteristics related to the completion of GLA:D® Back. Specifically, we investigated: 1) level of attendance of participants enrolled in the programme, and 2) participant-related factors associated with low attendance. METHODS: Primary care clinicians delivered GLA:D® Back, a standardised 10-week programme of 2 educational and 16 supervised exercise sessions, to patients with low back pain. Attendance was defined as low, medium or high based on self-reported number of attended sessions. Additional participant-reported data included demographic characteristics, pain, prognostic risk profiles, self-efficacy, illness-beliefs, function and clinician-reported physical performance tests. Results for high, medium, low, and unknown attendance were reported descriptively. Odds ratios for low attendance compared to medium/high attendance were calculated by including all baseline factors in a mixed-model logistic regression model. RESULTS: Of 1730 participants, 52% had high, 23% medium, and 25% low levels of attendance. Level of attendance was not strongly associated with participants' individual factors, but in combination, prediction of low attendance was fair (AUC 0.77; 95% CI 0.74-0.79). The strongest indicator of low attendance was not completing the baseline questionnaire. CONCLUSIONS: Most participants of a 10-week low back pain programme attended almost all session. Non-response to the baseline questionnaire was strongly associated with low attendance, whereas individual patient characteristics were weakly related to attendance. Not completing baseline questionnaires might be an early indicator of poor adherence in programs for people with persistent low back pain. TRIAL REGISTRATION: The Health Research Ethics for Southern Denmark decided there was no need for ethical approval (S-20172000-93). The Danish data collection has obtained authorisation from the Danish Data Protection Agency as part of the University of Southern Denmark's institutional authorisation (DPA no. 2015-57-0008 SDU no. 17/30591). The trial was registred at ClinicalTrials.gov NCT03570463 .

There's Nothing Broken. You've Had a Whiplash, That's It: A Qualitative Study of Comorbid Posttraumatic Stress Disorder and Whiplash Associated Disorders.

BACKGROUND: Posttraumatic stress disorder (PTSD) symptoms are common in chronic Whiplash associated disorders (WAD) and have been found to be associated with higher levels of pain and disability. Theoretical frameworks have suggested that PTSD and pain not only coexist, but also mutually maintain one another. Although the comorbidity has been subject to increasing quantitative research, patients' experiences of the comorbidity and symptom interaction remain largely uninvestigated using qualitative methods. OBJECTIVE: The present study set out to explore the potential relationship of PTSD and pain in people with WAD and properly assessed PTSD after motor vehicle accidents. METHODS: A qualitative explorative study of eight individual face-to-face semistructured interviews were conducted. Interviews were recorded and transcribed verbatim and analyzed using framework analysis. RESULTS: Through the analysis, we developed three overarching themes. The first theme illustrated the complex and burdensome comorbidity with overlapping and transdiagnostic symptoms, whereas the second theme highlighted how several circumstances, some related to the health care system, could extend and amplify the traumatic response. The final theme illustrated symptom associations and interactions, particularly between pain and PTSD, both supporting and rejecting parts of the mutual maintenance framework. CONCLUSIONS: These findings underlined the great complexity and variability of the comorbidity and the traumatic event, but also emphasized how experiences of psyche and soma seem closely connected in these patients. The results provide support for the importance of thorough assessment by multidisciplinary teams, minimizing distress post-injury, and a critical approach to the idea of mutual maintenance between pain and PTSD.

The associations of acceptance with quality of life and mental health following spinal cord injury: a systematic review.

STUDY DESIGN: Systematic review. OBJECTIVES: To identify, critically appraise, and synthesize research findings on the associations between acceptance, quality of life (QOL), and mental health outcomes in individuals living with spinal cord injury (SCI). METHODS: Five databases (PubMed, PsycINFO, Embase, Web of Science, and Scopus) were systematically searched. Studies were included if they provided findings on the association between acceptance and QOL, mental health outcomes, or both in an SCI population aged 16 years or older. Only peer-reviewed original quantitative and qualitative studies were included. Screening, quality assessment, and data extraction were conducted independently by two researchers. Findings were tabulated and synthesized by outcome. RESULTS: Forty-one studies were included. Greater acceptance was consistently associated with greater global and psychological QOL, life satisfaction, sense of well-being, mental health, and with lower levels of depression and anxiety. Inconsistent evidence was found with regards to social QOL and post-traumatic stress disorder. Acceptance was generally not associated with adjustment outcomes further than 2 years into the future. Study quality of the quantitative studies was mostly fair (n = 17) followed by good (n = 13), and poor (n = 9). CONCLUSION: Health-care professionals may regard acceptance as a psychological resource they can aim to support in improving QOL and mental health following SCI. A range of methodological and conceptual limitations were present in the research. Future studies should prioritize longitudinal designs, consider dyadic effects, explore subjective meaning(s) of acceptance, and investigate the effectiveness of therapeutic approaches that stimulate the acceptance process.

Assessing the existence of dissociative PTSD in sub-acute patients of whiplash.

Numerous studies investigating dissociative posttraumatic stress disorder (D-PTSD) have emerged. However, there is a lack of studies investigating D-PTSD following a wider range of traumatic exposure. Thus, the present study investigates D-PTSD using latent class analysis (LCA) in sub-acute patients of whiplash and associated risk factors. The results of LCA showed a three-class solution primarily distributed according to posttraumatic stress disorder (PTSD) symptom severity and thus no indication of D-PTSD. Dissociative symptoms, psychological distress (i.e. anxiety/depression), and pain severity significantly predicted PTSD severity. Combined, the results support the component model of dissociation and PTSD, while still stressing the importance of dissociative symptoms when planning treatment for PTSD.

Pain-Related Acceptance as a Mediator in the Fear Avoidance Model of Chronic Pain: A Preliminary Study.

Objective: The fear avoidance model has served as a popular, heuristic model in explaining the transition from acute to chronic pain. In addition, the significance of pain-related acceptance in chronic pain development and adjustment is underlined in a vast number of empirical studies. The objective of the current preliminary study was to investigate pain-related acceptance as a mediator within the key cognitive relationships proposed by the fear avoidance model of chronic pain. Materials and Methods. In a cross-sectional design, bodily pain, pain catastrophizing, fear avoidance beliefs, and pain-related acceptance were assessed by questionnaires in 125 chronic pain patients in a Danish multidisciplinary pain center. Mediation analyses were performed to test the effect of pain-related acceptance on bodily pain, pain catastrophizing, and fear avoidance beliefs. Results: Medium-sized correlations were found between all outcomes. Mediation analyses revealed that pain-related acceptance was a significant mediator between 1) bodily pain and pain catastrophizing and 2) pain catastrophizing and fear avoidance beliefs after controlling for bodily pain. Furthermore, pain-related acceptance accounted for a large proportion in both associations (82.2% and 56.1%). Conclusions: The results suggest that pain-related acceptance is a prominent psychological mechanism within the key cognitive associations of the fear avoidance model, which predicts a certain path of cognitive, emotional, and behavioral factors in the development and maintenance of chronic pain. This proposes pain-related acceptance to be an important mechanism that possibly counteracts the negative reactions of pain catastrophizing and fear avoidance beliefs. These findings should be investigated further and could potentially be an important place to intervene clinically in order to counteract the development and/or maintenance of chronic pain.

Validation of the PTSD-8 Scale in Chronic Pain Patients.

Objectives: The aim was to validate the short PTSD-8 scale against the Structured Clinical Interview (SCID-1) for post-traumatic stress disorder and to test the latent structure of post-traumatic stress disorder in chronic pain patients. Methods: A total of 51 chronic nonmalignant pain patients exposed to a traumatic event were consecutively recruited from a multidisciplinary pain center. All participants answered a baseline questionnaire followed by the PTSD-8 and the diagnostic interview for PTSD. Finally, the latent structure of PTSD-8 was tested in a large cohort of 419 patients with chronic nonmalignant pain using confirmatory factor analysis (CFA). Results: In total, 33.3% had a diagnosis of PTSD. A good overall accuracy was found validating the PTSD-8 against the diagnostic interview. Convergent validity was indicated as the PTSD-8 correlated strongly with scores of depression and anxiety. The results of the CFA for the PTSD-8 three-factor structure provided excellent fit for the eight post-traumatic stress disorder symptoms. Conclusions: Overall, the results showed that the PTSD-8 is a valid short screening tool to assess possible post-traumatic stress disorder among patients with chronic pain. In addition, the PTSD-8 scale comprises all of the upcoming ICD-11 post-traumatic stress disorder symptoms within its eight items. Thus, the PTSD-8 is likely also to measure the proposed ICD-11 post-traumatic stress disorder.

GLA:D® Back group-based patient education integrated with exercises to support self-management of back pain - development, theories and scientific evidence.

BACKGROUND: Clinical guidelines recommend that people with back pain be given information and education about their back pain, advice to remain active and at work, and exercises to improve mobility and physical activity. Guidelines, however, rarely describe how this is best delivered. The aim of this paper is to present the development, theories, and underlying evidence for 'GLA:D Back' - a group education and exercise program that translates guideline recommendations into a clinician-delivered program for the promotion of self-management in people with persistent/recurrent back pain. METHODS: GLA:D Back, which included a rationale and objectives for the program, theory and evidence for the interventions, and program materials, was developed using an iterative process. The content of patient education and exercise programs tested in randomised trials was extracted and a multidisciplinary team of expert researchers and clinicians prioritised common elements hypothesised to improve back pain beliefs and management skills. The program was tested on eight people with persistent back pain in a university clinic and 152 patients from nine primary care physiotherapy and chiropractic clinics. Following feedback from the clinicians and patients involved, the working version of the program was created. RESULTS: Educational components included pain mechanisms, pain modulation, active coping strategies, imaging, physical activity, and exercise that emphasised a balance between the sum of demands and the individual's capacity. These were operationalised in PowerPoint presentations with supporting text to aid clinicians in delivering two one-hour patient education lectures. The exercise program included 16 supervised one-hour sessions over 8 weeks, each comprising a warm-up section and eight types of exercises for general flexibility and strengthening of six different muscle groups at four levels of difficulty. The aims of the exercises were to improve overall back fitness and, at the same time, encourage patients to explore variations in movement by incorporating education content into the exercise sessions. CONCLUSION: From current best evidence about prognostic factors in back pain and effective treatments for back pain, research and clinical experts developed a ready-to-use structured program - GLA:D® Back - to support self-management for people with persistent/recurrent back pain.

Guided Internet-Based Cognitive Behavioral Therapy for Adult Depression and Anxiety in Routine Secondary Care: Observational Study.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) is a promising new treatment method for depression and anxiety. However, it is important to determine whether its results can be replicated in routine care before its implementation on a large scale. Although many studies have demonstrated the efficacy of iCBT under controlled conditions, only a few studies have investigated its effectiveness in routine care. Furthermore, several effects of iCBT such as treatment effects in routine care are unclear. OBJECTIVE: This study aimed to evaluate the clinical effectiveness of iCBT for depression and anxiety in routine secondary care. METHODS: n a retrospective cohort study, we analysed patients treated for depression or anxiety in a dedicated iCBT clinic in secondary care in Denmark. Patients were examined before treatment and weekly thereafter by using the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7 scales for the diagnoses of depression and anxiety, respectively. Primary analyses were conducted using a linear mixed-effects model with random slope and intercept. Secondary analyses were conducted using baseline characteristics as predictors (gender, age, highest level of education, occupational status, marital status, psychotropic medication use, consumption of alcohol, and leisure drugs). Additionally, logistic regression analyses were used to predict noncompletion of treatment. RESULTS: A total of 203 (depression, N=60; anxiety, N=143) patients were included. Participants were mainly female (78.3% with depression and 65.7% with anxiety), with a mean age of 36.03 (SD 10.97) years (range, 19-67 years) for patients with depression and 36.80 (SD 13.55) years (range, 19-69 years) for patients with anxiety. The completion rates were 62% (37) and 40% (57) for depression and anxiety treatments, respectively. The primary analyses revealed large and significant reductions in the symptom levels of depression (beta=-6.27, SE 0.83, P<.001, d=1.0) and anxiety (beta=-3.78, SE 0.43, P<.001, d=1.1). High baseline severity of the primary disorder was associated with high treatment gains (r=-0.31 for depression; r=-0.41 for anxiety). In patients with anxiety, high baseline severity also predicted a high risk of noncompletion (odds ratio=1.08, CI=1.01-1.16, P=.03). An increase in the baseline severity of the comorbid disorder slightly increased the risk of noncompletion for both disorders (depression: odds ratio=1.03, CI=1.01-1.06, P=.02; anxiety: odds ratio=1.08, CI=1.01-1.16, P=.03). CONCLUSIONS: iCBT can be clinically effective in routine care. Since depression and anxiety are costly and debilitating disorders that are vastly undertreated, this finding is important. Additionally, iCBT may help bridge the gap between the need for treatment and its provision. Our results are comparable to the within-group results of efficacy and effectiveness studies. Our noncompletion rates are similar to those observed in psychotherapy but are higher than those reported in similar clinics. Multiple factors predicted outcome and noncompletion. However, all predictor effects were statistically weak.

Somatic experiencing® for patients with low back pain and comorbid posttraumatic stress disorder - protocol of a randomized controlled trial.

BACKGROUND: Research has almost exclusively focused on the neck in order to explain the mechanisms of persistent pain after motor vehicle collisions (MVC). However, studies have shown that low back pain after MVC is as common as neck pain. Also, posttraumatic stress disorder (PTSD) is common after MVCs, and evidence indicate that PTSD may be linked to the development of pain and disability. PTSD has even been proposed as "the missing link" for some in the development of chronic low back pain. Unfortunately, PTSD often goes unattended in low back pain rehabilitation and very few randomized controlled studies exists targeting both conditions. Hence, the aim of the present study is to investigate the potential additional effect of the trauma therapy "Somatic Experiencing®" (SE) in addition to physiotherapy (PT) compared to PT alone for patients with chronic low back pain and comorbid PTSD. METHODS: The study is a two-group randomized controlled clinical trial in which participants (n = 140) are recruited consecutively from a large Danish spine center in the Region of Southern Denmark, between January 2016 and December 2017. Patients are randomly allocated to one of the two conditions: SE + PT or PT alone. Measurements of effect are carried out at baseline before randomization, post-intervention, 6 and 12 months post-randomization. The primary outcome is a 20% reduction in disability (Rolland Morris Disability Questionnaire) at 6 months post-randomization. Secondary outcomes are: PTSD symptoms, pain intensity, pain-catastrophizing, fear of movement, anxiety and depression. DISCUSSION: Comorbid PTSD is currently not targeted in back pain rehabilitation although highly prevalent. If the SE intervention shows to have an additional effect on disability and pain, the study is likely to have a positive impact on the management of chronic low back pain and will have immediate clinical applicability. TRIAL REGISTRATION: Current Controlled Trials Registration August 4, 2017: NCT03244046 . Retrospectively registered.

Blended CBT versus face-to-face CBT: a randomised non-inferiority trial.

BACKGROUND: Internet based cognitive behavioural therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (ftf) consultations in a blended format (B-CBT) may produce a new treatment format with multiple benefits from both traditional CBT and iCBT such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation. The primary aim of the present study is to compare directly the clinical effectiveness of B-CBT with face-to-face CBT for adult major depressive disorder. METHODS/DESIGN: The study is designed as a two arm randomised controlled non-inferiority trial comparing blended CBT for adult depression with treatment as usual (TAU). In the blended condition six sessions of ftf CBT is alternated with six to eight online modules (NoDep). TAU is defined as 12 sessions of ftf CBT. The primary outcome is symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Additionally, the study will include an economic evaluation. All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. Participants are randomised on an individual level by a researcher not involved in the project. The primary outcome is analysed by regressing the three-month follow-up PHQ-9 data on the baseline PHQ-9 score and a treatment group indicator using ancova. A sample size of 130 in two balanced groups will yield a power of at least 80% to detect standardised mean differences above 0.5 on a normally distributed variable. DISCUSSION: This study design will compare B-CBT and ftf CBT in a concise and direct manner with only a minimal of the variance explained by differences in therapeutic content. On the other hand, while situated in routine care, ecological validity is somewhat compromised by the controlled manner in which the study is conducted. TRIAL REGISTRATION: ClinicalTrials.gov NCT02796573 . Registered June 1st 2016. Currently recruiting participants.

A 13-Weeks Mindfulness Based Pain Management Program Improves Psychological Distress in Patients with Chronic Pain Compared with Waiting List Controls.

BACKGROUND: Eradication of pain is seldom an option in chronic pain management. Hence, mindfulness meditation has become popular in pain management. OBJECTIVE: This pilot study compared the effect of a 13-weeks cognitive behavioural therapy program with integrated mindfulness meditation (CBTm) in patients with chronic non-malignant pain with a control condition. It was hypothesised that the CBTm program would reduce pain intensity and psychological distress compared to the control condition and that level of mindfulness and acceptance both would be associated with the reduction in pain intensity and psychological distress. METHODS: A case-control design was used and data were collected from a convenience sample of 70 patients with chronic non-malignant pain. Fifty patients were consecutively recruited to the CBTm intervention and 20 patients matched waiting list controls. Assessments of clinical pain and psychological distress were performed in both groups at baseline and after 13 weeks. RESULTS: The CBTm program reduced depression, anxiety and pain-catastrophizing compared with the control group. Increased level of mindfulness and acceptance were associated with change in psychological distress with the exception of depression, which was only associated with change in level of mindfulness. Surprisingly, changes in level of mindfulness did not correlate with changes in acceptance. CONCLUSIONS: The results indicate that different mechanisms are targeted with cognitive behavioural therapy and mindfulness. The finding that changes in level of mindfulness did not correlate with changes in acceptance may indicate that acceptance is not a strict prerequisite for coping with pain related distress.

Value-based cognitive-behavioural therapy for the prevention of chronic whiplash associated disorders: protocol of a randomized controlled trial.

BACKGROUND: Whiplash injury is the most common traffic-related injury affecting thousands of people every year. Conservative treatments have not proven effective in preventing persistent symptoms and disability after whiplash injury. Early established maladaptive pain behaviours within the first weeks after the injury may explain part of the transition from acute to chronic whiplash associated disorder (WAD). Hence, early targeting of psychological risk factors such as pain catastrophizing, fear-avoidance-beliefs, depression, and symptoms of posttraumatic stress disorder (PTSD) may be important in preventing the development of chronic WAD. Some evidence exists that targeting fear-avoidance beliefs and PTSD with exposure strategies and value-based actions may prevent development of persistent disability after whiplash injury. Yet, the results have to be tested in a randomized controlled trial (RCT). The primary objective of the present study is to test whether a specifically tailored value-based cognitive-behavioural therapy program (V-CBT) is able to prevent the development of persistent disability, pain, and psychological distress if delivered within the first three months after a whiplash injury. METHODS/DESIGN: The current study is a two-armed randomized controlled study with a crossover design. Group A is scheduled for V-CBT within one week of randomization and group B with a delayed onset 3 months after randomization. DISCUSSION: If the study detects significant effects of V-CBT as a preventive intervention, the study will provide new insights of preventive treatment for patients with WAD and thereby serve as an important step towards preventing the chronic condition. TRIAL REGISTRATION: Current Controlled Trials Registration September 19, 2014: NCT02251028.

PTSD Symptoms Mediate the Effect of Attachment on Pain and Somatisation after Whiplash Injury.

INTRODUCTION: The development of persistent pain post-whiplash injury is still an unresolved mystery despite the fact that approximately 50% of individuals reporting whiplash develop persistent pain. There is agreement that high initial pain and PTSD symptoms are indicators of a poor prognosis after whiplash injury. Recently attachment insecurity has been proposed as a vulnerability factor for both pain and PTSD. In order to guide treatment it is important to examine possible mechanisms which may cause persistent pain and medically unexplained symptoms after a whiplash injury. AIM: The present study examines attachment insecurity and PTSD symptoms as possible vulnerability factors in relation to high levels of pain and somatisation after sub-acute whiplash injury. METHODS: Data were collected from 327 patients (women = 204) referred consecutively to the emergency unit after acute whiplash injury. Within 1-month post injury, patients answered a questionnaire regarding attachment insecurity, pain, somatisation, and PTSD symptoms. Multiple mediation analyses were performed to assess whether the PTSD symptom clusters mediated the association between attachment insecurity, pain, and somatisation. RESULTS: A total of 15% fulfilled the DSM-IV symptom cluster criteria for a possible PTSD diagnosis and 11.6% fulfilled the criteria for somatisation. PTSD increased the likelihood of belonging to the moderate-severe pain group three-fold. In relation to somatisation the likelihood of belonging to the group was almost increased four-fold. The PTSD symptom clusters of avoidance and hyperarousal mediated the association between the attachment dimensions, pain, and somatisation. CONCLUSION: Acknowledging that PTSD is part of the aetiology involved in explaining persistent symptoms after whiplash, may help sufferers to gain early and more suited treatment, which in turn may prevent the condition from becoming chronic.

The prevalence of four types of childhood maltreatment in denmark.

OBJECTIVES: To estimate the prevalence of four types of childhood maltreatment in Denmark while taking into considerations how each of the types of maltreatment vary as a function of gender or child-protection status. METHODS: Data were collected from a Danish national study conducted by The Danish National Centre for Social Research in 2008 and 2009. The study used a stratified random probability sample of young people aged 24 years. A sample of 4718 young adults were randomly selected by Statistics Denmark using the total birth cohort of all children born in 1984. The response rate was 63% leaving a total effective sample size of 2980. A structured residential or telephone interview enquired about a range of respondents maltreatment experiences. RESULTS: Maltreatment is experienced by a significant proportion of Danish children. The reported prevalence rates were; physical neglect (3.0%), emotional abuse (5.2%), physical abuse (5.4%) and sexual abuse (3.4%). All trauma types were experienced by a greater percentage of females compared to males with the exception of physical abuse and all trauma types were experienced by a greater percentage of children given child-protection status. CONCLUSIONS: Female children and children who are given child protection status are those most at risk for experiencing maltreatment in Denmark. However, variability in prevalence rates of maltreatment across studies is problematic. Methodological variations and variation in abuse definitions may be partly attributable.

Validation of the Danish PTSD Checklist for DSM-5 in trauma-exposed chronic pain patients using the Clinician-Administered PTSD Scale for DSM-5.

Background: Validation of post-traumatic stress disorder (PTSD) screening tools across various populations to ensure accurate PTSD estimates is important. Because of the high symptom overlap between PTSD and pain, it is particularly important to validate PTSD screening tools in trauma-exposed chronic pain patients.Objective: The present study is the first seeking to validate the PTSD Checklist for DSM-5 (PCL-5) in a sample of trauma-exposed, treatment-seeking chronic pain patients.Method: The validation and optimal scoring of the PCL-5 were investigated using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) in chronic pain patients exposed to traffic or work-related traumas (n = 84). Construct validity was investigated using confirmatory factor analyses testing six competing DSM-5 models in a sample of mixed trauma-exposed chronic pain patients (n = 566), and a subsample of chronic pain patients exposed to traffic or work-related trauma only (n = 202). Furthermore, concurrent validity and discriminant validity were investigated using correlation analysis.Results: The results showed moderate (κ = .46) diagnostic consistency between the PCL-5 and the CAPS-5 using the DSM-5 symptom cluster criteria, and the overall accuracy of the scale (area under the curve = .79) was highly acceptable. Furthermore, the Danish PCL-5 showed excellent construct validity both in the full sample and in the subsample of traffic and work-related accidents, with superior fit of the seven-factor hybrid model. Excellent concurrent validity and discriminant validity were also established in the full sample.Conclusion: The PCL-5 appears to have satisfactory psychometric properties in trauma-exposed, treatment-seeking chronic pain patients.

The present study is the first seeking to validate the PCL-5 using the CAPS-5 in chronic pain patients following traffic and work-related injury.The results showed moderate diagnostic consistency and acceptable overall accuracy using the DSM-5 criteria.Excellent construct, concurrent, and discriminant validity was established in chronic pain patients following mixed traumatic exposure and traffic and work-related trauma only.