No effect of social interaction on experimental pain sensitivity: a randomized experimental study.

ABSTRACT: Quantitative sensory testing (QST) is a commonly applied paradigm to investigate pain, which is a subjective experience influenced by a myriad of social and contextual factors. Therefore, it is important to consider the potential sensitivity of QST to the test setting and the social interaction that naturally is a part of it. This may particularly be the case in clinical settings where patients have something at stake. Therefore, we investigated differences in pain responses using QST in different test setups with varying degrees of human interaction. In a parallel three-armed randomized experimental study, we included 92 participants with low back pain and 87 healthy volunteers allocated to 1 of the 3 QST setups: 1 setup with manual tests performed by a human tester, 1 setup with automated tests performed by a robot and orally guided by a human tester, and 1 setup with automated tests performed solely by a robot without social interaction with a human tester. All 3 setups consisted of the same pain tests in the same order, including pressure pain threshold and cold pressor tests. We found no statistically significant differences between setups on the primary outcome of conditioned pain modulation nor any secondary QST outcomes. While this study is not without limitations, the results indicate that QST procedures are robust enough not to be influenced by social interaction to an appreciable degree.

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.

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.

Trajectories of disability in low back pain.

INTRODUCTION: Low back pain (LBP) is the leading course of years lived with disability. Unfortunately, not much knowledge exists about distinct trajectories of recovery from disability after LBP and their potential psychological predictors. OBJECTIVES: Hence, the aim of the present study was to identify trajectories of functional disability in LBP and their potential baseline psychological predictors. METHODS: A 1-year consecutive cohort (N = 1048) of patients with LBP referred to the Spine Centre if they have not improved satisfactorily from a course of treatment in primary care after 1 to 2 months were assessed by self-report questionnaires at their first visit and at 6- and 12-month follow-up. Data from patients who responded to the Roland Morris Disability Questionnaire at least twice (N = 747) were used to assess trajectories of functional disability by Latent Growth Mixture Modeling. The following measures were used as baseline predictors of the trajectories: Pain Intensity Numerical Rating Scales, Pain Catastrophizing Scale, Tampa Scale for Kinesiophobia, and Hospital Anxiety and Depression Scale. RESULTS: Four distinct trajectories were identified: high-stable (22.0%), high-decreasing (20.4%), medium-stable (29.7%), and low-decreasing (27.9%). Using the low-decreasing trajectory as reference, baseline pain intensity, depressive symptoms, and pain-catastrophizing predicted membership of all 3 symptomatic trajectories. However, using the high-decreasing trajectory as reference, age, baseline pain intensity, and depression were predictors of the high-stable trajectory. CONCLUSION: In particular, the finding of a high-stable trajectory characterized by high levels of baseline psychological distress is of potential clinical importance because psychological distress may be targeted by cognitive behavioral therapeutic approaches.

Long-Term Opioid Therapy in Spine Center Outpatients: Protocol for the Spinal Pain Opioid Cohort (SPOC) Study.

BACKGROUND: Spinal pain is the leading cause of patient-years lived with chronic pain and disability worldwide. Although opioids are well documented as an effective short-term pain-relieving medication, more than a few weeks of treatment may result in a diminishing clinical effect as well as the development of addictive behavior. Despite recognition of opioid addiction in pain patients as a major problem commonly experienced in the clinic, no reference material exists on the scope of long-term problems in novel opioid users and the link to clinical outcomes. OBJECTIVE: The main aims of this study are to describe baseline and follow-up characteristics of the Spinal Pain Opioid Cohort (SPOC), to evaluate the general use of opioids in spinal pain when an acute pain episode occurs, and to demonstrate the prevalence of long-term opioid therapy (LTOT). METHODS: Prospective clinical registry data were collected from an outpatient spine center setting during 2012-2013 including patients with a new spinal pain episode lasting for more than 2 months, aged between 18 and 65 years who had their first outpatient visit in the center. Variables include demographics, clinical data collected in SpineData, the Danish National Patient Register, and The Danish National Prescription Registry. The primary outcome parameter is long-term prescription opioid use registered from 4 years before the first spine center visit to 5 years after. RESULTS: This is an ongoing survey. It is estimated that more than 8000 patients fulfill the SPOC inclusion criteria. In 2019, we began the intellectual process of identifying the most relevant supplementary data available from the wide range of existing national registries available in Denmark. We have now begun merging SpineData with relevant opioid data from Danish national registers and will continue to extract data up to 2021-2022. We will also be looking at data regarding somatic or psychiatric hospitalization patterns, patient usage of health care resources, as well as their working status and disability pensions. CONCLUSIONS: To our knowledge, this survey will be the first to document the scope of long-term problems regarding LTOT and opioid addiction following new spinal pain episodes and comparing descriptive follow-up data between substance users and nonusers. TRIAL REGISTRATION: ISRCTN Registry ISRCTN69685117; http://www.isrctn.com/ISRCTN69685117. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21380.

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.

Trajectories of posttraumatic stress symptoms after whiplash: A prospective cohort study.

BACKGROUND: Posttraumatic stress disorder (PTSD) symptoms are highly prevalent after whiplash and associated with pain-related symptoms. While mutual maintenance between pain and PTSD has been suggested, knowledge on individual differences in the course of these symptoms is needed. The present study aimed to identify trajectories of PTSD symptoms following whiplash and test predictors and functional outcomes of such trajectories. METHODS: In a prospective cohort design with assessments at baseline (<4 weeks), 3 months, and 6 months post-injury (n = 229, whiplash grade I-III), we identified PTSD-trajectories using Latent Growth Mixture Modeling. Predictors (pain, fear-avoidance-beliefs, pain-catastrophizing, depression, age, and gender) were tested using multinomial logistic regression, and group mean differences in physical and psychosocial pain-related disability at 6 months were tested as outcomes after controlling for baseline levels. RESULTS: Three trajectories were identified: "Resilient" (75.1%) with little or no PTSD symptoms over time, "Recovering" (10.0%) with high initial PTSD symptom levels, then decreasing substantially, and "Chronic" (14.9%) with high initial PTSD symptom levels and a small increase over time. Initial higher pain and depression levels predicted the recovering and chronic trajectories, while the latter had more pain-related disability at 6 months compared to both other trajectories. CONCLUSIONS: Three trajectories were identified, with the chronic trajectory suggesting that a significant subset of people does not recover from PTSD symptoms. This class also reported more pain-related disability. Pain and depression predicted membership, but did, however, not succeed in differentiating between the two high-starting trajectories, suggesting that targeting PTSD symptoms may be important to ensure recovery. SIGNIFICANCE: Distinct recovery patterns after whiplash were identified with a significant subgroup reporting elevated and slightly increasing PTSD symptoms over time, highlighting both recovery variability and the presence of PTSD symptoms in a significant subgroup of individuals with whiplash. This subgroup also displayed enhanced pain-related disability over time compared to the recovering and resilient subgroups, thereby linking PTSD symptoms to functional pain outcomes over time. These findings suggest that clinicians should be attentive of potential PTSD symptoms in whiplash patients.

Whiplash Patients' Responses on the Impact of Events Scale-R: Congruent With Pain or PTSD Symptoms?

OBJECTIVES: Posttraumatic stress disorder (PTSD) symptoms are common among people with whiplash following a motor vehicle crash. The Impact of Events Scale-Revised (IES-R) screens for PTSD symptoms with psychologist referral recommended for above-threshold scores. Recent data indicate that PTSD symptoms post-whiplash may relate more to pain and disability than the crash itself. This study explored the interpretation of IES-R items by people with whiplash to establish whether responses relate to the crash or to whiplash pain and disability. METHODS: Adults with whiplash scoring >24 on the IES-R were eligible. The 3-step test-interview technique was used and responses analyzed using content analysis. A coding framework was developed, comprising 5 categories: "congruent"-responses related to the crash; "incongruent"-responses did not relate to the crash; "ambiguous"-responses were both congruent and incongruent; "confusion"-participants misunderstood the item content; "not applicable"-irrelevancy of items to participants' circumstances. RESULTS: The 15 participants (mean IES-R=37/88) were inclined to respond congruently to specific PTSD items and incongruently to nonspecific PTSD items. Participants were more inclined to rate nonspecific PTSD items in terms of pain and disability, for example, >60% responded incongruently to item 2: "I had trouble staying asleep"; item 4: "I felt irritable and angry"; item 15: "I had trouble falling asleep"; and item 18: "I had trouble concentrating." DISCUSSION: Incongruent responses on nonspecific PTSD items may inadvertently inflate levels of PTSD symptoms measured with the IES-R for some whiplash patients, raising implications for the assessment and treatment of the psychological sequelae of whiplash.

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.

Increased Pain Sensitivity in Accident-related Chronic Pain Patients With Comorbid Posttraumatic Stress.

OBJECTIVES: Posttraumatic stress disorder (PTSD) is prevalent in chronic pain, and associated with increased pain, hyperalgesia, and psychological distress. This study aimed to investigate antinociceptive and pronociceptive pain mechanisms, pain intensity, and psychological distress (depression, anxiety, pain catastrophizing, and fear of movement) in patients with accident-related chronic spinal pain with (N=44) and without (N=64) comorbid PTSD characteristics. MATERIALS AND METHODS: Cuff algometry was performed on lower legs to assess pressure pain threshold (cPPT), tolerance (cPTT), temporal summation of pain (increase in pain scores to 10 repeated stimulations), and conditioning pain modulation (increase in cPPT during cuff pain conditioning on the contralateral leg). Warmth detection threshold and heat pain threshold at the hand were also assessed. Clinical pain intensity (numerical rating scale), psychological distress, and PTSD symptomatology (ICD-11) were assessed with questionnaires. Mediation analyses were performed to investigate possible psychological mediators in the associations between PTSD and pain (intensity and mechanisms). RESULTS: Patients with PTSD demonstrated increased pain intensity, and psychological distress as well as reduced warmth detection threshold and cPTT compared with patients without PTSD (P<0.05). No significant differences in cPPT, heat pain threshold, temporal summation of pain, and conditioning pain modulation were found. The association between PTSD and pain intensity was mediated by pain catastrophizing, and fear of movement mediated the association with cPTT. DISCUSSION: The association between PTSD and pain intensity is in accordance with the mutual-maintenance and fear-avoidance models. Future studies should investigate changes in pain intensity and mechanisms after treatment targeting comorbid PTSD in chronic pain patients.

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.

Does size really matter? A multisite study assessing the latent structure of the proposed ICD-11 and DSM-5 diagnostic criteria for PTSD.

Background: Researchers and clinicians within the field of trauma have to choose between different diagnostic descriptions of posttraumatic stress disorder (PTSD) in the DSM-5 and the proposed ICD-11. Several studies support different competing models of the PTSD structure according to both diagnostic systems; however, findings show that the choice of diagnostic systems can affect the estimated prevalence rates. Objectives: The present study aimed to investigate the potential impact of using a large (i.e. the DSM-5) compared to a small (i.e. the ICD-11) diagnostic description of PTSD. In other words, does the size of PTSD really matter? Methods: The aim was investigated by examining differences in diagnostic rates between the two diagnostic systems and independently examining the model fit of the competing DSM-5 and ICD-11 models of PTSD across three trauma samples: university students (N = 4213), chronic pain patients (N = 573), and military personnel (N = 118). Results: Diagnostic rates of PTSD were significantly lower according to the proposed ICD-11 criteria in the university sample, but no significant differences were found for chronic pain patients and military personnel. The proposed ICD-11 three-factor model provided the best fit of the tested ICD-11 models across all samples, whereas the DSM-5 seven-factor Hybrid model provided the best fit in the university and pain samples, and the DSM-5 six-factor Anhedonia model provided the best fit in the military sample of the tested DSM-5 models. Conclusions: The advantages and disadvantages of using a broad or narrow set of symptoms for PTSD can be debated, however, this study demonstrated that choice of diagnostic system may influence the estimated PTSD rates both qualitatively and quantitatively. In the current described diagnostic criteria only the ICD-11 model can reflect the configuration of symptoms satisfactorily. Thus, size does matter when assessing PTSD.

Planteamiento: Los investigadores y clínicos del campo del trauma pronto decidirán entre dos descripciones diagnósticas diferentes del trastorno de estrés postraumático (TEPT) en el DSM-5 y la propuesta CIE-11. Varios estudios apoyan diferentes modelos en competencia sobre la estructura del TEPT en función de ambos sistemas de diagnóstico; sin embargo, los resultados demuestran que la elección de los sistemas de diagnóstico puede afectar las tasas de prevalencia estimadas. Objetivos: y métodos. El presente estudio tenía como objetivo investigar el impacto potencial de usar una descripción del TEPT amplia (es decir, el DSM-5) en comparación con una pequeña (es decir, la CIE-11). En otras palabras, ¿el tamaño del TEPT importa realmente? El objetivo se investigó mediante el examen de las diferencias en las frecuencias de diagnóstico entre los dos sistemas de diagnóstico y examinando de forma independiente cómo se ajustaban los modelos en competencia para el TEPT del DSM-5 y la CIE-11 en tres muestras de trauma: estudiantes universitarios (N = 4213), pacientes con dolor crónico (N = 573) y personal militar (N = 118). Resultados: Las tasas diagnósticas del TEPT fueron significativamente más bajas según los criterios de la propuesta CIE-11 en la muestra universitaria, pero no se encontraron diferencias significativas para los pacientes con dolor crónico y el personal militar. El modelo de tres factores propuesto por la CIE-11 proporcionó el mejor ajuste de los modelos de la CIE-11 que fueron probados en todas las muestras. En cambio, el modelo híbrido de siete factores del DSM-5 proporcionó el mejor ajuste en las muestras universitaria y del dolor, y el modelo de Anhedonia de seis factores del DSM-5 en la muestra militar de los modelos probados del DSM-5. Conclusiones: Se pueden debatir las ventajas y desventajas de utilizar un conjunto amplio o reducido de síntomas para el TEPT; sin embargo, este estudio demostró que la elección del sistema de diagnóstico puede influir en las tasas estimadas del TEPT, tanto cualitativa como cuantitativamente. Al mismo tiempo, parece que, dados los criterios diagnósticos descritos actualmente, solo el modelo de la CIE-11 puede reflejar satisfactoriamente la configuración de los síntomas. Por lo tanto, el tamaño importa cuando se evalúa el TEPT.

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.

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.