Introducing Braining-physical exercise as adjunctive therapy in psychiatric care: a retrospective cohort study of a new method.

BACKGROUND: Patients with severe mental disorders suffer from higher rates of poor somatic health and have shorter life expectancy than the average population. Physical activity can treat and prevent several diseases, e.g. cardiovascular and metabolic disorders as well as psychiatric symptoms. It is therefore of utmost importance to develop effective methods to integrate physical activity into psychiatric care. To meet this need, the physical activity intervention Braining was developed. This study aims to describe Braining, to assess the number of patients reached during the first years of pilot testing, to analyze clinical data in the group of patients participating in Braining 2017-2020 and to assess the intervention. METHODS: In this descriptive retrospective study we analyzed data from all patients participating in Braining training sessions ≥ 3 times (n = 239), the Braining Participants. Regular patients at the clinic served as a comparison. Furthermore, medical records were studied for a smaller cohort (n = 51), the Braining Pilot Cohort. Data was analyzed using Chi-square and Fisher's tests. RESULTS: During the introduction period of Braining, 580 patients attended an information meeting about Braining, or at least one training session. 239 patients participated in ≥ 3 training sessions, considered to be participants of Braining. These Braining Participants (n = 239), ages 19 to 82, males 23.4%, attended between 3 and 308 training sessions (median 9). The main diagnoses were affective and anxiety disorders. Number of diagnoses ranged from 0 to 10 (median = 2). For the subsample, the Braining Pilot Cohort (n = 51), participants attended between 3 and 208 training sessions (median = 20). Twelve percent were working full-time, and symptom severity of depression and general anxiety was moderate. Two thirds had ≥ 3 different classes of medication. Regarding metabolic morbidity, 28 had been diagnosed with hypertension, though blood lipids, blood glucose as well as blood pressure were within the normal range. Thirty-seven percent were prescribed Physical Activity on Prescription during 2017-2020. One severe adverse event was reported. CONCLUSIONS: The Braining intervention reached all age-groups and patients with a wide and representative diagnostic panorama, suggesting that Braining could be a promising and safe method for implementing physical activity in a psychiatric patient population.

Patient-controlled admissions to inpatient care: A twelve-month naturalistic study of patients with schizophrenia spectrum diagnoses and the effects on admissions to and days in inpatient care.

BACKGROUND: Patients with schizophrenia spectrum diagnoses have a poor prognostic outlook and rates of recovery. Inpatient care is common, but the decision to initiate such care is not solely up to the patient but also influenced by the healthcare providers. Recent ideas about shared decision-making however challenges this idea. Patient-Controlled Admissions (PCA) refers to a care model where a patient signs a contract that allows the decision for admission into inpatient care to be transferred onto the patient. METHODS: In Region Stockholm's public healthcare PCA was introduced to patients with schizophrenia spectrum diagnoses deemed to have the greatest care needs. Outcomes of a 12-month naturalistic within-group follow-up was analyzed using Wilcoxon signed-rank test. RESULTS: In total, 56 patients fulfilled the study's inclusion criteria, with between 20 to 42 patients having complete data and being able to analyze statistically, depending on the variable. Number of admissions, inpatient days, number of involuntary admissions, and involuntary admission days decreased, but only significantly so for inpatient days, p < .01 (a mean reduction of 11.5 days). Neither self-rated well-being, as assessed using the EQ5D-3L, or a clinician-administered rating of overall health status, the Clinical Global Impression Scale, demonstrated a significant change. CONCLUSIONS: The use of PCA points towards a trend in decreased hospitalization for patients with schizophrenia spectrum diagnoses, although this needs to be explored further in larger samples and over a longer follow-up.

Predictors of outcome in guided self-help cognitive behavioural therapy for common mental disorders in primary care.

Cognitive behavioural therapy (CBT) can effectively treat common mental disorders (CMDs), but access to treatment is insufficient. Guided self-help (GSH) CBT has shown effects comparable to face-to-face CBT and may be a resource-efficient treatment alternative. However, not all patients respond to GSH. Learning more about predictors of outcome may increase knowledge regarding which patients respond to GSH. The aim of this study was to investigate predictors of outcome for GSH CBT for patients with CMDs in primary care. Consecutive patients (N = 396) with a principal disorder of depression, anxiety, insomnia or stress-related disorders were included. All patients received GSH CBT. Outcomes were remission status, reliable change and post-treatment depression ratings. Predictors investigated were clinical, demographic and therapy-related variables. Analyses were conducted using logistic and linear regression. Higher educational level predicted remission, higher quality of life ratings predicted remission and decreased depression, and higher age at onset predicted reliable change. Therapy-related variables, i.e. patient adherence to treatment and patients' and clinicians' estimation of treatment response, were all related to outcome. More large-scale studies are needed, but the present study points at the importance of therapy-related variables such as monitoring and supporting treatment adherence for an increased chance of remission.

Effects of cognitive behavioural therapy and return-to-work intervention for patients on sick leave due to stress-related disorders: Results from a randomized trial.

The aim of this study was to evaluate specific effects for patients with adjustment or exhaustion disorder, the Stress subgroup (n = 152), regarding symptom severity and sick leave after CBT, a return-to-work intervention (RTW-I), and a combination of them (COMBO), using data from a randomized trial. In the original study, primary care patients on sick leave (N = 211) were randomized to CBT (n = 64), RTW-I (n = 67), or COMBO (n = 80). Blinded Clinician Severity Rating (CSR) of symptoms and sick leave registry data were primary outcomes. Subgroup analyses showed that for the Stress subgroup, CBT led to greater reduction of symptoms than RTW-I posttreatment, but COMBO did not differ from CBT or RTW-I. Regarding sick leave, there was no difference between treatments in the Stress subgroup. An exploratory analysis of the treatment effects in a subgroup of patients with depression, anxiety or insomnia indicates that RTW-I reduced sick leave faster than CBT. We conclude that CBT may be promising as an effective treatment of stress and exhaustion disorder.

Cost-Effectiveness of Therapist-Guided Internet-Based Cognitive Behavioral Therapy for Stress-Related Disorders: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Stress-related disorders are associated with significant suffering, functional impairment, and high societal costs. Internet-based cognitive behavioral therapy (ICBT) is a promising treatment for stress-related disorders but has so far not been subjected to health economic evaluation. OBJECTIVE: The objective of this study was to evaluate the cost-effectiveness and cost-utility of ICBT for patients with stress-related disorders in the form of adjustment disorder (AD) or exhaustion disorder (ED). We hypothesized that ICBT, compared with a waitlist control (WLC) group, would generate improvements at low net costs, thereby making it cost-effective. METHODS: Health economic data were obtained in tandem with a randomized controlled trial of a 12-week ICBT in which patients (N=100) were randomized to an ICBT (n=50) or a WLC (n=50) group. Health outcomes and costs were surveyed pre- and posttreatment. We calculated incremental cost-effectiveness ratios (ICERs) based on remission rates and incremental cost-utility ratios (ICURs) based on health-related quality of life. Bootstrap sampling was used to assess the uncertainty of our results. RESULTS: The ICER indicated that the most likely scenario was that ICBT led to higher remission rates compared with the WLC and was associated with slightly larger reductions in costs from pre- to posttreatment. ICBT had a 60% probability of being cost-effective at a willingness to pay (WTP) of US $0 and a 96% probability of being cost-effective at a WTP of US $1000. The ICUR indicated that ICBT also led to improvements in quality of life at no net societal cost. Sensitivity analyses supported the robustness of our results. CONCLUSIONS: The results suggest that ICBT is a cost-effective treatment for patients suffering from AD or ED. Compared with no treatment, ICBT for these patients yields large effects at no or minimal societal net costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT02540317; https://clinicaltrials.gov/ct2/show/NCT02540317.

Sickness absence: a systematic review and meta-analysis of psychological treatments for individuals on sick leave due to common mental disorders.

Sick leave due to common mental disorders (CMDs) increase rapidly and present a major societal challenge. The overall effect of psychological interventions to reduce sick leave and symptoms has not been sufficiently investigated and there is a need for a systematic review and meta-analysis of the field. The aim of the present meta-analysis was to calculate the effect size of psychological interventions for CMDs on sick leave and psychiatric symptoms based on all published randomized controlled trials. Methodological quality, the risk of bias and publication bias were also assessed. The literature searches gave 2240 hits and 45 studies were included. The psychological interventions were more effective than care as usual on both reduced sick leave (g = 0.15) and symptoms (g = 0.21). There was no significant difference in effect between work focused interventions, problem-solving therapy, cognitive behavioural therapy or collaborative care. We conclude that psychological interventions are more effective than care as usual to reduce sick leave and symptoms but the effect sizes are small. More research is needed on psychological interventions that evaluate effects on sick leave. Consensual measures of sick leave should be established and quality of psychotherapy for patients on sick leave should be improved.

Stepped care in primary care - guided self-help and face-to-face cognitive behavioural therapy for common mental disorders: a randomized controlled trial.

BACKGROUND: Common mental disorders (CMD) cause large suffering and high societal costs. Cognitive behavioural therapy (CBT) can effectively treat CMD, but access to treatment is insufficient. Guided self-help (GSH) CBT, has shown effects comparable with face-to-face CBT. However, not all patients respond to GSH, and stepping up non-responders to face-to-face CBT, could yield larger response rates. The aim was to test a stepped care model for CMD in primary care by first evaluating the effects of GSH-CBT and secondly, for non-responders, evaluating the additional effect of face-to-face CBT. METHODS: Consecutive patients (N = 396) with a principal disorder of depression, anxiety, insomnia, adjustment or exhaustion disorder were included. In Step I, all patients received GSH-CBT. In Step II, non-responders were randomized to face-to-face CBT or continued GSH. The primary outcome was remission status, defined as a score below a pre-established cutoff on a validated disorder-specific scale. RESULTS: After GSH-CBT in Step I, 40% of patients were in remission. After Step II, 39% of patients following face-to-face CBT were in remission compared with 19% of patients after continued GSH (p = 0.004). Using this stepped care model required less than six therapy sessions per patient and led to an overall remission rate of 63%. CONCLUSIONS: Stepped care can be effective and resource-efficient to treat CMD in primary care, leading to high remission rates with limited therapist resources. Face-to-face CBT speeded up recovery compared with continued GSH. At follow-ups after 6 and 12 months, remission rates were similar in the two groups.

Internet-Based Cognitive Behavioral Therapy for Chronic Stress: A Randomized Controlled Trial.

BACKGROUND: Prolonged exposure to stress can lead to substantial suffering, impairment and societal costs. However, access to psychological treatment is limited. Internet-based cognitive behavioral therapy (ICBT) can be effective in reducing symptoms of stress, but little is known of its effects in clinical samples. The aim of this study was to investigate the efficacy of ICBT for patients suffering from chronic stress, operationalized as adjustment disorder (AD) and exhaustion disorder (ED). METHODS: A total of 100 adults diagnosed with AD or ED were randomly assigned to a 12-week ICBT (n = 50) or waitlist control condition (n = 50). Primary outcome was the level of perceived stress (PSS). Secondary outcomes included several mental health symptom domains as well as functional impairment and work ability. All outcomes were assessed at baseline, after treatment and at the 6-month follow-up. The study was preregistered at Clinicaltrials.gov: NCT02540317. RESULTS: Compared to the control condition, patients in the ICBT group made large and significant improvements on the PSS (d = 1.09) and moderate to large improvements in secondary symptom domains. Effects were maintained at the 6-month follow-up. There was no significant between-group effect on functional impairment or work ability. CONCLUSIONS: A relatively short ICBT is indicated to be effective in reducing stress-related symptoms in a clinical sample of patients with AD and ED, and has the potential to substantially increase treatment accessibility. Results must be replicated, and further research is needed to understand the relationship between symptom reduction, functional impairment and work ability.

Cognitive-behavioural therapy and return-to-work intervention for patients on sick leave due to common mental disorders: a randomised controlled trial.

OBJECTIVES: Common mental disorders (CMDs) cause great individual suffering and long-term sick leave. Cognitive-behavioural therapy (CBT) effectively treats CMDs, but sick leave is not reduced to the same extent as psychiatric symptoms. Research results regarding return-to-work interventions (RTW-Is) and their effect on sick leave are inconclusive. The aim of this study was to evaluate CBT, a RTW-I and combined CBT and RTW-I (COMBO) for primary care patients on sick leave due to CMDs. METHODS: Patients with CMDs (n=211) were randomised to CBT (n=64), RTW-I (n=67) or COMBO (n=80). Sick-leave registry data after 1 year and blinded Clinician's Severity Rating (CSR) of symptoms post-treatment and at follow-ups after 6 and 12 months were primary outcomes. RESULTS: There was no significant difference between treatments in days on sick leave 1 year after treatment start (mean difference in sick-leave days range=9-27). CBT led to larger reduction of symptoms post-treatment (CSR; Cohen's d=0.4 (95% CI 0.1 to 0.8)) than RTW-I, whereas COMBO did not differ from CBT or RTW-I. At follow-up, after 1 year, there was no difference between groups. All treatments were associated with large pre-treatment to post-treatment improvements, and results were maintained at 1-year follow-up. CONCLUSION: No treatment was superior to the other regarding reducing sick leave. All treatments effectively reduced symptoms, CBT in a faster pace than RTW-I, but at 1-year follow-up, all groups had similar symptom levels. Further research is needed regarding how CBT and RTW-I can be combined more efficiently to produce a larger effect on sick leave while maintaining effective symptom reduction.

Is internet-based parent training for everyone? Predictors and moderators of outcomes in group vs. internet-based parent training for children with disruptive behavior problems.

Parent training is an effective treatment for disruptive behavior problems in children. However, as there is limited access to traditional face-to-face treatment, other delivery formats have been evaluated. This study aims to evaluate possible predictors and moderators of outcome, completion and engagement in parent training when delivered in group or through the internet. A recent randomized controlled non-inferiority trial (N = 161) demonstrated equal effectiveness of the parent training program Comet when delivered in group (gComet) and through the internet (iComet). Demographic, clinical and theory-driven variables were studied to find predictors and moderators of treatment effect, completion and engagement. Linear mixed effects models were used to determine predictors and moderators of change in disruptive behavior from baseline to the 3- and 12-month follow-up. Most variables did not have significant predictive or moderating effects. However, there were some variables that predicted or moderated outcomes that may have implications for practice (e.g., comorbid emotional problems, preferred treatment format, and ADHD). This trial can contribute to guiding clinical work with children with disruptive behavior and results indicate that parent training in both treatment formats can be offered regardless of a range of demographic and clinical factors. Taking patients' treatment preferences into account can increase treatment completion.

Parent Training via Internet or in Group for Disruptive Behaviors: A Randomized Clinical Noninferiority Trial.

OBJECTIVE: To evaluate if an internet-delivered parent training program is noninferior to its group-delivered counterpart in reducing child disruptive behavior problems (DBP). METHOD: This noninferiority randomized clinical trial enrolled families seeking treatment in primary care in Stockholm, Sweden, for DBP in a child 3-11 years of age. Participants were randomized to internet-delivered (iComet) or group-delivered (gComet) parent training. The primary outcome was parent-rated DBP. Assessments were made at baseline and 3, 6, and 12 months. Secondary outcomes included child and parent behaviors and well-being and treatment satisfaction. The noninferiority analysis was determined by a one-sided 95% CI of the mean difference between gComet and iComet using multilevel modeling. RESULTS: This trial included 161 children (mean age 8.0); 102 (63%) were boys. In both intention-to-treat and per-protocol analyses, iComet was noninferior to gComet. There were small differences in between-group effect sizes (d = -0.02 to 0.13) on the primary outcome with the upper limit of the one-sided 95% CI below the noninferiority margin at 3-, 6-, and 12-month follow-up. Parents were more satisfied with gComet (d = 0.49, 95% CI [0.26, 0.71]). At 3-month follow-up, there were also significant differences in treatment effect on attention-deficit/hyperactivity disorder symptoms (d = 0.34, 95% CI [0.07, 0.61]) and parenting behavior (d = 0.41, 95% CI [0.17, 0.65]) favoring gComet. At 12-month follow-up, there were no differences in any outcomes. CONCLUSION: Internet-delivered parent training was noninferior to group-delivered parent training in reducing child DBP. The results were maintained at 12-month follow-up. This study supports internet-delivered parent training being used as an alternative to group-delivered parent training in clinical settings. CLINICAL TRIAL REGISTRATION INFORMATION: Randomized Controlled Trial of Comet via the Internet or in Group Format; https://www. CLINICALTRIALS: gov/; NCT03465384.

Cognitive behavior therapy for adult post-traumatic stress disorder in routine clinical care: A systematic review and meta-analysis.

Although different cognitive behavioral therapies (CBT) have strong research support for treatment of adult post-traumatic stress disorder (PTSD) more knowledge is needed about the performance of CBT in routine clinical care. The present study is a systematic review and meta-analysis of CBT for PTSD in adults treated in routine clinical care. Ovid MEDLINE, Embase OVID, and PsycINFO were systematically searched for studies published until the end of May 2022. The effectiveness of CBT, methodological quality, and moderators of treatment outcome were examined, and benchmarked by meta-analytically comparing with efficacy studies for PTSD. Thirty-three studies, comprising 6482 participants, were included. The within-group effect sizes (ES) for PTSD-severity at post-treatment (1.75), and follow-up (1.70), on average 6 months post-treatment, were large. The effectiveness studies had very similar ESs as efficacy studies at post-treatment (1.75 vs. 1.72) and follow-up (1.70 vs. 2.02), based on the benchmarking analysis. As the heterogeneity was large, we can only cautiously consider CBT for PTSD an effective treatment when delivered in routine clinical care. The outcomes of effectiveness studies for PTSD seem to be comparable to the results obtained in efficacy studies. PROSPERO REGISTRATION ID: CRD42021228828.

Cognitive behavior therapy for adult depressive disorders in routine clinical care: A systematic review and meta-analysis.

BACKGROUND: Different cognitive behavioral therapies (CBT) have strong research support for treatment of adult depressive disorders (DD). Given the scarcity of knowledge about the performance of CBT in routine clinical care, a systematic review and meta-analysis of CBT for adults with DD treated in this context was conducted. METHODS: Published studies until the end of September 2022, were systematically searched in Ovid MEDLINE, Embase OVID, and PsycINFO. The effectiveness of CBT, methodological quality, and moderators of treatment outcome were examined, and benchmarked by meta-analytically comparing with efficacy studies for DD. RESULTS: Twenty-eight studies, comprising 3734 participants, were included. Large within-group effect sizes (ES) were obtained for DD-severity at post-treatment, and follow-up, on average 8 months post-treatment. Benchmarking analysis showed that effectiveness studies had very similar ESs as efficacy studies at post-treatment (1.51 vs. 1.71) and follow-up (1.71 vs. 1.85). Remission rates were also very similar; effectiveness studies 44 % and 46 %, efficacy studies 45 % and 46 %, at post-treatment and follow-up, respectively. LIMITATIONS: Only studies published in English-language peer-reviewed journals were included and the use of pre-post ES in the meta-analyses could contribute to biased outcomes. CONCLUSIONS: CBT for DD is an effective treatment when delivered in routine clinical care and the outcomes of effectiveness studies for DD are comparable to the effects obtained in efficacy studies. PROSPERO REGISTRATION: CRD42022285615.

Cognitive behavior therapy for obsessive-compulsive disorder in routine clinical care: A systematic review and meta-analysis.

Cognitive behavioral therapy (CBT) has strong research support for obsessive-compulsive disorder (OCD). However, less is known about how CBT performs when delivered in routine clinical care. A systematic review and meta-analysis was conducted of CBT for OCD in adults treated in routine clinical care. Ovid MEDLINE, Embase OVID, and PsycINFO were systematically searched for studies published until July 2021. The effectiveness of CBT, methodological quality, and moderators of treatment outcome were examined, and benchmarked by meta-analytically comparing with efficacy studies for OCD. Twenty-nine studies (8 randomized controlled trials) were included, comprising 1669 participants. Very large within-group effect sizes (ES) were obtained for OCD-severity at post-treatment (2.12), and follow-up (2.30), on average 15 months post-treatment. Remission rates were 59.2% post-treatment and 57.0% at follow-up. Attrition rate was 15.2%. Risk of bias was considerable in the majority of studies. The benchmarking analysis showed that effectiveness studies had almost exactly the same ES as efficacy studies at post-treatment and somewhat higher at follow-up. Furthermore, effectiveness studies had significantly higher remission rates than efficacy studies, both at post- and follow-up assessment. CBT for OCD is an effective treatment when delivered in routine clinical care, with ES comparable to those found in efficacy studies. However, the evidence needs to be interpreted with caution because of the risk of bias in a high proportion of studies. PROSPERO REGISTRATION ID: CRD42021228828.

What are the effects of implementing patient-controlled admissions in inpatient care? A study protocol of a large-scale implementation and naturalistic evaluation for adult and adolescent patients with severe psychiatric conditions throughout Region Stockholm.

INTRODUCTION: Patient-controlled admissions (PCAs) represent a change in psychiatric inpatient care where patients are allowed to decide for themselves when hospitalisation might be required. Prior research has demonstrated that PCA increase the number of admissions, but decrease days in inpatient care, while both the admissions to and days in involuntary care decrease. However, investigations have been restricted to specific patient groups and have not examined other possible benefits, such as effects on symptoms, quality of life and autonomy. METHODS AND ANALYSIS: This study explores the implementation process and effects of PCA in Region Stockholm, who is currently introducing PCA for all patients with severe psychiatric conditions and extensive healthcare utilisation. In total, the study comprises approximately 45 inpatient wards, including child and adolescent psychiatry. In a naturalistic evaluation, patients assigned PCA will be followed up to 36 months, both with regard to hospitalisation rates and self-reported outcomes. In addition, qualitative studies will explore the experiences of patients, caregivers of adolescents and healthcare providers. ETHICS AND DISSEMINATION: Approval has been granted by the Swedish Ethical Review Authority (Dnr: 2020-06498). The findings from this study will be disseminated via publications in international peer-reviewed journals, at scientific conferences, as part of two doctoral theses, and through the Swedish Partnership for Mental Health. TRIAL REGISTRATION NUMBER: NCT04862897.

The mediating role of insomnia severity in internet-based cognitive behavioral therapy for chronic stress: Secondary analysis of a randomized controlled trial.

The aim of this study was to investigate insomnia symptom severity as a putative mediator of treatment response in therapist-guided internet-based cognitive behavioral therapy (ICBT) for chronic stress, using data from a randomized controlled trial. Participants (N = 100) were randomized to 12 weeks of ICBT or to a waitlist control condition (WLC). Insomnia severity was assessed weekly with the Insomnia Severity Index (ISI), as were the stress-related outcomes the Perceived Stress Scale (PSS) and the Shirom-Melamed Burnout Questionnaire (SMBQ). Latent growth models indicated that ICBT (vs. WLC) predicted a decrease in insomnia severity (α-path), and that growth in insomnia severity was predictive of growth in perceived stress and exhaustion (ß-paths). Most importantly, there were also significant indirect effects (αß products) such that the beneficial effects of ICBT on perceived stress and exhaustion were mediated by a reduction in insomnia symptom severity (PSS: αß = -0.44, 95% CI [-0.92, -0.14]; SMBQ: αß = -0.08, 95% CI [-0.15, -0.04]). Explorative analysis of moderated mediation showed that more severe insomnia symptoms at baseline were associated with larger mediated effects. We conclude that reducing insomnia severity could be of importance for achieving successful treatment outcomes in ICBT for chronic stress.

Therapist-Guided Internet-Delivered Cognitive Behavioral Therapy vs Internet-Delivered Supportive Therapy for Children and Adolescents With Social Anxiety Disorder: A Randomized Clinical Trial.

Importance: Social anxiety disorder (SAD) is a prevalent childhood-onset disorder associated with lifelong adversity and high costs for the individual and society at large. Cognitive behavioral therapy (CBT) is an established evidence-based treatment for SAD, but its availability is limited. Objective: To assess the efficacy and cost-effectiveness of therapist-guided internet-delivered cognitive behavioral therapy (ICBT) for SAD in youths vs an active comparator, internet-delivered supportive therapy (ISUPPORT). Design, Setting, and Participants: This single-masked, superiority randomized clinical trial enrolled participants at a clinical research unit integrated within the child and adolescent mental health services in Stockholm, Sweden, from September 1, 2017, to October 31, 2018. The final participant reached the 3-month follow-up (primary end point) in May 2019. Children and adolescents 10 to 17 years of age with a principal diagnosis of SAD and their parents were included in the study. Interventions: ICBT and ISUPPORT, both including 10 online modules, 5 separate parental modules, and 3 video call sessions with a therapist. Main Outcomes and Measures: The Clinician Severity Rating (CSR), derived from the Anxiety Disorder Interview Schedule, rated by masked assessors 3 months after the end of treatment. The CSR ranges from 0 to 8, with scores of 4 or higher indicating caseness. Secondary outcomes included masked assessor-rated diagnostic status of SAD and global functioning, child- and parent-reported social anxiety and depressive symptoms, and health-related costs. Results: Of the 307 youths assessed for eligibility, 103 were randomized to 10 weeks of therapist-guided ICBT (n = 51) or therapist-guided ISUPPORT (n = 52) for SAD. The sample consisted of 103 youths (mean [SD] age, 14.1 [2.1] years; 79 [77%] female). Internet-delivered cognitive behavioral therapy was significantly more efficacious than ISUPPORT in reducing the severity of SAD symptoms. Mean (SD) CSR scores for ICBT at baseline and at the 3-month follow-up were 5.06 (0.95) and 3.96 (1.46), respectively, compared with 4.94 (0.94) and 4.48 (1.30) for ISUPPORT. There was a significant between-group effect size of d = 0.67 (95% CI, 0.21-1.12) at the 3-month follow-up. Similarly, all of the secondary outcome measures demonstrated significant differences with small to large effect sizes, except for child-rated quality of life (nonsignificant). The cost-effectiveness analyses indicated cost savings associated with ICBT compared with ISUPPORT, with the main drivers of the savings being lower medication costs (z = 2.38, P = .02) and increased school productivity (z = 1.99, P = .047) in the ICBT group. There was 1 suicide attempt in the ISUPPORT group; no other serious adverse events occurred in either group. Conclusions and Relevance: In this randomized clinical trial, internet-delivered cognitive behavioral therapy was an efficacious and cost-effective intervention for children and adolescents with SAD. Implementation in clinical practice could markedly increase the availability of effective interventions for SAD. Trial Registration: ClinicalTrials.gov Identifier: NCT03247075.

Inflammatory cytokines in patients with common mental disorders treated with cognitive behavior therapy.

Peripheral inflammation has been found associated with psychiatric disorders. However, results are inconclusive as to its role in common mental disorders (CMDs), i.e., depression, anxiety, insomnia and stress-related disorders. Further, some research suggests that cognitive behavior therapy (CBT) could reduce inflammatory markers in CMDs. In the present study, we measured pro-inflammatory cytokines (tumor necrosis factor alpha [TNF-α], interleukin-6 [IL-6] and IL-8) pre- and post-treatment in two clinical trials (N â€‹= â€‹367) investigating CBT for patients with CMDs in primary care. We hypothesized that higher levels of these cytokines would be associated with more severe psychiatric symptoms (i.e., symptoms of depression, stress and anxiety). We also hypothesized that level of cytokines would decrease after CBT and that the reduced levels would correlate with a reduction in symptoms. Results showed that in men, higher levels of TNF-α were associated with more severe psychiatric symptoms. Further, age moderated the association between TNF-α, as well as IL-6, and stress, and exploratory stratified analyses revealed significant associations in subgroups. No other significant associations between cytokines and psychiatric symptoms were found. None of the cytokines were reduced following CBT, and the marked improvements in psychiatric symptoms after treatment were not associated with changes in cytokines. In conclusion, although inflammation might be of relevance in subgroups, it seems to be of limited importance for clinical improvements across mild to moderate CMDs.

Processes in cognitive behavior therapy for social anxiety disorder: Predicting subsequent symptom change.

Although cognitive behavior therapy (CBT) is an effective treatment for social anxiety disorder, little is known about the processes during treatment that bring about change. The aim of this study was to investigate whether the proposed processes of change according to the cognitive model of social anxiety disorder predicted subsequent symptom reduction in CBT delivered as therapist-guided bibliotherapy. We analyzed data from patients with social anxiety disorder (N = 61) who participated in an effectiveness trial of CBT in primary care. Seven putative processes and outcome (i.e., social anxiety) were assessed on a weekly basis throughout treatment. We used linear mixed models to analyze within-person relations between processes and outcome. The results showed a unidirectional effect of reduced avoidance on subsequent decrease in social anxiety. Further, we found support for reciprocal influences between four of the proposed processes (i.e., estimated probability and cost of adverse outcome, self-focused attention, and safety behaviors) and social anxiety. The remaining two processes, (i.e., anticipatory and post-event processing) did not predict subsequent social anxiety, but were predicted by prior symptom reduction. The findings support that several of the change processes according to the cognitive model of social anxiety disorder are involved in symptom improvement.