Treatment feasibility of a digital tool for brief self-help behavioural therapy for insomnia (FastAsleep).

Cognitive behavioural therapy for insomnia is efficacious and recommended for insomnia, but availability is scarce. Cognitive behavioural therapy for insomnia self-help interventions could increase availability, especially if unguided. Optimizing cognitive behavioural therapy for insomnia methods and system user-friendliness, we developed a short, digital, self-help programme-FastAsleep-based on the behavioural components of sleep restriction and stimulus control. This study investigated its feasibility and preliminary effects. Thirty media-recruited participants with moderate to severe insomnia were assessed via telephone before using FastAsleep for 4 weeks, and were interviewed afterwards. Self-ratings with web questionnaires were conducted at screening, pre-, mid- and post-treatment, and at 3-month follow-up. Primary outcomes were feasibility (credibility, adherence, system user-friendliness and adverse effects), and secondary outcomes were changes in symptom severity (insomnia, depression and anxiety). Adherence was generally high, participants' feasibility ratings were favourable, and adverse effects matched previously reported levels for cognitive behavioural therapy for insomnia. Symptoms of insomnia decreased after the treatment period (Hedge's g = 1.79, 95% confidence interval = 1.20-2.39), as did symptoms of depression and anxiety. FastAsleep can be considered feasible and promising for alleviating insomnia symptoms among patients fit for self-care. Future controlled trials are needed to establish the efficacy of FastAsleep and its suitability in a stepped care model.

Genome-wide association study of panic disorder reveals genetic overlap with neuroticism and depression.

Panic disorder (PD) has a lifetime prevalence of 2-4% and heritability estimates of 40%. The contributory genetic variants remain largely unknown, with few and inconsistent loci having been reported. The present report describes the largest genome-wide association study (GWAS) of PD to date comprising genome-wide genotype data of 2248 clinically well-characterized PD patients and 7992 ethnically matched controls. The samples originated from four European countries (Denmark, Estonia, Germany, and Sweden). Standard GWAS quality control procedures were conducted on each individual dataset, and imputation was performed using the 1000 Genomes Project reference panel. A meta-analysis was then performed using the Ricopili pipeline. No genome-wide significant locus was identified. Leave-one-out analyses generated highly significant polygenic risk scores (PRS) (explained variance of up to 2.6%). Linkage disequilibrium (LD) score regression analysis of the GWAS data showed that the estimated heritability for PD was 28.0-34.2%. After correction for multiple testing, a significant genetic correlation was found between PD and major depressive disorder, depressive symptoms, and neuroticism. A total of 255 single-nucleotide polymorphisms (SNPs) with p < 1 × 10-4 were followed up in an independent sample of 2408 PD patients and 228,470 controls from Denmark, Iceland and the Netherlands. In the combined analysis, SNP rs144783209 showed the strongest association with PD (pcomb = 3.10 × 10-7). Sign tests revealed a significant enrichment of SNPs with a discovery p-value of <0.0001 in the combined follow up cohort (p = 0.048). The present integrative analysis represents a major step towards the elucidation of the genetic susceptibility to PD.

The 14-item short health anxiety inventory (SHAI-14) used as a screening tool: appropriate interpretation and diagnostic accuracy of the Swedish version.

BACKGROUND: The 14-item Short Health Anxiety Inventory (SHAI-14) is a common measure of health anxiety but its screening properties have not been studied. The aims of this study were to evaluate the SHAI-14 as a screening instrument, identify cut-offs for clinically significant health anxiety and investigate which scores correspond to different severity levels. METHOD: The study included 1729 psychiatric patients and 85 healthy controls. Participants completed the SHAI-14 and underwent a diagnostic interview. Cut-off scores were evaluated in three scenarios to approximate screening 1) in a psychiatric clinic, 2) in a low prevalence setting and, 3) of healthy volunteers (cut-off for remission). Receiver operating characteristics were used. Classification of severity was based on the distribution of SHAI-14 scores reported by patients with clinically significant health anxiety. RESULTS: The area under the curve (AUC) values were high in all scenarios (above 0.95). The optimal cut-off scores on the SHAI-14 were 22 in the psychiatric context, 29 in a setting with low prevalence of psychiatric disorders and 18 versus healthy controls. SHAI-14 scores of 0-27 represented no or mild health anxiety, 28-32 moderate health anxiety and 33-42 substantial health anxiety. CONCLUSION: Brief self-report measures used as screening instruments are a simple way of gathering information about the presence of specific symptoms and thus a way to detect the likelihood of a diagnosis. The SHAI-14 shows evidence of good diagnostic utility in both clinical and non-clinical settings. However, which cut-off score is to be used, depends on the intended purpose and the setting where the cut-off is used.

Return on investment of internet delivered exposure therapy for irritable bowel syndrome: a randomized controlled trial.

BACKGROUND: Irritable bowel syndrome (IBS) is a debilitating and costly disorder. Cognitive behavior therapy (CBT) is effective in the treatment of IBS, both when delivered over the internet and in face-to-face settings. CBT consists of different components and little is known about their relative importance. We have in an earlier study showed that inclusion of exposure in the CBT for IBS makes it even more effective. In the present study we wanted to evaluate the economic effects for society of inclusion vs exclusion of exposure in an internet delivered CBT for IBS. METHODS: We used data from a previous study with 309 participants with IBS. Participants were randomized to internet delivered CBT with (ICBT) or without exposure (ICBT-WE). We compared direct and indirect costs at baseline, after treatment, and 6 months after treatment (primary endpoint; 6MFU). Data was also collected on symptom severity and time spent by therapists and participants. The relative Incremental Cost Effectiveness Ratio (ICER) was calculated for the two treatment conditions and the return on investment (ROI). RESULTS: Results showed that ICBT cost $213.5 (20%) more than ICBT-WE per participant. However, ICBT was associated with larger reductions regarding both costs and symptoms than ICBT-WE at 6MFU. The ICER was - 301.69, meaning that for every point improvement on the Gastrointestinal Symptom Rating Scale-IBS version in ICBT, societal costs would be reduced with approximately $300. At a willingness to pay for a case of clinically significant improvement in IBS symptoms of $0, there was an 84% probability of cost-effectiveness. ROI analysis showed that for every $1 invested in ICBT rather than ICBT-WE, the return would be $5.64 six months after treatment. Analyses of post-treatment data showed a similar pattern although cost-savings were smaller. CONCLUSIONS: Including exposure in Cognitive Behavior Treatment for IBS is more cost-effective from a societal perspective than not including it, even though it may demand more therapist and patient time in the short term. TRIAL REGISTRATION: This study is reported in accordance with the CONSORT statement for non-pharmacological trials [1]. Clinicaltrials.gov registration ID: NCT01529567 (14/02/2013).

Genetics of response to cognitive behavior therapy in adults with major depression: a preliminary report.

Major depressive disorder is heritable and a leading cause of disability. Cognitive behavior therapy is an effective treatment for major depression. By quantifying genetic risk scores based on common genetic variants, the aim of this report was to explore the utility of psychiatric and cognitive trait genetic risk scores, for predicting the response of 894 adults with major depressive disorder to cognitive behavior therapy. The participants were recruited in a psychiatric setting, and the primary outcome score was measured using the Montgomery Åsberg Depression Rating Scale-Self Rated. Single-nucleotide polymorphism genotyping arrays were used to calculate the genomic risk scores based on large genetic studies of six phenotypes: major depressive disorder, bipolar disorder, attention-deficit/hyperactivity disorder, autism spectrum disorder, intelligence, and educational attainment. Linear mixed-effect models were used to test the relationships between the six genetic risk scores and cognitive behavior therapy outcome. Our analyses yielded one significant interaction effect (B = 0.09, p < 0.001): the autism spectrum disorder genetic risk score correlated with Montgomery Åsberg Depression Rating Scale-Self Rated changes during treatment, and the higher the autism spectrum disorder genetic load, the less the depressive symptoms decreased over time. The genetic risk scores for the other psychiatric and cognitive traits were not related to depressive symptom severity or change over time. Our preliminary results indicated, as expected, that the genomics of the response of patients with major depression to cognitive behavior therapy were complex and that future efforts should aim to maximize sample size and limit subject heterogeneity in order to gain a better understanding of the use of genetic risk factors to predict treatment outcome.

Internet Interventions for Adults with Anxiety and Mood Disorders: A Narrative Umbrella Review of Recent Meta-Analyses.

Internet-delivered cognitive behaviour therapy (ICBT) has existed for 20 years and there are now several controlled trials for a range of problems. In this paper, we focused on recent meta-analytic reviews of the literature and found moderate to large effects reported for panic disorder, social anxiety disorder, generalized anxiety disorder, posttraumatic stress disorder, and major depression. In total, we reviewed 9 recent meta-analytic reviews out of a total of 618 meta-analytic reviews identified using our search terms. In these selected reviews, 166 studies were included, including overlap in reviews on similar conditions. We also covered a recent review on transdiagnostic treatments and 2 reviews on face-to-face v. internet treatment. The growing number of meta-analytic reviews of studies now suggests that ICBT works and can be as effective as face-to-face therapy.

Exposure-based cognitive behavior therapy for atopic dermatitis: an open trial.

Atopic dermatitis (AD) is a common and debilitating inflammatory dermatological disorder and is marked by itch and inflamed skin. Scratching, sleep loss, and avoidance of situations associated with more AD symptoms are central hypothesized mechanisms that perpetuate the disorder and cause reduced quality of life. We developed an exposure-based cognitive behavioral treatment (CBT) that entailed mindfulness practice as a means to increase tolerance for aversive experiences during exposure. The aim of the present study was to test the treatment's acceptability and preliminary efficacy in adults with AD. We used an uncontrolled pretest-posttest design and recruited participants (N = 9) from a university hospital dermatological clinic. The treatment comprised 10 weekly sessions over 10 weeks and assessments of AD symptoms as well as psychiatric symptoms and quality of life were conducted at baseline, posttreatment and 6-month follow-up. The results showed significant and large baseline to posttreatment improvements on self-reported measures of AD symptoms (p = .020) and general anxiety (p = .005), but there was no significant improvement in depression or quality of life. Treatment satisfaction was high and a majority of participants (67%) completed the treatment. We conclude that exposure-based CBT for adult AD can be feasible, acceptable, and potentially efficacious.

The effects of component-specific treatment compliance in individually tailored internet-based treatment.

The objective of this study was to explore the effects of treatment compliance in a guided individually tailored internet-based treatment (TAIL) in relation to depression and co-morbid symptoms. Compliance with the homework in the different treatment components in TAIL, each aimed at a specific condition, was rated for 207 participants by independent assessors. Six subgroups (n = 34-131) were constructed consisting of participants with co-occurring symptoms of worry, panic, social anxiety, stress, insomnia, or pain. For each group, hierarchical regression was used to investigate whether the total sum of compliance points, Overall Compliance, predicted reductions in depression and in condition-specific symptoms. Also, in each subgroup, it was tested whether working with specific treatment components, Specific Compliance, predicted reduction of the targeted symptoms. Overall Compliance predicted 15% of the reduction in depression symptoms. For participants with worry, panic, social anxiety, stress, or insomnia, Overall Compliance also predicted symptom reductions in that specific condition. Specific Compliance predicted reduction in the targeted symptoms for participants with social anxiety, stress, and insomnia. Specific Compliance with stress and insomnia components also predicted reductions in depression. Our results strengthen the importance of compliance in internet-based treatments. Because compliance with stress and insomnia components was particularly important for broad symptom reductions, these conditions should not be ignored when treating patients with co-morbid symptoms.

Effects of internet-based cognitive behavioural therapy and physical exercise on sick leave and employment in primary care patients with depression: two subgroup analyses.

OBJECTIVES: Depression can negatively impact work capacity, but treatment effects on sick leave and employment are unclear. This study evaluates if internet-based cognitive behavioural therapy (ICBT) or physical exercise (PE), with already reported positive effects on clinical outcome and short-term work ability, has better effects on employment, sick leave and long-term work ability compared with treatment as usual (TAU) for depressed primary care patients (German clinical trials: DRKS00008745). METHODS: After randomisation and exclusion of patients not relevant for work-related analysis, patients were divided into two subgroups: initially unemployed (total n=118) evaluated on employment, and employed (total n=703) evaluated on long-term sick leave. Secondary outcomes were self-rated work ability and average number of sick days per month evaluated for both subgroups. Assessments (self-reports) were made at baseline and follow-up at 3 and 12 months. RESULTS: For the initially unemployed subgroup, 52.6% were employed after 1 year (response rate 82%). Both PE (risk ratio (RR)=0.44; 95% CI 0.23 to 0.87) and ICBT (RR=0.37; 95% CI 0.16 to 0.84) showed lower rates compared with TAU after 3 months, but no difference was found after 1 year (PE: RR=0.97; 95% CI 0.69 to 1.57; ICBT: RR=1.23; 95% CI 0.72 to 2.13). For those with initial employment, long-term sick leave (response rate 75%) decreased from 7.8% to 6.5%, but neither PE (RR=1.4; 95% CI 0.52 to 3.74) nor ICBT (RR=0.99; 95% CI 0.39 to 2.46) decreased more than TAU, although a temporary positive effect for PE was found. All groups increased self-rated work ability with no differences found. CONCLUSIONS: No long-term effects were found for the initially unemployed on employment status or for the initially employed on sick leave. New types of interventions need to be explored.

Group acceptance and commitment therapy (ACT) for bipolar disorder and co-existing anxiety - an open pilot study.

Previous studies have supported acceptance and commitment therapy (ACT) for reducing impairment related to various chronic conditions. ACT may possibly be beneficial for bipolar disorder (BD) with co-existing anxiety, which is associated with a poorer treatment outcome. Efforts are needed to identify suitable psychological interventions for BD and co-existing anxiety. In this open clinical trial, we included 26 patients with BD type 1 or 2 at an outpatient psychiatric unit specializing in affective disorders. The intervention consisted of a 12-session manualized group treatment that included psychoeducation, mindfulness, engaging in values-based behaviour, cognitive defusion, acceptance and relapse prevention modules. Participants completed four self-report questionnaires covering anxiety symptoms (Beck Anxiety Inventory - BAI), depressive symptoms (Beck Depression Inventory - BDI-II), quality of life (Quality of Life Inventory - QOLI) and psychological flexibility (Acceptance and Action Questionnaire - AAQ-2) before, during and after the treatment. At post-treatment, the participants reported significant improvements in all outcome measures, with large effects (Cohen's d between 0.73 and 1.98). The mean reduction in anxiety symptoms was 45%. At post-treatment, 96% of the patients were classified as responders on at least one of the outcome measures. A limitation is that the trial is uncontrolled. The results suggest that ACT has the potential to be an effective treatment for BD patients with co-existing anxiety. Further randomized studies are warranted.

Exercise and internet-based cognitive-behavioural therapy for depression: multicentre randomised controlled trial with 12-month follow-up.

BACKGROUND: Evidence-based treatment of depression continues to grow, but successful treatment and maintenance of treatment response remains limited. AIMS: To compare the effectiveness of exercise, internet-based cognitive-behavioural therapy (ICBT) and usual care for depression. METHOD: A multicentre, three-group parallel, randomised controlled trial was conducted with assessment at 3 months (post-treatment) and 12 months (primary end-point). Outcome assessors were masked to group allocation. Computer-generated allocation was performed externally in blocks of 36 and the ratio of participants per group was 1:1:1. In total, 945 adults with mild to moderate depression aged 18-71 years were recruited from primary healthcare centres located throughout Sweden. Participants were randomly assigned to one of three 12-week interventions: supervised group exercise, clinician-supported ICBT or usual care by a physician. The primary outcome was depression severity assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). RESULTS: The response rate at 12-month follow-up was 84%. Depression severity reduced significantly in all three treatment groups in a quadratic trend over time. Mean differences in MADRS score at 12 months were 12.1 (ICBT), 11.4 (exercise) and 9.7 (usual care). At the primary end-point the group × time interaction was significant for both exercise and ICBT. Effect sizes for both interventions were small to moderate. CONCLUSIONS: The long-term treatment effects reported here suggest that prescribed exercise and clinician-supported ICBT should be considered for the treatment of mild to moderate depression in adults.

Physical exercise and internet-based cognitive-behavioural therapy in the treatment of depression: randomised controlled trial.

BACKGROUND: Depression is common and tends to be recurrent. Alternative treatments are needed that are non-stigmatising, accessible and can be prescribed by general medical practitioners. AIMS: To compare the effectiveness of three interventions for depression: physical exercise, internet-based cognitive-behavioural therapy (ICBT) and treatment as usual (TAU). A secondary aim was to assess changes in self-rated work capacity. METHOD: A total of 946 patients diagnosed with mild to moderate depression were recruited through primary healthcare centres across Sweden and randomly assigned to one of three 12-week interventions (trail registry: KCTR study ID: KT20110063). Patients were reassessed at 3 months (response rate 78%). RESULTS: Patients in the exercise and ICBT groups reported larger improvements in depressive symptoms compared with TAU. Work capacity improved over time in all three groups (no significant differences). CONCLUSIONS: Exercise and ICBT were more effective than TAU by a general medical practitioner, and both represent promising non-stigmatising treatment alternatives for patients with mild to moderate depression.

Long-Term Treatment Outcome in Adult Male Prisoners With Attention-Deficit/Hyperactivity Disorder: Three-Year Naturalistic Follow-Up of a 52-Week Methylphenidate Trial.

Despite high rates of attention-deficit/hyperactivity disorder (ADHD) among adult lawbreakers, particularly the long-term effects of ADHD pharmacotherapy remain unclear, not the least because of ethical challenges with preventing control subjects in randomized controlled trials from receiving medication over prolonged time. We followed up adult male prisoners with ADHD who completed a 5-week randomized, double-blind, placebo-controlled trial followed by a 47-week open-label extension of osmotic-release oral system methylphenidate in a Swedish high-security prison from 2007 to 2010 (ClinicalTrials.gov: NCT00482313). Twenty-five trial completers were prospectively followed up clinically 1 year (24/25, 96% participated fully or in part) and 3 years (20/25, 80% participation) after trial regarding ADHD symptoms (observer and self-reports), psychosocial functioning, substance misuse, and criminal reoffending. Methylphenidate-related improvements in ADHD symptoms and psychosocial functioning obtained during the 52-week trial were maintained at 1- and 3-year follow-ups. Specifically, after 3 years, 75% (15/20) of the respondents had been released from prison, and 67% of these (10/15) had employment, usually full time. In contrast, nonmedicated respondents at the 3-year follow-up (5/20) reported more ADHD symptoms, functional impairment, and substance misuse compared with currently medicated respondents (15/20). Further, 40% of the respondents self-reported reoffending, indicating a substantially lower relapse rate than expected (70%-80%).In summary, although these observations need validation from new and larger samples, positive effects were maintained after 4 years of methylphenidate treatment. Most study completers were employed and had no relapse in substance misuse or criminality. These results suggest that motivational support and continued medication are important for improved outcome in adult criminal offenders with ADHD.

Testing the Mediating Effects of Obsessive Beliefs in Internet-Based Cognitive Behaviour Therapy for Obsessive-Compulsive Disorder: Results from a Randomized Controlled Trial.

UNLABELLED: Although cognitive interventions for obsessive-compulsive disorder (OCD) have been tested in randomized trials, there are few trials that have tested the specific mechanisms of cognitive interventions, i.e. how they achieve their effects. In this study, we aimed to investigate the mediating effects of a short cognitive intervention in the treatment of OCD and used data from a recently conducted randomized controlled trial where 101 participants were allocated to either Internet-based CBT (ICBT) or to a control condition. Obsessive beliefs were measured at pre-treatment, at the time they had received the cognitive intervention, and also at post-treatment. Weekly OCD symptoms were measured throughout the 10 weeks of treatment. We hypothesized that (1) the ICBT group would have greater reductions in obsessive beliefs (controlling for change in OCD symptoms) after completing the cognitive intervention, and that (2) this reduction would, in turn, predict greater OCD symptom reduction throughout the rest of the treatment period. Contrary to our expectations, the longitudinal mediation analysis indicated that (1) being randomized to ICBT actually increased the degree of obsessive beliefs after receiving the cognitive intervention at weeks 1-3, and (2) increase in obsessive beliefs predicted better outcome later in treatment. However, when repeating the analysis using cross-sectional data at post-treatment, the results were in line with the initial hypotheses. Results were replicated when the control condition received ICBT. We conclude that, although obsessive beliefs were significantly reduced at post-treatment for the ICBT group, early increase rather than decrease in obsessive beliefs predicted favourable outcome. KEY PRACTITIONER MESSAGE: This study investigated the impact of cognitive interventions on obsessive beliefs for patients with obsessive-compulsive disorder. Results showed that a sudden increase in obsessive beliefs is not an indicator of worse treatment response. On the contrary, it is more likely that the patient is better off when having this sudden increase. Clinicians should not be alarmed if the patient has a sudden increase in obsessive beliefs, but we do recommend the clinician to investigate the reasons for this further.

[CBT administered via the internet]. / Internetförmedlad psykologisk egenvård.

Cognitive behavioral therapy (CBT) can be administered clinically to individuals and in group settings. More recently, CBT has been administered successfully via the internet (ICBT). We provide a concept aiming at further developing ICBT in a self-care format. We use recent development in user interface (UI) design in order to optimize the user interface and allow easy and flexible use via smartphone, tablet, or computer. Preliminary evidence indicates that an optimized user interface and adjusted information facilitate increased use of training programs compared to a traditional ICBT interface. Our aims are to allow increased availability of evidence-based CBT tools for self-care to improve people's health and recovery from disease. So far, evidence for effects and safe use is indicated for atopic dermatitis, insomnia and high-risk use of alcohol.

Telephone versus internet administration of self-report measures of social anxiety, depressive symptoms, and insomnia: psychometric evaluation of a method to reduce the impact of missing data.

BACKGROUND: Internet-administered self-report measures of social anxiety, depressive symptoms, and sleep difficulties are widely used in clinical trials and in clinical routine care, but data loss is a common problem that could render skewed estimates of symptom levels and treatment effects. One way of reducing the negative impact of missing data could be to use telephone administration of self-report measures as a means to complete the data missing from the online data collection. OBJECTIVE: The aim of the study was to compare the convergence of telephone and Internet administration of self-report measures of social anxiety, depressive symptoms, and sleep difficulties. METHODS: The Liebowitz Social Anxiety Scale-Self-Report (LSAS-SR), Montgomery-Åsberg Depression Rating Scale-Self-Rated (MADRS-S), and the Insomnia Severity Index (ISI) were administered over the telephone and via the Internet to a clinical sample (N=82) of psychiatric patients at a clinic specializing in Internet-delivered treatment. Shortened versions of the LSAS-SR and the ISI were used when administered via telephone. RESULTS: As predicted, the results showed that the estimates produced by the two administration formats were highly correlated (r=.82-.91; P<.001) and internal consistencies were high in both administration formats (telephone: Cronbach alpha=.76-.86 and Internet: Cronbach alpha=.79-.93). The correlation coefficients were similar across questionnaires and the shorter versions of the questionnaires used in the telephone administration of the LSAS-SR and ISI performed in general equally well compared to when the full scale was used, as was the case with the MADRS-S. CONCLUSIONS: Telephone administration of self-report questionnaires is a valid method that can be used to reduce data loss in routine psychiatric practice as well as in clinical trials, thereby contributing to more accurate symptom estimates.

Internet-delivered CBT for children with specific phobia: a pilot study.

BACKGROUND: Cognitive behavior therapy (CBT) has been shown to be an effective treatment for specific phobia in youth, but not all affected seek or receive treatment. Internet-delivered CBT could be a way to increase the availability of empirically supported treatments. AIMS: An open trial was conducted to evaluate Internet-delivered CBT for children with specific phobia. METHOD: Children (N = 30) aged 8-12, and their parents, with a principal diagnosis of specific phobia were recruited through media advertisement. Participants received six weeks of Internet-delivered CBT with therapist support. The treatment was aimed for the parents and the children, with the first part being only for the parents. The primary outcome measure was the Clinician Severity Rating (CSR), and secondary measures included clinician-rated global functioning and child- and parent-reported anxiety and quality of life. All assessments were made at pretreatment, posttreatment, and three-month follow-up. RESULTS: At posttreatment, there were significant reductions on the CSR, with a large within-group effect size (Cohen's d = 1.0) and 35% of children no longer meeting criteria for specific phobia. Self-report measures from parents and children showed significant effects on anxiety, with small to moderate effect sizes. Effects were maintained at three-month follow-up. CONCLUSIONS: Results show that Internet-delivered CBT with therapist support for children with specific phobia has the potential to reduce symptom severity. Randomized controlled trials are needed to further evaluate this treatment format.

Transforming guided internet interventions into simplified and self-guided digital tools - Experiences from three recent projects.

Introduction: Therapist-guided internet interventions are often more efficacious than unguided ones. However, the guidance itself requires clinician time, and some research suggests that self-guided interventions could potentially be equally effective. The concept of digital psychological self-care, self-guided internet interventions based on the use of digital tools and provided within a structured clinical process, is presented. Methods: Three new self-care interventions, a sleep diary-based intervention for insomnia, an alcohol diary-based intervention for problematic alcohol use and an intervention with exposure and mindfulness tools for atopic dermatitis (eczema), were developed. Newly developed digital self-care interventions were compared to the earlier therapist-guided interventions they were based on, using published results from three feasibility trials (n's = 30, 36 and 21) and three randomized trials (n's = 148, 166 and 102). The comparison included type of content, duration, length of written material and within-group effect-sizes. Results: In comparison to the guided interventions, clinician time was greatly reduced and the new interventions involved much less reading for participants. The digital self-care tools also showed within-group effect sizes and response rates on par with the more comprehensive guided internet interventions. Discussion: Preliminary results suggest that some guided internet interventions can be transformed into self-guided digital tools. These three examples show that digital psychological self-care, if provided with telephone interviews before and after the intervention, can be viable alternatives to more comprehensive guided internet interventions. Although these examples are promising, further studies, including randomized experiments, are needed to compare treatment efficacies, and to identify which groups of patients may need more comprehensive guided internet interventions.

Brief self-guided digital intervention versus a comprehensive therapist-guided online cognitive behavioural therapy for atopic dermatitis: a trial protocol for a randomised non-inferiority trial.

INTRODUCTION: Our aim is to investigate whether a shortened digital self-care intervention is non-inferior to, and cost-effective compared with, a comprehensive and therapist-guided cognitive behavioural therapy treatment for atopic dermatitis (AD). METHODS AND ANALYSIS: This is a single-blind, randomised clinical non-inferiority trial at Karolinska Institutet, a medical university in Stockholm, Sweden. We will recruit 174 adult participants with AD through self-referral. Participants will be randomised 1:1 to the two experimental conditions. Participants randomised to guided care will receive internet-delivered cognitive behavioural therapy for 12 weeks. Participants randomised to digital self-care will have access to this self-guided intervention for 12 weeks. At post-treatment (primary endpoint), non-inferiority will be tested and resource use will be compared between the two treatment groups. Cost-effectiveness will be explored at 1-year follow-up. Potential mediators will be investigated. Data will be analysed intention to treat. We define non-inferiority as a three-point difference on the primary outcome measure (Patient-oriented Eczema Measure). Recruitment started in November 2022. ETHICS AND DISSEMINATION: This study is approved by the Swedish ethics authority (reg. no 2021-06704-01) and is preregistered at ClinicalTrials.gov. The study will be reported according to the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. The results of the study will be published in peer-reviewed scientific journals and disseminated to patient organisations and media. TRIAL REGISTRATION NUMBER: NCT05517850.

A Digital Self-help Intervention for Atopic Dermatitis: Analysis of Secondary Outcomes From a Feasibility Study.

BACKGROUND: Atopic dermatitis (AD) is a common inflammatory skin disease characterized by dry skin, eczematous lesions, and an often severe pruritus. The disease may have a negative effect on quality of life and is also associated with symptoms of anxiety and depression. Few individuals with AD receive any form of behavioral intervention. Behavioral interventions for AD are potentially efficacious but need to be constructed so that they are safe, credible, and user-friendly. We have previously reported on a feasibility study that demonstrated that a self-management version of a digital intervention based on cognitive behavioral therapy (CBT) for AD can potentially be effective in reducing AD symptoms. The aim of this secondary report was to further examine treatment feasibility and preliminary effects on dermatological quality of life, itching sensations, depressive symptoms, and perceived stress. OBJECTIVE: This is a secondary report on intervention credibility, usability, adverse events, and preliminary effects on secondary measures of a self-management digital intervention for atopic dermatitis. METHODS: In total, 21 adults with AD, recruited nationwide in Sweden, were assessed by telephone, and used the digital intervention for 8 weeks. Participants were also assessed directly afterward and 3 months after the end of the intervention. There was no therapist guidance. Feasibility indicators included intervention credibility, usability, and possible adverse effects. Other measures included preliminary effects on dermatological quality of life, itching sensations, depressive symptoms, and perceived stress. RESULTS: The intervention was regarded as credible and no serious adverse events were reported. System usability was, however, found to be below the predetermined cutoff for acceptable usability. Preliminary effects at 3-month follow-up were in the moderate to large range for dermatological quality of life (Cohen d=0.89, 95% CI 0.18-1.56), itching sensations (Cohen d=0.85, 95% CI 0.15-1.52), depressive symptoms (Cohen d=0.78, 95% CI 0.1-1.45), and perceived stress (Cohen d=0.75, 95% CI 0.01-1.36). CONCLUSIONS: This 8-week self-management digital CBT-based intervention was, together with telephone calls before and after, a feasible intervention for participants with AD. Preliminary effects were promising and should be explored further in a randomized controlled trial. Intervention usability was, however, rated below cutoff scores. Efforts should be made to improve written material to increase usability.