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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.
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Distúrbios do Início e da Manutenção do Sono , Humanos , Distúrbios do Início e da Manutenção do Sono/terapia , Estudos de Viabilidade , Resultado do Tratamento , Terapia Comportamental , SonoRESUMO
INTRODUCTION: Internet interventions for alcohol problems are effective, but not all participants are helped. Further, the importance of adherence has often been neglected in research on internet interventions for alcohol problems. Prediction analysis can help in prospectively assessing participants' probability of success, and ideally, this information could be used to tailor internet interventions to individual needs. METHODS: Data were obtained from a randomized controlled trial on internet interventions for alcohol use disorders. Twenty-nine candidate predictors were run in univariate logistic regressions with two dichotomous dependent outcomes: adherence (defined as completing at least 60% of the treatment modules) and low-risk drinking (defined as drinking within national public health guidelines) at two time points - immediately post-treatment and at the 6-month follow-up. Significant predictors were entered hierarchically into domain-specific logistic regressions. In the final models, predictors still showing significant effects were run in multiple logistic regressions. RESULTS: One predictor significantly predicted adherence: treatment credibility (as in how logical the treatment is and how successful one perceives the treatment to be) assessed during the third week of the intervention. Four predictors significantly predicted low-risk drinking at the post-treatment follow-up: pre-treatment abstinence (i.e., not drinking during the 7 days before treatment started), being of the male gender, and two personality factors - a low degree of antagonism and a high degree of alexithymia. At the 6-month follow-up, pre-treatment abstinence was the only significant predictor. CONCLUSION: Adherence was not predictive of low-risk drinking. Personality variables may have predictive value and should be studied further. Those who abstain from alcohol during the week before treatment starts have a higher likelihood of achieving low-risk drinking than people who initially continue drinking.
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Transtornos Relacionados ao Uso de Álcool , Alcoolismo , Intervenção Baseada em Internet , Humanos , Masculino , Alcoolismo/terapia , Consumo de Bebidas Alcoólicas/terapia , Transtornos Relacionados ao Uso de Álcool/terapia , Cooperação e Adesão ao Tratamento , InternetRESUMO
Treating comorbid insomnia is important for recovery from, and prevention of, depression. The objective of this study was to compare comorbidity and patient characteristics among patients having treatment for depression before and after implementation of cognitive behavioural therapy for insomnia (CBT-I) in a routine care internet treatment clinic. We hypothesized that insomnia comorbidity would be lower among patients having treatment for depression after the treatment for insomnia became available, and that depression levels would be high among patients in the insomnia treatment group compared to previous studies of insomnia. Patients were assessed face-to-face by physicians and guided through internet-delivered treatment by psychologists in a psychiatric setting. We retrieved patient data from 3 years before and 3 years after the CBT-I implementation. Measures were the Montgomery-Åsberg Depression Rating Scale-Self rated (MADRS-S) and Insomnia Severity Index (ISI). Pretreatment symptom levels were high in both the depression (MADRS-S = 23, n = 1467) and insomnia treatment (ISI = 20, n = 552) groups, indicating a true psychiatric sample. Contrary to the hypothesis, there were no significant changes in the group having treatment for depression regarding insomnia severity or comorbid insomnia diagnosis (from 66% to 68%) after CBT-I implementation. Also contrary to the hypothesis, comorbid depression levels among insomnia patients having CBT-I were similar to or slightly higher than in previous studies. It is likely that more patients with this comorbidity, who currently receive treatment for depression, would benefit from CBT-I. We suggest an emphasis on information on the benefits of CBT-I among patients and clinical staff involved in the implementation of treatments for insomnia in psychiatry, and further research into possible differences between patients actively seeking treatment for insomnia or depression.
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Terapia Cognitivo-Comportamental , Distúrbios do Início e da Manutenção do Sono , Comorbidade , Depressão/epidemiologia , Depressão/terapia , Humanos , Distúrbios do Início e da Manutenção do Sono/epidemiologia , Distúrbios do Início e da Manutenção do Sono/terapia , Resultado do TratamentoRESUMO
Insomnia is a common and chronic disorder, and cognitive behavioral therapy (CBT) is the recommended treatment. Very long-term follow-ups of CBT are very rare, and this study aimed to investigate if improvements were stable one and ten years after CBT for insomnia (CBT-i). Based on a three-armed randomized controlled trial of bibliotherapeutic CBT-i, participants received an insomnia-specific self-help book and were randomized to therapist guidance, no guidance, or a waitlist receiving unguided treatment after a delay. Six weeks of treatment was given to 133 participants diagnosed with insomnia disorder. After one and ten years, participants were assessed with self-reports and interviews. Improvements were statistically significant and well maintained at one- and ten-year follow-ups. Average Insomnia Severity Index score [95%CI] was 18.3 [17.7-18.8] at baseline, 10.1 [9.3-10.9] at post-treatment, 9.2 [8.4-10.0] at one- and 10.7 [9.6-11.8] at ten-year follow-up, and 64% and 66% of participants no longer fulfilled criteria for an insomnia diagnosis at one and ten years, respectively. Positive effects of CBT were still present after ten years. Insomnia severity remained low, and two-thirds of participants no longer fulfilled criteria for an insomnia diagnosis. This extends previous findings of CBT, further confirming it as the treatment of choice for insomnia.
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Terapia Cognitivo-Comportamental , Distúrbios do Início e da Manutenção do Sono , Seguimentos , Humanos , Autorrelato , Distúrbios do Início e da Manutenção do Sono/terapia , Resultado do TratamentoRESUMO
The objectives were to investigate the potential for sleep-related behaviours, acceptance and cognitions to predict outcome (insomnia severity) of cognitive behavioural therapy for insomnia (CBT-I). Baseline and outcome data from four randomised controlled trials (n = 276) were used. Predictors were the Dysfunctional Beliefs and Attitudes about Sleep-10 (DBAS-10), Sleep-Related Behaviours Questionnaire (SRBQ), and Sleep Problems Acceptance Questionnaire (SPAQ), and empirically derived factors from a factor analysis combining all items at baseline (n = 835). Baseline values were used to predict post-treatment outcome, and pre-post changes in the predictors were used to predict follow-up outcomes after 3-6 months, 1 year, or 3-10 years, measured both as insomnia severity and as better or worse long-term sleep patterns. A majority (29 of 52) of predictions of insomnia severity were significant, but when controlling for insomnia severity, only two (DBAS-10 at short-term and SRBQ at mid-term follow-up) of the 12 predictions using established scales, and three of the 40 predictions using empirically derived factors, remained significant. The strongest predictor of a long-term, stable sleep pattern was insomnia severity reduction during treatment. Using all available predictors in an overfitted model, 21.2% of short- and 58.9% of long-term outcomes could be predicted. We conclude that although the explored constructs may have important roles in CBT-I, the present study does not support that the DBAS-10, SRBQ, SPAQ, or factors derived from them, would be unique predictors of outcome.
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Terapia Cognitivo-Comportamental , Distúrbios do Início e da Manutenção do Sono , Cognição , Humanos , Sono , Distúrbios do Início e da Manutenção do Sono/terapia , Inquéritos e Questionários , Resultado do TratamentoRESUMO
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.
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Transtorno Depressivo/terapia , Internet , Cooperação do Paciente , Terapia Assistida por Computador/métodos , Adulto , Idoso , Transtornos de Ansiedade/diagnóstico , Transtornos de Ansiedade/psicologia , Transtornos de Ansiedade/terapia , Comorbidade , Transtorno Depressivo/diagnóstico , Transtorno Depressivo/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise de Regressão , Distúrbios do Início e da Manutenção do Sono/diagnóstico , Distúrbios do Início e da Manutenção do Sono/psicologia , Distúrbios do Início e da Manutenção do Sono/terapia , Resultado do Tratamento , Adulto JovemRESUMO
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.
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Terapia Cognitivo-Comportamental , Depressão/terapia , Transtorno Depressivo/terapia , Emprego/psicologia , Exercício Físico , Atenção Primária à Saúde , Licença Médica , Absenteísmo , Adolescente , Adulto , Terapia Cognitivo-Comportamental/métodos , Feminino , Alemanha , Humanos , Internet , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
BACKGROUND: A large proportion of individuals with alcohol problems do not seek psychological treatment, but access to such treatment could potentially be increased by delivering it over the Internet. Cognitive behavior therapy (CBT) is widely recognized as one of the psychological treatments for alcohol problems for which evidence is most robust. This study evaluated a new, therapist-guided internet-based CBT program (entitled ePlus) for individuals with alcohol use disorders. METHODS: Participants in the study (n = 13) were recruited through an alcohol self-help web site ( www.alkoholhjalpen.se ) and, after initial internet screening, were diagnostically assessed by telephone. Eligible participants were offered access to the therapist-guided 12-week program. The main outcomes were treatment usage data (module completion, treatment satisfaction) as well as glasses of alcohol consumed the preceding week, measured with the self-rated Timeline Followback (TLFB). Participant data were collected at screening (T0), immediately pre-treatment (T1), post-treatment (T2) and 3 months post-treatment (T3). RESULTS: Most participants were active throughout the treatment and found it highly acceptable. Significant reductions in alcohol consumption with a large within-group effect size were found at the three-month follow-up. Secondary outcome measures of craving and self-efficacy, as well as depression and quality of life, also showed significant improvements with moderate to large within-group effect sizes. CONCLUSIONS: Therapist-guided internet-based CBT may be a feasible and effective alternative for people with alcohol use disorders. In view of the high acceptability and the large within-group effect sizes found in this small pilot, a randomized controlled trial investigating treatment efficacy is warranted. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02384278 , February 26, 2015).
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Transtornos Relacionados ao Uso de Álcool/terapia , Terapia Cognitivo-Comportamental/métodos , Depressão/terapia , Qualidade de Vida/psicologia , Adulto , Consumo de Bebidas Alcoólicas/prevenção & controle , Feminino , Comportamentos Relacionados com a Saúde , Humanos , Internet , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Telefone , Resultado do TratamentoRESUMO
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.
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Terapia Cognitivo-Comportamental/métodos , Transtorno Depressivo/terapia , Terapia por Exercício/métodos , Internet , Adolescente , Adulto , Idoso , Terapia Combinada/métodos , Emprego/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Autoeficácia , Resultado do Tratamento , Avaliação da Capacidade de Trabalho , Adulto JovemRESUMO
BACKGROUND: The continual development and implementation of effective digital interventions is one important strategy that may serve to bridge the well-known treatment gap related to problematic alcohol use. Research suggests that clinician guidance, provided in different ways during the digital intervention (i.e., written weekly messages, phone calls etc.), can boost intervention engagement and effects. Digital psychological self-care (DPSC) is a new delivery format wherein an unguided digital intervention is provided within the framework of a structured care process that includes initial clinical assessment and follow-up interviews. In a recent feasibility study, a DPSC intervention for problematic alcohol use, ALVA, provided without any extra guidance, was found safe and credible and to have promising within-group effects on alcohol consumption. The aim of the current study is to gather information on the effects and efficiency of different forms of guidance added to ALVA, in order to optimize the intervention. METHODS: This protocol describes a randomized factorial trial where the effects of two different ways of providing guidance (mid-treatment interview, weekly written messages, respectively) in DPSC for problematic alcohol use are investigated. Optimization criteria will be applied to the results regarding how effective the intervention is at reducing alcohol consumption measured by the number of standard drinks per week together with the clinician time spent on guidance. DISCUSSION: This study will investigate the added benefit of different forms of guidance to DPSC for problematic alcohol use. These added effects will be compared to the added cost of guidance, according to pre-defined optimization criteria. TRIAL REGISTRATION: Clinicaltrials.gov: NCT05649982. Registered on 06 December 2022. Prospectively registered.
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Transtornos Relacionados ao Uso de Álcool , Autocuidado , Humanos , Transtornos Relacionados ao Uso de Álcool/diagnóstico , Transtornos Relacionados ao Uso de Álcool/terapia , Consumo de Bebidas Alcoólicas/efeitos adversos , Consumo de Bebidas Alcoólicas/prevenção & controle , Telefone , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
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.
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Terapia Cognitivo-Comportamental , Dermatite Atópica , Humanos , Internet , Etanol , AutocuidadoRESUMO
BACKGROUND: Emerging adulthood is often associated with mental health problems. About one in three university students report symptoms of depression and anxiety that can negatively affect their developmental trajectory concerning work, intimate relationships, and health. This can interfere with academic performance, as mood and anxiety disorders are key predictors of dropout from higher education. A treatment gap exists, where a considerable proportion of students do not seek help for mood and anxiety symptoms. Offering internet interventions to students with mental health problems could reduce the treatment gap, increase mental health, and improve academic performance. A meta-analysis on internet interventions for university students showed small effects for depression and none for anxiety. Larger trials are recommended to further explore effects of guidance, transdiagnostic approaches, and individual treatment components. METHODS: This study will offer 1200 university students in Sweden participation in a three-armed randomized controlled trial (RCT) evaluating a guided or unguided transdiagnostic internet intervention for mild to moderate depression and anxiety, where the waitlist control group accesses the intervention at 6-month follow-up. Students reporting suicidal ideation/behaviors will be excluded and referred to treatment within the existing healthcare system. An embedded study within the trial (SWAT) will assess at week 3 of 8 whether participants in the guided and unguided groups are at higher risk of failing to benefit from treatment. Those at risk will be randomized to an adaptive treatment strategy, or to continue the treatment as originally randomized. Primary outcomes are symptoms of depression and anxiety. Follow-ups will occur at post-treatment and at 6-, 12-, and 24-month post-randomization. Between-group outcome analyses will be reported, and qualitative interviews about treatment experiences are planned. DISCUSSION: This study investigates the effects of a transdiagnostic internet intervention among university students in Sweden, with an adaptive treatment strategy employed during the course of treatment to minimize the risk of treatment failure. The study will contribute knowledge about longitudinal trajectories of mental health and well-being following treatment, taking into account possible gender differences in responsiveness to treatment. With time, effective internet interventions could make treatment for mental health issues more widely accessible to the student group.
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Intervenção Baseada em Internet , Saúde Mental , Humanos , Adulto , Universidades , Ansiedade/diagnóstico , Ansiedade/prevenção & controle , Estudantes/psicologia , Internet , Ensaios Clínicos Controlados Aleatórios como Assunto , Metanálise como AssuntoRESUMO
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.
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Transtornos de Ansiedade , Depressão , Internet , Autorrevelação , Distúrbios do Início e da Manutenção do Sono , Telefone , Feminino , Humanos , Masculino , Psicometria , Comportamento SocialRESUMO
BACKGROUND: Digital interventions based on cognitive-behavioural therapy and relapse prevention can increase treatment access for people with problematic alcohol use, but for these interventions to be cost-effective, clinician workload needs to remain low while ensuring patient adherence and effects. Digital psychological self-care is the provision of a self-guided digital intervention within a structured care process. AIMS: To investigate the feasibility and preliminary effects of digital psychological self-care for reducing alcohol consumption. METHOD: Thirty-six adults with problematic alcohol use received digital psychological self-care during 8 weeks, including telephone assessments as well as filling out self-rated questionnaires, before, directly after and 3 months after the intervention. Intervention adherence, usefulness, credibility and use of clinician time were assessed, along with preliminary effects on alcohol consumption. The study was prospectively registered as a clinical trial (NCT05037630). RESULTS: Most participants used the intervention daily or several times a week. The digital intervention was regarded as credible and useful, and there were no reported adverse effects. Around 1 h of clinician time per participant was spent on telephone assessments. At the 3-month follow-up, preliminary within-group effects on alcohol consumption were moderate (standardised drinks per week, Hedge's g = 0.70, 95% CI = 0.19-1.21; heavy drinking days, Hedge's g = 0.60, 95% CI = 0.09-1.11), reflecting a decrease from 23 to 13 drinks per week on average. CONCLUSIONS: Digital psychological self-care for reducing alcohol consumption appears both feasible and preliminarily effective and should be further optimised and studied in larger trials.
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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.
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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.
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Terapia Cognitivo-Comportamental , Dermatite Atópica , Adulto , Humanos , Pessoal Técnico de Saúde , Dermatite Atópica/terapia , Autocuidado , Método Simples-Cego , Estudos de Equivalência como AsuntoRESUMO
Background: Research shows that internet-based cognitive behavioural therapy (iCBT) is an effective treatment for depression. However, little is known about how the length of the text material in iCBT affects outcomes. Objective: The aim of this study was to test whether a condensed iCBT version for depression would be non-inferior to the existing full-text version in reducing depressive symptoms at post-treatment. We also wanted to test non-inferiority for secondary outcomes and explore reading speed and ADHD symptoms as potential moderators. Method: A single-blind randomized controlled trial was conducted (N = 267) comparing two versions of guided iCBT for depression; full-text (around 60,000 words) and condensed (around 30,000 words, with the option to listen to the text). Estimated between-group effect sizes and their confidence intervals for depression, anxiety and quality of life, were compared to a pre-determined non-inferiority margin (ES = 0.4). Moderation analyses of reading speed and ADHD symptoms were conducted. Results: The condensed version of iCBT was non-inferior to the full-text version on post-treatment measures for depressive symptoms (95 % CI = -0.42-0.24), anxiety symptoms (95 % CI = -0.24-0.32), and quality of life (95 % CI = -0.09-0.49). Non-inferiority was inconclusive for depressive symptoms at the one-year follow-up (95 % CI = -0.60-0.47). There was no significant moderation effects of reading speed (p = 0.06) or ADHD symptoms (p = 0.11) on depressive symptoms. Conclusion: These results indicate that a condensed version of iCBT for depression is as effective at treating depression as the full-text version. By shortening texts, iCBT may be made available to more people. Due to unequal dropout rates between the groups, these results are preliminary and need to be replicated.
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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.
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Alcohol Use Disorders (AUD) are widespread and have serious consequences, but are among the most undertreated mental disorders. Internet interventions have been found effective in treating AUD, but we know little about long-term outcomes, two years or more after treatment. This study explored 12- and 24-month outcomes in alcohol consumption following initial 6-month improvements after a therapist-guided high-intensity internet intervention and an unguided low-intensity internet intervention among individuals with alcohol use disorder. Between-group comparisons were analyzed, as well as within-group comparisons with (1) pre-treatment measurements (2) post-treatment measurements. Participants consisted of a general population sample of internet help-seekers in Sweden. A total of 143 adults (47% men) with a score of 14 (women)/16 (men) or more on the Alcohol Use Disorders Identification Test, alcohol consumption of 11 (women)/14 (men) or more standard drinks the preceding week and ≥ 2 DSM-5 alcohol use disorder (AUD) criteria based on a diagnostic interview were included. The high- and low-intensity internet interventions (n = 72 and n = 71 respectively) consisted of modules based on relapse prevention and cognitive-behavioral therapy. The primary outcome was self-reported alcohol consumption in the preceding week measured as (1) number of standard drinks and (2) number of heavy drinking days. Attrition from self-reported questionnaires was 36% at the 12-month follow-up and 53% at the 24-month follow-up. No significant between-group differences occurred in outcomes at either long-term follow-up. Regarding within-group differences, compared to pre-treatment, alcohol consumption was lower in both high- and low-intensity interventions at both long-term follow-ups [within-group standard drinks effect sizes varied between g = 0.38-1.04 and heavy drinking days effect sizes varied between g = 0.65-0.94]. Compared to post-treatment, within-group alcohol consumption in the high intensity intervention increased at both follow-ups; for the low-intensity intervention, within-group consumption decreased at 12-month follow-up, but did not differ compared to post-treatment at 24 months. Both high- and low-intensity internet interventions for AUD were thus associated with overall reductions in alcohol consumption at long term follow-ups, with no significant differences between the two. However, conclusions are hampered by differential and non-differential attrition.
RESUMO
OBJECTIVES: In routine psychiatric care in Stockholm, Sweden, a comprehensive therapist-guided intervention for clinically significant health anxiety is implemented. However, there is a need for more easily accessible self-care interventions to improve treatment dissemination. This study aimed to transform an existing therapist-guided digital intervention into a self-care intervention, reducing patient burden and used clinical resources while maintaining quality and safety. DESIGN: An uncontrolled feasibility study. SETTING: Conducted at Karolinska Institutet, a medical university in Sweden, with nationwide recruitment trough online advertisements. PARTICIPANTS: Twenty-five adults used the self-care intervention and underwent telephone assessments, along with completing self-rated questionnaires. INTERVENTION: The newly developed 8-week self-care intervention was designed to be user-friendly without therapist guidance, and to facilitate high levels of behavioural engagement. PRIMARY AND SECONDARY OUTCOME MEASURES: Indicators of quality and safety, including changes in health anxiety severity (primary), clinician time, participant adherence, perceived credibility/satisfaction with the intervention and adverse events, were benchmarked against a previous study of the more comprehensive intervention it was based on. RESULTS: Compared with the original guided intervention, the self-care intervention was condensed in terms of text (up to 70% less reading), duration (8 weeks instead of 12) and number of exercises. Quality indicators were similar to the original version. Most participants worked actively with core components in the self-care intervention. Within-group effects on health anxiety from pretreatment to the 3-month follow-up were large (g=1.37; 95% CI 0.74 to 2.00). No serious adverse events were reported. CONCLUSIONS: This brief digital self-care intervention shows potential for increasing access to treatment for individuals with health anxiety while reducing the burden on patients and clinical resources. Future studies should investigate the optimal type of intervention and support for different individuals, and if non-inferiority can be established. TRIAL REGISTRATION NUMBER: NCT05446766.