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Mental disorders, most commonly anxiety disorders and fourth most common depression, are prevalent in children and adolescents. Internet- and mobile-based interventions might represent a scalable approach to improve mental health care, however, evidence so far is inconclusive and systematic reports on negative effects are missing. Four data-bases were searched for randomized controlled trials evaluating internet- and mobile-based interventions (IMIs) targeting anxiety disorders or depression in children and adolescents up to 18 years exhibiting clinically relevant symptoms. Meta-analytic evaluations were conducted in comparison to active and passive control groups, furthermore, pre-defined sub-groups were explored and reported negative effects examined. Pooled estimates showed a moderate positive effect for IMIs targeting anxiety disorders compared to passive control groups (g = -0.69; CI -0.94 to -0.45; k = 8; n = 559; p ≤ 0,001), but not for depression. Pooled estimates compared to active control groups remained non-significant. Subgroup analyses were largely omitted due to an insufficient number of trials or were non-significant. Negative effects were mainly reported as drop-out rates and (non)-response rates, while additional negative effects, such as deterioration rates or the development of additional symptoms, were reported by only one third of included studies. The focus on children and adolescents with clinically relevant symptoms allowed the present findings to complement previous work, however, the limited amount of trials hindered many planned comparisons. The overview of reported negative effects highlighted that negative effects are being neglected in the majority of RCTs. Hence, in the future RCTs should include more information about potential negative effects, at best a combination of quantitative and qualitative information. Open Science Framework (osf.io/ch5nj).
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INTRODUCTION: It is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I. METHODS AND ANALYSIS: In this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Medical Centre-University of Freiburg. The results of the study will be published irrespective of the outcome. TRIAL REGISTRATION NUMBER: DRKS00021503.
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Cognitive Behavioral Therapy , Sleep Initiation and Maintenance Disorders , Cognitive Behavioral Therapy/methods , Humans , Internet , Randomized Controlled Trials as Topic , Sleep , Sleep Initiation and Maintenance Disorders/therapy , Treatment OutcomeABSTRACT
INTRODUCTION: Children of parents with mental disorders have a high chance of developing a mental disorder themselves. However, this at-risk group is regularly overlooked and typically not seen by any mental health professionals. Internet- and mobile-based interventions (IMIs) can provide a means of promoting mental health for children of parents with mental disorders. OBJECTIVE: The introduced study will evaluate the clinical- and cost-effectiveness of the iCHIMPS IMI in promoting mental health for children of parents with mental disorders. METHODS: A two-armed multicentered cluster-randomized controlled trial (cRCT) comparing the clinical- and cost-effectiveness of the iCHIMPS IMI in the intervention group (IG) to a treatment-as-usual (TAU) control group will be conducted. Recruitment will be handled at currently 21 adult mental health clinics throughout Germany. Participating families will be randomly divided into the two groups until the final sample size of 306 participating adolescents (age 12-18) has been reached. The adolescents in the intervention group will receive access to the IMI and can take part in up to eight intervention modules. Assessment will be conducted during the recruitment (baseline), 1-month, 2-months, and 6-month post-inclusion. Primary outcome is the mental health of the participating adolescents at 6-months post-inclusion as measured by the Youth Self Report score. Secondary self-report outcomes are mental wellbeing, self-efficacy, coping strategies and negative effects as well as mental health of the adolescents as reported by their parent(s). Included moderators are sociodemographic characteristics, working alliance, social support and the mental health diagnoses of the parents. Statistical analyses will be conducted on the intention-to-treat principle as well as with additional per-protocol analyses. Additionally, the cost-effectiveness as well as qualitative data concerning the adherence, acceptance, and feasibility of the IMI will be analyzed. DISCUSSION: The iCHIMPS cRCT examines the clinical- as well as cost-effectiveness of the iCHIMPS mental health promotion IMI for children of parents with mental disorders. This provides the opportunity to gain insights into an innovative as well as time- and location-independent form of support for this often-overlooked at-risk group. Additionally, the larger CHIMPS-NET project allows comparisons between internet-based and face-to-face interventions for a similar target group. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov, identifier: DRKS00025158.
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PURPOSE OF REVIEW: Internet and mobile-based interventions (IMI) can be used as online delivered forms of psychotherapeutic mental health treatments. These interventions can be an effective as well as time and cost-efficient treatment with the potential to scale up mental healthcare. In this review, we map implementation possibilities into routine mental healthcare settings and provide the most recent evidence. RECENT FINDINGS: Fourteen articles on digital mental healthcare approaches published in the last 18 months were included. Despite the limited number, the studies provide evidence for the effectiveness of IMI in treating inpatients and outpatients with various disorders in different mental healthcare settings. IMI were investigated as stand-alone interventions, in combination with other treatment forms (blended-care), or as aftercare. SUMMARY: Although there is encouraging evidence for the effectiveness of IMI in mental healthcare settings, several limitations have to be considered. The small number of studies conducted within the healthcare system, especially with inpatient samples, calls for more collaboration between researchers and clinical practitioners to unravel barriers and develop efficient protocols for the integration into routine care. Nonetheless, IMI are a promising tool for the endeavour of closing the treatment gap and should, therefore, be further explored in varying settings.
