Background
Students beginning university are at a heightened risk for developing mental health disorders. Online prevention and early intervention programmes targeting mental health have the ...potential to reduce this risk, however, previous research has shown uptake to be rather poor. Understanding university stakeholders’ (e.g. governing level and delivery staff DS and students) views and attitudes towards such online prevention programmes could help with their development, implementation and dissemination within university settings.
Methods
Semi-structured interviews, focus groups and online surveys were completed with staff at a governing level, university students and DS (i.e. student health or teaching staff) from six European countries. They were asked about their experiences with, and needs and attitudes towards, online prevention programmes, as well as the factors that influence the translation of these programmes into real-world settings. Results were analyzed using thematic analysis.
Results
Participating stakeholders knew little about online prevention programmes for university settings; however, they viewed them as acceptable. The main themes to emerge were the basic conditions and content of the programmes, the awareness and engagement, the resources needed, the usability and the responsibility and ongoing efforts to increase reach.
Conclusions
Overall, although these stakeholders had little knowledge about online prevention programmes, they were open to the idea of introducing them. They could see the potential benefits that these programmes might bring to a university setting as a whole and the individual students and staff members.
Introduction: Although evidence-based treatments for posttraumatic stress disorder (PTSD) in adolescents and young adults exist, affected youth do not have sufficient access to these treatments due ...to structural and attitudinal barriers. Internet- and mobile-based interventions (IMIs) can help fill this healthcare gap, but such programmes have not yet been sufficiently evaluated in youth with PTSD.
Aim: This study aims to investigate the feasibility of an IMI for youth with PTSD in a one-arm, non-randomised, prospective proof-of-concept feasibility study.
Methods: We aim to recruit 32 youth between 15 and 21 years old with clinically relevant posttraumatic stress symptoms (CATS ≥ 21), who will receive access to the IMI. The IMI consists of nine sessions involving psychoeducation, emotion regulation and coping skills, written-based imaginal exposure, cognitive restructuring and relapse prevention. Participants will be guided by an eCoach, who provides weekly semi-standardised written feedback on completed sessions and adherence reminders. We will use a formal feasibility framework to assess different dimensions of feasibility: (1) recruitment capability and resulting sample characteristics, (2) data collection procedures and outcome measures, (3) acceptability of the IMI and study procedures, (4) resources and ability to manage and implement the study and IMI and (5) participants' responses to the IMI in terms of symptom severity and satisfaction. Additionally, potential negative effects related to the intervention will be assessed. Assessments take place pre-, mid- and post-intervention and at follow-up, including semi-structured clinical telephone interviews for PTSD diagnostics at pre- and post-intervention assessment. Qualitative interviews will be conducted to investigate the youth perspectives on the IMI.
Discussion: This study aims to determine the feasibility of a guided IMI for youth with PTSD to adapt the IMI as closely as possible to youth needs and to inform the design, procedure and safety management of a large-scale efficacy RCT.
Trial registration:
German Clinical Trials Register identifier: DRKS00023341
.
Evidence-based care for adolescents after trauma is not widely available.* This study evaluates the feasibility of a guided trauma-focused Internet intervention as a time- and location-independent low-threshold treatment option for adolescents and young adults with posttraumatic stress disorder.
Introduction:
Internet- and mobile-based interventions (IMIs) and their integration into routine psychotherapy (i.e., blended therapy) can offer a means of complementing psychotherapy in a flexible ...and resource optimized way.
Objective:
The present study will evaluate the non-inferiority, cost-effectiveness, and safety of two versions of integrated blended psychotherapy for depression and anxiety compared to standard cognitive behavioral therapy (CBT).
Methods:
A three-armed multicenter cluster-randomized controlled non-inferiority trial will be conducted comparing two implementations of blended psychotherapy (PSYCHOnlineTHERAPY
fix/flex
) compared to CBT. Seventy-five outpatient psychotherapists with a CBT-license will be randomized in a 1:1:1 ratio. Each of them is asked to include 12 patients on average with depressive or anxiety disorders resulting in a total sample size of
N
= 900. All patients receive up to a maximum of 16 psychotherapy sessions, either as routine CBT or alternating with Online self-help sessions (fix: 8/8; flex: 0–16). Assessments will be conducted at patient study inclusion (pre-treatment) and 6, 12, 18, and 24 weeks and 12 months post-inclusion. The primary outcome is depression and anxiety severity at 18 weeks post-inclusion (post-treatment) using the Patient Health Questionnaire Anxiety and Depression Scale. Secondary outcomes are depression and anxiety remission, treatment response, health-related quality of life, patient satisfaction, working alliance, psychotherapy adherence, and patient safety. Additionally, several potential moderators and mediators including patient characteristics and attitudes toward the interventions will be examined, complemented by ecological day-to-day digital behavior variables via passive smartphone sensing as part of an integrated smart-sensing sub-study. Data-analysis will be performed on an intention-to-treat basis with additional per-protocol analyses. In addition, cost-effectiveness and cost-utility analyses will be conducted from a societal and a public health care perspective. Additionally, qualitative interviews on acceptance, feasibility, and optimization potential will be conducted and analyzed.
Discussion:
PSYCHOnlineTHERAPY will provide evidence on blended psychotherapy in one of the largest ever conducted psychotherapy trials. If shown to be non-inferior and cost-effective, PSYCHOnlineTHERAPY has the potential to innovate psychotherapy in the near future by extending the ways of conducting psychotherapy. The rigorous health care services approach will facilitate a timely implementation of blended psychotherapy into standard care.
Trial Registration:
The trial is registered in the German Clinical Trials Register (DRKS00023973; date of registration: December 28th 2020).
Depression and anxiety are common and co-morbid disorders that affect a significant proportion of students. Innovative prevention strategies targeting both conditions are needed to reduce their ...health burden and costs. ICare Prevent is such an innovative strategy and contains a transdiagnostic individually tailored Internet-based and mobile-supported intervention. It addresses common risk factors of depression and anxiety as part of a large EU-funded multi-country project* (ICare). Little is known about the clinical and cost-effectiveness of this type of intervention compared to care as usual (CAU) for college students. We hypothesize that ICare Prevent will be more (cost-)effective than CAU in the reduction of symptoms of depression and anxiety.
A three-arm, parallel, randomized controlled superiority trial will be conducted comparing a guided and an unguided version of ICare Prevent with a control group receiving CAU. The trial will be open-label but outcome assessors will be blinded. A total of 252 college students (age ≥ 16 years) with subclinical symptoms of depression defined as a score ≥ 16 on the Center for Epidemiological Studies Depression Scale (CES-D), and/or anxiety, defined as a score ≥ 5 on the Generalized Anxiety Disorder scale (GAD-7), will be included. Those meeting diagnostic criteria for a depressive or anxiety disorder will be excluded. The primary outcome is change in disorder specific symptom severity from baseline to post-intervention. Secondary endpoints include self-reported depression and anxiety symptoms as well as time to onset of a mood or anxiety disorder until 12-month follow-up. Societal costs and quality of life will be assessed to estimate the intervention's cost-effectiveness compared to CAU.
Transdiagnostic individually tailored Internet-based prevention could be a (cost-)effective approach to tackle the disease burden of depression and anxiety among college students.
Dutch trial register, NTR 6562 . Registered on 6 July 2017.
Depression and anxiety are highly prevalent and often co-occur. Several studies indicate the potential of disorder-specific psychological interventions for the prevention of each of these disorders. ...To treat comorbidity, transdiagnostic treatment concepts seem to be a promising approach, however, evidence for transdiagnostic concepts of prevention remains inconclusive. Internet- and mobile-based interventions (IMIs) may be an effective means to deliver psychological interventions on a large scale for the prevention of common mental disorders (CMDs) such as depression and anxiety. IMIs have been shown to be effective in treating CMDs, e.g. in reducing symptoms of depression and anxiety. However, there is a lack of studies examining the efficacy of interventions reducing the incidence of CMDs. Moreover, the comparative cost-effectiveness of guided versus unguided IMIs for the prevention of depression and anxiety has not been studied yet. Hence, this study aims at investigating the (cost-) effectiveness of guided and unguided internet- and mobile-based transdiagnostic individually tailored indicated prevention of depression and anxiety.
A multi-country three-armed randomized controlled trial will be conducted to compare a guided and unguided intervention to treatment as usual (TAU). Both active conditions are based on the same intervention, ICare Prevent, and differ only with regard to guidance format. Altogether, 954 individuals with subclinical symptoms of depression (CES-D ≥ 16) and anxiety (GAD-7 ≥ 5) who do not have a full-blown disorder will be recruited in Germany, Switzerland, Spain and the Netherlands, and randomized to one of three conditions (guided intervention, unguided intervention, or TAU). The TAU arm will receive access to the training after a 12-month waiting period. The primary outcome will be time to CMD onset (any depression/anxiety disorder) within a follow-up period of 12 months after baseline. Secondary outcomes will include disorder-specific symptom severity (depression/anxiety) assessed by diagnostic raters blinded to intervention condition at post-intervention, self-reports, acceptability, health related quality of life, and psychosocial variables associated with developing a CMD. Assessments will take place at baseline, mid-intervention (5 weeks into the intervention), post-intervention (8 weeks after randomization) and follow-up (6 and 12 months after randomization). Data will be analyzed on an intention-to-treat basis and per protocol. Cost-effectiveness will be evaluated from a public health and a societal perspective, including both direct and indirect costs.
The present study will further enhance the evidence-base for transdiagnostic preventive interventions and provide valuable information about optimal trade-off between treatment outcome and costs.
German Clinical Trial Registration (DRKS - http://www.drks.de/drks_web/): DRKS00011099.
•Depression and anxiety are highly comorbid, but often not treated together.•Transdiagnostic treatment provides potential to reduce comorbidity.•Individual tailoring can help adapt treatment to individual profiles.•Large multi-country transdiagnostic prevention trial in a subclinical population.•Cost-effectiveness for a guided and unguided internet- and mobile-based intervention will be investigated.
Despite a large body of evidence demonstrating the effectiveness of psychotherapy for posttraumatic stress for children and adolescents, the adoption of empirically supported treatments (ESTs) in ...routine care is low.
This implementation study aims to evaluate the dissemination of Trauma-Focused Cognitive Behavioural Therapy (TF-CBT) for children and adolescents with posttraumatic stress symptoms (PTSS) after child abuse and neglect (CAN) with a focus on supervision.
In a cluster-randomized controlled trial, the study will evaluate the implementation of TF-CBT focussing on the training of therapists including the provision of supervision. The effectiveness of specialized trauma-focused supervision will be compared to supervision as usual with respect to the successful implementation of TF-CBT for youths with PTSS administered by psychotherapists with different levels of professional experience. The primary outcome is whether the patient receives a treatment with sufficient adherence to the TF-CBT manual. The unit of randomization will be the therapists. The main outcome will be analysed using multilevel logistic regressions. Secondary outcomes will concern further patient-related (reduction of PTSS and depressive symptoms) and therapist-related (professional quality of life) variables. Additional exploratory analyses are planned.
Since the trial is designed as an implementation study, it permits naturalistic referrals to the participating therapists by patients, caregivers, child and youth welfare agencies and paediatricians. The strict primary outcome will help evaluating the role of model-based supervision in the implementation process. The explorative outcomes will evaluate whether implementation success translates into better patient outcomes. We expect that the dissemination measures will lead to a successful implementation of TF-CBT and promote sustainable structures in routine care that will remain in place after study completion and offer access to ESTs for future children and youths with a history of CAN.
Mental disorders are highly prevalent among university students. Distance-learning students are particularly burdened and have limited access to conventional university health services. Interventions ...for stress are sought after in distance learners and may help increase treatment coverage. Internet-based interventions have been shown to be effective in preventing and treating depression, but it remains unclear if interventions directed at academic stress also have this potential.
The trial presented here investigates the effectiveness of an Internet- and App-based stress intervention in distance-learning students with elevated levels of depression.
A sample of
= 200 students of a large German distance university with elevated levels of depression Center for Epidemiological Studies' Depression Scale (CES-D) ≥ 16 will be randomly assigned to either an Internet- and App-based stress management intervention group (IG) or a control group (CG) receiving an Internet-based psychoeducational program for academic stress. The IG consists of eight Internet-based sessions promoting stress management skills using cognitive-behavioral and problem-solving techniques. A mobile App will be employed to facilitate training transfer. Self-report data will be assessed at baseline (T0), post-treatment (T1; 7 weeks), and 3-month follow-up (T2). Potential moderators will be assessed at baseline. The primary outcome is depression (CES-D) post-treatment. Secondary outcomes include mental health outcomes, modifiable risk and protective factors, and academic outcomes. Data will be analyzed on an intention-to-treat principle along with sensitivity analyses to assess the robustness of findings. Additional health economic analyses will be conducted.
Results will provide the basis to assess the acceptance and effectiveness of Internet-delivered stress interventions in distance-learning students with symptoms of depression.
The study has been reviewed and approved by the University of Erlangen-Nuremberg ethics committee (Erlangen, Germany; 33_17 Bc). Results of the study will be disseminated through peer-reviewed publications.
German Clinical Trial Registration (DRKS), identifier DRKS00011800.
Depression is highly prevalent and often accompanied by comorbid anxiety disorder. Internet-based interventions have shown to be one effective treatment modality; however, comorbidities are often not ...targeted. Transdiagnostic tailored internet-and mobile-based interventions (IMIs) might be promising to overcome such issues.
This study aims to evaluate the efficacy, moderators, and cost-effectiveness of a transdiagnostic tailored internet- and mobile-based guided intervention for depression and comorbid anxiety in individuals with major depressive disorder (MDD).
Two-hundred participants with MDD will be randomly assigned to an 8-week guided self-help internet intervention (IC) or a 6-month wait-list control group (WLC). Participants of the IC will receive weekly content-focused feedback on module completion as well as monitored adherence reminders from an eCoach. The primary outcome is clinician-rated depression severity (QIDS-C) at post-assessment assessed by diagnostic raters blind to study condition. Secondary outcomes include, e.g., change in diagnostic status (MDD and anxiety disorders), remission and response rates, disorder symptom severity, health related quality of life, incongruence related to needs and values, and behavioral activation. Assessments will take place at baseline (T1), post-assessment (T2), 6-month follow-up (T3), and 12-month follow-up in the IC. Data will be analyzed on an intention-to-treat basis and per protocol. A large number of a priori defined moderators of treatment outcome will be assessed at baseline and tested in predicting treatment outcome. Cost-effectiveness will be evaluated from a societal perspective.
The present study will provide evidence on the efficacy, potential cost-effectiveness, and moderators of a transdiagnostic tailored guided internet- and mobile-based treatment protocol.
German Register of Clinical Studies DRKS00011690 (https://www.drks.de/drks_web/).
Internet Use Disorder (IUD), characterized as the inability to control one's internet use, is emerging as an increasing societal concern as it is associated with reduced quality of life and mental ...health comorbidities. Evidence-based treatment options are, however, scarce due to the novelty of the diagnosis. Internet- and mobile-based interventions may be an effective means to deliver psychological treatment to individuals with IUD as they address individuals affected in their online setting. The aim of the study is to evaluate the efficacy of a newly developed, guided internet- and mobile-based intervention for IUD.
In a two-armed randomized controlled trial (
= 130), individuals showing problematic internet use patterns (Internet Addiction Test ≥ 49) will be randomly allocated to the internet- and mobile-based intervention or a waiting control group. Assessments will take place at baseline, 7 weeks, 6- and 12 months after randomization. The primary outcome is internet addiction symptom severity (IAT) at 7 weeks. Secondary outcomes include quality of life, depressive symptoms, anxiety, and other psychosocial variables associated with IUD.
The intervention consists of seven sessions: Goal setting and motivational interviewing, impulse control, problem solving, cognitive restructuring, self-worth, relapse prevention, and a booster session. Participants are supported by an eCoach who provides individual feedback after completion of each session. Participants can choose between several elective sessions based on individual need.
This is the first study to evaluate an internet- and mobile-based intervention for IUD, which could be a promising first step to reduce individuals' disease burden.
DRKS00015314. The study is currently ongoing. First participants were enrolled in the study on September 14th 2018. Recruitment will continue approximately through March 2020.
Mental health problems are common and place a burden on the individual as well as on societal resources. Despite the existence of evidence-based treatments, access to treatment is often prevented or ...delayed due to insufficient health care resources. Effective internet-based self-help interventions have the potential to reduce the risk for mental health problems, to successfully bridge waiting time for face-to-face treatment and to address inequities in access. However, little is known about the cost-effectiveness of such interventions. This paper describes the study protocol for the economic evaluation of the studies that form the ICare programme of internet-based interventions for the prevention and treatment of a range of mental health problems.
An overarching work package within the ICare programme was developed to assess the cost-effectiveness of the internet-based interventions alongside the clinical trials. There are two underlying tasks in the ICare economic evaluation. First, to develop schedules that generate equivalent and comparable information on use of services and supports across seven countries taking part in clinical trials of different interventions and second, to estimate unit costs for each service and support used. From these data the cost per person will be estimated by multiplying each participant's use of each service by the unit cost for that service. Additionally, productivity losses will be estimated. This individual level of cost data matches the level of outcome data used in the clinical trials. Following the analyses of service use and costs data, joint analysis of costs and outcomes will be undertaken to provide findings on the relative cost-effectiveness of the interventions, taking both a public sector and a societal perspective. These analyses use a well-established framework, the Production of Welfare approach, and standard methods and techniques underpinned by economic theory.
Existing research tends to support the effectiveness of internet-based interventions, but there is little information on their cost-effectiveness compared to ‘treatment as usual’. The economic evaluation of ICare interventions will add considerably to this evidence base.
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