BackgroundTreatment of alcohol use disorders (AUDs) is characterized by an adherence rate below 50%. Clinical research has found that patient adherence enhances treatment effect; hence, health authorities, clinicians, and researchers strive to explore initiatives contributing to patients receiving treatment. Concurrently, videoconferencing-based treatment is gaining ground within other addiction and psychiatric areas.ObjectiveThe aim of this study was to test whether optional videoconferencing increases adherence to and effectiveness of AUD treatment in a randomized controlled trial (RCT). We hypothesized that the intervention would decrease premature dropout (the primary outcome), as well as increase successful treatment termination, treatment duration, and treatment outcome (secondary outcomes).MethodsWe conducted this study in the public outpatient alcohol clinic in Odense, Denmark, between September 2012 and April 2013. It was an RCT with 2 groups: treatment as usual (TAU) and treatment as usual with add-on intervention (TAU+I). The TAU+I group had the option, from session to session, to choose to receive treatment as usual via videoconferencing. Data consisted of self-reported responses to the European version of the Addiction Severity Index (EuropASI). We collected data at baseline, at follow-up at 3, 6, and 12 months, and at discharge.ResultsAmong consecutive patients attending the clinic, 128 met the inclusion criteria, and 71 of them were included at baseline. For the primary outcome, after 180 days, 2 of 32 patients (6%) in the TAU+I group and 12 of 39 patients (31%) in the TAU group had dropped out prematurely. The difference is significant (P=.008). After 365 days, 8 patients (25%) in the TAU+I group and 17 patients (44%) in the TAU group had dropped out prematurely. The difference is significant (P=.02). For the secondary outcomes, significantly more patients in the TAU+I group were still attending treatment after 1 year (P=.03). We found no significant differences between the 2 groups with regard to successful treatment termination and treatment outcome.ConclusionsThe results indicate that offering patients optional videoconferencing may prevent premature dropouts from treatment and prolong treatment courses. However, the small sample size precludes conclusions regarding the effect of the intervention, which was not detectable in the patients’ use of alcohol and severity of problems.Trial RegistrationThe Regional Health Research Ethics Committee System in Denmark: S-20110052; https://komite.regionsyddanmark.dk/wm258128 (Archived by WebCite at http://www.webcitation.org/6tTL3CO6u)
Background Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union’s Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities. Methods A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study. Discussion The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges. Trial registration ClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018
Objective: Binge-eating disorder (BED) is characterized by recurrent episodes of binge eating, accompanied by a lack of control and feelings of shame. Online intervention is a promising, accessible treatment approach for BED. In the current study, we compared completers with noncompleters in a 10-session guided internet-based treatment program (iBED) based on cognitive behavioral therapy. Methods: Adults (N = 75) with mild to moderate BED participated in iBED with weekly written support from psychologists. Participants were compared on the Eating Disorder Examination Questionnaire (EDE-Q), diagnostic criteria for BED (BED-Q), major depression inventory (MDI), quality of life (EQ-5D-5L), body mass index (BMI) and sociodemographic variables. Results: Minor differences were observed between completers and noncompleters on depression. No differences were found in BED-symptoms, BMI, and sociodemographic variables. Participants who completed treatment showed large reductions in eating disorder pathology. Discussion: More research is needed to determine risk factors for attrition or treatment outcome in internet-based interventions for BED. It is suggested that iBED is an efficient intervention for BED. However, more studies of internet-interventions are needed.
Background Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. Objective This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. Methods A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. Results In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. Conclusions The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. Trial Registration ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883 International Registered Report Identifier (IRRID) RR2-10.1186/s13063-020-04686-4
Eating disorders are more prevalent in athletes than in the general population and may have severe consequences for sports performance and health. Identifying symptoms can be difficult in athletes because restrictive eating and slim body images are often idealised in a sports setting. The Eating Disorders Examination Questionnaire (EDE-Q) and the SCOFF (Sick, Control, One stone, Fat and Food) questionnaire (SCOFF) are widely used generic instruments to identify symptoms of eating disorders. This study aimed to investigate the instruments’ validity and explore eating disorder symptoms in a sample of athletes.A sample of 28 athletes (25 females) competing at a national level was interviewed based on the diagnostic criteria for eating disorders. We interviewed 18 athletes with a high score on EDE-Q and 10 with a low score. All interviews were transcribed and analysed from a general inductive approach. We identified 20 athletes with an eating disorder diagnosis, while 8 had no diagnosis. EDE-Q found 90% of the cases, while SCOFF found 94%. EDE-Q found no false-positive cases, while SCOFF found one.The qualitative results showed that most athletes reported eating concerns, restrictive eating, eating control (counting calories), weight concerns, body dissatisfaction (feeling fat and non-athletic), excessive exercise and health problems (eg, pain, fatigue).In conclusion, EDE-Q and SCOFF seem valid instruments to screen athletes’ samples but may fail to find 6%–10% cases with eating disorders. Despite athletic bodies and normal body mass index, many athletes report severe eating problems and dissatisfaction with weight and body appearance. Implementation of regular screening may identify these symptoms at an early stage.
Objectives:The objectives of this study are (1) to compare the satisfaction between patients who have received treatment as usual face-to-face (TAU group) and patients who have received optional videoconferencing-based treatment for alcohol use disorders (TAU+I group); and (2) to elaborate on the TAU+I group’s satisfaction with the treatment in general and the technical equipment.Methods:The design consisted of mixed methods: a survey and a qualitative study. Data consisted of self-reported data from questionnaires filled out by both groups and semistructured interviews with the TAU+I group. Data from the questionnaires were analyzed statistically using Stata. The semistructured interviews were analyzed using a general inductive approach.Results:The survey indicated that the TAU+I group and TAU group were equally satisfied with the elements in the treatment. The interview indicated that the TAU+I group seemed to have a high satisfaction with most elements in the treatment. Patients who used videoconferencing were satisfied with establishing the videoconferencing connection and with the picture quality but less satisfied with the sound quality.Conclusions:Overall, the patients were satisfied with the treatment. We saw a nonsignificant tendency that the TAU+I group were more satisfied with the treatment in general, compared with the TAU group. It is a possibility that patients in this group felt more satisfied with the treatment as they had the opportunity to choose videoconferencing. Offering videoconferencing-based treatment may be a positive feature in the treatment and lead to improved outcomes of the treatment courses. The technical equipment and routine using it should be improved in future studies or during implementation.
Background A major challenge to psychological treatment for alcohol use disorder (AUD) is patient non-compliance. A promising new treatment approach that is hypothesized to increase patient compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the internet within the same protocol. While this treatment concept has been developed and proven effective for a variety of mental disorders, it has not yet been examined for AUD. Aims The study described in this protocol aims to examine and evaluate patient compliance with blended AUD treatment as well as the clinical and cost effectiveness of such treatment compared to face-to-face treatment only. Methods The study design is a pragmatic, stepped-wedge cluster randomized controlled trial. The included outpatient institutions (planned number of patients: n = 1800) will be randomized in clusters to implement either blended AUD treatment or face-to-face treatment only, i.e. treatment as usual (TAU). Both treatment approaches consist of motivational interviewing and cognitive behavioral therapy. Data on sociodemographics, treatment (e.g. intensity, duration), type of treatment conclusion (compliance vs. dropout), alcohol consumption, addiction severity, consequences of drinking, and quality of life, will be collected at treatment entry, at treatment conclusion, and 6 months after treatment conclusion. The primary outcome is compliance at treatment conclusion, and the secondary outcomes include alcohol consumption and quality of life at six-months follow-up. Data will be analyzed with an Intention-to-treat approach by means of generalized linear mixed models with a random effect for cluster and fixed effect for each step. Also, analyses evaluating cost-effectiveness will be conducted. Discussion Blended treatment may increase treatment compliance and thus improve treatment outcomes due to increased flexibility of the treatment course. Since this study is conducted within an implementation framework it can easily be scaled up, and when successful, blended treatment has the potential to become an alternative offer in many outpatient clinics nationwide and internationally. Trial registration Clinicaltrials.gov.: NCT04535258, retrospectively registered 01.09.20.
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