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Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial.

ABSTRACT: Patients' treatment expectations are a key factor in psychotherapy. Several studies have linked higher expectations to better treatment success. Therefore, we want to evaluate the impact of a targeted video-based intervention on patients' expectations and the treatment success of inpatient rehabilitation.All patients who will be referred to inpatient psychosomatic rehabilitation in three clinics will receive a study flyer with information about how to log in to the study platform together with the usual clinic information leaflet. Patients will receive the study information and informed consent upon login and will be randomized into the intervention or the control group. The intervention group (n?=?394) will get access to our virtual online clinic, containing several videos about inpatient rehabilitation, until their admission to inpatient rehabilitation. The control group (n?=?394) will receive no special treatment preparation. Questionnaires will be given at study inclusion (T0), two weeks before admission to (T1), and at the end of (T2) inpatient rehabilitation. The primary outcome is the outcome expectancy measured with the Credibility Expectancy Questionnaire at T1. Secondary outcomes include treatment motivation, mental health, work ability, depression, anxiety, and satisfaction with and usage of the Internet platform.We expect the intervention group to benefit from the additional preparation concerning their outcome expectancy. If successful, this approach could be used in the future to enhance the efficacy of inpatient rehabilitation.ClinicalTrials.gov: NCT02532881 . Registered on 25 August 2015.

SUBMITTER: Becker J

PROVIDER: S-EPMC4906995 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial.

Becker Jan J Beutel Manfred E ME Gerzymisch Katharina K Schulz Dirk D Siepmann Martin M Knickenberg Rudolf J RJ Schmädeke Stefan S Ferdinand Peter P Zwerenz Rüdiger R

Trials 20160613 1

<h4>Background</h4>Patients' treatment expectations are a key factor in psychotherapy. Several studies have linked higher expectations to better treatment success. Therefore, we want to evaluate the impact of a targeted video-based intervention on patients' expectations and the treatment success of inpatient rehabilitation.<h4>Methods/design</h4>All patients who will be referred to inpatient psychosomatic rehabilitation in three clinics will receive a study flyer with information about how to lo ...[more]

PMID: 27296249

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Project description:BackgroundOnline self-help interventions have proven to be effective in treating various specific mental disorders, mainly depression and anxiety. Knowledge regarding their acceptance, efficacy, and usefulness in addition to inpatient or outpatient psychotherapy is limited. Therefore, we plan to evaluate an affect-focused, transdiagnostic, psychodynamic online self-help intervention following inpatient psychotherapy for mixed diagnoses in a feasibility study to determine acceptance, satisfaction, and preliminary estimates of efficacy.MethodsThe intervention is based on the book "Living Like You Mean It" by Ronald J. Frederick (2009) and the Swedish adaption by Johansson and colleagues (2013). The book was translated into German and thoroughly revised using parts of the Swedish adaption and additional tasks from their intervention. In a pilot phase, corrections concerning comprehensibility of the content and exercises were made based on patient's feedback. In the second step, we developed a website presenting the German adaption in eight units. In the third step, at least N = 66 patients from the Department of Psychosomatic Medicine and Psychotherapy will be recruited for a feasibility study. Patients are randomized into two groups. The intervention group (IG) will receive ten weeks of access to the online self-help intervention together with weekly therapeutic feedback on their progress. The wait-list control group (WLC) will receive access to the intervention for ten weeks as well, but without therapeutic feedback and with a ten-week delay. We will conduct assessments at the beginning of the intervention of the IG (T0), the end of the intervention of the IG (T1), two months later (only IG, T2), and at the end of the intervention of the WLC (T3). The primary outcome is satisfaction with the treatment as measured by the ZUF-8 at T1 and T3 respectively. Secondary outcome measures include emotional competence, depression, anxiety, and quality of life.ConclusionWe expect insight into the usefulness and acceptance of an online self-help intervention used to maintain inpatient treatment effects. Furthermore, we await both groups to benefit from the participation in the intervention. Pre- post and between subject differences will be used as estimate effect sizes to calculate the necessary sample size for a larger efficacy trial.

Project description:BackgroundThere is a lack of studies on internet-based interventions in inpatient settings. This is especially true for studies of internet-based interventions in acute psychiatric inpatient care. Internet-based interventions in this specific setting may provide benefits such as patient empowerment and overall improved treatment outcomes. However, there may also be specific barriers to their implementation that are unique due to the complexity of acute psychiatric inpatient care.ObjectiveThe aim of this study is to examine the feasibility and preliminary evidence for effectiveness of a web-based emotion regulation intervention provided as an add-on to acute psychiatric inpatient care.MethodsThe goal is to randomly allocate 60 patients with a range of different diagnoses in a 1:1 ratio to either treatment as usual (TAU), which consists of acute psychiatric inpatient treatment, or to the intervention group, which will receive TAU plus access to a web-based intervention that focuses on reduction of emotion regulation difficulties and improvement of emotion regulation skills. The primary outcome is symptom severity, assessed with the short form of the Brief Symptom Inventory at baseline, after 4 weeks, after 8 weeks, and at hospital discharge. Secondary outcomes include 2 emotion regulation parameters, intervention use, usability, patient satisfaction, and reasons for patient loss to follow-up.ResultsParticipant recruitment started in August 2021 and as of March 2023 was ongoing. First publication of study results is expected in 2024.ConclusionsThis study protocol describes a study that intends to examine a web-based emotion regulation intervention in acute psychiatric inpatient care. The study will provide information on the feasibility of the intervention and possible effects on symptom severity and emotion regulation. The results will provide new insights on blended treatment, in this case the combination of a web-based intervention and face-to-face psychiatric treatment, in an understudied patient group and setting.Trial registrationClinicalTrials.gov NCT04990674; https://clinicaltrials.gov/ct2/show/NCT04990674.International registered report identifier (irrid)DERR1-10.2196/47656.

Project description:Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay.A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters.The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively involved in its design, and because of the use of Open-Source software, the intervention can easily and at low-cost be reproduced and expanded by others. Challenges are the recruitment in the elderly population and the possible underrepresentation of women in the study sample. Funding by Northern Norway Regional Health Authority.Trial registry http://www.clinicaltrials.gov: NCT01223170.

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Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial.

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Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial.

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