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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:Background:Online 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. Methods:The 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. Conclusion:We 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.

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Project description:Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC.Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05.ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose.www.ClinicalTrials.gov Identifier: NCT00871715

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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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