- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02532881
Evaluation of a Video-based Internet Intervention as Preparation for Inpatient Psychosomatic Rehabilitation (Reh@:Info)
November 11, 2016 updated by: Dr. Rüdiger Zwerenz, Johannes Gutenberg University Mainz
Evaluation of a Video-based Internet Intervention as Preparation for Inpatient Psychosomatic Rehabilitation: A Randomized Controlled Trial
The purpose of this study is to determine the effect of an internet-based preparation on the outcome expectancy and treatment credibility of rehabilitants concerning inpatient psychosomatic rehabilitation.
Both study groups receive the usual written information for preparation (TAU).
The patients of the experimental group have access to various videos on the study website until their inpatient rehabilitation begins, the patients of the placebo group receive no special treatment.
The investigators hypothesize that the experimental group gains more positive outcome expectancy and treatment credibility compared to the control group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
492
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bavaria
-
Bad Kissingen, Bavaria, Germany, 97688
- Center for Rehabilitation Bad Kissingen
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Bad Neustadt, Bavaria, Germany, 97616
- Psychosomatic Clinic Bad Neustadt
-
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Rhineland-Palatinate
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Bad Dürkheim, Rhineland-Palatinate, Germany, 67098
- AHG Clinic for Psychosomatic Rehabilitation Bad Dürkheim
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Koblenz, Rhineland-Palatinate, Germany, 56070
- Knowledge Media Institute of the University of Koblenz-Landau
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Mainz, Rhineland-Palatinate, Germany, 55131
- University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Authorized inpatient rehabilitation in one of the cooperation clinics
- Internet access
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment as ususal (TAU) + Video Access
Patients in this arm receive access to various videos on the study website as well as treatment as usual (written information provided by the clinic).
|
Treatment as usual
Various videos showing four characteristic patient stories and five expert statements on special topics concerning inpatient psychosomatic rehabilitation.
|
Placebo Comparator: Treatment as usual (TAU)
Patients in this arm receive treatment as usual (written information provided by the clinic).
|
Treatment as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Outcome expectancy measured with the "Credibility Expectancy Questionnaire" (CEQ)
Time Frame: Two weeks before inpatient rehabilitation (T1)
|
Two weeks before inpatient rehabilitation (T1)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Work-related therapy motivation measured with the "Work-Related Therapy Motivation Questionnaire" (FBTM)
Time Frame: Two weeks before inpatient rehabilitation (T1)
|
Two weeks before inpatient rehabilitation (T1)
|
Treatment motivation measured with the "Questionnaire for Assessment of Rehabilitation Expectancy and Motivation" (FREM-17) and the "Patient Questionnaire for Assessment of Rehabilitation Motivation-20" (PAREMO-20)
Time Frame: Two weeks before inpatient rehabilitation (T1)
|
Two weeks before inpatient rehabilitation (T1)
|
Functioning in everyday life measured with the "Indicators of Rehabilitation Status-24" (IRES-24)
Time Frame: At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
|
At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
|
Satisfaction with inpatient rehabilitation measured with the "Patient Satisfaction Questionnaire-8" (ZUF-8)
Time Frame: At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
|
At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
|
Depression and anxiety measured with the "Patient Health Questionnaire-4" (PHQ-4)
Time Frame: At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
|
At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
|
Satisfaction with and usage of IP with a self devised questionnaire
Time Frame: Two weeks before inpatient rehabilitation (T1)
|
Two weeks before inpatient rehabilitation (T1)
|
Perceived advantage of after care measured with a self devised questionnaire
Time Frame: Two weeks before inpatient rehabilitation (T1)
|
Two weeks before inpatient rehabilitation (T1)
|
Internet usage and technology affinity measured with a self devised questionnaire
Time Frame: At study inclusion (T0)
|
At study inclusion (T0)
|
Use of online clinic review portals and the cooperation clinics websites measured with a self devised questionnaire
Time Frame: Two weeks before inpatient rehabilitation (T1)
|
Two weeks before inpatient rehabilitation (T1)
|
Treatments, especially rehabilitations, prior to this inpatient rehabilitation measured with a self devised questionnaire
Time Frame: At study inclusion (T0)
|
At study inclusion (T0)
|
Subjective prognosis of work ability measured with the questionnaire "Subjective Prognosis of Work-Ability" (SPE)
Time Frame: At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
|
At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
|
Treatment credibility measured with the "Credibility Expectancy Questionnaire" (CEQ)
Time Frame: Two weeks before inpatient rehabilitation (T1)
|
Two weeks before inpatient rehabilitation (T1)
|
Mental condition "Indicators of Rehabilitation Status-24" (IRES-24)
Time Frame: At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
|
At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rüdiger Zwerenz, Dr., University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
July 30, 2015
First Submitted That Met QC Criteria
August 25, 2015
First Posted (Estimate)
August 26, 2015
Study Record Updates
Last Update Posted (Estimate)
November 15, 2016
Last Update Submitted That Met QC Criteria
November 11, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- RK-93184
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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