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

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
      • Bad Neustadt, Bavaria, Germany, 97616
        • Psychosomatic Clinic Bad Neustadt
    • Rhineland-Palatinate
      • Bad Dürkheim, Rhineland-Palatinate, Germany, 67098
        • AHG Clinic for Psychosomatic Rehabilitation Bad Dürkheim
      • Koblenz, Rhineland-Palatinate, Germany, 56070
        • Knowledge Media Institute of the University of Koblenz-Landau
      • 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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