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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
492

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: Treatment as usual
Treatment as usual
Other: Videos
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).
Other: Treatment as usual
Treatment as usual

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johannes Gutenberg University Mainz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Deutsche Rentenversicherung
University of Koblenz-Landau

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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