Overview

This trial has been completed.

Condition outcome expectancy
Treatments videos, treatment as usual
Phase phase 2
Sponsor Johannes Gutenberg University Mainz
Collaborator Knowledge Media Institute, University Koblenz-Landau
Start date August 2015
End date August 2016
Trial size 492 participants
Trial identifier NCT02532881, RK-93184

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
Arm
(Experimental)
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).
videos
Various videos showing four characteristic patient stories and five expert statements on special topics concerning inpatient psychosomatic rehabilitation.
treatment as usual
Treatment as usual
(Placebo Comparator)
Patients in this arm receive treatment as usual (written information provided by the clinic).
treatment as usual
Treatment as usual

Primary Outcomes

Measure
Outcome expectancy measured with the "Credibility Expectancy Questionnaire" (CEQ)
time frame: Two weeks before inpatient rehabilitation (T1)

Secondary Outcomes

Measure
Work-related therapy motivation measured with the "Work-Related Therapy Motivation Questionnaire" (FBTM)
time frame: 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)
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)
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)
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)
Satisfaction with and usage of IP with a self devised questionnaire
time frame: 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)
Internet usage and technology affinity measured with a self devised questionnaire
time frame: 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)
Treatments, especially rehabilitations, prior to this inpatient rehabilitation measured with a self devised questionnaire
time frame: 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)
Treatment credibility measured with the "Credibility Expectancy Questionnaire" (CEQ)
time frame: 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)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Authorized inpatient rehabilitation in one of the cooperation clinics - Internet access Exclusion Criteria:

Additional Information

Official title Evaluation of a Video-based Internet Intervention as Preparation for Inpatient Psychosomatic Rehabilitation: A Randomized Controlled Trial
Principal investigator Rüdiger Zwerenz, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Johannes Gutenberg University Mainz.