Clinical trial NCT02532881: Evaluation of a Video-based Internet Intervention as Preparation for Inpatient Psychosomatic Rehabilitation
Official title: Evaluation of a Video-based Internet Intervention as Preparation for Inpatient Psychosomatic Rehabilitation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Outcome Expectancy
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: University of Kaiserslautern-Landau
name: Deutsche Rentenversicherung
First posted: 2015-08-26
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Authorized inpatient rehabilitation in one of the cooperation clinics
* Internet access

Exclusion Criteria:

* None

Primary outcomes:
measure: Outcome expectancy measured with the "Credibility Expectancy Questionnaire" (CEQ)
timeFrame: Two weeks before inpatient rehabilitation (T1)
Secondary outcomes:
measure: Work-related therapy motivation measured with the "Work-Related Therapy Motivation Questionnaire" (FBTM)
timeFrame: Two weeks before inpatient rehabilitation (T1)
measure: 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)
timeFrame: Two weeks before inpatient rehabilitation (T1)
measure: Functioning in everyday life measured with the "Indicators of Rehabilitation Status-24" (IRES-24)
timeFrame: At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
measure: Satisfaction with inpatient rehabilitation measured with the "Patient Satisfaction Questionnaire-8" (ZUF-8)
timeFrame: At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
measure: Depression and anxiety measured with the "Patient Health Questionnaire-4" (PHQ-4)
timeFrame: At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
measure: Satisfaction with and usage of IP with a self devised questionnaire
timeFrame: Two weeks before inpatient rehabilitation (T1)
measure: Perceived advantage of after care measured with a self devised questionnaire
timeFrame: Two weeks before inpatient rehabilitation (T1)
measure: Internet usage and technology affinity measured with a self devised questionnaire
timeFrame: At study inclusion (T0)
measure: Use of online clinic review portals and the cooperation clinics websites measured with a self devised questionnaire
timeFrame: Two weeks before inpatient rehabilitation (T1)
measure: Treatments, especially rehabilitations, prior to this inpatient rehabilitation measured with a self devised questionnaire
timeFrame: At study inclusion (T0)
measure: Subjective prognosis of work ability measured with the questionnaire "Subjective Prognosis of Work-Ability" (SPE)
timeFrame: At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
measure: Treatment credibility measured with the "Credibility Expectancy Questionnaire" (CEQ)
timeFrame: Two weeks before inpatient rehabilitation (T1)
measure: Mental condition "Indicators of Rehabilitation Status-24" (IRES-24)
timeFrame: At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
Other outcomes:
Locations:
city: Bad Kissingen
country: Germany
facility: Center for Rehabilitation Bad Kissingen
state: Bavaria
city: Bad Neustadt
country: Germany
facility: Psychosomatic Clinic Bad Neustadt
state: Bavaria
city: Bad Dürkheim
country: Germany
facility: AHG Clinic for Psychosomatic Rehabilitation Bad Dürkheim
state: Rhineland-Palatinate
city: Koblenz
country: Germany
facility: Knowledge Media Institute of the University of Koblenz-Landau
state: Rhineland-Palatinate
city: Mainz
country: Germany
facility: University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
name: Rüdiger Zwerenz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Becker J, Beutel ME, Gerzymisch K, Schulz D, Siepmann M, Knickenberg RJ, Schmadeke S, Ferdinand P, Zwerenz R. Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial. Trials. 2016 Jun 13;17(1):287. doi: 10.1186/s13063-016-1417-y.