Evaluation of a Video-based Internet Intervention as Preparation for Inpatient Psychosomatic Rehabilitation

NCT02532881 | Completed Phase 2

• 1 other identifier: RK-93184
• Study Type: interventional
• Target: 492
• Locations: 1 country
• Sites: 5

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.

Conditions

Outcome Expectancy

Outcome Measures

Primary Outcomes (1)

• Outcome expectancy measured with the "Credibility Expectancy Questionnaire" (CEQ)

  Two weeks before inpatient rehabilitation (T1)

Secondary Outcomes (13)

• Work-related therapy motivation measured with the "Work-Related Therapy Motivation Questionnaire" (FBTM)

  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)

  Two weeks before inpatient rehabilitation (T1)

• Functioning in everyday life measured with the "Indicators of Rehabilitation Status-24" (IRES-24)

  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)

  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)

  At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)

Study Arms (2)

Treatment as ususal (TAU) + Video Access

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).

Other: Videos; Other: Treatment as usual

Treatment as usual (TAU)

PLACEBO COMPARATOR

Patients in this arm receive treatment as usual (written information provided by the clinic).

Other: Treatment as usual

Interventions

Videos OTHER

Various videos showing four characteristic patient stories and five expert statements on special topics concerning inpatient psychosomatic rehabilitation.

Treatment as ususal (TAU) + Video Access

Treatment as usual OTHER

Treatment as usual

Treatment as usual (TAU); Treatment as ususal (TAU) + Video Access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• University of Kaiserslautern-Landau: collaborator
• Deutsche Rentenversicherung: collaborator

Study Sites (5)

Center for Rehabilitation Bad Kissingen

Bad Kissingen, Bavaria, 97688, Germany

Location

Psychosomatic Clinic Bad Neustadt

Bad Neustadt an der Saale, Bavaria, 97616, Germany

Location

AHG Clinic for Psychosomatic Rehabilitation Bad Dürkheim

Bad Dürkheim, Rhineland-Palatinate, 67098, Germany

Location

Knowledge Media Institute of the University of Koblenz-Landau

Koblenz, Rhineland-Palatinate, 56070, Germany

Location

University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (1)

• 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.

  PMID: 27296249 DERIVED

MeSH Terms

Interventions

Videotape Recording; Therapeutics

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Rüdiger Zwerenz, Dr.

  University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 26, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

DE (5)