Outcome ExpectancyPhase 2Reh@:InfoNCT02532881
Evaluation of a Video-based Internet Intervention as Preparation for Inpatient Psychosomatic Rehabilitation
A Phase 2 study testing Videos and Treatment as usual in people with Outcome Expectancy, run by Johannes Gutenberg University Mainz at 5 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outcome Expectancy
- What is being tested?
- Videos and Treatment as usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 492 participants
- Where
- 5 sitesGermany
- Study dates
- Aug 2015to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Authorized inpatient rehabilitation in one of the cooperation clinics
- Internet access
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
AHG Clinic for Psychosomatic Rehabilitation Bad Dürkheim
Bad Dürkheim, Rhineland-Palatinate, 67098
Center for Rehabilitation Bad Kissingen
Bad Kissingen, Bavaria, 97688
Psychosomatic Clinic Bad Neustadt
Bad Neustadt an der Saale, Bavaria, 97616
Knowledge Media Institute of the University of Koblenz-Landau
Koblenz, Rhineland-Palatinate, 56070
University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: 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.
- Conditions
- Outcome Expectancy
- Being tested
- Videos, Treatment as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideosOther
Various videos showing four characteristic patient stories and five expert statements on special topics concerning inpatient psychosomatic rehabilitation.
Treatment as usualOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome expectancy measured with the "Credibility Expectancy Questionnaire" (CEQ)
Measured: Two weeks before inpatient rehabilitation (T1)
Secondary outcomes (13)
Work-related therapy motivation measured with the "Work-Related Therapy Motivation Questionnaire" (FBTM)
Measured: 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)
Measured: Two weeks before inpatient rehabilitation (T1)
Functioning in everyday life measured with the "Indicators of Rehabilitation Status-24" (IRES-24)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Two weeks before inpatient rehabilitation (T1)
Perceived advantage of after care measured with a self devised questionnaire
Measured: Two weeks before inpatient rehabilitation (T1)
Internet usage and technology affinity measured with a self devised questionnaire
Measured: At study inclusion (T0)
Use of online clinic review portals and the cooperation clinics websites measured with a self devised questionnaire
Measured: Two weeks before inpatient rehabilitation (T1)
Treatments, especially rehabilitations, prior to this inpatient rehabilitation measured with a self devised questionnaire
Measured: At study inclusion (T0)
Subjective prognosis of work ability measured with the questionnaire "Subjective Prognosis of Work-Ability" (SPE)
Measured: 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)
Measured: Two weeks before inpatient rehabilitation (T1)
Mental condition "Indicators of Rehabilitation Status-24" (IRES-24)
Measured: At the end of inpatient rehabilitation, an expected average of six weeks after admission to inpatient rehabilitation (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Outcome ExpectancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kaiserslautern-Landau, Deutsche Rentenversicherung
- Responsible party
- Principal investigator, Dr. Rüdiger Zwerenz, Johannes Gutenberg University Mainz
- Investigators
- Rüdiger Zwerenz, Dr., Principal investigator, University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532881
- Sponsor's protocol ID
- RK-93184
- Acronym
- Reh@:Info
- Status last verified
- Nov 2016
- First submitted
- 30 Jul 2015
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27296249
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Video-based Internet Intervention as Preparation for Inpatient Psychosomatic Rehabilitation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02532881
- Acronym / sponsor ID
- Reh@:Info / RK-93184
- Conditions
- Outcome Expectancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- University of Kaiserslautern-Landau, Deutsche Rentenversicherung
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as ususal (TAU) + Video Access | Experimental | Other: Videos, Other: Treatment as usualPatients 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 (TAU) | Placebo comparator | Other: Treatment as usualPatients in this arm receive treatment as usual (written information provided by the clinic). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Authorized inpatient rehabilitation in one of the cooperation clinics
- Internet access
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideosVarious videos showing four characteristic patient stories and five expert statements on special topics concerning inpatient psychosomatic rehabilitation. | Other | Treatment as ususal (TAU) + Video Access |
| Treatment as usualTreatment as usual | Other | Treatment as usual (TAU), Treatment as ususal (TAU) + Video Access |
Primary outcome
Outcome expectancy measured with the "Credibility Expectancy Questionnaire" (CEQ)
Time frame: Two weeks before inpatient rehabilitation (T1)
13 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Derived from this study: PubMed 27296249Becker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rüdiger Zwerenz, Dr. principal investigator
University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Videos and Treatment as usual in people with Outcome Expectancy, run by Johannes Gutenberg University Mainz at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome expectancy measured with the "Credibility Expectancy Questionnaire" (CEQ) (time frame: Two weeks before inpatient rehabilitation (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02532881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.