Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study (KEN)

October 27, 2017 updated by: Dr. Rüdiger Zwerenz, Johannes Gutenberg University Mainz

Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study as an After Care After Inpatient Psychosomatic Treatment

The purpose of this study is to determine the feasibility and effectiveness of an internet-based self help program concerning satisfaction with the treatment and their life, depression and anxiety. Both study groups get access to the internet-based self-help program. The intervention group receives additional feedback to their progress in the program from an online therapist. The investigators hypothesize that (1) at least 75% of the patients in the intervention group are "satisfied" or "very satisfied" with the self-help program, (2) 50% of the patients in the intervention group work with all eight units and (3) patients of the intervention group have a higher emotional competence than the patients of the control group at the end of the self-help program.

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.
83

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
    • Rhineland-Palatinate
      • 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:

  • day care/ inpatient treatment in the Department of Psychosomatic Medicine and Psychotherapy at the University Medical Center of the Johannes Gutenberg-University Mainz
  • minimum age of 18 years
  • private internet access
  • e-mail address

Exclusion Criteria:

  • acute suicidality
  • psychosis
  • current alcohol or drug addiction
  • life time diagnosis of a schizophrenic, schizoaffective, bipolar or organic psychic disorder

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: None (Open Label)

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: self-help program + feedback
Patients in this arm receive access to the internet-based self-help program and get feedback on their progress in the program.
Behavioral: self-help program
Access to the internet-based self-help program
Behavioral: therapeutic feedback
Therapeutic feedback on the written information sent to the online therapist
Active Comparator: self-help program
Patients in this arm receive access to the internet-based self-help program and don't get any therapeutic feedback
Behavioral: self-help program
Access to the internet-based self-help program

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
Satisfaction of the intervention group with the internet-based self-help program measured with an reworded version of the "patient satisfaction questionnaire" (ZUF-8)
Time Frame: 10 weeks after study inclusion (T1)
10 weeks after study inclusion (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
Emotional competence measured with the "SEK-27" (questionnaire for self-assessment of emotional competence)
Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Depression measured with the German version of the "PHQ-9" (Patient Health Questionnaire)
Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Quality of life measured with the German version of the "EUROHIS-QOL 8" (European Health Interview Survey Quality of Life 8)
Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Anxiety measured with the German version of the "GAD-7" (General Anxiety Disorder Screener)
Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Self-esteem measured with the German version of the "RSE" (Rosenberg Self-Esteem Scale)
Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Somatoform afflictions measured with the German version of the "SSS-8" (Somatic Symptom Scale)
Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Subjective prognosis of work ability measured with the "SPE" (Subjective Prognosis of Work Ability)
Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Therapeutic alliance measured with the German version of the "WAI-SR" (Working Alliance Inventory - Short Revised)
Time Frame: 10 weeks after study inclusion (T1)
10 weeks after study inclusion (T1)
Depersonalisation measured with the German short version of the "CDS-2" (Cambridge Depersonalisation Scale)
Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Acceptance of the internet-based self-help program measured with an especially for the self-help program devised questionnaire
Time Frame: End of every unit (weekly) and 10 weeks after study inclusion (T1)
End of every unit (weekly) and 10 weeks after study inclusion (T1)
Usage of the internet-based self-help program measured with an especially for the self-help program devised questionnaire
Time Frame: 10 weeks after study inclusion (T1)
10 weeks after study inclusion (T1)
Utilization of alternative after care measures (psychotherapy and drugs) with a self-devised questionnaire
Time Frame: 10 weeks after study inclusion (T1)
10 weeks after study inclusion (T1)

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

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.
  • Study Director: Manfred E Beutel, Prof. Dr., Department for Psychosomatic Medicine and Psychotherapy at the University Medical Center of the 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.
September 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.
May 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.
July 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).
January 15, 2016

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.
January 29, 2016

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.
February 2, 2016

Study Record Updates

Last Update Posted (Actual)

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.
October 30, 2017

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.
October 27, 2017

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.
October 1, 2017

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-91809

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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