Enhancing Inpatient Psychotherapeutic Treatment With Online Self-help : Acceptance and Efficacy

March 16, 2017 updated by: M.E. Beutel, Johannes Gutenberg University Mainz

Enhancing Inpatient Psychotherapeutic Treatment With Online Self Help in a Randomised Controlled Trial: Acceptance and Efficacy

The purpose of this study is to determine the acceptance and efficacy of the online self-help program deprexis® for depressed patients in reducing the clinical symptoms of their depression. The patients of the experimental group use deprexis® for 90 days, the patients of the placebo group receive weekly online information about depression for 90 days as well. Both groups receive their treatment in addition to their regular inpatient psychosomatic treatment and as an aftercare intervention.The investigators hypothesize that the online self-help group achieves a greater reduction of depression compared to the control group.

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.
229

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.
  • Not Applicable

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
    • Bavaria
      • Bad Neustadt, Bavaria, Germany, 97616
        • Psychosomatic Clinic Bad Neustadt
    • 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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inpatient treatment
  • Private internet access
  • Informed consent
  • Age between 18 and 65 years
  • Knowledge of the German language
  • Score in the BDI-II > 13 and clinical diagnosis of a depression (ICD-10: F32.x, F33.x, F34.1, F43.2) verified by the inpatient therapist

Exclusion Criteria:

  • Psychosis
  • Current alcohol or drug dependency
  • Borderline, antisocial, schizoid or schizotypal personality disorder
  • Anorexia nervosa
  • Life time diagnosis of a schizophrenia, schizoaffective , bipolar oder 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
  • Masking: NONE

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: deprexis®
Patients in this arm use deprexis® as an additional treatment during their inpatient stay and as an aftercare intervention.
Other: deprexis®
Online self-help program in addition to inpatient psychosomatic treatment for 90 days.
Placebo Comparator: Information
Patients in this arm receive online information about depression as a placebo comparator in addition to their treatment during their inpatient stay and as an aftercare intervention.
Other: Information
The patients receive online information about depression once a week for 90 days.

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
Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II)
Time Frame: Three months after randomization
Three months after randomization

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
Measure Description
Time Frame
Reduction of depression measured with the depression scale of the "Patient Health Questionnaire" (PHQ-9)
Time Frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II)
Time Frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Reduction of anxiety measured with the "Generalized Anxiety Disorder Scale" (GAD-7)
Time Frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Reduction of dysfunctional depression related cognitions measured with the "Dysfunctional Attitude Scale" (DAS)
Time Frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Improved self-esteem measured with the "Rosenberg Self-Esteem Scale" (RSE)
Time Frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Improved quality of life measured with the "European Health Interview Survey Quality of Life-8" (EUROHIS-QOL 8)
Time Frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Improved working ability measured with the short form of the "Work Ability Index" (WAI)
Time Frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Acceptance and utilization of deprexis® measured with a self devised questionnaire
Time Frame: End of inpatient treatment (average 6 weeks), three months after randomization
End of inpatient treatment (average 6 weeks), three months after randomization
Acceptance and utilization of the information used in the placebo condition measured with a self devised questionnaire
Time Frame: End of inpatient treatment (average 6 weeks), three months after randomization
End of inpatient treatment (average 6 weeks), three months after randomization
Degree of childhood traumas measured with the "Childhood Trauma Questionnaire" (CTQ)
Time Frame: Randomization
Assumption that childhood traumas, assessed at the beginning of treatment, have a moderating effect on the reduction in the primary outcome measure.
Randomization
Degree of structural deficits measured with the short form of the OPD-Structure Questionnaire (OPD-SFK)
Time Frame: Randomization
Assumption that structural deficits, as assessed with the OPD-SFK questionnaire at the beginning of treatment have a moderating effect on the reduction in the primary outcome measure.
Randomization
Therapeutic alliance between participant and inpatient psychotherapist measured with the "Helping Alliance Questionnaire" (HAQ).
Time Frame: Randomization, end of inpatient treatment (average 6 weeks)
Randomization, end of inpatient treatment (average 6 weeks)
Course of mood, depressiveness and utilization of units
Time Frame: During inpatient treatment (average 6 weeks)
During inpatient treatment (average 6 weeks)
Utilization of other treatments after the end of inpatient treatment
Time Frame: Six months after randomization
Six months after randomization
Satisfaction with inpatient treatment
Time Frame: End of inpatient treatment (average 6 weeks)
End of inpatient treatment (average 6 weeks)
Willingness to pay
Time Frame: Three months after randomization
Three months after randomization
Remission from depression
Time Frame: End of inpatient treatment (average 6 weeks), three months after randomization, six months after randomization
BDI score below the cutoff of 13 and a reliable change regarding Reliable Change Index (RCI)
End of inpatient treatment (average 6 weeks), three months after randomization, six months after randomization

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rhön-Klinikum AG

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.
  • Principal Investigator: Manfred E Beutel, Prof. Dr., University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, 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.
June 1, 2014

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.
November 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.
November 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).
July 16, 2014

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.
July 21, 2014

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.
July 22, 2014

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.
March 17, 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.
March 16, 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.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

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-97880

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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