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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • 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

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
Intervention / Treatment
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

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

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

Johannes Gutenberg University Mainz

Collaborators

Rhön-Klinikum AG

Investigators

  • 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

June 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 22, 2014

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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