Enhancing Inpatient Psychotherapeutic Treatment With Online Self-help : Acceptance and Efficacy
1 other identifier
interventional
229
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jun 2014
Typical duration for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 16, 2014
CompletedFirst Posted
Study publicly available on registry
July 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedMarch 17, 2017
March 1, 2017
2.4 years
July 16, 2014
March 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II)
Three months after randomization
Secondary Outcomes (17)
Reduction of depression measured with the depression scale of the "Patient Health Questionnaire" (PHQ-9)
Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II)
Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Reduction of anxiety measured with the "Generalized Anxiety Disorder Scale" (GAD-7)
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)
Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
Improved self-esteem measured with the "Rosenberg Self-Esteem Scale" (RSE)
Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
- +12 more secondary outcomes
Study Arms (2)
deprexis®
EXPERIMENTALPatients in this arm use deprexis® as an additional treatment during their inpatient stay and as an aftercare intervention.
Information
PLACEBO COMPARATORPatients 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.
Interventions
Online self-help program in addition to inpatient psychosomatic treatment for 90 days.
The patients receive online information about depression once a week for 90 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johannes Gutenberg University Mainzlead
- Rhön-Klinikum AGcollaborator
Study Sites (2)
Psychosomatic Clinic Bad Neustadt
Bad Neustadt an der Saale, Bavaria, 97616, Germany
University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University
Mainz, Rhineland-Palatinate, 55131, Germany
Related Publications (2)
Zwerenz R, Baumgarten C, Becker J, Tibubos A, Siepmann M, Knickenberg RJ, Beutel ME. Improving the Course of Depressive Symptoms After Inpatient Psychotherapy Using Adjunct Web-Based Self-Help: Follow-Up Results of a Randomized Controlled Trial. J Med Internet Res. 2019 Oct 24;21(10):e13655. doi: 10.2196/13655.
PMID: 31651403DERIVEDZwerenz R, Becker J, Knickenberg RJ, Hagen K, Dreier M, Wolfling K, Beutel ME. Enhancing inpatient psychotherapeutic treatment with online self-help: study protocol for a randomized controlled trial. Trials. 2015 Mar 17;16:98. doi: 10.1186/s13063-015-0620-6.
PMID: 25872505DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manfred E Beutel, Prof. Dr.
University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
July 16, 2014
First Posted
July 22, 2014
Study Start
June 1, 2014
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
March 17, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share