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

NCT ID: NCT02196896

Last Updated: 2017-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

deprexis®

Patients in this arm use deprexis® as an additional treatment during their inpatient stay and as an aftercare intervention.

Group Type EXPERIMENTAL

deprexis®

Intervention Type OTHER

Online self-help program in addition to inpatient psychosomatic treatment for 90 days.

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.

Group Type PLACEBO_COMPARATOR

Information

Intervention Type OTHER

The patients receive online information about depression once a week for 90 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

deprexis®

Online self-help program in addition to inpatient psychosomatic treatment for 90 days.

Intervention Type OTHER

Information

The patients receive online information about depression once a week for 90 days.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rhön-Klinikum AG

UNKNOWN

Sponsor Role collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

M.E. Beutel

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Manfred E Beutel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Psychosomatic Clinic Bad Neustadt

Bad Neustadt an der Saale, Bavaria, Germany

Site Status

University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31651403 (View on PubMed)

Zwerenz 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.

Reference Type DERIVED
PMID: 25872505 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RK-97880

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exercise for Depression
NCT02874833 COMPLETED NA
Treatment for Post-Stroke Depression
NCT00029172 COMPLETED PHASE4
Imagery Rescripting in Depression
NCT03299127 COMPLETED NA
Self-guided Treatment for Depression
NCT06028984 ACTIVE_NOT_RECRUITING NA