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

• ClinicalTrials.gov Identifier: NCT02196896
• Recruitment Status: Completed
• First Posted: July 22, 2014
• Last Update Posted: March 17, 2017
• Sponsor: Johannes Gutenberg University Mainz
• Collaborator: Rhön-Klinikum AG
• Information provided by (Responsible Party): M.E. Beutel, Johannes Gutenberg University Mainz

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression	Other: deprexis®; Other: Information	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 229 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Enhancing Inpatient Psychotherapeutic Treatment With Online Self Help in a Randomised Controlled Trial: Acceptance and Efficacy
• Study Start Date: June 2014
• Actual Primary Completion Date: November 2016
• Actual Study Completion Date: November 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]
5. 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 ]
6. 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 ]
7. 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 ]
8. Acceptance and utilization of deprexis® measured with a self devised questionnaire [ Time Frame: End of inpatient treatment (average 6 weeks), three months after randomization ]
9. 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 ]
10. 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.
11. 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.
12. Therapeutic alliance between participant and inpatient psychotherapist measured with the "Helping Alliance Questionnaire" (HAQ). [ Time Frame: Randomization, end of inpatient treatment (average 6 weeks) ]
13. Course of mood, depressiveness and utilization of units [ Time Frame: During inpatient treatment (average 6 weeks) ]
14. Utilization of other treatments after the end of inpatient treatment [ Time Frame: Six months after randomization ]
15. Satisfaction with inpatient treatment [ Time Frame: End of inpatient treatment (average 6 weeks) ]
16. Willingness to pay [ Time Frame: Three months after randomization ]
17. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Germany

Psychosomatic Clinic Bad Neustadt

Bad Neustadt, Bavaria, Germany, 97616

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

Mainz, Rhineland-Palatinate, Germany, 55131

Sponsors and Collaborators

Johannes Gutenberg University Mainz

Rhön-Klinikum AG

Investigators

• Principal Investigator: Manfred E Beutel, Prof. Dr.; University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Zwerenz R, Becker J, Knickenberg RJ, Hagen K, Dreier M, Wölfling 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.

• Responsible Party: M.E. Beutel, Prof. Dr., Johannes Gutenberg University Mainz
• ClinicalTrials.gov Identifier: NCT02196896
• Other Study ID Numbers: RK-97880
• First Posted: July 22, 2014
• Last Update Posted: March 17, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Depression; Behavioral Symptoms