Enhancing Inpatient Psychotherapeutic Treatment With Online Self-help : Acceptance and Efficacy
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ClinicalTrials.gov Identifier: NCT02196896 |
Recruitment Status :
Completed
First Posted : July 22, 2014
Last Update Posted : March 17, 2017
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Condition or disease | Intervention/treatment | Phase |
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Depression | Other: deprexis® Other: Information | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: deprexis®
Patients in this arm use deprexis® as an additional treatment during their inpatient stay and as an aftercare intervention.
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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.
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Other: Information
The patients receive online information about depression once a week for 90 days. |
- Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II) [ Time Frame: Three months after randomization ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Acceptance and utilization of deprexis® measured with a self devised questionnaire [ Time Frame: 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 ]
- 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.
- 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.
- Therapeutic alliance between participant and inpatient psychotherapist measured with the "Helping Alliance Questionnaire" (HAQ). [ Time Frame: Randomization, end of inpatient treatment (average 6 weeks) ]
- Course of mood, depressiveness and utilization of units [ Time Frame: During inpatient treatment (average 6 weeks) ]
- Utilization of other treatments after the end of inpatient treatment [ Time Frame: Six months after randomization ]
- Satisfaction with inpatient treatment [ Time Frame: End of inpatient treatment (average 6 weeks) ]
- Willingness to pay [ Time Frame: 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)

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196896
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 |
Principal Investigator: | Manfred E Beutel, Prof. Dr. | University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz |
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 Key Record Dates |
Last Update Posted: | March 17, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Depression Behavioral Symptoms |