Clinical trial NCT02196896: Enhancing Inpatient Psychotherapeutic Treatment With Online Self-help : Acceptance and Efficacy
Official title: Enhancing Inpatient Psychotherapeutic Treatment With Online Self Help in a Randomised Controlled Trial: Acceptance and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Rhön-Klinikum AG
First posted: 2014-07-22
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II)
timeFrame: Three months after randomization
Secondary outcomes:
measure: Reduction of depression measured with the depression scale of the "Patient Health Questionnaire" (PHQ-9)
timeFrame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II)
timeFrame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Reduction of anxiety measured with the "Generalized Anxiety Disorder Scale" (GAD-7)
timeFrame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Reduction of dysfunctional depression related cognitions measured with the "Dysfunctional Attitude Scale" (DAS)
timeFrame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Improved self-esteem measured with the "Rosenberg Self-Esteem Scale" (RSE)
timeFrame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Improved quality of life measured with the "European Health Interview Survey Quality of Life-8" (EUROHIS-QOL 8)
timeFrame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Improved working ability measured with the short form of the "Work Ability Index" (WAI)
timeFrame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Acceptance and utilization of deprexis® measured with a self devised questionnaire
timeFrame: End of inpatient treatment (average 6 weeks), three months after randomization
measure: Acceptance and utilization of the information used in the placebo condition measured with a self devised questionnaire
timeFrame: End of inpatient treatment (average 6 weeks), three months after randomization
measure: Degree of childhood traumas measured with the "Childhood Trauma Questionnaire" (CTQ)
timeFrame: Randomization
measure: Degree of structural deficits measured with the short form of the OPD-Structure Questionnaire (OPD-SFK)
timeFrame: Randomization
measure: Therapeutic alliance between participant and inpatient psychotherapist measured with the "Helping Alliance Questionnaire" (HAQ).
timeFrame: Randomization, end of inpatient treatment (average 6 weeks)
measure: Course of mood, depressiveness and utilization of units
timeFrame: During inpatient treatment (average 6 weeks)
measure: Utilization of other treatments after the end of inpatient treatment
timeFrame: Six months after randomization
measure: Satisfaction with inpatient treatment
timeFrame: End of inpatient treatment (average 6 weeks)
measure: Willingness to pay
timeFrame: Three months after randomization
measure: Remission from depression
timeFrame: End of inpatient treatment (average 6 weeks), three months after randomization, six months after randomization
Other outcomes:
Locations:
city: Bad Neustadt
country: Germany
facility: Psychosomatic Clinic Bad Neustadt
state: Bavaria
city: Mainz
country: Germany
facility: University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
name: Manfred E Beutel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.