NCT02196896CompletedNot Applicable
Enhancing Inpatient Psychotherapeutic Treatment With Online Self Help in a Randomised Controlled Trial: Acceptance and Efficacy
Johannes Gutenberg University Mainz4 sites in 1 country229 target enrollmentStarted: June 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 229
- Locations
- 4
- Primary Endpoint
- Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II)
Time Frame: Three months after randomization
Secondary Outcomes
- 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)
- Improved quality of life measured with the "European Health Interview Survey Quality of Life-8" (EUROHIS-QOL 8)(Randomization, end of inpatient treatment (average 6 weeks), six months after randomization)
- Acceptance and utilization of deprexis® measured with a self devised questionnaire(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(End of inpatient treatment (average 6 weeks), three months after randomization)
- Degree of childhood traumas measured with the "Childhood Trauma Questionnaire" (CTQ)(Randomization)
- Improved working ability measured with the short form of the "Work Ability Index" (WAI)(Randomization, end of inpatient treatment (average 6 weeks), six months after randomization)
- Degree of structural deficits measured with the short form of the OPD-Structure Questionnaire (OPD-SFK)(Randomization)
- Therapeutic alliance between participant and inpatient psychotherapist measured with the "Helping Alliance Questionnaire" (HAQ).(Randomization, end of inpatient treatment (average 6 weeks))
- Course of mood, depressiveness and utilization of units(During inpatient treatment (average 6 weeks))
- Utilization of other treatments after the end of inpatient treatment(Six months after randomization)
- Satisfaction with inpatient treatment(End of inpatient treatment (average 6 weeks))
- Willingness to pay(Three months after randomization)
- Remission from depression(End of inpatient treatment (average 6 weeks), three months after randomization, six months after randomization)
- 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)
Investigators
M.E. Beutel
Prof. Dr.
Johannes Gutenberg University Mainz
Study Sites (4)
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