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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
Sponsor:
Collaborator:
Rhön-Klinikum AG
Information provided by (Responsible Party):
M.E. Beutel, Johannes Gutenberg University Mainz

Tracking Information
First Submitted Date  ICMJE July 16, 2014
First Posted Date  ICMJE July 22, 2014
Last Update Posted Date March 17, 2017
Study Start Date  ICMJE June 2014
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II) [ Time Frame: Three months after randomization ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2014)
Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II) [ Time Frame: Six months after randomization ]
Change History Complete list of historical versions of study NCT02196896 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2014)
  • Reduction of depression measured with the depression scale of the "Patient Health Questionnaire" (PHQ-9) [ Time Frame: Participants will be followed for the duration of inpatient treatment, an expected average of 6 weeks, and six months after randomization. ]
  • Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II) [ Time Frame: Participants will be followed for the duration of inpatient treatment, an expected average of 6 weeks. ]
  • Reduction of anxiety measured with the "Generalized Anxiety Disorder Scale" (GAD-7) [ Time Frame: Participants will be followed for the duration of inpatient treatment, an expected average of 6 weeks, and six months after randomization. ]
  • Reduction of dysfunctional depression related cognitions measured with the "Dysfunctional Attitude Scale" (DAS) [ Time Frame: Participants will be followed for the duration of inpatient treatment, an expected average of 6 weeks, and six months after randomization. ]
  • Improved self-esteem measured with the "Rosenberg Self-Esteem Scale" (RSE) [ Time Frame: Participants will be followed for the duration of inpatient treatment, an expected average of 6 weeks, and six months after randomization. ]
  • Improved quality of life measured with the "European Health Interview Survey Quality of Life-8" (EUROHIS-QOL 8) [ Time Frame: Participants will be followed for the duration of inpatient treatment, an expected average of 6 weeks, and six months after randomization. ]
  • Improved working ability measured with the short form of the "Work Ability Index" (WAI) [ Time Frame: Participants will be followed for the duration of inpatient treatment, an expected average of 6 weeks, and six months after randomization. ]
  • Acceptance and utilization of deprexis® measured with a self devised questionnaire [ Time Frame: Participants will be followed for the duration of inpatient treatment, an expected average of 6 weeks, and six months after randomization. ]
  • Acceptance and utilization of the information used in the placebo condition measured with a self devised questionnaire [ Time Frame: Participants will be followed for the duration of inpatient treatment, an expected average of 6 weeks, and six 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: Participants will be followed for the duration of inpatient treatment, an expected average of 6 weeks. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing Inpatient Psychotherapeutic Treatment With Online Self-help : Acceptance and Efficacy
Official Title  ICMJE Enhancing Inpatient Psychotherapeutic Treatment With Online Self Help in a Randomised Controlled Trial: Acceptance and Efficacy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Other: deprexis®
    Online self-help program in addition to inpatient psychosomatic treatment for 90 days.
  • Other: Information
    The patients receive online information about depression once a week for 90 days.
Study Arms  ICMJE
  • Experimental: deprexis®
    Patients in this arm use deprexis® as an additional treatment during their inpatient stay and as an aftercare intervention.
    Intervention: Other: deprexis®
  • 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.
    Intervention: Other: Information
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2017)
229
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2014)
240
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02196896
Other Study ID Numbers  ICMJE RK-97880
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party M.E. Beutel, Johannes Gutenberg University Mainz
Study Sponsor  ICMJE Johannes Gutenberg University Mainz
Collaborators  ICMJE Rhön-Klinikum AG
Investigators  ICMJE
Principal Investigator: Manfred E Beutel, Prof. Dr. University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
PRS Account Johannes Gutenberg University Mainz
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP