NCT00662428

Brief Summary

The cost-effectiveness of a new, guideline oriented sequential inpatient - outpatient treatment model will be investigated. Secondary outcomes are: patient satisfaction, practitioners' satisfaction and influence on work.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

April 15, 2008

Last Update Submit

June 20, 2012

Conditions

Depressive Disorder

Keywords

cost-benefit analysispractice guidelineinpatients

Outcome Measures

Primary Outcomes (1)

  • Cost-effectiveness: ratio of treatment response and treatment costs

    one year after discharge

Secondary Outcomes (2)

  • Symptom reduction

    at discharge, 6 month after discharge, and one year after discharge

  • patient satisfaction

    at discharge

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Symptom based discharge management

Control

ACTIVE COMPARATOR
Other: Treatment as usual

Interventions

Symptom based discharge managementOTHER

Depressive symptoms of patients are weekly assessed by Beck Depression Inventory (BDI II). Patients are discharged when BDI-score is under 20 points. Patients are treated in the same hospital for two more weeks as outpatients before being referred to outpatient care (general practitioner or specialist).

Intervention
Treatment as usualOTHER

Treatment as usual is the usual stationary depression treatment which consists of a combination of several psychopharmacological and psychotherapeutical treatments. Duration of treatment is varying widely.

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current depressive episode at time of admission
  • ICD-10 diagnosis:
  • Depressive episode, F 32.xx
  • Recurrent depressive episode, F 33.xx
  • Depression is primary treatment indication
  • The ability to give informed consent
  • Sufficient German language skills
  • Being resident sufficiently close to the hospital for being able to take part in the outpatient program
  • permanent residence

You may not qualify if:

  • Dementia
  • Alcohol or drug dependence (not misuse)
  • Psychotic symptoms
  • Schizoaffective disorders
  • Bipolar disorders
  • Schizophrenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Krankenhaus Hofheim

Hofheim, Hesse, 65719, Germany

Location

Bezirkskrankenhaus Bayreuth

Bayreuth, D-95445, Germany

Location

Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy

Freiburg im Breisgau, D-79104, Germany

Location

Städtisches Klinikum Karlsruhe

Karlsruhe, D-76133, Germany

Location

Klinikum am Weissenhof

Weinsberg, D-74189, Germany

Location

Related Publications (1)

  • Hölzel L.P., Bermejo I. & Härter M. (2011). Geordnetes Entlassmanagement - Bewertung eines neuen Behandlungsmodells zur Verkürzung der Verweildauer bei depressiven Erkrankungen. Deutsches Ärzteblatt, 108, 1050-1051.

    RESULT

MeSH Terms

Conditions

Depressive Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • Martin Härter, Prof. Dr. Dr.

    Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

  • Isaac Bermejo, Dr.

    Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

  • Lars P Hölzel, Dr.

    Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Dr.

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 21, 2008

Study Start

May 1, 2008

Primary Completion

September 1, 2010

Study Completion

August 1, 2011

Last Updated

June 21, 2012

Record last verified: 2012-06

Locations

DE(5)