Depressive DisorderINCANCT00662428
Increasing Cost-effectiveness of Inpatient Treatment of Affective Disorders
A study testing Symptom based discharge management and Treatment as usual in people with Depressive Disorder, run by University Hospital Freiburg at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Symptom based discharge management and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 5 sitesGermany
- Study dates
- May 2008to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Sufficient German language skills
- Being resident sufficiently close to the hospital for being able to take part in the outpatient program
- permanent residence
Who cannot join
- Dementia
- Alcohol or drug dependence (not misuse)
- Psychotic symptoms
- Schizoaffective disorders
- Bipolar disorders
- Schizophrenia
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Bezirkskrankenhaus Bayreuth
Bayreuth, D-95445
Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy
Freiburg im Breisgau, D-79104
Krankenhaus Hofheim
Hofheim, Hesse, 65719
Städtisches Klinikum Karlsruhe
Karlsruhe, D-76133
Klinikum am Weissenhof
Weinsberg, D-74189
About this study
Official title: Evaluation of a Guideline-based Net Care Intervention to Reduce the Duration of Inpatient Depression Treatment
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.
Read the detailed description
Great diversity concerning duration of inpatient treatment of depression in psychiatric-psychotherapeutic hospitals is often used as an argument for the possible reduction of length of stay. Yet shorter duration of inpatient treatment of depressive episodes has not been examined systematically concerning clinical outcomes and health economic consequences. In this study the cost-effectiveness of a new sequential inpatient-outpatient treatment model will be examined. The research hypothesis is that the new treatment model will be more cost-effective than treatment as usual. The design provides a randomized controlled trial (RCT) in four psychiatric-psychotherapeutic clinics with a total of 240 patients. First medical practitioners and psychologist will receive a retraining concerning guideline-based care and the new treatment model will be implemented in the hospitals. New patients admitted to one of the hospitals will then be assigned randomly to one of the two study conditions und prospectively examined at five measuring times: Condition A (control group) contains treatment as usual (individual treatment programme, discharge after remission), Condition B (intervention group) contains the sequential inpatient-outpatient treatment (guideline-based treatment, discharge after partly remission: BDI <20, outpatient treatment in the hospital and guided transfer to outpatient care).
Primary outcome is the reduction of costs of treatment in relation to reduction of symptoms. Secondary outcomes will be reduction of the depressive pathology as well as the extent of satisfaction among patients and practitioners. A total of 240 patients will be examined from admission until 12 month after discharge. Both information from the patients and the practitioners will be charged with well implemented and established instruments (psychiatric basic documentation system, BADO). A specific questionnaire will be used to measure the practitioners' satisfaction and the consequences of the sequential inpatient-outpatient treatment. To answer the main question about the cost-effectiveness analyses of central health economic outcome variables (direct and indirect costs of treatment) will be performed. This study is going to give differentiated and scientific evidence of the efficiency of a new sequential inpatient-outpatient treatment for depressive disorders. The participation of psychiatric-psychotherapeutic hospitals with different functions and structures in the public health care systems (academic medical centre, psychiatric department of general hospital, psychiatric centres) enable the evaluation of the new treatment model under diverse structural and organizational conditions.
- Conditions
- Depressive Disorder
- Being tested
- Symptom based discharge management, Treatment as usual
- Keywords
- cost-benefit analysis, practice guideline, inpatients
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Symptom based discharge management |
| Control | Active comparator | Not described Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness: ratio of treatment response and treatment costs
Measured: one year after discharge
Secondary outcomes (2)
Symptom reduction
Measured: at discharge, 6 month after discharge, and one year after discharge
patient satisfaction
Measured: at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- German Medical Association
- Responsible party
- Principal investigator, Martin Härter, University Hospital Freiburg
- Investigators
- Martin Härter, Prof. Dr. Dr., Principal investigator, Freiburg University Medical Center, Dept. of Psychiatry and PsychotherapyIsaac Bermejo, Dr., Principal investigator, Freiburg University Medical Center, Dept. of Psychiatry and PsychotherapyLars P Hölzel, Dr., Study chair, Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662428
- Sponsor's protocol ID
- BÄK 06-69
- Acronym
- INCA
- Status last verified
- Jun 2012
- First submitted
- 15 Apr 2008
- Last updated
- 21 Jun 2012
- Results posted
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Guideline-based Net Care Intervention to Reduce the Duration of Inpatient Depression Treatment
- ClinicalTrials.gov ID
- NCT00662428
- Acronym / sponsor ID
- INCA / BÄK 06-69
- Conditions
- Depressive Disorder
- Keywords
- cost-benefit analysis, practice guideline, inpatients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- German Medical Association
- Study start
- May 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Great diversity concerning duration of inpatient treatment of depression in psychiatric-psychotherapeutic hospitals is often used as an argument for the possible reduction of length of stay. Yet shorter duration of inpatient treatment of depressive episodes has not been examined systematically concerning clinical outcomes and health economic consequences. In this study the cost-effectiveness of a new sequential inpatient-outpatient treatment model will be examined. The research hypothesis is that the new treatment model will be more cost-effective than treatment as usual. The design provides a randomized controlled trial (RCT) in four psychiatric-psychotherapeutic clinics with a total of 240 patients. First medical practitioners and psychologist will receive a retraining concerning guideline-based care and the new treatment model will be implemented in the hospitals. New patients admitted to one of the hospitals will then be assigned randomly to one of the two study conditions und prospectively examined at five measuring times: Condition A (control group) contains treatment as usual (individual treatment programme, discharge after remission), Condition B (intervention group) contains the sequential inpatient-outpatient treatment (guideline-based treatment, discharge after partly remission: BDI <20, outpatient treatment in the hospital and guided transfer to outpatient care).
Primary outcome is the reduction of costs of treatment in relation to reduction of symptoms. Secondary outcomes will be reduction of the depressive pathology as well as the extent of satisfaction among patients and practitioners. A total of 240 patients will be examined from admission until 12 month after discharge. Both information from the patients and the practitioners will be charged with well implemented and established instruments (psychiatric basic documentation system, BADO). A specific questionnaire will be used to measure the practitioners' satisfaction and the consequences of the sequential inpatient-outpatient treatment. To answer the main question about the cost-effectiveness analyses of central health economic outcome variables (direct and indirect costs of treatment) will be performed. This study is going to give differentiated and scientific evidence of the efficiency of a new sequential inpatient-outpatient treatment for depressive disorders. The participation of psychiatric-psychotherapeutic hospitals with different functions and structures in the public health care systems (academic medical centre, psychiatric department of general hospital, psychiatric centres) enable the evaluation of the new treatment model under diverse structural and organizational conditions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Symptom based discharge management |
| Control | Active comparator | Other: Treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Current depressive episode at time of admission
- ICD-10 diagnosis:
- Depression is primary treatment indication
- The ability to give informed consent
- Sufficient German language skills
Key exclusion criteria (6 listed)
- Dementia
- Alcohol or drug dependence (not misuse)
- Psychotic symptoms
- Schizoaffective disorders
- Bipolar disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom based discharge managementDepressive 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). | Other | Intervention |
| Treatment as usualTreatment 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. | Other | Control |
Primary outcome
Cost-effectiveness: ratio of treatment response and treatment costs
Time frame: one year after discharge
2 secondary outcomes
Symptom reduction
Time frame: at discharge, 6 month after discharge, and one year after discharge
patient satisfaction
Time frame: at discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
- Results publicationHölzel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Härter, Prof. Dr. Dr. principal investigator
Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy
Isaac Bermejo, Dr. principal investigator
Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy
Lars P Hölzel, Dr. study chair
Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom based discharge management and Treatment as usual in people with Depressive Disorder, run by University Hospital Freiburg at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness: ratio of treatment response and treatment costs (time frame: one year after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00662428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.