Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005857

Trial Description

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Title

Randomized-controlled Trial of Aftercare-Coordination by Phone for Patients With Depression and Anxiety Subsequent to an Inpatient Treatment.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The primary objective of this study is to test in a randomized controlled trial if
aftercare-coordination by phone subsequent to inpatient treatment is an effective aftercare
approach in the treatment of depression and anxiety.

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Brief Summary in Scientific Language

Depression and anxiety are among the most prevalent mental health problems and are
associated with a high risk of chronification. Despite the large capacities in the German
health care system only a small percentage of these patients receive treatment. Relevant
barriers on the pathways of patients are communication und coordination difficulties between
different services and providers.The aftercare subsequent to an inpatient treatment
represents one of these interfaces. Here the aim is to consolidate the treatment outcomes
and to minimize the so called rebound-effect, the reduction of the positive treatment
effects after the inpatient treatment. Although evidence-based treatments for depression and
anxiety disorders exist, treatment effects often decrease after treatment due to the lack of
an integration of different steps in care. The method of a case management-based aftercare
coordination by phone could be a promising approach to overcome the interface between
inpatient treatment and aftercare: case management is a patient-centered and situation-based
approach which comprises systematic tracking and support of patients by a case-manager.
Primary goal is to coordinate and integrate services across treatment settings. This
approach can help to maintain and even improve longterm treatment outcomes.

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Organizational Data

  •   DRKS00005857
  •   2014/08/22
  •   2014/01/22
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02044913  (ClinicalTrials.gov)
  •   0421-FSCP-Z202  (Universitätsklinikum Hamburg-Eppendorf)
  •   0421-FSCP-Z202 
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Health Condition or Problem studied

  •   Depression, Anxiety
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F34.1 -  Dysthymia
  •   F40.0 -  Agoraphobia
  •   F40.1 -  Social phobias
  •   F41.0 -  Panic disorder [episodic paroxysmal anxiety]
  •   F41.1 -  Generalized anxiety disorder
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Interventions/Observational Groups

  •   Behavioral: Phonebased Aftercare-Coordination
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

- Measure of the symptom severity - Beck Depression Inventory (BDI); time frame: Change in the BDI from the beginning of the intervention to follow up (6 months after termination of the intervention)

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Secondary Outcome

- Measure of health related quality of life - Short Form 8 Health Survey (SF-8), Measure of health related quality of life (EQ-5D); time frame: Change in the SF-8 and EQ-5D from the beginning of the intervention to follow up (6 months after termination of the intervention)
- Proportion of patients who get routine outpatient aftercare treatment at follow up (6 months after the intervention); time frame: 6 months after termination of the intervention
- Patient-rated acceptance and satisfaction with the intervention; time frame: Approximately 3 months (end of intervention); Patients rate their acceptance of the intervention and their satisfaction using non-standardized items.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/03/31
  •   152
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Depressive disorder (F32.x; F33.x; F34.1) and/or Anxiety disorder (F40.0; F40.1,
F41.0; F41.1) according to ICD-10

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Exclusion Criteria

- Concurrent outpatient psychotherapeutic treatment which will be continued after the
inpatient rehabilitation treatment.

- No knowledge of the German language

- Risk of suicide

- Acute psychosis or psychotic symptoms

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf
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    •   [---]*
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    • University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology
    • Dr. phil. Hanne Melchior 
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    • Laura Kivelitz, M.Sc. Psych. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.