Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010032

Trial Description

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Title

Positive Psychological Interventions Erlangen

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Trial Acronym

PositIvE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Depression is one of the most common mental disorders. It strongly impairs the life of affected individuals and often runs a chronic relapsing course with re-occurring long and heavy episodes of illness and inpatient treatments. This study investigates if a novel psychotherapeutic program based on positive psychology is effective in the treatment of depressed inpatients when administered as a supplement to treatment as usual.

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Brief Summary in Scientific Language

This randomized clinical trial tests if depressed inpatients who take part in the Positive psychological Interventions Erlangen (PositIvE) program show an additional reduction in depressive symptoms in comparison to those who receive only treatment as usual as measured using the Beck Depression Inventory II, the Hamilton Depression Rating Scale and the Subjective Happiness Scale.

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Organizational Data

  •   DRKS00010032
  •   2016/02/22
  •   [---]*
  •   yes
  •   Approved
  •   56_14 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   Positive psychological interventions (six mainly self-administered modules based on mindfulness, gratitude, strengths and positive emotions) plus treatment as usual (including medical treatment, single and group psychotherapy, gymnastic and athletic exercises, occupational therapy, and others) for a period of 2-3 weeks
  •   Treatment as usual (including medical treatment, single and group psychotherapy, gymnastic and athletic exercises, occupational therapy, and others) for a period of 2-3 weeks
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Change in Beck Depression Inventory II scores after a period of 2-3 weeks

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Secondary Outcome

Change in Hamilton Depression Rating Scale and Subjective Happiness Scale scores after a period of 2-3 weeks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/04/28
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

ICD-10 F32.1-3, F33.1-3, written informed consent, inpatient treatment

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Exclusion Criteria

ICD-10 F20, F25, pregnancy, lactation

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Addresses

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    • Universitätsklinikum Erlangen, Psychiatrische und Psychotherapeutische Klinik
    • Mr.  Dr.  Bernd  Lenz 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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    • Universitätsklinikum Erlangen, Psychiatrische und Psychotherapeutische Klinik
    • Mr.  Dr.  Bernd  Lenz 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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    • Universitätsklinikum Erlangen, Psychiatrische und Psychotherapeutische Klinik
    • Mr.  Dr.  Bernd  Lenz 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Erlangen, Psychiatrische und Psychotherapeutische Klinik
    • Mr.  Dr.  Bernd  Lenz 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/08/07
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.