Trial document




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  DRKS00016495

Trial Description

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Title

Behavioural activation for depressive syndromes in rehabilitation

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Trial Acronym

VADIR

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We would like to test whether behavioral activation in rehabilitation patients works better than the previous offers for depression treatment. At the same time, we are investigating whether behavioural activation is better accepted by patients and contributes more to behavioural change in everyday life. We will also examine whether behavioural activation is more effective than conventional therapy in improving activity and participation and whether its effectiveness is independent of the educational level and socio-economic status of rehab patients. The project also provides extensive data to evaluate and improve depression treatment in inpatient rehabilitation.

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Brief Summary in Scientific Language

We would like to test whether behavioural acitivation in rehabilitation patients works better than the previous offers for depression treatment. At the same time, we are exploring whether behavioural activation is better accepted and contributes more to behavioural change in everyday life. We will also examine whether behavioural activation is more effective than conventional therapy in improving activity and participation in terms of ICF and whether its effectiveness is independent of the educational level and socio-economic status of the rehabilitants. The influence of social and personal factors on treatment success and their effects on behavioural activity (e.g. number of daily steps) will also be investigated. The project also provides extensive data for the formative evaluation of depression treatment in the context of inpatient rehabilitation.

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Organizational Data

  •   DRKS00016495
  •   2019/02/27
  •   [---]*
  •   yes
  •   Approved
  •   EK 327082018, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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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

  •   Treatment as usual (Psychoeducation)
  •   behavioral activation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Questionnaire. target criterion: severity of depression

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Secondary Outcome

Questionnaire and Pedometer. Activity and participation. Acceptance of Treatment. Efficacy of the Intervention as a function of Level of education and socioeconomic Status.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2019/03/01
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

• Patients undergoing treatment in one of the two cooperating clinics (Reha-Zentrum Seehof; Lichterfelder Allee 55, 14513 Teltow or [is still outstanding])
• Age between 18 and 70 years
• Presence of an unipolar depression according to the clinical impression of the clinical professional (reference physician or reference therapist)
• Inclusion in the study is based on clinical considerations in accordance with regular clinical procedures (allocation to the group offer by the respective reference physician or therapist with appropriate indication and on the basis of information from routine diagnostics).
• All patients included according to the above criteria are used to test the hypotheses associated with the questions. In order to increase the severity of the test, only those patients are included in the evaluation in additional analyses for whom the rating in the Quick Inventory of Depressive Symptomatology (QIDS; Rush et al., 2003) reaches a cut-off value in the QIDS of at least 8 (mild depression severity, comparable to BDI-II ≥14 mild depression).

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Exclusion Criteria

• current presence of psychotic or manic symptoms
• current substance abuse or substance dependence
• Presence of a severe anxiety disorder (e.g. social phobia or agoraphobia with a pronounced avoidance behaviour)
• acute suicidal tendencies in the context of depression
• the severity of depression does not allow active participation in group therapy according to clinical assessment
• brainorganic impairments
• mental disabilities
• severe chronic and physical diseases

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Addresses

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    • Deutsche Rentenversicherung Bund
    • 10713  Berlin
    • Germany
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    • Institut für Klinische Psychologie und Psychotherapie, Professur für Behaviorale Psychotherapie
    • Mr.  Prof.  Jürgen  Hoyer 
    • Hohe Straße 53
    • 01187  Dresden
    • Germany
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    • Reha-Zentrum Seehof
    • Mr.  Prof.  Volker  Köllner 
    • Lichterfelder Allee 55
    • 14513  Teltow
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Bund Abteilung Rehabilitation
    • Hohenzollerndamm 45
    • 10713  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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