Trial document




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  DRKS00007850

Trial Description

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Title

Improve effects of psychological interventions for depressed and anxious cardiac inpatients by implementing sensory stimulation techniques with bifocal mindfulness? A cluster randomised control group trial.

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Trial Acronym

SESBA

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Using a prospective, cluster-randomized controlled trial, the effects of a new behavioral group intervention program for anxious or depressed cardiac inpatients will be evaluated. Patients who will be taught techniques of sensory stimulation with bifocal mindfulness (WHEE or Quick REMAP) are compared with patients who received conventional training with progressive muscle relaxation (PMR).

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Organizational Data

  •   DRKS00007850
  •   2015/03/26
  •   [---]*
  •   yes
  •   Approved
  •   25/2015, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   I21 -  Acute myocardial infarction
  •   I25 -  Chronic ischaemic heart disease
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Interventions/Observational Groups

  •   Techniques of sensory stimulation with bifocal mindfulness based on
    Wholistic Hybrid derived from EMDR and EFT (WHEE), 4 sessions within 2 weeks. The sessions comprises a total of 60 minutes, with one half of the time is reserved for information and discussions (coping) and the other half is for learning the techniques.
  •   Techniques of sensory stimulation with bifocal mindfulness based on
    Reed Eye Movement Psychotherapy Acupressure (Quick REMAP), 4 sessions within 2 weeks. The sessions comprises a total of 60 minutes, with one half of the time is reserved for information and discussions (coping) and the other half is for learning the techniques.
  •   Progressive Muscle Relaxation (PMR), 4 sessions within 2 weeks. The sessions comprises a total of 60 minutes, with one half of the time is reserved for information and discussions (coping) and the other half is for learning the techniques.
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Characteristics

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

Reduction of the HADS-values from baseline to the end of the rehabilitation and 6 months after rehabilitation.
The HADS is a self-report scale designed to measure current anxiety and depressive symptomatology in non-psychiatric hospital patients.

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Secondary Outcome

Generalized anxiety and depression (PHQ-4)
Self-efficacy (ASKU) from baseline to the end of the rehabilitation and 6 months after rehabilitation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/03/23
  •   208
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Cardiac rehabilitation patients with depression and / or anxiety (HADS-values > 7).

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Exclusion Criteria

Problems of language understanding

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Addresses

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    • Verein zur Förderung der Rehabilitationsforschung, Norderney
    • Mr.  Franz-Josef  Muhmann 
    • Gartenstraße 194
    • 48147  Münster
    • Germany
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    • Institut für Rehabilitationsforschung, Norderney, Abteilung Königsfeld
    • Mr.  Dr. rer. medic. Dipl.-Psych.  Jörg  Kittel 
    • Holthauser Talstraße 2
    • 58256  Ennepetal
    • Germany
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    • Institut für Rehabilitationsforschung, Norderney, Abteilung Königsfeld
    • Ms.  Brigitte  Wiesner 
    • Holthauser Talstraße 2
    • 58256  Ennepetal
    • Germany
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Sources of Monetary or Material Support

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    • Verein zur Förderung der Rehabilitationsforschung e.V., Norderney
    • Mr.  Franz-Josef  Muhmann 
    • Kaiserstraße 26
    • 26548  Norderney
    • Germany
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Status

  •   Recruiting ongoing
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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.