Trial document




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  DRKS00003247

Trial Description

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Title

Integrative psychosocial treatment program for patients with diabetes type I and type II (psy-PAD) - evaluation of an interdisciplinary psychosocial care model

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

For many patients with diabetes it is difficult to treat their disease properly and to follow recommendations and arrangements in order to change their lifestyles. This is especially difficult if there are mental and social strains at the same time. Different studies could show that these strains have a negative impact on the treatment of diabetes. In the present study, patients are able to discover obstacles concerning the handling of diabetes with the help of a physician specialized in psychosomatics or a psychologist in order to define and realize attainable goals. The dialogue being offered is viewed as “coaching“ and includes 8 individual sessions within a period of 6 months. The study has a randomized-controlled design. The main target variable is the long-time blood glucose value (HbA1c). In addition, questionnaires on quality of life and on mental and psychosocial well-being are being used. Testing is taking place at 3 dates: at the beginning of the study, 6 months later, and 12 months later.

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Brief Summary in Scientific Language

In the present study, the exemplary implementation of an integrative psychosocial treatment program for patients with diabetes type I and type II (psy-PAD) with unsatisfactory blood glucose values shall be examined and evaluated regarding to their blood glucose control as well as the individual therapeutic goal attainment with respect to the patients’ quality of life and their psychosocial strains. Cost-effectiveness is also being analyzed as well as the work satisfaction of the physicians. The study is realized as RCT in diabetic outpatient clinics. Patients in the intervention group receive psy-PAD, the control group receives an optimized standard care. Psy-PAD includes a manualized coaching and treatment program being conducted by psychotherapists in diabetic outpatient clinics in collaboration with diabetologists.

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Organizational Data

  •   DRKS00003247
  •   2011/11/28
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  •   yes
  •   Approved
  •   163/09, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

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Health Condition or Problem studied

  •   E10 -  Insulin-dependent diabetes mellitus
  •   psychosocial stress
  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   Intervention group (psy-PAD Patients in the intervention group receive psy-PAD; Psy-PAD includes a manualized coaching and treatment program being conducted by psychotherapists in diabetic outpatient clinics in collaboration with diabetologists.)
  •   Control group (optimized standard care)
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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
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Primary Outcome

HbA1c at follow-up (6 months, 12 months)

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Secondary Outcome

Triglycerides, BMI, blood pressure, health-related quality of life (SF-36), manifestation of mental and psychosocial problems (PAID, HADS, PHQ-D short form), degree of attainment of individual therapeutic goals (GAS). Explorative: increase of the work satisfaction of the physician. Testing is taking place at 3 dates: at the beginning of the study, 6 months later, and 12 months later.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/11/28
  •   150
  •   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 with secured diabetes type I and type II; HbA1c >/= 7, 5%; increased emotional stress scores (PAID-Score>33, PAID-K-Score>/= 6, WHO-5-Score</=13 or perceived as very stressed by the therapeutic team); age 18-70 years; treatment in a diabetic outpatient clinics; completed diabetes training; written informed consent

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Exclusion Criteria

Patients with (a) severe comorbid physical diseases (e.g., advanced oncologic diseases), (b) severe mental diseases (dementia, severe depressive episode, psychosis, addiction), (c) inadequate knowledge of German language

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Addresses

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    • Klinik für Psychosomatik und Psychotherapie der Justus-Liebig-Universität Giessen
    • Mr.  Prof. Dr. med.  Johannes  Kruse 
    • Friedrichstr. 33
    • 35392  Giessen
    • Germany
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    • Klinik für Psychosomatik und Psychotherapie der Justus-Liebig-Universität Giessen
    • Mr.  Prof. Dr. med.  Johannes  Kruse 
    • Friedrichstr. 33
    • 35392  Giessen
    • Germany
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    • Klinik für Psychosomatik und Psychotherapie der Justus-Liebig-Universität Gießen
    • Ms.  Dipl.-Psych.  Birgit  Köhler 
    • Ludwigstr. 76
    • 35392  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesärztekammer
    • Herbert-Lewin-Platz 1
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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