Trial document





This trial has been registered retrospectively.
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  DRKS00000662

Trial Description

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Title

A telephone- and text-message based telemedical care concept for patients with mental health disorders

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The availability of inpatient psychotherapeutic health services in many rural regions is insufficient. In this study, it is analysed whether the health situation of patients with depression, anxiety disorder, adjustment disorder or a somatoform disorder can be improved using a telemedical concept consisting of telephone contacts and short text-messages.

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Brief Summary in Scientific Language

The availability of psychotherapeutic health services in many rural regions is insufficient. To improve the treatment of patients with mental disorders in rural regions, we developed a telemedical care concept based on telephone contacts and text-messages.
All participants are recruited from psychiatric day hospitals. The interventions consist of regular patient-individual telephone consultations and regular patient-individual telephone consultations with complementing text-messages on the patients’ mobile phone. The interventions will be conducted during a time period of 6 months.
The primary objective of this study is to evaluate the effects of the telemedical interventions on psychopathological outcomes, e. g. anxiety, depressive symptoms, and somatisation. Secondary objective of the study is the analysis of intervention effects on the frequency of medical contacts with healthcare services. Furthermore, the frequency of patients’ crises and the frequency and kind of interventions, initiated by the project nurses will be evaluated. We will also evaluate the acceptance of the telemedical care concept by the patients.

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Organizational Data

  •   DRKS00000662
  •   2011/01/24
  •   [---]*
  •   yes
  •   Approved
  •   BB 50/09, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

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

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F34 -  Persistent mood [affective] disorders
  •   F38 -  Other mood [affective] disorders
  •   F39 -  Unspecified mood [affective] disorder
  •   F40 -  Phobic anxiety disorders
  •   F41 -  Other anxiety disorders
  •   F43 -  Reaction to severe stress, and adjustment disorders
  •   F45 -  Somatoform disorders
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Interventions/Observational Groups

  •   Regular telephone contacts, conducted by specially trained nurses. The first month, the telephone contacts take place once a week, thereafter, once a month. The content of the telephone contacts is based on the individual therapy goals of the patients.
    If necessary, the frequency of the telephone contacts can be increased, appointments with outpatient healthcare services can be made.
    Duration of the intervention: 6 months.

    After enrolment in the study, the participants obtain a standardized interview by telephone (sociodemographic data, BSI 18, Quality of Life, utilization of health services, medication). In each telephone contact, BSI 18, utilization of health services, and medication is questioned again. The questionnaire to assess quality of life is repeated after 6 months.
  •   Regular telephone contacts, conducted by specially trained nurses. The first month, the telephone contacts take place once a week, thereafter, once a month. Additionally, once a week short text-messages are sent. The content of the telephone contacts and short text-mesages is based on the individual therapy goals of the patients.
    If necessary, the frequency of the telephone contacts can be increased, appointments with outpatient healthcare services can be made.
    Duration of the intervention: 6 months.

    After enrolment in the study, the participants obtain a standardized interview by telephone (sociodemographic data, BSI 18, Quality of Life, utilization of health services, medication). In each telephone contact, BSI 18, utilization of health services, and medication is questioned again. The questionnaire to assess quality of life is repeated after 6 months.
  •   Control group: after enrolment in the study, the participants in the control group obtain a standardized interview by telephone (sociodemographic data, BSI 18, quality of life, utilization of health services, medication). This interview is repeated after 6 months.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Treatment
  •   Parallel
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  •   [---]*
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Primary Outcome

Primary outcome of the study ist the evaluation of the effects of the telemedical interventions on psychopathological outcomes. Psychopathological outcomes are measured after 6 months in the context of a telephone interview using the questionnaire BSI 18.

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Secondary Outcome

Analysis of effects of the interventions on the frequency of medical contacts with healthcare services, both psychotherapeutic and in other medical fields.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/09/01
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with a diagnosed depression, anxiety disorder, adjustment disorder or a somatoform disorder

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Exclusion Criteria

- interval patients, defined as patients who return to the day hospital after 3-6 months to continue their therapy
- patients who show a distinct emotional instability with recurrent suicide crises and self-injuring behaviour

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Addresses

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    • Universitätsmedizin Greifswald
    • Fleischmannstraße 8
    • 17475  Greifswald
    • Germany
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    • Universität Greifswald Institut für Community Medicine
    • Ms.  Dr.  Neeltje  van den Berg 
    • Ellernholzstr. 1-2
    • 17487  Greifswald
    • Germany
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    • Universität Greifswald Institut für Community Medicine
    • Ms.  Dr.  Neeltje  van den Berg 
    • Ellernholzstr. 1-2
    • 17487  Greifswald
    • Germany
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Sources of Monetary or Material Support

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    • Ministerium für Soziales und Gesundheit Mecklenburg-Vorpommern
    • Werderstr. 124
    • 19055  Schwerin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/01/31
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* This entry means the parameter is not applicable or has not been set.