Trial document





This trial has been registered retrospectively.
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  DRKS00004451

Trial Description

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Title

Development and evaluation of an internet-based psychological support program for parents caring for a child with CF

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Trial Acronym

Muko-WEP

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URL of the Trial

https://muko-wep.ulmer-onlineklinik.de

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Brief Summary in Lay Language

Parents caring for a child with Cystic Fibrosis (CF) are at high risk for the
development of psychological distress (especially symptoms of anxiety and/or
depression). Currently there is a severe under-treatment of these problems, which are
likely to impact upon disease management and family relations. The objective of the study is therefore to develop and evaluate an internet-based psychological intervention program for severely distressed parental caregivers of children with CF. Parents reporting clinically relevant symptoms of anxiety (and depression) are invited to participate in the support program. The web-therapy is based on a standardized treatment manual, will be carried out by trained therapists in written form and will take 10-12 weeks to be completed. It consists of nine writing assignments related to three treatment components: coping with fear of disease progression, sharing responsibility for the CF-treatment, and providing self-care. The intervention program will be evaluated regarding its acceptance and efficacy in reducing anxious symptoms. Furthermore effects on depressive symptoms, parental quality of life, coping skills, adherence and parent-child relationship will be evaluated.

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Brief Summary in Scientific Language

Parents caring for a child with Cystic Fibrosis (CF) are at high risk for the development of psychological distress (especially symptoms of anxiety and/or depression). Currently there is a severe under-treatment of these problems, which are likely to impact upon disease management and family relations. The objective of the study is therefore to develop an internet-based psychological intervention program for severely distressed parental caregivers of minors with CF and to evaluate its feasibility, acceptance and efficacy. Parental caregivers of minors with CF reporting clinically relevant symptoms of anxiety (and depression) are invited to participate in the support program. The standardized cognitive-behavioral web-therapy will be carried out by trained therapists in written form and will take 10-12 weeks to be completed. It consists of nine writing assignments related to three treatment components: coping with fear of disease progression, sharing responsibility for the CF-treatment, and providing self-care. The intervention program will be evaluated regarding its feasibility, acceptance and efficacy. Primary endpoint is the reduction of anxious symptoms, secondary endpoints are the reduction of depressive symptoms, improvement of the parents`quality of life and coping skills. Additionally, effects on adherence and parent-child relationship are evaluated.

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Organizational Data

  •   DRKS00004451
  •   2012/10/09
  •   [---]*
  •   yes
  •   Approved
  •   268/10, Ethik-Kommission der Universität Ulm
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Secondary IDs

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

  •   F43 -  Reaction to severe stress, and adjustment disorders
  •   F41.1 -  Generalized anxiety disorder
  •   F41.2 -  Mixed anxiety and depressive disorder
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Interventions/Observational Groups

  •   Internetbased intervention to reduce symptoms of parental distress (mostly anxiety), and to enhance parents` quality of life and coping skills. Treatment consists of 9 writing assignments à 45 minutes, treatment duration is 10-12 weeks. Participants complete their writing assignments at the agreed dates and receive feedback from their therapist within 48 hours. Feedback is embedded in the treatment manual but individually tailored to patients needs.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoint is the reduction of anxious symptoms measured online with the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS, Zigmond & Snaith) at baseline (before the intervention), after completion of the last treatment session and three month after completion of the intervention program.

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Secondary Outcome

Secondary endpoints are the reduction of illness related fears (measured with an adapted version of the Fear of Progression Questionnaire, FoP-Q, Herschbach et al.), the reduction of depressive symptoms (Center for Epidemiological Studies Depression Scale CES, German Version: ADS-K, Hautzinger & Bailer), the improvement of the parents`quality of life (Ulm quality of life inventory for parents of chronically ill children, Goldbeck & Storck) and coping skills (Coping Health Inventory for Parents, CHIP, German Version, McCubbin & McCubbin). All questionnaires are administered online at baseline, after completion of the last treatment session and three month after completion of the intervention program. Additionally, the acceptance of the intervention is evaluated at the end of treatment. For this purpose a short questionnaire was developed.

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2012/06/25
  •   30
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- caregiver of a minor child (0-17 years) with a confirmed diagnosis of CF
- have a score ≥ 8 points on the HADS Anxiety subscale
- have permanent access to a computer with internet connection
- be able to read and write fluent German

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Exclusion Criteria

- acute suicidality
- psychotic symptoms
- concurrent psychotherapy
- change in psychotropic medication six weeks before the start of the treatment and during treatment

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Addresses

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    • Universitätsklinikum Ulm, Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie
    • Mr.  Prof. Dr.  Lutz  Goldbeck 
    • Steinhövelstr. 5
    • 89075  Ulm
    • Germany
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    • Freie Universität Berlin
    • Ms.  Prof. Dr.  Christine  Knaevelsrud 
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    •   [---]*
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    • Universitätsklinikum Ulm, Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie
    • Ms.  Dr.  Marion  Herle 
    • Steinhövelstr. 1
    • 89075  Ulm
    • Germany
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    • Universitätsklinikum Ulm, Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie
    • Ms.  Dr.  Marion  Herle 
    • Steinhövelstr. 5
    • 89075  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Mukoviszidose Institut gGmbH
    • In den Dauen 6
    • 53177  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.