Trial document





This trial has been registered retrospectively.
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  DRKS00018026

Trial Description

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Title

Smartphone-assisted psychoeducation in ADHD

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Trial Acronym

SAPA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Psychoeducation is an important therapeutic component within the treatment of attention deficit hyperactivity disorder (ADHD). It provides the patient with a basic understanding of the development and maintenance factors of ADHD, treatment options and various coping strategies. Psychoeducative group offers are well accepted by ADHD patients, but the provided learning contents and working materials are often insufficiently followed up at home. As a result, the transfer to everyday life is also inadequate. A different kind of content presentation might possibly close the gap between group therapy and everyday life transfer. A digital preparation of the contents in form of a smartphone app seems practicable in several respects. The app functions as a support in the organization of psychoeducational content, enables more flexible access to the content in terms of time and location, and is able to increase patient motivation through direct feedback if necessary.

Within the scope of the study, 40 patients with ADHD are randomly divided into two psychoeducation groups (brochure-assisted and app-assisted). The psychoeducation is carried out in eight weekly one-hour group sessions, which are identical for both groups. The follow-up of the psychoeducational content, which takes place outside the group, differs according to group membership. The aim of the study is to investigate whether and to what extent the patients' adherence to therapy and the success of the therapy can be increased by app-assisted group psychoeducation compared to brochure-assisted group psychoeducation. The success of the therapy is measured on the basis of clinical interviews, various questionnaires, a weekly knowledge check specifically tailored to the psychoeducational content used and the tasks completed in the follow-up.

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Brief Summary in Scientific Language

Psychoeducation is an important therapeutic component within the treatment of attention deficit hyperactivity disorder (ADHD). It provides the patient with a basic understanding of the development and maintenance factors of ADHD, treatment options and various coping strategies. Psychoeducative group offers are well accepted by ADHD patients, but the provided learning contents and working materials are often insufficiently followed up at home. As a result, the transfer to everyday life is also inadequate. A different kind of content presentation might possibly close the gap between group therapy and everyday life transfer. A digital preparation of the contents in form of a smartphone app seems practicable in several respects. The app functions as a support in the organization of psychoeducational content, enables more flexible access to the content in terms of time and location, and is able to increase patient motivation through direct feedback if necessary.

On the basis of a detailed diagnostic initial examination (inclusion criteria: Diagnostic criteria for ADHD according to DSM-IV, age between 18 and 65 years; exclusion criteria: Schizophrenia, manic or bipolar disorders and/or severe affective disorders, antisocial personality disorder, current alcohol or substance dependence, severe organic diseases, epilepsy), 40 patients will be included in the study. These are randomly divided into two different intervention groups (brochure-assisted and app-assisted psychoeducation). Psychoeducation is performed in eight weekly one-hour group sessions, which are identical for both groups. The weekly homebased follow-up of the psychoeducational contents differs according to group membership. The aim of the study is to investigate whether and to what extent patient compliance and therapy success can be increased by app-assisted group psychoeducation compared to brochure-assisted group psychoeducation.
On the basis of validated clinical interviews (IDA-R, SKID-I, SKID-II), various questionnaires (WURS-k, WFIRS, AAQoL-29, SCL-90-S BDI-2), a weekly knowledge review specifically tailored to the psychoeducational content used and the tasks completed in the follow-up, the inclusion and exclusion criteria as well as the success of therapy are evaluated by expert raters.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

The raw data on which the conclusions are based will be made available by the authors without undue reservations to any qualified researcher on request, starting 6 months after publication.

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Organizational Data

  •   DRKS00018026
  •   2020/02/12
  •   [---]*
  •   yes
  •   Approved
  •   232/18, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   F90.0 -  Disturbance of activity and attention
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Interventions/Observational Groups

  •   A total of eight weekly, one-hour psychoeducation groups for adults with ADHD, which are prepared and followed up by a specially programmed smartphone application. (Intervention)
  •   A total of eight weekly, one-hour psychoeducation groups for adults with ADHD, prepared and followed up by brochures printed on paper. (Control intervention)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Therapy success, measured by the average change in ADHD symptoms in the clinical interview "IDA-R" from pre- to post-intervention

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Secondary Outcome

- Success of psychoeducational knowledge transfer, measured by weekly multiple-choice questions at the end of the respective follow-up

- Therapy compliance (number of group sessions attended, number of completed follow-up tasks and drop-out analysis)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/03/11
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Diagnostic criteria for ADHS according to DSM-IV, aged between 18 and 65 years

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Exclusion Criteria

Schizophrenia, manic or bipolar disorders and/or severe affective disorders, antisocial personality disorder, current alcohol or substance dependence, severe organic diseases, epilepsy

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Addresses

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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Bonn
    • Ms.  Prof. Dr.  Alexandra  Philipsen 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Ascora GmbH
    • Birkenallee 43
    • 27777  Ganderkesee
    • Germany
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    • OFFIS e.V.

    • Escherweg 2
    • 
26121  Oldenburg
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Bonn
    • Mr.  Dr.  Niclas  Braun 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Bonn
    • Mr.  Benjamin  Selaskowski 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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