Trial document




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  DRKS00013193

Trial Description

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Title

ACTonDiabetes - A randomised-controlled feasibility trial of an acceptance and commitment therapy-based internet intervention for people with diabetes mellitus

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Trial Acronym

ACTonDiabetes

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URL of the Trial

http://act-on-diabetes.de

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Brief Summary in Lay Language

People with diabetes mellitus do often feel a high amount of psychological strains as well as sorrows and anxiety. By systematically providing psychotherapeutic strategies and supporting the training of these strategies, the internet intervention aims at increasing psychological wellbeing. Similar interventions have been tried and tested e.g. in people with chronic pain. Within this feasibility trial, the study should be scientifically tested in terms of usability and first assessment of the effectiveness of the intervention for people with diabetes mellitus (type 1 and type 2). Participants can use the intervention independent of location and time.

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Brief Summary in Scientific Language

The study is a randomised-controlled feasibility trial of an acceptance and commitment therapy-based internet intervention for people with diabetes mellitus (type 1 and type 2). Within the scope of the trial, the reduction in diabetes related strains will be examined. Additionally, the levels of self-reported anxiety, depression, glycaemic control, diabetic self-management, fear of progression, diabetes acceptance will be investigated.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013193
  •   2017/11/02
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  •   yes
  •   Approved
  •   283/17, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   Diabetes mellitus (type 1 and type 2)
  •   E11 -  Type 2 diabetes mellitus
  •   E10 -  Type 1 diabetes mellitus
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Interventions/Observational Groups

  •   intervention group: access to the guided internet intervention "ACTonDiabetes". Participants complete one session weekly. Overall, ACTonDiabetes contains 8 sessions. One session lasts between 45 and 60 minutes.
  •   waitlist control group: access to the guided internet intervention "ACTonDiabetes" eight weeks after randomization. Participants complete one session weekly. Overall, ACTonDiabetes contains 8 sessions. One session lasts between 45 and 60 minutes.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Feasibility: there are two measurements, respectively (T1: prior to intervention, T2: eight weeks after randomizaton). Process-related: Recruitment (strategies and figures), questions due to satisfaction with contents after each session
time of measurement: Drop-out rate (T2), acceptance (questionnaire APOI (T1, T2),), adverse events (questionnaire INEP) (T1,T2)

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Secondary Outcome

Each measurements are questionnaires (self-report):
T1: prior to intervention,
T2: 8 weeks after randomization
Problem Areas in Diabetes (PAID, T1,T2)

Quality of Life (AQoL-8D, T1,T2)
Patient Health Questionnaire (PHQ-9, T1,T2)
Generalized Anxiety Disorder (GAD-7, T1,T2)
Progredienzangst (PA-F-KF, T1,T2)
Acceptance and Action Diabetes Questionnaire (AADQ, T1,T2)
Diabetes Self-Care Questionnaire (DSMQ, T1,T2)

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
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Locations of Recruitment

  • Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2017/10/20
  •   60
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

diabetes mellitus (type 1 and type2),
internet access,
participants agreement

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Exclusion Criteria

temporary diabetes (e.g. gestational diabetes), medical objections

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Addresses

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    • Abteilung für klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik,Universität Ulm
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
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    • Abteilung für klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik,Universität Ulm
    • Mr.  Prof. Dr.  Harald  Baumeister 
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
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    • Abteilung für klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik,Universität Ulm
    • Ms.  M.Sc.  Eileen  Bendig 
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung für klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik,Universität Ulm
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/04/30
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Trial Publications, Results and other Documents

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