ACTonDiabetes-Aftercare. A pragmatic randomised-controlled trial for the evaluation of an acceptance and commitment-based internet intervention for people living with diabetes type 1 or type 2.
Not Applicable
Recruiting
- Conditions
- E10E11Type 1 diabetes mellitusType 2 diabetes mellitus
- Registration Number
- DRKS00016738
- Lead Sponsor
- Abteilung für Klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik,Universität Ulm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
Diagnosis of diabetes mellitus type 1 or type 2, elevated level of diabetes-related distress: cut-off PAID =32 (untransformed raw value, this equals the transformed scale value of PAID=40, after multiplying the raw value by 1.25), sufficient knowledge of German language, Internet access, valid e-mail-address, recently treated as an inpatient at the diabetes centre (< 4 weeks), written informed consent
Exclusion Criteria
other specific types of diabetes, cognitive impairment
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method diabetes-related distress (PAID) at post-treatment (T2)
- Secondary Outcome Measures
Name Time Method Depression (PHQ-8), Psychological well-being (WHO-5), Psychological Flexibility (FAH-II), Quality of Life (AQoL-8D), diabetes-related self-management (DSMQ), Fear of Progression (FoP-Q-SF), Side-Effects (INEP), Healthcare utilisation (TiC-P), Emotion Regulation (ERQ), Centrality of Life Events (CES), Gratitude (GQ-6), Therapeutical alliance (WAI), Satisfaction with the intervention (ZUF-8), Diabetes Acceptance (AADQ), Metacognition (MaSCS).<br><br>Measuring points: Screening, T0=Baseline, T1=5 weeks post-randomisation, T2=10 weeks post-randomisation (=post-measurement), T3=6 months post-randomisation, T4=12 months post-randomisation