Web-based MINDfulness and Skills-based distress reduction in cancer (MINDS): study protocol for a multicentre observational healthcare study
Florian Junne, Stephan Zipfel, Yesim Erim, Alexander Bäuerle, Martin Teufel, Caterina Schug, Mingo Beckmann, Norbert Schäffeler, Johanna Graf
BMJ Open May 28, 2021 DOI: 10.1136/bmjopen-2019-036466 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Observational study protocol Longitudinal Peer reviewed |
|---|---|
| Population | Adult patients with cancer with adequate German language skills recruited at Essen, Erlangen and Tübingen University Hospitals and via online channels |
| Intervention | cognitive-behavioural therapy |
| Duration | 4-month intervention period; assessments at baseline, directly after the intervention, and 3 and 6 months later |
| Topics | Meditation |
| Key findings | The protocol proposes to assess patient characteristics to define target populations for Make It Training, evaluate its usability, feasibility, and sustainability, and gather longitudinal data on its efficacy. The self-guided intervention comprises eight 30-minute modules drawing on mindfulness therapy, cognitive-behavioural therapy, and acceptance and commitment therapy over four months, with follow-up assessments at 3 and 6 months. |
Abstract
Introduction Although a high percentage of patients with cancer experience severe psychological distress, few of them receive psycho-oncological care, largely due to barriers on the side of patients and healthcare providers that pose great challenges to delivering such care. In response, low-threshold, self-guided eHealth interventions can enable patients with cancer to deal independently and effectively with disease-related challenges and distress. Mindfulness and Skills-Based Distress Reduction in Oncology Training, nicknamed Make It Training, is one such innovative, self-guided eHealth intervention. In our study, we propose to assess different characteristics of such patients in order to define target populations for Make It Training, evaluate the intervention in terms of its usability, feasibility and sustainability and gather longitudinal data concerning the intervention’s efficacy.Methods and analysis Self-guided and web-based Make It Training consists of eight 30 min modules involving the use of techniques of mindfulness therapy, cognitive–behavioural therapy and acceptance and commitment therapy to be completed in a 4-month period. In our observational study, adult patients with cancer who possess adequate German language skills and provide their informed consent will be recruited at Essen, Erlangen and Tübingen University Hospitals at outpatient oncological institutions and via online channels. Patients will undergo a baseline online assessment (T0), an assessment directly after completing the intervention (T1) and assessments 3 and 6 months later (T2 and T3, respectively). With the results of those assessments, we will perform descriptive analyses of their sociodemographic and medical data, compare means and conduct regression analyses.Ethics and dissemination The Ethics Committees of the University Hospitals Essen, Erlangen and Tübingen have approved the study (19-8643-BO, 27_19 B, 293/2018BO1). Results will be published in peer-reviewed journals and conference presentations.Trial registration number DRKS00017119.