1. Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-being.
- Author
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Bendig E, Meißner D, Erb B, Weger L, Küchler AM, Bauereiss N, Ebert D, and Baumeister H
- Subjects
- Adult, Austria, Crisis Intervention, Germany, Humans, Quality of Life, Randomized Controlled Trials as Topic, Software, Switzerland, Acceptance and Commitment Therapy
- Abstract
Introduction: Only a minority of people living with mental health problems are getting professional help. As digitalisation moves on, the possibility of providing internet/mobile-based interventions (IMIs) arises. One type of IMIs are fully automated conversational software agents (chatbots). Software agents are computer programs that can hold conversations with a human by mimicking a human conversational style. Software agents could deliver low-threshold and cost-effective interventions aiming at promoting psychological well-being in a large number of individuals. The aim of this trial is to evaluate the clinical effectiveness and acceptance of the brief software agent-based IMI SISU in comparison with a waitlist control group., Methods and Analysis: Within a two-group randomised controlled trial, a total of 120 adult participants living with low well-being (Well-being Scale/WHO-5) will be recruited in Germany, Austria and Switzerland. SISU is based on therapeutic writing and acceptance and commitment therapy-based principles. The brief intervention consists of three modules. Participants work through the intervention on 3 consecutive days. Assessment takes place before (t1), during (t2) and after (t3) the interaction with SISU, as well as 4 weeks after randomisation (t4). Primary outcome is psychological well-being (WHO-5). Secondary outcomes are emotional well-being (Flourishing Scale), psychological flexibility (Acceptance and Action Questionnaire-II), quality of life (Assessment of Quality of Life -8D), satisfaction with the intervention (Client Satisfaction Questionnaire-8) and side effects (Inventory for the assessment of negative effectsof psychotherapy). Examined mediators and moderators are sociodemographic variables, personality (Big Five Inventory-10), emotion regulation (Emotion Regulation Questionnaire), alexithymia (Toronto Alexithymia Scale-20), centrality of events (Centrality of Events Scale), treatment expectancies (Credibility Expectancy Questionnaire) and technology alliance (Inventory of Technology Alliance-Online Therapy). Data analysis will be based on intention-to-treat principles. SISU guides participants through a 3-day intervention., Ethics and Dissemination: This trial has been approved by the ethics committee of the Ulm University (No. 448/18, 18.02.2019). Results will be submitted for publication in a peer-reviewed journal and presented at conferences., Trial Registration: The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS): DRKS00016799 (date of registration: 25 April 2019). In case of important protocol modifications, trial registration will be updated. This is protocol version number 1., Competing Interests: Competing interests: HB reports to have received consultancy fees and fees for lectures/workshops from chambers of psychotherapists and training institutes for psychotherapists in the e-mental health context. A-MK has received fees for lectures/workshops from chambers of psychotherapists and health insurance companies. DE reports to have received consultancy fees/served in the scientific advisory board from several companies such as Minddistrict, Lantern, Schoen Kliniken and German health insurance companies. He is a stakeholder of the Institute for Health Training online (GET.ON), which aims to implement scientific findings related to digital health interventions into routine care. All other authors declare not to have competing interests., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2021
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