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
| Autor: | Bendig, Eileen, Meißner, Dominik, Erb, Benjamin, Weger, Lena, Küchler, Ann-Marie, Bauereiss, Natalie, Ebert, David, Baumeister, Harald |
|---|---|
| Přispěvatelé: | Clinical Psychology |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: | |
| Zdroj: | BMJ Open, 11(2):e041573, 1-13. BMJ Publishing Group Bendig, E, Meißner, D, Erb, B, Weger, L, Küchler, A M, Bauereiss, N, Ebert, D & Baumeister, H 2021, ' 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 ', BMJ Open, vol. 11, no. 2, e041573, pp. 1-13 . https://doi.org/10.1136/bmjopen-2020-041573 |
| ISSN: | 0001-6799 2044-6055 |
| DOI: | 10.1136/bmjopen-2020-041573 |
| Popis: | 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. publishedVersion |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|