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
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). Softwar...
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BMJ Publishing Group
2021-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/2/e041573.full |
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| author | Harald Baumeister Ann-Marie Küchler David Ebert Natalie Bauereiss Eileen Bendig Benjamin Erb Lena Weger Echo Meißner |
| author_facet | Harald Baumeister Ann-Marie Küchler David Ebert Natalie Bauereiss Eileen Bendig Benjamin Erb Lena Weger Echo Meißner |
| author_sort | Harald Baumeister |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-50cdcbf6d8d74b07ada5f9ef531cdef1 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-02-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-50cdcbf6d8d74b07ada5f9ef531cdef12025-01-20T00:30:13ZengBMJ Publishing GroupBMJ Open2044-60552021-02-0111210.1136/bmjopen-2020-041573Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-beingHarald Baumeister0Ann-Marie Küchler1David Ebert2Natalie Bauereiss3Eileen Bendig4Benjamin Erb5Lena Weger6Echo Meißner7Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, GermanyDepartment of Clinical Psychology & Psychotherapy, Ulm University, Ulm, Baden-Württemberg, GermanyGET.ON Institute, Hamburg, GermanyDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, GermanyDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, GermanyDepartment of Computer Science, Institute of Distributed Systems, Ulm University, Ulm, GermanyDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, GermanyDepartment of Computer Science, Institute of Distributed Systems, Ulm University, Ulm, GermanyIntroduction 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.https://bmjopen.bmj.com/content/11/2/e041573.full |
| spellingShingle | Harald Baumeister Ann-Marie Küchler David Ebert Natalie Bauereiss Eileen Bendig Benjamin Erb Lena Weger Echo Meißner 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/11/2/e041573.full |
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