Dataset Information

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.

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.

SUBMITTER: Bendig E

PROVIDER: S-EPMC7871683 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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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.

Bendig Eileen E Meißner Dominik D Erb Benjamin B Weger Lena L Küchler Ann-Marie AM Bauereiss Natalie N Ebert David D Baumeister Harald H

BMJ open 20210208 2

<h4>Introduction</h4>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 ...[more]

PMID: 33558351

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Dataset Information

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

Methods and analysis

Ethics and dissemination

Trial registration

Publications

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.

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