PREWELL Digital Well-being Promotion Intervention With the BitHabit App

NCT07868146 | Active Not Recruiting

• 2 other identifiers: 844/13.00/2023363107
• Study Type: interventional
• Target: 1,700
• Locations: 1 country
• Sites: 1

Brief Summary

Mental wellbeing is a major public health concern, and digital interventions have emerged as a scalable approach for promoting mental well-being and healthy lifestyle behaviors. However, evidence regarding long-term effectiveness and the role of user engagement remains limited. This study evaluates the effectiveness of the BitHabit digital wellbeing application in promoting mental wellbeing and healthy lifestyle among adults living in North Savo, Finland. The BitHabit application is a digital behavior change intervention designed to support mental wellbeing through the adoption of small, self-selected wellbeing-promoting habits. The application incorporates principles of self-determination theory, habit formation, self-monitoring, and behavior change techniques. Participants select habits from a library of well-being-promoting activities and track their implementation over time. The intervention study uses a stepped-wedge randomized controlled design in which all participants eventually receive access to the intervention, while participants awaiting access serve as controls. Adults aged 18 to 64 years living in North Savo were recruited between 2024 and 2025 through population registry sampling and open public recruitment. Following informed consent and baseline assessment, participants were randomly allocated to receive access to the intervention at different time points during the study. Power calculations using Monte Carlo simulations indicated that approximately 1,600 participants would provide 80% power to detect a standardized mean difference of 0.30 in mental wellbeing (SWEMWBS), assuming four intervention sequences, five measurement occasions, a within-person intraclass correlation coefficient of 0.70, and 30% attrition. The primary outcome mental wellbeing is assessed using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS). Secondary outcomes include depressive symptoms measured with the Patient Health Questionnaire (PHQ-9), self-reported capabilities, loneliness measured with the UCLA 3-item Loneliness Scale (UCLA-3), life satisfaction measured on a 0-10 scale, and self-reported health behaviours. Outcomes are measured at baseline and repeated follow-up assessments throughout the study. App usage data are used to evaluate intervention adoption and engagement and to examine whether effectiveness differs according to actual intervention use. Statistical analyses will be conducted using mixed-effects regression models that account for the stepped-wedge design and repeated measurements within participants. Models will include fixed effects for intervention exposure and time, and a random intercept for participants. Estimates will be reported with 95% confidence intervals and a two-sided significance level of 0.05. In addition to quantitative outcome assessments, participant experiences and acceptability of the intervention will be evaluated with user satisfaction questionnaires and qualitative interviews conducted among a subset of participants. These data will be used to assess perceived usefulness, user experiences, and opportunities for further development of the intervention. In addition to questionnaire and app usage data, participants will be linked to regional and national administrative registers. Register-based follow-up covers the period from one year before study enrolment until up to ten years after study completion. Data sources include health and social care registers, prescription and reimbursement registers, employment-related registers, and population registers. These data will be used to evaluate the long-term effectiveness and cost-effectiveness of the intervention, including health service use, medication use, social outcomes, and associated costs.

Conditions

General Mental Health and Well-Being; Mental Disorders; Common Mental Disorders (CMD)

Keywords

Mental health; Health promotion; Mobile applications; Health behavior; Self-management; Depression; Loneliness; Quality of life; Adults; Behavior Therapy; Lifestyle; Patient engagement; Preventive health services; Public health; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS)

  A self-reported validated measure of health and wellbeing measured with the Warwick-Edinburgh Mental Wellbeing Scale (Sarasjärvi et al 2025; Tennant et al 2007). Scores range from 7 to 35 and higher scores indicate higher positive mental wellbeing.

  At baseline, 3 months, 6 months, 9 months, 12 months and 24 months.

Secondary Outcomes (2)

• Self-reported capabilities

  At baseline, 3 months, 6 months, 9 months, 12 months and 24 months.

• Life satisfaction

  At baseline, 3 months, 6 months, 9 months, 12 months and 24 months.

Study Arms (2)

Intervention

EXPERIMENTAL

Digital wellbeing promoting intervention with the BitHabit app

Behavioral: Digital wellbeing promoting intervention with the BitHabit app

Control/Treatment as Usual

NO INTERVENTION

Control group

Interventions

Digital wellbeing promoting intervention with the BitHabit app BEHAVIORAL

The BitHabit intervention is a digital wellbeing application designed to support mental wellbeing through the adoption of small, self-selected wellbeing-promoting habits. Participants choose habits from a library covering areas such as physical activity, sleep, stress management, social relationships, recovery, and healthy daily routines. The intervention is based on self-determination theory, habit formation principles, and evidence-based behavior change techniques. Users can monitor their habit performance, receive reminders and notifications, and gradually integrate wellbeing-promoting behaviors into everyday life. Access to the intervention is provided through a web-based application and participants may continue using the application throughout the intervention period.

Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18 and 64 years
• living in North Savo, Finland

You may not qualify if:

• no access to personal mobile devices or to the internet

Sponsors & Collaborators

• University of Eastern Finland: lead
• University of Bern: collaborator
• London School of Economics and Political Science: collaborator

Study Sites (1)

University of Eastern Finland & Wellbeing Services County of North Savo

Kuopio, Northern Savonia, FI-70211, Finland

Location

Related Links

• PREWELL www-page

MeSH Terms

Conditions

Mental Disorders; Psychological Well-Being; Health Behavior; Depression; Patient Participation

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance

Study Officials

• Tomi E Mäki-Opas, Professor

  University of Eastern Finland & Wellbeing Services County of North Savo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, social and public policy

Model Details: This study uses a stepped-wedge randomized controlled design in which all participants eventually receive the intervention. Participants were randomly assigned to one of four intervention sequences in two waves determining when access to the intervention was initiated. At each step, a proportion of participants transitioned from the control condition to the intervention condition, while participants awaiting intervention served as controls. Questionnaire data were collected at baseline and repeated follow-up assessments (request send every three months but respondents can also give follow-ups more often when they wish) throughout the study. This design enabled within- and between-participant comparisons of outcomes before and after intervention exposure while ensuring that all participants ultimately received access to the intervention.

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 9, 2026
• Study Start: May 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2035
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)