A Bot-based Self-help Program (WELL)
WELL
A Randomized Controlled Trial of a Bot-based Self-help Program (WELL)
1 other identifier
interventional
1,595
1 country
1
Brief Summary
In the current project, the effectiveness of a new bot-based universal prevention program aimed at improving well-being will be developed and tested. This prevention program includes a variety of modules that target common areas related to well-being including interpersonal relationships, emotional regulation, beliefs and behaviors, problem-solving, sleep hygiene, goal setting, personal growth, and healthy habits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 4, 2022
CompletedFirst Submitted
Initial submission to the registry
December 13, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2024
CompletedMay 16, 2024
May 1, 2024
1.7 years
December 13, 2023
May 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Subjective well-being
The WHO-5 Well-Being Scale (WHO-5) is a 5-item short self-reported measure of current subjective wellbeing. Participants are asked to rate the frequency of well-being past month (e.g., "My daily life has been filled with things that interest me") based on a Likert scale from 0 to 5 ("At no time" to "All of the time"). Scores range from 0 to 25 with higher scores indicating higher subjective well-being.
At pre-assessment and 1, 6 and 12 months after pre-assessment
Psychosocial flourishing
The Flourishing Scale (FS) is an 8-item scale of positive human functioning. Items assess features of human flourishing such as positive relationships, feelings of competence, meaning and purpose in life, and engagement with daily activities. Statements are rated on a 7-point scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Scores can range from 8 to 56, with higher scores reflecting higher well-being.
At pre-assessment and 1, 6 and 12 months after pre-assessment
Psychological well-being
The Mental Health Continuum Short Form (MHC-SF) measures positive psychological health and comprises 14 items, representing various feelings of well-being. Three items were chosen (happy, interested in life, and satisfied) to represent emotional well-being, six items (one item from each of the 6 dimensions) were chosen to represent psychological well-being, and five items (one item from each of the 5 dimensions) were chosen to represent social well-being. Respondents rate the frequency of every feeling in the past month on a 6-point Likert scale, ranging from 1 (never) to 6 (every day).
At pre-assessment and 1, 6 and 12 months after pre-assessment
Secondary Outcomes (2)
User satisfaction
1 month after pre-assessment
Participation/Engagement
1 month after pre-assessment
Other Outcomes (6)
Module rating of user satisfaction
1 month after pre-assessment
Days chatted bot
1 month after pre-assessment
Total messages
1 month after pre-assessment
- +3 more other outcomes
Study Arms (2)
Conversational Agent Zenny
EXPERIMENTALParticipants received access to a self-help program delivered via an automated conversational agent on WhatsApp.
Web-based Wellness Resources
ACTIVE COMPARATORParticipants received a list of three freely accessible wellness resources available on the web.
Interventions
The intervention group involves a newly developed conversational agent self-care program. This program consists of 40 separate modules based on empirically supported techniques. Modules include the following core sections: cognitive behavioral skills, interpersonal relationships, positive psychological growth, relaxation, goal setting, and emotional regulation skills. The modules focus on cognitive-behavioral skills for reducing emotional distress, improving behavioral activation and healthy behaviors, and problem-solving skills. The intervention was delivered via a decision-tree based conversational agent in WhatsApp messenger.
The control group involved referral to a menu of freely-available evidence-based wellness resources linked from the study website, "Your Healthiest Self: Wellness Toolkits", "Doing What Matters in Times of Stress", and "How Right Now". These website choices involved self-selection of relevant modules for improving mood, reducing stress and anxiety, addressing relationship problems, and other wellness topics. These programs required only access to the websites and could be completed in a self-help format by participants at their own pace.
Eligibility Criteria
You may qualify if:
- years or older
- proficient in spoken and written English
- residents of the United States
- provided consent to be eligible to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Klagenfurtlead
- Meta Platforms, Inc.collaborator
Study Sites (1)
Meta Platforms Inc.
Menlo Park, California, 94025, United States
Related Publications (1)
Foran HM, Kubb C, Mueller J, Poff S, Ung M, Li M, Smith EM, Akinyemi A, Kambadur M, Waller F, Graf M, Boureau YL. An Automated Conversational Agent Self-Help Program: Randomized Controlled Trial. J Med Internet Res. 2024 Dec 6;26:e53829. doi: 10.2196/53829.
PMID: 39641985DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather M Heather, Ph.D.
University of Klagenfurt
- PRINCIPAL INVESTIGATOR
Y-Lan Boureau, Ph.D.
Meta Platforms
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2023
First Posted
January 17, 2024
Study Start
July 4, 2022
Primary Completion
March 20, 2024
Study Completion
March 20, 2024
Last Updated
May 16, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share