Well-Being, PsychologicalWELLNCT06208566
A Bot-based Self-help Program (WELL)
A study testing Conversational Agent Zenny and Web-based Wellness Resources in people with Well-Being, Psychological, run by University of Klagenfurt at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- Conversational Agent Zenny and Web-based Wellness Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,595 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jul 2022to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- proficient in spoken and written English
- residents of the United States
- provided consent to be eligible to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Bot-based Self-help Program (WELL)
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.
Read the detailed description
The purpose of the data collection is to evaluate a new intervention as part of a research study.
In the current project, 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. The intervention modules are based on existing empirically supported intervention techniques from traditional cognitive-behavioral therapies and other third generation therapies such as mindfulness training and dialectical behavioral therapy. The focus of the program is to introduce psychological concepts that have been shown to be effective for managing emotions and problems to a broader public audience. Another focus is on helping individuals connect with resources that are available related to subjective well-being. Often individuals who may be interested in self-help interventions do not know where to seek help and interventions that they may find (e.g., apps), may not be scientifically valid. By providing recommendations on resources that are specific to an individual's needs, this may reduce one barrier to care.
The focus of this project is not only on testing the effectiveness of the program on well-being compared to an online control condition in a randomized controlled trial, but on improving REACH to individuals who may benefit from such an intervention. Thus, the focus is on brief, low burden assessments, rather than a full battery typical in psychological studies, to improve acceptability, recruitment rates, and retention rates. The implementation science model, RE-AIM, will be used as a framework for this study (http://www.re-aim.org/).
H1: The intervention group will evidence significant improvements in well-being at the post-assessment and follow-up assessments (1-month, 6- month, 12-month) compared to the control group.
H2: The effectiveness of the intervention will be similar across gender and age after controlling for participation/engagement and user satisfaction.
H3: The intervention group will have significantly higher psychological growth compared to the control group at post-assessment and follow-ups assessments (1-month, 6- month, 12-month).
H4: The intervention group will have higher response rates, higher retention rates, and more self-reported active participation/engagement than the control group.
H5: Higher user satisfaction and more active participation/engagement will be associated with greater improvements in well-being.
H6: Higher user satisfaction will lead to subsequent increases in participation/engagement over time.
- Conditions
- Well-Being, Psychological
- Being tested
- Conversational Agent Zenny, Web-based Wellness Resources
- Keywords
- well-being, digital intervention, randomized trial, conversational agent
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversational Agent ZennyBehavioural
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.
Web-based Wellness ResourcesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conversational Agent Zenny | Experimental | Participants received access to a self-help program delivered via an automated conversational agent on WhatsApp. Receives: Behavioral: Conversational Agent Zenny |
| Web-based Wellness Resources | Active comparator | Participants received a list of three freely accessible wellness resources available on the web. Receives: Behavioral: Web-based Wellness Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: At pre-assessment and 1, 6 and 12 months after pre-assessment
Secondary outcomes (2)
User satisfaction
This is assessed with four items during the post-assessment for both conditions. Satisfaction with the program is formed by individual items on satisfaction, usefulness, relevance, and helpfulness. Participants rate these dimensions on 4-point Likert scales between 0 (strong disagreement) to 4 (strong agreement). Only the item on usefulness is rated on a 5-point Likert scale. A sum score is calculated by summarizing all single item scores, resulting in a range from 0 to 17. Higher scores indicate greater satisfaction with the content.
Measured: 1 month after pre-assessment
Participation/Engagement
This is assessed by the reported frequency using the intervention or control condition resources at the post-assessment. For the first item, participants rate on a 6-point Likert scale how often they participated in the last month, ranged from "not at all" (1) to "daily" (6). On a second item, participants are asked to rate their perceived level of activity on a 4-point Likert scale, ranging from "not at all active" (1) to "very active" (4). The scores for both items are summarized into a sum score, with higher scores indicating greater participation/engagement.
Measured: 1 month after pre-assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start4 Jul 2022
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,595 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Klagenfurt
- Sponsor type
- University, hospital or other
- Collaborators
- Meta Platforms, Inc.
- Responsible party
- Sponsor
- Investigators
- Heather M Heather, Ph.D., Principal investigator, University of KlagenfurtY-Lan Boureau, Ph.D., Principal investigator, Meta Platforms
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208566
- Sponsor's protocol ID
- 101095530
- Acronym
- WELL
- Status last verified
- May 2024
- First submitted
- 13 Dec 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39641985
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Bot-based Self-help Program (WELL)
- ClinicalTrials.gov ID
- NCT06208566
- Acronym / sponsor ID
- WELL / 101095530
- Conditions
- Well-Being, Psychological
- Keywords
- well-being, digital intervention, randomized trial, conversational agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,595 participants (actual)
- Lead sponsor
- University of KlagenfurtUniversity, hospital or other
- Collaborators
- Meta Platforms, Inc.
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the data collection is to evaluate a new intervention as part of a research study.
In the current project, 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. The intervention modules are based on existing empirically supported intervention techniques from traditional cognitive-behavioral therapies and other third generation therapies such as mindfulness training and dialectical behavioral therapy. The focus of the program is to introduce psychological concepts that have been shown to be effective for managing emotions and problems to a broader public audience. Another focus is on helping individuals connect with resources that are available related to subjective well-being. Often individuals who may be interested in self-help interventions do not know where to seek help and interventions that they may find (e.g., apps), may not be scientifically valid. By providing recommendations on resources that are specific to an individual's needs, this may reduce one barrier to care.
The focus of this project is not only on testing the effectiveness of the program on well-being compared to an online control condition in a randomized controlled trial, but on improving REACH to individuals who may benefit from such an intervention. Thus, the focus is on brief, low burden assessments, rather than a full battery typical in psychological studies, to improve acceptability, recruitment rates, and retention rates. The implementation science model, RE-AIM, will be used as a framework for this study (http://www.re-aim.org/).
H1: The intervention group will evidence significant improvements in well-being at the post-assessment and follow-up assessments (1-month, 6- month, 12-month) compared to the control group.
H2: The effectiveness of the intervention will be similar across gender and age after controlling for participation/engagement and user satisfaction.
H3: The intervention group will have significantly higher psychological growth compared to the control group at post-assessment and follow-ups assessments (1-month, 6- month, 12-month).
H4: The intervention group will have higher response rates, higher retention rates, and more self-reported active participation/engagement than the control group.
H5: Higher user satisfaction and more active participation/engagement will be associated with greater improvements in well-being.
H6: Higher user satisfaction will lead to subsequent increases in participation/engagement over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conversational Agent Zenny | Experimental | Behavioral: Conversational Agent ZennyParticipants received access to a self-help program delivered via an automated conversational agent on WhatsApp. |
| Web-based Wellness Resources | Active comparator | Behavioral: Web-based Wellness ResourcesParticipants received a list of three freely accessible wellness resources available on the web. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- proficient in spoken and written English
- residents of the United States
- provided consent to be eligible to participate in the study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conversational Agent ZennyThe 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. | Behavioural | Conversational Agent Zenny |
| Web-based Wellness ResourcesThe 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. | Behavioural | Web-based Wellness Resources |
Primary outcome
Subjective well-being
Time frame: At pre-assessment and 1, 6 and 12 months after pre-assessment
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.
Psychosocial flourishing
Time frame: At pre-assessment and 1, 6 and 12 months after pre-assessment
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.
Psychological well-being
Time frame: At pre-assessment and 1, 6 and 12 months after pre-assessment
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).
2 secondary outcomes
User satisfaction
Time frame: 1 month after pre-assessment
Participation/Engagement
Time frame: 1 month after pre-assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 39641985Foran 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.
- Open Science Framework Preregistration (June 3, 2022)Link provided by the sponsor.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather M Heather, Ph.D. principal investigator
University of Klagenfurt
Y-Lan Boureau, Ph.D. principal investigator
Meta Platforms
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conversational Agent Zenny and Web-based Wellness Resources in people with Well-Being, Psychological, run by University of Klagenfurt at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective well-being (time frame: At pre-assessment and 1, 6 and 12 months after pre-assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06208566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.