A Bot-based Self-help Program (WELL)

NCT ID: NCT06208566

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1595 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2024-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Well-Being, Psychological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conversational Agent Zenny

Participants received access to a self-help program delivered via an automated conversational agent on WhatsApp.

Group Type EXPERIMENTAL

Conversational Agent Zenny

Intervention Type BEHAVIORAL

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 Resources

Participants received a list of three freely accessible wellness resources available on the web.

Group Type ACTIVE_COMPARATOR

Web-based Wellness Resources

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conversational Agent Zenny

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.

Intervention Type BEHAVIORAL

Web-based Wellness Resources

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meta Platforms, Inc.

UNKNOWN

Sponsor Role collaborator

University of Klagenfurt

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heather M Heather, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Klagenfurt

Y-Lan Boureau, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Meta Platforms

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Meta Platforms Inc.

Menlo Park, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39641985 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

101095530

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Student Wellness 2.0
NCT06804213 COMPLETED NA
Deep Dive Randomized Control Trial
NCT00793260 COMPLETED NA
Check Yourself Study
NCT02360410 COMPLETED NA
Working Toward Wellness
NCT00694681 COMPLETED NA
Mood Lifters: A Self Help Program
NCT02558075 COMPLETED NA