Clinical trial NCT06208566: A Bot-based Self-help Program (WELL)
Official title: A Randomized Controlled Trial of a Bot-based Self-help Program (WELL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-Being, Psychological
Keywords: well-being
digital intervention
randomized trial
conversational agent
Lead sponsor: University of Klagenfurt
Sponsor class: OTHER
Collaborators: name: Meta Platforms, Inc.
First posted: 2024-01-17
Enrollment: 1595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective well-being
timeFrame: At pre-assessment and 1, 6 and 12 months after pre-assessment
measure: Psychosocial flourishing
timeFrame: At pre-assessment and 1, 6 and 12 months after pre-assessment
measure: Psychological well-being
timeFrame: At pre-assessment and 1, 6 and 12 months after pre-assessment
Secondary outcomes:
measure: User satisfaction
timeFrame: 1 month after pre-assessment
measure: Participation/Engagement
timeFrame: 1 month after pre-assessment
Other outcomes:
measure: Module rating of user satisfaction
timeFrame: 1 month after pre-assessment
measure: Days chatted bot
timeFrame: 1 month after pre-assessment
measure: Total messages
timeFrame: 1 month after pre-assessment
measure: Modules started
timeFrame: 1 month after pre-assessment
measure: Modules completed
timeFrame: 1 month after pre-assessment
measure: Modules started not completed
timeFrame: 1 month after pre-assessment
Locations:
city: Menlo Park
country: United States
facility: Meta Platforms Inc.
state: California
Study officials:
affiliation: University of Klagenfurt
name: Heather M Heather, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Meta Platforms
name: Y-Lan Boureau, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: