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Completed

NCT Number: NCT06208566

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meta Platforms Inc.

Menlo Park, California, 94025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conversational Agent Zenny

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. User satisfaction

    Time frame: 1 month after pre-assessment

    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.

  2. Participation/Engagement

    Time frame: 1 month after pre-assessment

    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.

Other outcomes

  1. Module rating of user satisfaction

    Time frame: 1 month after pre-assessment

    Within the intervention group, user satisfaction is assessed following each module. Users are able to rate satisfaction with each completed module from 1 "not at all" (1) to "extremely" (5). An average satisfaction rating across modules over a thirty-day period is computed.

  2. Days chatted bot

    Time frame: 1 month after pre-assessment

    Engagement with the conversational agent is defined as the count of days that a user engaged in conversations within the last 30 days from 0 days to 30 days.

  3. Total messages

    Time frame: 1 month after pre-assessment

    The number of messages sent by the user to the conversational agent is quantified as a further objective measure. This refers to any situation where the user is starting an interaction with the conversational agent or is responding to a message from the conversational agent within the last 30 days from 0 days to 30 days.

  4. Modules started

    Time frame: 1 month after pre-assessment

    This is the total number of modules that is initiated by the participant within the first 30 days, whether they were completed or not (i.e., sum of finished and unfinished modules).

  5. Modules completed

    Time frame: 1 month after pre-assessment

    This is the number of modules that is completed within the first 30 days (i.e., finished modules).

  6. Modules started not completed

    Time frame: 1 month after pre-assessment

    This is the number of modules that is started but not completed within the first 30 days (i.e., unfinished modules).

Sponsors and collaborators

Lead sponsor

University of Klagenfurt

Other

Collaborators

  • Meta Platforms, Inc.

Registry information

Official study title

A Randomized Controlled Trial of a Bot-based Self-help Program (WELL)

Acronym: WELL

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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