MedPath

A Bot-based Self-help Program (WELL)

Not Applicable
Completed
Conditions
Well-Being, Psychological
Interventions
Behavioral: Conversational Agent Zenny
Behavioral: Web-based Wellness Resources
Registration Number
NCT06208566
Lead Sponsor
University of Klagenfurt
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1595
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Conversational Agent ZennyConversational Agent ZennyParticipants received access to a self-help program delivered via an automated conversational agent on WhatsApp.
Web-based Wellness ResourcesWeb-based Wellness ResourcesParticipants received a list of three freely accessible wellness resources available on the web.
Primary Outcome Measures
NameTimeMethod
Subjective well-beingAt 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 flourishingAt 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-beingAt 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 Outcome Measures
NameTimeMethod
Participation/Engagement1 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.

User satisfaction1 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.

Trial Locations

Locations (1)

Meta Platforms Inc.

🇺🇸

Menlo Park, California, United States

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