Clinical trial NCT05672745: How Phenotypical Characteristics of Woebot Users Are Related to Clinical Outcomes
Official title: An Open-label Pilot Study to Learn How the Phenotypical Characteristics of Woebot Users Are Related to Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: To Understand the Characteristics of Digital Mental Health Intervention Users as They Relate to Mental Health Outcomes
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
First posted: 2023-01-05
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this observational study is to understand the characteristics of Woebot users as they relate to clinical outcomes.

The objectives it aims to address are:

1. To assess Woebot usage patterns, satisfaction ratings, self-efficacy, stress, resilience, work productivity and activity impairment, alexthymia, and bond over time based on demographic, clinical baseline levels, and attitudinal characteristics
2. Among users who present with clinical levels of anxiety or depression, to assess the contribution of demographic characteristics, attitudinal characteristics, and patterns of engagement on clinical outcomes of interest over time
3. To collect and explore attitudinal characteristics of Woebot users regarding their experiences with mental health care and perceived value of digital tools for emotional support
4. Explore meaningful subgroups of Woebot users based on demographic and attitudinal characteristics, clinical outcomes, and patterns of engagement

Participants who meet study eligibility requirements will be:

* invited to engage with the Woebot Life program for 8 weeks
* complete survey assessments at day 3, week 4 (mid-intervention), and week 8 (end of intervention)


Eligibility criteria: Inclusion Criteria:

* 18+ years old
* US resident
* English literacy
* Availability to complete survey assessments
* Ownership or regular access to a smartphone with WiFi and sufficient data access for the duration of the study.

Exclusion Criteria:

* Current suicidal ideation with a plan or intent or a suicide attempt within the past 12 months
* A reported lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder) or bipolar disorder
* Previous use of the Woebot application

Primary outcomes:
measure: App engagement metrics
timeFrame: Baseline to Post-intervention at Week 8
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-intervention at Week 8
measure: Working Alliance Inventory (WAI)
timeFrame: Change from Day 3 to Mid-Intervention at Week 4; change from Day 3 to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8
measure: Mental Health Self-Efficacy Scale (MHSES)
timeFrame: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8
measure: Patient-Reported Outcomes Measurement Information System Global Health (PROMIS)
timeFrame: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8
measure: Patient Health Questionnaire
timeFrame: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8
measure: Generalized Anxiety Disorder Questionnaire
timeFrame: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8
measure: Brief Resilience Questionnaire (BRS)
timeFrame: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8
measure: Perceived Stress Scale (PSS)
timeFrame: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8
measure: Toronto Alexithymia Scale (TAS)
timeFrame: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8
measure: Burnout
timeFrame: Change from Baseline to Mid-Intervention at Week 4; change from Baseline to Post-intervention at Week 8; change from Mid-Intervention at Week 4 to Post-intervention at Week 8
Secondary outcomes:
measure: Perceived Barriers to Care (PBC)
timeFrame: Day 3 of Intervention
measure: Woebot Attitudinal Survey (WAS)
timeFrame: Post-intervention at Week 8
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Woebot Health
state: California
Study officials:
References: