To Understand the Characteristics of Digital Mental Health Intervention Users as They Relate to Mental Health OutcomesNCT05672745
How Phenotypical Characteristics of Woebot Users Are Related to Clinical Outcomes
A study testing WB-LIFE in people with To Understand the Characteristics of Digital Mental Health Intervention Users as They Relate to Mental Health Outcomes, run by Woebot Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Understand the Characteristics of Digital Mental Health Intervention Users as They Relate to Mental Health Outcomes
- What is being tested?
- WB-LIFE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 23 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Pilot Study to Learn How the Phenotypical Characteristics of Woebot Users Are Related to Clinical Outcomes
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:
Read more
- 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
- 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
- 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
- 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)
- Being tested
- WB-LIFE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB-LIFEDevice
WB-LIFE is a mobile application program grounded in validated psychotherapies (including cognitive behavioral therapy, interpersonal, and dialectical behavioral therapy), that enlists the relational agent Woebot to guide users in managing their mood. The user experience is driven by artificial intelligence and centers around mood tracking, evidence-based tools, and goal-oriented, tailored conversations.
| Study group | Role | What they receive |
|---|---|---|
| WB-LIFE | Experimental | Not described Receives: Device: WB-LIFE |
What is being measured
The primary outcome is the main question the study is designed to answer.
App engagement metrics
Data tracking mobile application use, including conversational interactions with Woebot and patterns of engagement over time, will be collected throughout the duration of treatment (8-weeks).
Measured: Baseline to Post-intervention at Week 8
Client Satisfaction Questionnaire (CSQ-8)
An 8-item measure used to assess client's satisfaction with treatment.Total scores range from 8-32, with high scores indicating greater satisfaction with the treatment.
Measured: Post-intervention at Week 8
Working Alliance Inventory (WAI)
Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Total scores range from 12-60, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing "therapist" with "Woebot".
Measured: 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
Mental Health Self-Efficacy Scale (MHSES)
Six items assess confidence in managing stress, depression, and anxiety, and are scored on a 10 point Likert scale (from 1, not at all confident to 10, very confident). Ratings across the 6 items are summed for an overall measure of MHSES (range 10 to 60), with higher scores indicating more self-efficacy. This measure is included as a way to capture an individual's confidence that they can successfully manage their mental health concerns.
Measured: 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
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS)
Ten items used to assess five core domains of health (physical function, pain, fatigue, emotional distress, and social). Total scores range from 5-50, where greater scores represent the best health and functioning.
Measured: 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
Patient Health Questionnaire
Measure of depression. An 8-item self-report questionnaire where total scores range from 0 to 24, with higher scores indicating greater levels of depression
Measured: 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
Generalized Anxiety Disorder Questionnaire
Measure of anxiety. A 7-item brief self-report questionnaire, where total score range is between 0-21, with higher scores indicate greater levels of anxiety.
Measured: 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
Brief Resilience Questionnaire (BRS)
The BRS is a measure used to assess a person's ability to bounce back or recover after experiencing a stressor. Total scores range from 1 (low resilience) to 5 (high resilience).
Measured: 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
Perceived Stress Scale (PSS)
The PSS is a 10-item tool to assess individual levels of stress in the past month. Total scores range from 0 (no stress) to 40 (very high levels of stress).
Measured: 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
Toronto Alexithymia Scale (TAS)
The TAS-20 is an instrument that measures alexithymia, or difficulty with identifying and describing emotions and focusing attention externally. Total scores range from 20-100, with with low levels of alexithymia indicative of high levels of emotional self-awareness and vice versa.
Measured: 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
Work Productivity and Activity Impairment (WPAI)
The WPAI measures presenteeism, absenteeism, work productivity loss for the currently employed, and activity impairment.
WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
Measured: 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
Burnout
Single-item question to measure burnout on a scale from 1-5, where 5 is feeling completely burned out to the point change is needed.
Measured: 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 (2)
Perceived Barriers to Care (PBC)
The PBC is a 30-item assesses perceived barriers to access mental health care on a scale of 1= not at all to 5 = impossible, including Stigma, Lack of motivation, Emotional concerns, Negative evaluations of therapy, Misfit of therapy to needs, Time constraints, Participation restriction, Availability of Services, and Cost.
Measured: Day 3 of Intervention
Woebot Attitudinal Survey (WAS)
The 9-item survey was designed to assess the user's perceptions of their Woebot experience - perceptions of skills learned, emotional challenges addressed, relational quality (comprehension of information, relevance of suggestions offered, perceptions of support, lack of judgment), applications of Woebot suggestions in daily life, and perceptions about the session duration and length of engagement with Woebot app needed for Woebot to work effectively.
Measured: Post-intervention at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start11 May 2022
- Primary completion23 Jul 2022
- Study completion23 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for To Understand the Characteristics of Digital Mental Health Intervention Users as They Relate to Mental Health OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woebot Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672745
- Sponsor's protocol ID
- W-LIFE-001
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiauzzi E, Williams A, Mariano TY, Pajarito S, Robinson A, Kirvin-Quamme A, Forman-Hoffman V. Demographic and clinical characteristics associated with anxiety and depressive symptom outcomes in users of a digital mental health intervention incorporating a relational agent. BMC Psychiatry. 2024 Jan 30;24(1):79. doi: 10.1186/s12888-024-05532-6.
PubMed 38291369Hoffman V, Flom M, Mariano TY, Chiauzzi E, Williams A, Kirvin-Quamme A, Pajarito S, Durden E, Perski O. User Engagement Clusters of an 8-Week Digital Mental Health Intervention Guided by a Relational Agent (Woebot): Exploratory Study. J Med Internet Res. 2023 Oct 13;25:e47198. doi: 10.2196/47198.
PubMed 37831490Forman-Hoffman VL, Pirner MC, Flom M, Kirvin-Quamme A, Durden E, Kissinger JA, Robinson A. Engagement, Satisfaction, and Mental Health Outcomes Across Different Residential Subgroup Users of a Digital Mental Health Relational Agent: Exploratory Single-Arm Study. JMIR Form Res. 2023 Sep 27;7:e46473. doi: 10.2196/46473.
PubMed 37756047
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pilot Study to Learn How the Phenotypical Characteristics of Woebot Users Are Related to Clinical Outcomes
- ClinicalTrials.gov ID
- NCT05672745
- Acronym / sponsor ID
- W-LIFE-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Woebot HealthIndustry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 23 Jul 2022 (actual)
- Study completion
- 23 Jul 2022 (actual)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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
- 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
- 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)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WB-LIFE | Experimental | Device: WB-LIFE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WB-LIFEWB-LIFE is a mobile application program grounded in validated psychotherapies (including cognitive behavioral therapy, interpersonal, and dialectical behavioral therapy), that enlists the relational agent Woebot to guide users in managing their mood. The user experience is driven by artificial intelligence and centers around mood tracking, evidence-based tools, and goal-oriented, tailored conversations. | Device | WB-LIFE |
Primary outcome
App engagement metrics
Time frame: Baseline to Post-intervention at Week 8
Data tracking mobile application use, including conversational interactions with Woebot and patterns of engagement over time, will be collected throughout the duration of treatment (8-weeks).
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post-intervention at Week 8
An 8-item measure used to assess client's satisfaction with treatment.Total scores range from 8-32, with high scores indicating greater satisfaction with the treatment.
Working Alliance Inventory (WAI)
Time frame: 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 of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Total scores range from 12-60, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing "therapist" with "Woebot".
Mental Health Self-Efficacy Scale (MHSES)
Time frame: 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
Six items assess confidence in managing stress, depression, and anxiety, and are scored on a 10 point Likert scale (from 1, not at all confident to 10, very confident). Ratings across the 6 items are summed for an overall measure of MHSES (range 10 to 60), with higher scores indicating more self-efficacy. This measure is included as a way to capture an individual's confidence that they can successfully manage their mental health concerns.
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS)
Time frame: 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
Ten items used to assess five core domains of health (physical function, pain, fatigue, emotional distress, and social). Total scores range from 5-50, where greater scores represent the best health and functioning.
Patient Health Questionnaire
Time frame: 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 of depression. An 8-item self-report questionnaire where total scores range from 0 to 24, with higher scores indicating greater levels of depression
Generalized Anxiety Disorder Questionnaire
Time frame: 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 of anxiety. A 7-item brief self-report questionnaire, where total score range is between 0-21, with higher scores indicate greater levels of anxiety.
Brief Resilience Questionnaire (BRS)
Time frame: 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
The BRS is a measure used to assess a person's ability to bounce back or recover after experiencing a stressor. Total scores range from 1 (low resilience) to 5 (high resilience).
Perceived Stress Scale (PSS)
Time frame: 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
The PSS is a 10-item tool to assess individual levels of stress in the past month. Total scores range from 0 (no stress) to 40 (very high levels of stress).
Toronto Alexithymia Scale (TAS)
Time frame: 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
The TAS-20 is an instrument that measures alexithymia, or difficulty with identifying and describing emotions and focusing attention externally. Total scores range from 20-100, with with low levels of alexithymia indicative of high levels of emotional self-awareness and vice versa.
Work Productivity and Activity Impairment (WPAI)
Time frame: 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
The WPAI measures presenteeism, absenteeism, work productivity loss for the currently employed, and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
Burnout
Time frame: 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
Single-item question to measure burnout on a scale from 1-5, where 5 is feeling completely burned out to the point change is needed.
2 secondary outcomes
Perceived Barriers to Care (PBC)
Time frame: Day 3 of Intervention
Woebot Attitudinal Survey (WAS)
Time frame: Post-intervention at Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Derived from this study: PubMed 38291369Chiauzzi E, Williams A, Mariano TY, Pajarito S, Robinson A, Kirvin-Quamme A, Forman-Hoffman V. Demographic and clinical characteristics associated with anxiety and depressive symptom outcomes in users of a digital mental health intervention incorporating a relational agent. BMC Psychiatry. 2024 Jan 30;24(1):79. doi: 10.1186/s12888-024-05532-6.
- Derived from this study: PubMed 37831490Hoffman V, Flom M, Mariano TY, Chiauzzi E, Williams A, Kirvin-Quamme A, Pajarito S, Durden E, Perski O. User Engagement Clusters of an 8-Week Digital Mental Health Intervention Guided by a Relational Agent (Woebot): Exploratory Study. J Med Internet Res. 2023 Oct 13;25:e47198. doi: 10.2196/47198.
- Derived from this study: PubMed 37756047Forman-Hoffman VL, Pirner MC, Flom M, Kirvin-Quamme A, Durden E, Kissinger JA, Robinson A. Engagement, Satisfaction, and Mental Health Outcomes Across Different Residential Subgroup Users of a Digital Mental Health Relational Agent: Exploratory Single-Arm Study. JMIR Form Res. 2023 Sep 27;7:e46473. doi: 10.2196/46473.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WB-LIFE in people with To Understand the Characteristics of Digital Mental Health Intervention Users as They Relate to Mental Health Outcomes, run by Woebot Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
App engagement metrics (time frame: Baseline to Post-intervention at Week 8). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05672745, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.