Substance Use DisordersPhase 1NCT04096001
Woebot for Substance Use Disorders
A Phase 1 study testing Woebot-SUDs (W-SUDs) in people with Substance Use Disorders, run by Woebot Health at 1 site in United States.
Trial summary
Phase 1 of this study aims to develop a digitally-delivered substance use disorder program through the Woebot app-based platform (W-SUDs) and evaluate the effectiveness of, patient satisfaction with and the acceptability of W-SUDs as a substance use management tool. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Woebot-SUDs (W-SUDs)
- Type of treatment
- Medical device
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2020to 31 Aug 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All genders
- 18-65 years
- Must have access to a smartphone and able to download the W-SUDs app
- Committed to engage with app and complete assessments
- Be willing to provide email address (to distribute incentives)
- Be literate in English (as W-SUDs conversational and video materials will be in English)
- Endorse a substance use concern according to the DAST-10 and/or AUDIT-C scale cutoffs for problematic use
Who cannot join
- Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
- Suicide attempt or within the past year
- Drug or alcohol overdose within the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RCT of Woebot for Substance Use Disorders Phase 1
Phase 1 of this study aims to develop a digitally-delivered substance use disorder program through the Woebot app-based platform (W-SUDs) and evaluate the effectiveness of, patient satisfaction with and the acceptability of W-SUDs as a substance use management tool.
- Conditions
- Substance Use Disorders
- Being tested
- Woebot-SUDs (W-SUDs)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Woebot-SUDs (W-SUDs)Device
Woebot-SUDs (W-SUDS), an artificially intelligence-powered conversational agent on a smartphone app, eliminates most current SUDs treatment barriers while simultaneously leveraging technology to enhance user experience and engagement. W-SUDs expands and refines existing SUDs treatments by adapting skills from cognitive behavioral therapy, motivational interviewing, and dialectical behavior therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks
The AUDIT-C is a widely used 3-item self-report screen for hazardous or harmful alcohol consumption that is based off of the 10-item original AUDIT. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Measured: Change from Baseline to Post-treatment at 8 weeks
Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks
The DAST-10 is a brief, 10-item self-report assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity.
Measured: Change from Baseline to Post-treatment at 8 weeks
Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks
The number of days a substance was used the past 30 days
Measured: Change from Baseline and Post-treatment at 8 weeks
Secondary outcomes (8)
The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks
The CSQ-8 is an 8-item self-report scale measuring satisfaction with treatment. Scores from 8 to 32, with higher values indicating higher satisfaction.
Measured: Post-treatment at 8 weeks
Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks
URPI-Acceptability Subscale is 6-item subscale from the URP Intervention Revised (URP-IR) scale. The URPI-Acceptability inquires about intervention acceptability. Responses range from 1= "slightly disagree" to 6="strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability.
Measured: Post-treatment at 8 weeks
Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 Weeks
URPI-Feasibility Subscale is 6-item subscale from the URP Intervention Revised (URP-IR) scale. The URPI-Feasibility inquires about factors that impact treatment usage (i.e., intervention quality). Responses range from 1= "slightly disagree" to 6="strongly agree". Scores are averages, with greater scores indicating greater intervention feasibility.
Measured: Post-treatment at 8 weeks
Change From Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks
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. Scores range from 15-60, 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 Mid-treatment at 4 weeks to Post-treatment at 8 weeks
Change Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks
Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.
Measured: Change from Baseline to Post-Treatment at 8 weeks
Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks
Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety.
Measured: Change from Baseline to Post-Treatment at 8 weeks
Change Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks
The 8-item BSCQ is a state dependent measure that assesses self-confidence to resist the urge to drink heavily or use drugs in a variety of situations. Each of the 8 scale situations consists of a 100-mm line, anchored by 0% ("not at all confident") and 100% ("totally confident") where clients are asked to indicate confidence on a scale from 0% to 100%. Higher scores are associated with greater confidence.
Measured: Change from Baseline to Post-treatment at 8 weeks
Change Pain Rating From Baseline to Post-Treatment at 8 Weeks
Range from 0-100 (no pain to worst pain imaginable).
Measured: Change from Baseline to Post-treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start26 Mar 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woebot Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096001
- Sponsor's protocol ID
- 1R44DA048712-01
- Status last verified
- Aug 2022
- First submitted
- 16 Sep 2019
- Last updated
- 31 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Prochaska JJ, Vogel EA, Chieng A, Kendra M, Baiocchi M, Pajarito S, Robinson A. A Therapeutic Relational Agent for Reducing Problematic Substance Use (Woebot): Development and Usability Study. J Med Internet Res. 2021 Mar 23;23(3):e24850. doi: 10.2196/24850.
PubMed 33755028
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Woebot for Substance Use Disorders Phase 1
- ClinicalTrials.gov ID
- NCT04096001
- Acronym / sponsor ID
- 1R44DA048712-01
- Conditions
- Substance Use Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Woebot HealthIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 26 Mar 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Posted 31 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 of this study aims to develop a digitally-delivered substance use disorder program through the Woebot app-based platform (W-SUDs) and evaluate the effectiveness of, patient satisfaction with and the acceptability of W-SUDs as a substance use management tool.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All genders
- 18-65 years
- Must have access to a smartphone and able to download the W-SUDs app
- Committed to engage with app and complete assessments
- Be willing to provide email address (to distribute incentives)
Key exclusion criteria (3 listed)
- Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
- Suicide attempt or within the past year
- Drug or alcohol overdose within the past year
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 |
|---|---|---|
| Woebot-SUDs (W-SUDs)Woebot-SUDs (W-SUDS), an artificially intelligence-powered conversational agent on a smartphone app, eliminates most current SUDs treatment barriers while simultaneously leveraging technology to enhance user experience and engagement. W-SUDs expands and refines existing SUDs treatments by adapting skills from cognitive behavioral therapy, motivational interviewing, and dialectical behavior therapy. | Device | – |
Primary outcome
Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks
Time frame: Change from Baseline to Post-treatment at 8 weeks
The AUDIT-C is a widely used 3-item self-report screen for hazardous or harmful alcohol consumption that is based off of the 10-item original AUDIT. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks
Time frame: Change from Baseline to Post-treatment at 8 weeks
The DAST-10 is a brief, 10-item self-report assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity.
Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks
Time frame: Change from Baseline and Post-treatment at 8 weeks
The number of days a substance was used the past 30 days
8 secondary outcomes
The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks
Time frame: Post-treatment at 8 weeks
Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks
Time frame: Post-treatment at 8 weeks
Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 Weeks
Time frame: Post-treatment at 8 weeks
Change From Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks
Time frame: Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks
Change Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks
Time frame: Change from Baseline to Post-Treatment at 8 weeks
Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks
Time frame: Change from Baseline to Post-Treatment at 8 weeks
Change Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks
Time frame: Change from Baseline to Post-treatment at 8 weeks
Change Pain Rating From Baseline to Post-Treatment at 8 Weeks
Time frame: Change from Baseline to Post-treatment at 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33755028Prochaska JJ, Vogel EA, Chieng A, Kendra M, Baiocchi M, Pajarito S, Robinson A. A Therapeutic Relational Agent for Reducing Problematic Substance Use (Woebot): Development and Usability Study. J Med Internet Res. 2021 Mar 23;23(3):e24850. doi: 10.2196/24850.
- Individual participant dataSharing planned: Undecided
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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 Phase 1 study testing Woebot-SUDs (W-SUDs) in people with Substance Use Disorders, 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 7 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 31 Aug 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks (time frame: Change from Baseline to Post-treatment at 8 weeks). The study lists 3 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 NCT04096001, which also lists 1 linked publication.
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 31 Aug 2022.