Substance Use DisordersPhase 1NCT04460027
W-SUDs for COVID-19
A Phase 1 study testing Woebot Substance Use Disorder in people with Substance Use Disorders and Alcohol Use Disorder, run by Woebot Health at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Use Disorders, Alcohol Use Disorder
- What is being tested?
- Woebot Substance Use Disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2020to 30 Nov 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 aged 18-65 years
- Access to a smartphone
- Available and committed to engage with app and complete assessments
- Be willing to provide email address (as this is how assessment incentives will be distributed),
- Literate in English (as W-SUDs conversational and video materials will be in English).
Who cannot join
- Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
- History of severe drug/alcohol use
- History of opioid misuse without medication-assisted treatment
- Suicide attempt within the past year
- Opioid overdose within the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Woebot for Substance Use Disorders During COVID-19
The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic.
This study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.
- Conditions
- Substance Use Disorders, Alcohol Use Disorder
- Being tested
- Woebot Substance Use Disorder
- Medical subject headings
- Substance-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Woebot Substance Use DisorderOther
Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
| Study group | Role | What they receive |
|---|---|---|
| W-SUDs | Experimental | Not described Receives: Other: Woebot Substance Use Disorder |
| Wait List Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks
Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks
Measured: Change from Baseline to Post-treatment at 8 weeks
Secondary outcomes (12)
Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks
Measure of substance use problems. The SIP-AD assesses substance use problems in the past 30 days. Total score consists of of the sum of all 15 items, ranging from 0-45, where greater scores indicate greater substance use problems.
Measured: Change from Baseline to Post-treatment at 8 weeks
Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks
Measure of drug abuse related consequences. The DAST-10 is a brief, 10-item self-report measure that assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity. Adapted from past 12 months to past 30 days.
Measured: Change from Baseline to Post-treatment at 8 weeks
Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks
Measure of self-confidence. 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 in Craving Ratings From Baseline to Post-treatment at 8 Weeks
A one-item, self-reported rating of craving intensity to use substances over the past 7 days. Score ranges is from 0-4, where a greater score indicates a more intense urge to use.
Measured: Change from Baseline to Post-treatment at 8 weeks
Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks
A one item, self-reported rating of pain. Scores range from 0-100 where higher scores indicate greater levels of pain.
Measured: Change from Baseline to Post-treatment at 8 Weeks
Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks
Measure of depression. An 8-item self-report questionnaire that assesses the frequency and severity of depression symptoms. Total scores range from 0 to 24 where higher scores indicate greater levels of depression.
Measured: Change from Baseline to Post-treatment at 8 weeks
Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks
Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety.
Measured: Change from Baseline to Post-treatment at 8 weeks
Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks
Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact, and growth. Possible total score range from 0-22, where greater scores are related to greater impact.
Measured: Change from Baseline to Post-treatment at 8 weeks
Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks
Measure of satisfaction. An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale. Example questions include, "How would you rate the quality of service you received"? and "Did you get the kind of service you wanted?" Total sums range from 8-32, with high scores indicating greater satisfaction with the W-SUDs mobile application.
Measured: Post-treatment (8 weeks from Baseline)
Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks
Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Total scores range from 6-36, where greater scores indicate greater intervention acceptability.
Measured: Post-treatment (8 weeks from Baseline)
Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks
Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Total scores range from 6-36, where greater scores indicate greater intervention feasibility.
Measured: Post-treatment (8 weeks from Baseline)
Change in 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. 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 Mid-treatment at 4 weeks 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 posted7 Jul 2020
- Study start22 Jun 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woebot Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460027
- Sponsor's protocol ID
- 56439
- Other IDs
- 4R44DA048712-02
- Status last verified
- Nov 2022
- First submitted
- 1 Jul 2020
- Last updated
- 21 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Woebot for Substance Use Disorders During COVID-19
- ClinicalTrials.gov ID
- NCT04460027
- Acronym / sponsor ID
- 56439
- Conditions
- Substance Use Disorders, Alcohol Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Woebot HealthIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University, National Institute on Drug Abuse (NIDA)
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Posted 21 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic.
This study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| W-SUDs | Experimental | Other: Woebot Substance Use Disorder |
| Wait List Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All genders aged 18-65 years
- Access to a smartphone
- Available and committed to engage with app and complete assessments
- Be willing to provide email address (as this is how assessment incentives will be distributed),
- Literate in English (as W-SUDs conversational and video materials will be in English).
Key exclusion criteria (5 listed)
- Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
- History of severe drug/alcohol use
- History of opioid misuse without medication-assisted treatment
- Suicide attempt within the past year
- Opioid 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 Substance Use DisorderWoebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation. | Other | W-SUDs |
Primary outcome
Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks
Time frame: Change from Baseline to Post-treatment at 8 weeks
Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks
12 secondary outcomes
Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks
Time frame: Change from Baseline to Post-treatment at 8 weeks
Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks
Time frame: Change from Baseline to Post-treatment at 8 weeks
Change in 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 in Craving Ratings From Baseline to Post-treatment at 8 Weeks
Time frame: Change from Baseline to Post-treatment at 8 weeks
Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks
Time frame: Change from Baseline to Post-treatment at 8 Weeks
Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks
Time frame: Change from Baseline to Post-treatment at 8 weeks
Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks
Time frame: Change from Baseline to Post-treatment at 8 weeks
Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks
Time frame: Change from Baseline to Post-treatment at 8 weeks
Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks
Time frame: Post-treatment (8 weeks from Baseline)
Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks
Time frame: Post-treatment (8 weeks from Baseline)
Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks
Time frame: Post-treatment (8 weeks from Baseline)
Change in 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Substance Use Disorder in people with Substance Use Disorders and Alcohol Use Disorder, 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 5 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 21 Dec 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 21 Dec 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 Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks (time frame: Change from Baseline to Post-treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2022.