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Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use

Primary Purpose

Alcohol Use Disorder (AUD), Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
W-SUDs
Education
Sponsored by
Woebot Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder (AUD)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Have a smartphone
  2. Endorse a substance use concern
  3. Be between 18 and 65 years of age
  4. Be available and committed to engage with the Woebot app
  5. Be literate in English.(This is required for inclusion because all materials will be in English).

Exclusion Criteria:

  1. Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
  2. Suicide attempt within the past year (12 months)
  3. Symptoms of severe drug/alcohol history: History of delirium tremens; Experiencing hypertension, drenching sweats, seizures or confusion after stopping alcohol or drugs; Liver trouble (cirrhosis or hepatitis); Convulsions or GI bleeding due to drug/alcohol use
  4. Opioid overdose within the past year (12 months)
  5. Opioid misuse without medication-assisted treatment
  6. Not residing in the U.S.
  7. Ever used Woebot

Sites / Locations

  • Stanford University
  • Woebot Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

W-SUDs

Education

Arm Description

Woebot (W-SUDs), a Conversational Agent (CA) instantaneously available 24 hours per day, 7 days per week, 'checks in' with users. Using conversational tones, it encourages mood tracking and delivers general psychoeducation as well as tailored empathy, cognitive behavior therapy (CBT)-based behavior change tools, and behavioral pattern insight. Woebot's app-based platform and user-centered design philosophy makes it an optimal modality for Substance Use Disorders (SUD) treatment delivery. It offers immediate, evidence-based tailored support in the patient's peak moment of craving.

Education digitally delivers weekly fact sheets that include information on: Alcohol-specific topics; Drug-specific topics; General addiction topics; Statistics relating to alcohol and substance use.

Outcomes

Primary Outcome Measures

Number of substance use occasions
Number of substance use occasions in the past 30 days

Secondary Outcome Measures

Quick Drinking Screen (QDS)
Alcohol Quantity/Frequency/Binge
Short Inventory of Problems- Alcohol and Drugs (SIP-AD)
The SIP-AD assesses substance use problems in the past 30 days. The scored variables, total scores and 15-item mean, summarize consequences of alcohol and drug use. Scores range from 0-45, where greater scores indicate greater substance use problems.
Craving Ratings
Self-reported ratings of craving intensity
Working Alliance Inventory (WAI-SR)
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 5-20, 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".
Stanford Presenteeism Scale (SPS-6)
A six item measure derived from a 34 item measure of workforce productivity impacted by health status. The 6-item scale has excellent psychometric propertiesand has been validated.
Thoughts About Abstinence (TAA)
Modified for alcohol and substances. 5-item questionnaire assessing desire to quit, expected success at quitting, expected difficulty of quitting, and confidence in ability to quit measured on 10-point Likert scales. The fifth item assesses partcipants' abstinence goal.
CAIR Pandemic Impact Questionnaire (C-PIQ)
Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact and growth
Patient Health Questionnaire (PHQ-8)
Total score between 0-27, higher scores indicate greater levels of depression.
Generalized Anxiety Disorder (GAD-7)
Total score between 0-21, higher scores indicate greater levels of anxiety
Brief Situational Confidence Questionnaire (BSCQ)
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.
Usage Rating Profile - Intervention (URPI)-Acceptability
Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability.
Usage Rating Profile Intervention - Intervention (URPI)-Feasibility
Measure of feasibility. A 6-item subscale that 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.
Client Satisfaction Questionnaire (CSQ)
Range from 8 to 32, with higher values indicating higher satisfaction
Mini-International Neuropsychiatric Interview (MINI)
A clinical interview used to assess a substance use diagnosis
Phosphatidylethanol (PEth)
PEth is an alcohol biomarker, where a positive result is an indication of alcohol exposure during the 2-4 weeks prior to specimen collection.
Engagement with control condition
Assessment of number of emails opened duration of study

Full Information

First Posted
July 13, 2021
Last Updated
August 31, 2023
Sponsor
Woebot Health
Collaborators
Stanford University, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04974645
Brief Title
Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use
Official Title
Pilot: Randomized Controlled Trial of an Digital Therapeutic Versus Education for the Management of Problematic Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
May 18, 2022 (Actual)
Study Completion Date
May 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Woebot Health
Collaborators
Stanford University, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prior to launching a randomized controlled trial, this pilot study will investigate the feasibility and acceptability of the administration of a diagnostic interview and collection of a biomarker test, as well as engagement and preliminary efficacy with W-SUDs and the education arm, among a sample of adults who screen positive for problematic substance use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD), Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
W-SUDs
Arm Type
Experimental
Arm Description
Woebot (W-SUDs), a Conversational Agent (CA) instantaneously available 24 hours per day, 7 days per week, 'checks in' with users. Using conversational tones, it encourages mood tracking and delivers general psychoeducation as well as tailored empathy, cognitive behavior therapy (CBT)-based behavior change tools, and behavioral pattern insight. Woebot's app-based platform and user-centered design philosophy makes it an optimal modality for Substance Use Disorders (SUD) treatment delivery. It offers immediate, evidence-based tailored support in the patient's peak moment of craving.
Arm Title
Education
Arm Type
Other
Arm Description
Education digitally delivers weekly fact sheets that include information on: Alcohol-specific topics; Drug-specific topics; General addiction topics; Statistics relating to alcohol and substance use.
Intervention Type
Device
Intervention Name(s)
W-SUDs
Intervention Description
Woebot (W-SUDs) is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
The education arm will receive digitally delivered psychoeducation for those seeking treatment for their alcohol and/or substance use concern. Psychoeducation is commonly provided for those with substance use. Psychoeducation in substance use is intended to increase the users' knowledge of their substances of use, and effects on the body, behaviors, and consequences. The recipient of psychoeducation is expected to increase their own awareness of their substance use and ideally incorporate this newfound knowledge when making changes to their substance use. The information provided in this group are from factsheets found on NIAAA, NIDA, and CDC web pages.
Primary Outcome Measure Information:
Title
Number of substance use occasions
Description
Number of substance use occasions in the past 30 days
Time Frame
Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks
Secondary Outcome Measure Information:
Title
Quick Drinking Screen (QDS)
Description
Alcohol Quantity/Frequency/Binge
Time Frame
Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks
Title
Short Inventory of Problems- Alcohol and Drugs (SIP-AD)
Description
The SIP-AD assesses substance use problems in the past 30 days. The scored variables, total scores and 15-item mean, summarize consequences of alcohol and drug use. Scores range from 0-45, where greater scores indicate greater substance use problems.
Time Frame
Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks
Title
Craving Ratings
Description
Self-reported ratings of craving intensity
Time Frame
Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks
Title
Working Alliance Inventory (WAI-SR)
Description
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 5-20, 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".
Time Frame
Difference between mid-treatment at 4 weeks and post-treatment at 8 weeks
Title
Stanford Presenteeism Scale (SPS-6)
Description
A six item measure derived from a 34 item measure of workforce productivity impacted by health status. The 6-item scale has excellent psychometric propertiesand has been validated.
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
Thoughts About Abstinence (TAA)
Description
Modified for alcohol and substances. 5-item questionnaire assessing desire to quit, expected success at quitting, expected difficulty of quitting, and confidence in ability to quit measured on 10-point Likert scales. The fifth item assesses partcipants' abstinence goal.
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
CAIR Pandemic Impact Questionnaire (C-PIQ)
Description
Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact and growth
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
Patient Health Questionnaire (PHQ-8)
Description
Total score between 0-27, higher scores indicate greater levels of depression.
Time Frame
Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks
Title
Generalized Anxiety Disorder (GAD-7)
Description
Total score between 0-21, higher scores indicate greater levels of anxiety
Time Frame
Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks
Title
Brief Situational Confidence Questionnaire (BSCQ)
Description
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.
Time Frame
Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks
Title
Usage Rating Profile - Intervention (URPI)-Acceptability
Description
Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability.
Time Frame
Post-treatment (8 weeks from baseline)
Title
Usage Rating Profile Intervention - Intervention (URPI)-Feasibility
Description
Measure of feasibility. A 6-item subscale that 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.
Time Frame
Post-treatment (8 weeks from baseline)
Title
Client Satisfaction Questionnaire (CSQ)
Description
Range from 8 to 32, with higher values indicating higher satisfaction
Time Frame
Post-treatment (8 weeks from baseline)
Title
Mini-International Neuropsychiatric Interview (MINI)
Description
A clinical interview used to assess a substance use diagnosis
Time Frame
Baseline
Title
Phosphatidylethanol (PEth)
Description
PEth is an alcohol biomarker, where a positive result is an indication of alcohol exposure during the 2-4 weeks prior to specimen collection.
Time Frame
Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline from12 weeks
Title
Engagement with control condition
Description
Assessment of number of emails opened duration of study
Time Frame
Baseline to Post-treatment at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a smartphone Endorse a substance use concern Be between 18 and 65 years of age Be available and committed to engage with the Woebot app Be literate in English.(This is required for inclusion because all materials will be in English). Exclusion Criteria: Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population) Suicide attempt within the past year (12 months) Symptoms of severe drug/alcohol history: History of delirium tremens; Experiencing hypertension, drenching sweats, seizures or confusion after stopping alcohol or drugs; Liver trouble (cirrhosis or hepatitis); Convulsions or GI bleeding due to drug/alcohol use Opioid overdose within the past year (12 months) Opioid misuse without medication-assisted treatment Not residing in the U.S. Ever used Woebot
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States
Facility Name
Woebot Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use

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