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The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use

Primary Purpose

Alcohol Use Disorder (AUD), Substance Use Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
W-SUDs
Digitally-delivered Psychoeducation
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) focused on measuring Alcohol Use Disorder, Substance Use Disorder, AUD, SUD, AUD Treatment, SUD Treatment, Smartphone Application, Digital Therapeutic, Alcohol Use Disorder Treatment, Substance Use Disorder Treatment

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. Previous Woebot use

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

W-SUDs

Digitally-delivered Psychoeducation

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.

Psychoeducation 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

Drug Abuse Screening Test (DAST-10)
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.
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)
Measure of workforce productivity. A six item measure derived from a 34 item measure of workforce productivity impacted by health status. The 6-item scale has excellent psychometric properties and has been validated.
Thoughts About Abstinence (TAA)
Measure of thoughts about abstinence. 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.
Usage Rating Profile - Intervention (URPI)-Acceptability
Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Responses range from 1 = "strongly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability.
Usage Rating Profile - 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 = "strongly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention feasibility.
Client Satisfaction Questionnaire (CSQ)
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.
Short Inventory of Problems- Alcohol and Drugs (SIP-AD)
Measure of substance use problems. 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.
Patient Health Questionnaire (PHQ-8)
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.
Generalized Anxiety Disorder (GAD-7)
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.
Brief Situational Confidence Questionnaire (BSCQ)
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.
Craving Ratings
Measure of craving. A self-reported rating of craving intensity.
Quick Drinking Screen (QDS)
Measure of alcohol use. A self-report measure used to assess alcohol use including quantity consumed, frequency of drinking, and binge incidences.

Full Information

First Posted
May 25, 2021
Last Updated
August 31, 2023
Sponsor
Woebot Health
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04925570
Brief Title
The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use
Official Title
Woebot for Substance Use Disorders Phase 2 RCT: Digitally Delivered Intervention for Reducing Problematic Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
August 17, 2023 (Actual)
Study Completion Date
August 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Woebot Health
Collaborators
Stanford University

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
This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder program (W-SUDs) to reduce substance use relative to a psychoeducation control condition, which has no cognitive behavioral therapy and the content is not delivered through a conversational user interface.
Detailed Description
Phase II will evaluate the efficacy of W-SUDs in a large scale RCT relative to a psychoeducation control condition. Primary outcomes will be measures of the quantity and frequency of substance use including number of substance use occasions, heavy drinking days (if applicable) and percent of days abstinent. Additionally, Phase II will evaluate whether W-SUDs results in a greater reduction in substance-related problems compared to a psychoeducation control group and explore if engagement with W-SUDs, relative to psychoeducation control, improves symptoms of depression and anxiety; improves work productivity (i.e. reduce presenteeism/absenteeism); reduces cravings; improves situational confidence to resist 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
Keywords
Alcohol Use Disorder, Substance Use Disorder, AUD, SUD, AUD Treatment, SUD Treatment, Smartphone Application, Digital Therapeutic, Alcohol Use Disorder Treatment, Substance Use Disorder Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
258 (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
Digitally-delivered Psychoeducation
Arm Type
Other
Arm Description
Psychoeducation 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)
Digitally-delivered Psychoeducation
Intervention Description
A form of 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 Follow-up at 12 weeks
Secondary Outcome Measure Information:
Title
Drug Abuse Screening Test (DAST-10)
Description
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.
Time Frame
Change from Baseline to Post-treatment at 8 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
Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks
Title
Stanford Presenteeism Scale (SPS-6)
Description
Measure of workforce productivity. A six item measure derived from a 34 item measure of workforce productivity impacted by health status. The 6-item scale has excellent psychometric properties and has been validated.
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
Thoughts About Abstinence (TAA)
Description
Measure of thoughts about abstinence. 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
Usage Rating Profile - Intervention (URPI)-Acceptability
Description
Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Responses range from 1 = "strongly 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 (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 = "strongly 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
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.
Time Frame
Post-treatment (8 weeks from Baseline)
Title
Short Inventory of Problems- Alcohol and Drugs (SIP-AD)
Description
Measure of substance use problems. 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 Follow-up at 12 weeks
Title
Patient Health Questionnaire (PHQ-8)
Description
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.
Time Frame
Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks
Title
Generalized Anxiety Disorder (GAD-7)
Description
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.
Time Frame
Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks
Title
Brief Situational Confidence Questionnaire (BSCQ)
Description
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.
Time Frame
Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks
Title
Craving Ratings
Description
Measure of craving. A self-reported rating 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 Follow-up at 12 weeks
Title
Quick Drinking Screen (QDS)
Description
Measure of alcohol use. A self-report measure used to assess alcohol use including quantity consumed, frequency of drinking, and binge incidences.
Time Frame
Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 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. Previous Woebot use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Prochaska, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use

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