Trial Outcomes & Findings for W-SUDs for COVID-19 (NCT NCT04460027)

NCT ID: NCT04460027

Last Updated: 2022-12-21

Results Overview

Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 180 participants
• Primary outcome timeframe: Change from Baseline to Post-treatment at 8 weeks
• Results posted on: 2022-12-21

Participant Flow

Participant milestones

Measure	W-SUDs Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Overall Study STARTED	88	92
Overall Study COMPLETED	71	81
Overall Study NOT COMPLETED	17	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

W-SUDs for COVID-19

Baseline characteristics by cohort

Measure	W-SUDs n=88 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Wait List Control n=92 Participants Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.	Total n=180 Participants Total of all reporting groups
Age, Continuous	40.8 years STANDARD_DEVIATION 12.1 • n=93 Participants	39.8 years STANDARD_DEVIATION 11.2 • n=4 Participants	40.3 years STANDARD_DEVIATION 11.6 • n=27 Participants
Sex: Female, Male Female	58 Participants n=93 Participants	59 Participants n=4 Participants	117 Participants n=27 Participants
Sex: Female, Male Male	30 Participants n=93 Participants	33 Participants n=4 Participants	63 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=93 Participants	80 Participants n=4 Participants	156 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants	7 Participants n=4 Participants	11 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Race (NIH/OMB) White	70 Participants n=93 Participants	70 Participants n=4 Participants	140 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control n=81 Participants Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks	-9.1 occasions Standard Deviation 2.0	-4.7 occasions Standard Deviation 1.0

SECONDARY outcome

Timeframe: Change 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.

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control n=81 Participants Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks	-5.3 score on a scale Standard Deviation 1.1	-4.7 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Change 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.

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control n=81 Participants Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks	1.3 score on a scale Standard Deviation 1.8	2.2 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Change 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.

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control n=81 Participants Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks	11.8 score on a scale Standard Deviation 3.4	5.3 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Change 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.

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control n=81 Participants Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks	-.5 scores on a scale Standard Deviation .1	-.4 scores on a scale Standard Deviation .1

SECONDARY outcome

Timeframe: Change 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.

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control n=81 Participants Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks	-5.1 units on a scale Standard Deviation 2.8	-.8 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Change 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.

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control n=81 Participants Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks	-1.6 units on a scale Standard Deviation .6	-1.7 units on a scale Standard Deviation .6

SECONDARY outcome

Timeframe: Change 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.

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control n=81 Participants Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks	-1.6 units on a scale Standard Deviation .6	-.7 units on a scale Standard Deviation .5

SECONDARY outcome

Timeframe: Change 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.

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control n=81 Participants Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks	-1.8 units on a scale Standard Deviation .5	-1.4 units on a scale Standard Deviation .5

SECONDARY outcome

Timeframe: Post-treatment (8 weeks from Baseline)

Population: This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.

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.

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks	25.5 score on a scale Standard Deviation 5.0	—

SECONDARY outcome

Timeframe: Post-treatment (8 weeks from Baseline)

Population: This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.

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.

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks	29.0 score on a scale Standard Deviation 4.8	—

SECONDARY outcome

Timeframe: Post-treatment (8 weeks from Baseline)

Population: This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.

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.

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks	32.0 score on a scale Standard Deviation 3.6	—

SECONDARY outcome

Timeframe: Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks

Population: This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.

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".

Outcome measures

Measure	W-SUDs n=71 Participants Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Waitlist Control Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
Change in Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks	44.0 score on a scale Standard Deviation 12.5	—

Adverse Events

W-SUDs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait List Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	W-SUDs n=88 participants at risk Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.	Wait List Control n=92 participants at risk Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.
General disorders Hospitalization	0.00% 0/88 • Serious adverse events were assessed at post-treatment, 8 weeks from baseline. Serious adverse events occurring during treatment were assessed for hospitalization related to substance use, suicide attempt, alcohol or drug overdose, and severe withdrawal (eg, delirium tremens). Positive endorsements were followed up with questions about the timing, diagnosis, and resolution. If additional details were needed to determine whether the event was study related, a team member reached out to the participant.	1.1% 1/92 • Number of events 1 • Serious adverse events were assessed at post-treatment, 8 weeks from baseline. Serious adverse events occurring during treatment were assessed for hospitalization related to substance use, suicide attempt, alcohol or drug overdose, and severe withdrawal (eg, delirium tremens). Positive endorsements were followed up with questions about the timing, diagnosis, and resolution. If additional details were needed to determine whether the event was study related, a team member reached out to the participant.

Other adverse events

Adverse event data not reported

Additional Information

Judith J. Prochaska, PhD

Stanford Prevention Research Center, Department of Medicine, Stanford University

Phone: 650-724-3608

Email: jpro@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place