NCT04925570

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

Woebot for Substance Use Disorders Phase 2 RCT: Digitally Delivered Intervention for Reducing Problematic Substance Use

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Woebot Health · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 reduction in substance use occasions. 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, 1. improves symptoms of depression and anxiety; 2. improves work productivity (i.e. reduce presenteeism/absenteeism); 3. reduces cravings; 4. improves situational confidence to resist substance use.

Conditions

• Alcohol Use Disorder (AUD)
• Substance Use Disorders

Interventions

Type	Name	Description
DEVICE	W-SUDs	Woebot (W-SUDs) is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
OTHER	Digitally-delivered Psychoeducation	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.

Timeline

• Start date: 2022-11-14
• Primary completion: 2023-08-17
• Completion: 2023-08-17
• First posted: 2021-06-14
• Last updated: 2024-10-24
• Results posted: 2024-10-24

Locations

1 site across 1 country: United States