Socializing a Science-Based Digital Therapeutic for Substance Use Disorders

The purpose of this study is to evaluate the effectiveness of an intervention delivered on a smartphone. This study examines whether this intervention might improve treatment outcomes for people with substance use disorders. The intervention, called Laddr®, is a smartphone application ("app") that provides information and skills that can help people stop using substances. The social version of Laddr® being tested in this study has new features that allow people in treatment for substance use disorders to include a support person in their treatment journey, including a friend, family member, or other acquaintance. This research study will compare the effectiveness of Laddr® in combination with standard outpatient substance use treatment to standard treatment only for substance use disorders.

Study Overview

• Status: Active, not recruiting
• Conditions: Substance-Related Disorders; Substance Use Disorders
• Intervention / Treatment: Behavioral: Laddr® plus Behavioral- Group and individual counseling; Behavioral: Behavioral- Group and individual counseling

Detailed Description

Digital therapeutics, or software used to prevent, treat, or manage a medical disorder or disease, are redefining the future of healthcare by providing on-demand access to state-of-the-science care. Digital therapeutics have been developed to treat a wide range of disorders, including substance use disorders (SUD). Developed by the study Principal Investigator (PI) and Co-Investigator (Co-I), Laddr® is a unique mobile platform integrating science-based therapeutic processes to address a wide range of behavioral problems, including SUD.

The current project expands Laddr® to allow users to engage a support network of their choosing in their journey of behavioral change. Individuals can share data from Laddr about their successes and challenges, and their support network can offer anytime/anywhere social support. Social support will be embedded within a strongly science-based digital therapeutic process - thus providing support persons with a clear framework in which to offer support. Research has shown that engaging a support network of non-substance users (e.g., family members, friends) in one's SUD treatment can greatly enhance treatment outcomes - and is aligned with the "community reinforcement" tenet of the CRA treatment model. Interventions that leverage social support networks can help keep individuals engaged in treatment, reinforce their successes, and help them troubleshoot challenges.

This pragmatic, randomized controlled trial aims to evaluate the effectiveness of the social version of Laddr® in improving SUD treatment outcomes. Adults entering outpatient SUD treatment at the Farnum Center in Manchester, New Hampshire (NH) will be offered the opportunity to be randomized to 12 weeks of standard treatment (treatment as usual [TAU] arm), or standard treatment plus the social version of Laddr® (Laddr® arm). The primary study outcome is retention in SUD treatment (time to treatment dropout), and the investigators hypothesize that participants receiving Laddr® will be retained in treatment for a longer duration. Secondary outcomes include participant substance use (self-report and urine toxicology), stages of change, coping skills, recovery capital, and treatment acceptability.

• Study Type: Interventional
• Enrollment (Estimated): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Manchester, New Hampshire, United States, 03103
      • Farnum Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• In first 30 days of new outpatient treatment episode at the Farnum Center
• 18 years of age or older
• Ability to provide informed consent
• Has access to a functioning smartphone
• Able to identify a support person who can participate in the study with them
• Available to participate for the full duration of the study.

Exclusion Criteria:

• Inability to understand or read English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard outpatient treatment plus Laddr®; Laddr® is a smartphone application integrating science-based, therapeutic processes to address a wide range of behavioral problems in the context of a single mobile platform. Laddr includes tools for activating behavior change, solving problems and overcoming obstacles to effective behavior change; teaching skills and providing guidance on the execution of behavior change; and maintaining the end user's motivation to change. It enables longitudinal assessment of individuals' behavior and health status in naturalistic contexts, offers science-based self-regulation behavior change tools of relevance to an array of populations, and enables ongoing monitoring of health behavior. This study evaluates the effectiveness of new features to Laddr®. These new features are designed to be used with a support person, which could include a friend, family member, or acquaintance. In addition to Laddr®, participants will receive standard outpatient substance use disorder treatment.	Behavioral: Laddr® plus Behavioral- Group and individual counseling; Smartphone application utilizing the Community Reinforcement Approach (CRA) to facilitate social support in substance use treatment. Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services.
Active Comparator: Standard outpatient treatment; The active control condition consists of standard outpatient treatment for substance use disorders. Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services.	Behavioral: Behavioral- Group and individual counseling; The active control condition consists of standard outpatient treatment for substance use disorders. Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in treatment Retention in treatment Retention in treatment Retention in treatment Retention in treatment	Time between randomization and dropout from standard outpatient treatment	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substance use composite measure (Timeline Follow-Back and Urine Toxicology)	Abstinence from substance use. Each half-week of treatment will be categorized as abstinent if the toxicology screen is negative and the self-report indicates no drug use/heavy drinking days. If self-report is missing but the urine screen is positive, the half-week will be scored as not abstinent.	16 weeks
Treatment acceptability	Acceptability of the treatment model will be assessed among both patients in SUD treatment (for both treatment conditions) and support persons in the Laddr condition. Acceptability will be comprised of both utility and satisfaction with each treatment model across five indicators (0-10 point scales) asking how useful (not at all to very), how much new information (none to a great deal), how easy to understand (very easy to very difficult; reverse coded), how interesting (not at all to very), and how satisfied (not at all to very) they were with the treatment condition to which they were exposed.	16 weeks
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)	Motivation to change substance use. SOCRATES scores are calculated for three domains of change readiness, Recognition (Range: 7-35), Ambivalence (Range: 4-20), and Taking Steps (Range: 8-40), with higher scores indicating higher levels of change readiness.	16 weeks
Coping Strategies Scale (CSS)	Assessment of strategies to refuse drugs, solve problems, avoid high risk situations, cope with cravings, manage emotions, and develop assertiveness. The CSS total score is calculated by taking the mean of all items and will range from 1-4 points, with higher scores indicating more frequent use of coping strategies.	16 weeks
Assessment of Recovery Capital (ARC)	Assessment of resources to help in recovery. This 50 item assessment is scored by assigning one point for each "Yes" response. Total scores range from 0-50 with higher scores indicating higher recovery capital.	16 weeks

Collaborators and Investigators

• Sponsor: Square2 Systems, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Smartphone; Social support; Digital therapeutic
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2R44DA047150 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No