Socializing a Science-Based Digital Therapeutic for Substance Use Disorders
1 other identifier
interventional
189
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2022
CompletedFirst Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
December 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 6, 2025
November 1, 2024
2.1 years
December 5, 2022
January 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Substance use composite measure (Timeline Follow-Back and Urine Toxicology)
16 weeks
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
16 weeks
Coping Strategies Scale (CSS)
16 weeks
Assessment of Recovery Capital (ARC)
16 weeks
Treatment acceptability
16 weeks
Study Arms (2)
Standard outpatient treatment plus Laddr®
EXPERIMENTALLaddr® 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.
Standard outpatient treatment
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- In first 30 days of new outpatient treatment episode at the Farnum Center
- 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.
You may not qualify if:
- Inability to understand or read English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Square2 Systems, Inc.lead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Farnum Center
Manchester, New Hampshire, 03103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 5, 2022
First Posted
December 13, 2022
Study Start
November 9, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
January 6, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share