NCT04574193

Brief Summary

This project extends successful Phase I work that developed a Continuing Care mobile application (app) for probationers and parolees with SUDs who are at elevated risk of relapse, re-arrest, and incarceration. This Phase II STTR project will finalize app development and evaluate its efficacy in a randomized controlled trial. The project has high public health significance due to its potential to provide an accessible recovery support tool for individuals on probation or parole that could improve their substance use disorder treatment outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 14, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 8, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

September 14, 2020

Last Update Submit

October 4, 2023

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

  • Weeks Retained in Substance Use Treatment

    Number of weeks retained in treatment based on a review of clinical records

    up to 12 weeks

Secondary Outcomes (3)

  • Completion of Substance Use Treatment

    up to 12 weeks

  • Days of Substance Use

    up to 18 weeks

  • Days of Criminal Activity; Re-arrest; Incarceration

    up to 18 weeks

Other Outcomes (1)

  • Rating of App Satisfaction

    up to 12 weeks

Study Arms (2)

Continuing Care App

EXPERIMENTAL

Participants will receive the Continuing Care app, in addition to usual care at the treatment program (12-weeks of weekly group cognitive behavioral therapy).

Device: digital therapeutic for substance use disorders

Treatment As Usual

ACTIVE COMPARATOR

Participants will only receive 12-weeks of weekly group cognitive behavioral therapy.

Other: Treatment As Usual

Interventions

digital therapeutic for substance use disordersDEVICE

The Continuing Care application (app) is a HIPAA-compliant, mobile-friendly, software program designed to meet the recovery and personal support needs of probationers and parolees with SUDs who are at elevated risk of relapse, re-arrest, and incarceration.

Continuing Care App
Treatment As UsualOTHER

12-weeks of weekly group cognitive behavioral therapy

Treatment As Usual

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Currently on community supervision (probation or parole) or justice-involvement in the past 12 months
  • Currently a client receiving outpatient substance use treatment
  • Willing to receive supplemental treatment services through a mobile app
  • Willing to provide informed consent and complete research assessments

You may not qualify if:

  • Severe psychiatric problems (e.g., untreated psychosis, untreated bipolar disorder)
  • Suicidality within the past 6-months, as determined by clinical staff, which could make participation in a novel treatment hazardous

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

REACH Health Services

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Steven B Carswell, Ph.D.

    COG Analytics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The evaluation will involve a two-group RCT in which 100 men and women on probation or parole, who are currently receiving outpatient substance use treatment at THC, will be randomly assigned to one of two conditions: (1) Continuing Care app (CC app; n=50): Participants will receive the CC app, in addition to usual care at the treatment program (12-weeks of weekly group cognitive behavioral therapy), or (2) Treatment As Usual (TAU; n=50): Participants will only receive 12-weeks of weekly group cognitive behavioral therapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2020

First Posted

October 5, 2020

Study Start

March 8, 2021

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

COG Analytics (COG) and Friends Research Institute (FRI) are committed to the open and timely dissemination of research outcomes. Investigators in the proposed study recognize that promising new methods, technologies, strategies and computer software may arise during the course of this research. The investigators are aware of, and agree to abide by, the principles for sharing research resources as described by the National Institutes of Health (NIH) in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources."

Locations

US(1)