Connect2BWell: An Evidence-Based Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program

Substance Use Disorders Clinical Trial

Official title:

Stage-Based Intervention for Substance Use Disorders in Primary Care: Implementation and Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745065
• Other study ID #: 4R44DA044840-02
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: June 26, 2022

Study information

• Verified date: January 2024
• Source: Pro-Change Behavior Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of the digital + telehealth Connect2BWell program among 336 safety net patients. Adults patients with an upcoming medical medical visit, and/or who screen positive for substance use disorder (SUD) during routine SBIRT screening during their visit, will receive an email invitation from the research team to complete an online risk assessment to assess study eligibility. The assessment will include the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). Patients scoring in the moderate- or high-risk range for one or more drugs--including alcohol, excluding tobacco--and who meet all other study inclusion criteria, will alternately be assigned to the Connect2BWell Condition or a Comparison Condition. ASSIST scores will be sent to the patient's Electronic Health Record (EHR). Patients assigned to the Treatment Condition will receive three brief online intervention sessions followed by dashboard-guided telehealth sessions with a study nurse, text messages, and access to a patient portal. Patients assigned to the Comparison Condition will receive an SBIRT session delivered via telehealth by a member of their clinic care team. Outcomes, assessed at baseline, 3, 6 and 9 months, include days of use of most problematic drug during the past 30 days, the ASSIST risk score of the most problematic drug, depression, well-being, satisfaction with care, and treatment uptake, if indicated. All patient-facing materials are available in English and Spanish.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: June 26, 2022
• Est. primary completion date: June 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate/high risk use of at least 1 substance (identified using the ASSIST)
• Can receive text messages
• Can access Internet via smart phone, tablet, or computer

Exclusion Criteria:

• Pregnant
• Admitted to inpatient psychiatric hospital or substance use treatment program, past 30 days
• Has serious medical condition that could impede study participating, next 9 months
• Receiving treatment with goal of quitting or reducing use of substances

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Connect2BWell
Please see the description provided for arm 1.

Locations

Country	Name	City	State
United States	Community Health Center, Inc.	Middletown	Connecticut
United States	Pro-Change Behavior Systems, Inc.	South Kingstown	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Pro-Change Behavior Systems	Community Health Center, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Probability of Mild or Moderate Depression Relative to Greater Levels of Depression at Baseline Compared to 9 Months	Depression assessed using Patient Health Questionnaire (PHQ-8), which consists of eight of the nine DSM-V (Diagnostic and Statistical Manual) diagnostic criteria for depression. Respondents indicate how many days in the past two weeks they experienced each of the 8 symptoms. Responses are summed to yield a severity score (0-24) and were then categorized into 5 categories of 1 = 'minimal depression, 0 to 4' 2 = 'mild depression, 5 to 9' 3 = 'moderate depression, 10 to 14' 4 = 'moderately severe depression, 15 to 19' 5 = 'severe depression, 20 to 24'. The estimates provided in the results table are the probability of mild or moderate depression relative to greater levels of depression, at both baseline and 9 months, calculated using ordinal logistic regression.	baseline, 9 months
Primary	Change From Baseline in Days of Use of Most Problematic Drug at 9 Months	Days of use will be assessed using the Timeline Followback (TLFB) method, which includes a calendar for indicating each day of use during the past 30 days. The approach has been validated for alcohol use, other drug use, and for administration by telephone and computer. The online assessment will present an interactive calendar showing the past 30 days, and ask participants to mark each day that they used their most problematic drug. Total days marked will represent days of use. Change scores will range from -30 to + 30, with lower scores indicating better outcomes.	baseline, 9 months
Secondary	Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months	The ASSIST yields drug-specific risk scores for 8 classes of drugs, including alcohol, plus ""Other"". The ASSIST score (range = 0 to 39) for the participant's most problematic drug identified at baseline will be examined. ASSIST scores are correlated with other measures of substance use, have predictive validity, and discriminate between non-problematic substance use. Change scores will range from -39 to +39, with lower scores indicating better outcomes.	baseline, 9 months
Secondary	Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months	This measure will be calculated by taking the sum of all items for all substances (excluding tobacco) assessed on the ASSIST (range = 0 to 351). Like drug-specific ASSIST scores, ASSIST total substance involvement scores are correlated with other measures of substance use, have predictive validity, and discriminate between non-problematic substance use. Change scores will range from -351 to + 351, with lower scores indicating better outcomes.	baseline, 9 months