Impact of Work Activity on SUD Outcomes

Not Applicable

Recruiting

• Conditions: Substance-related Disorders
• Interventions: Other: treatment as usual; Behavioral: referral to work focused program

• Registration Number: NCT04969081
• Lead Sponsor: VA Office of Research and Development

Brief Summary

To date, there are no studies of the therapeutic effects of varied work-focused programs in Veterans undergoing outpatient substance use disorder (SUD) treatment. The investigators propose a randomized clinical trial to test the effects of work-focused programs on improving sobriety and other clinical outcomes in Veterans early in the course of recovery from SUD. Veterans will be randomized to either receive or not receive referral for work-focused therapeutic programs. Primary aim is to examine effects of work-focused programs on sobriety outcomes, namely sobriety and global functioning. Secondary aim is to examine effects of work-focused programs on psychiatric symptoms, self esteem/efficacy, and quality of life.

Detailed Description

The investigators propose a trial to test the effects of Incentive Therapy (IT) and Other Therapeutic and Supported Employment Services (Other TSES) on improving SUD outcomes in newly recovering Veterans in outpatient treatment. In line with eligibility criteria for different TSES programs, the investigators will employ a two branch study: One branch will be for Veterans who are not interested in pursuing competitive employment, and will be a two arm RCT with randomization (2:1) to referral for IT + treatment as usual (TAU; including usual SUD outpatient treatment) or TAU alone. The second branch will be for Veterans who express interest in competitive employment, and will be a two arm RCT with randomization (2:1) to referral for TSES competitive employment services + TAU or TAU alone. Total Intent to Treat sample will be 140 (n=70 per branch). Primary outcomes will be percent days abstinent during 3 month active phase and clinical global impression scale scores at 6 months. Secondary outcome will be psychiatric symptoms, self esteem/efficacy and quality of life.

Study Timeline

• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-20
• Study Start: 2022-01-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-10
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Participants will be Veterans enrolled in VACHS substance use treatment, who at time of consenting into the study are within 30 days of detoxification or last substance use as per medical record.

• Additional criteria will be as follows:

  • 18 years of age and older,
  • meeting DSM-V criteria for any current Substance Use Disorder (SUD) (e.g., opioids, cocaine, marijuana, amphetamine, or alcohol),
  • competent to give written informed consent and HIPAA authorization.

Exclusion Criteria

• involvement in a legal case that may lead to incarceration during study period;
• developmental disability or medical illness that would prevent therapeutic work activity, as judged by PI or clinical staff providing this service;
• plans to relocate outside geographic area that would make follow-up unlikely;
• and/or lack of willingness to provide contact information of someone who can help us contact the participant in the event that we are unable to maintain contact directly.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment as usual	treatment as usual	usual substance use treatment
treatment as usual plus referral to work focused program	referral to work focused program	usual substance use treatment plus referral to a competitive or non-competitive work-focused program
treatment as usual plus referral to work focused program	treatment as usual	usual substance use treatment plus referral to a competitive or non-competitive work-focused program

Primary Outcome Measures

Name	Time	Method
percent days abstinent	3 months	percent days abstinent during 3-month active phase
Clinical Global Impression	6 months	Clinical Global Impression ratings conducted at 6 months from study entry.

Secondary Outcome Measures

Name	Time	Method
change from baseline in BASIS-24	3 months	change in Behavior and Symptom Identification Scale, self-report
change from baseline in Rosenberg self-esteem scale	6 months	change in self report of self-esteem
change from baseline in New General Self-Efficacy Scale	6 months	change in self-report of self-efficacy
change in WHOQOL BREF	6 months	change in self-report of quality of life

Trial Locations

Locations (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States