Impact of Work Activity on SUD Outcomes

NCT ID: NCT04969081

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2028-12-31

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.

Conditions

Substance-related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

treatment as usual

usual substance use treatment

Group Type: ACTIVE_COMPARATOR

treatment as usual

Intervention Type: OTHER

usual treatment

treatment as usual plus referral to work focused program

usual substance use treatment plus referral to a competitive or non-competitive work-focused program

Group Type: EXPERIMENTAL

referral to work focused program

Intervention Type: BEHAVIORAL

referral to Incentive Therapy or to Other Therapeutic and Supported Employment Services

treatment as usual

Intervention Type: OTHER

usual treatment

Interventions

referral to work focused program

referral to Incentive Therapy or to Other Therapeutic and Supported Employment Services

Intervention Type: BEHAVIORAL

treatment as usual

usual treatment

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna M. Fiszdon, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Locations

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

D3493-R

Identifier Type: -

Identifier Source: org_study_id