Impact of Work Activity on SUD Outcomes

NCT04969081 | Active Not Recruiting

• 1 other identifier: D3493-R
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-related Disorders

Keywords

substance-related disorders; rehabilitation, vocational

Outcome Measures

Primary Outcomes (2)

• percent days abstinent

  percent days abstinent during 3-month active phase

  3 months

• Clinical Global Impression

  Clinical Global Impression ratings conducted at 6 months from study entry.

  6 months

Secondary Outcomes (4)

• change from baseline in BASIS-24

  3 months

• change from baseline in Rosenberg self-esteem scale

  6 months

• change from baseline in New General Self-Efficacy Scale

  6 months

• change in WHOQOL BREF

  6 months

Study Arms (2)

treatment as usual

ACTIVE COMPARATOR

usual substance use treatment

Other: treatment as usual

treatment as usual plus referral to work focused program

EXPERIMENTAL

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

Behavioral: referral to work focused program; Other: treatment as usual

Interventions

referral to work focused program BEHAVIORAL

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

treatment as usual plus referral to work focused program

treatment as usual OTHER

usual treatment

treatment as usual; treatment as usual plus referral to work focused program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

West Haven, Connecticut, 06516-2770, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Joanna M. Fiszdon, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blind to randomization status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Two branch study: one branch for Vets not interested in competitive employment, and one for Vets interested in competitive employment. Within each branch, Veterans will be randomized to either treatment as usual, or treatment as usual plus referral to competitive or non-competitive work-focused program.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 20, 2021
• Study Start: January 3, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study completion
• Access Criteria: After study completion for no less than 7 years.

Locations

US (1)