Impact of Work Activity on SUD Outcomes

Augmenting Early Phase Substance Use Treatment With Therapeutic Work Activity to Improve Clinical Outcomes: a New Indication for an Old Intervention

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Substance-related Disorders
• Intervention / Treatment: Other: treatment as usual; Behavioral: referral to work focused program

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 Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516-2770
      • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: treatment as usual; usual substance use treatment	Other: treatment as usual; usual treatment
Experimental: treatment as usual plus referral to work focused program; usual substance use treatment plus referral to a competitive or non-competitive work-focused program	Other: treatment as usual; usual treatment; Behavioral: referral to work focused program; referral to Incentive Therapy or to Other Therapeutic and Supported Employment Services

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Joanna M. Fiszdon, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: substance-related disorders; rehabilitation, vocational
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Therapeutics
• Other Study ID Numbers: D3493-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified, anonymized dataset will be created. This dataset may be shared with other investigators, upon written request, under a data use agreement prohibiting the recipient from identifying or re-de-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The data sharing agreement will also restrict redistribution to third parties and proper acknowledgment of the data source. These datasets will be shared per guidelines provided by VACHS Information Security Officer.
• IPD Sharing Time Frame: After study completion
• IPD Sharing Access Criteria: After study completion for no less than 7 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No