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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04969081
Enrollment
103
Registered
2021-07-20
Start date
2022-01-03
Completion date
2026-08-10
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance-related Disorders

Keywords

substance-related disorders, rehabilitation, vocational

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 Randomized Controlled Trial (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.

Interventions

BEHAVIORALreferral to work focused program

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

OTHERtreatment as usual

usual treatment

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessors will be blind to randomization status.

Intervention model description

Two branch study: one branch for Veterans not interested in competitive employment, and one for Veterans 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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: * 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 the investigators are unable to maintain contact directly

Design outcomes

Primary

MeasureTime frameDescription
percent days abstinent3 monthspercent days abstinent during 3-month active phase
Clinical Global Impression6 monthsClinical Global Impression ratings conducted at 6 months from study entry.

Secondary

MeasureTime frameDescription
change from baseline in BASIS-243 monthschange in Behavior and Symptom Identification Scale, self-report
change from baseline in Rosenberg self-esteem scale6 monthschange in self report of self-esteem
change from baseline in New General Self-Efficacy Scale6 monthschange in self-report of self-efficacy
change in WHOQOL BREF6 monthschange in self-report of quality of life

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJoanna M. Fiszdon, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026