Impact of Work Activity on SUD Outcomes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Substance-related Disorders

Intervention / Treatment
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* Behavioral: referral to work focused program
* Other: treatment as usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, vocational, substance-related disorders