Clinical trial NCT04969081: Impact of Work Activity on SUD Outcomes
Official title: Augmenting Early Phase Substance Use Treatment With Therapeutic Work Activity to Improve Clinical Outcomes: a New Indication for an Old Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance-related Disorders
Keywords: substance-related disorders
rehabilitation, vocational
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-07-20
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: percent days abstinent
timeFrame: 3 months
measure: Clinical Global Impression
timeFrame: 6 months
Secondary outcomes:
measure: change from baseline in BASIS-24
timeFrame: 3 months
measure: change from baseline in Rosenberg self-esteem scale
timeFrame: 6 months
measure: change from baseline in New General Self-Efficacy Scale
timeFrame: 6 months
measure: change in WHOQOL BREF
timeFrame: 6 months
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Joanna M. Fiszdon, PhD
role: PRINCIPAL_INVESTIGATOR
References: