Impact of Work Activity on SUD Outcomes

Substance-related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04969081
• Other study ID #: D3493-R
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: Joanna M Fiszdon, PhD
• Phone: (203) 932-5711
• Email: joanna.fiszdon[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Substance-related Disorders

Intervention

Behavioral:
• referral to work focused program
referral to Incentive Therapy or to Other Therapeutic and Supported Employment Services

Other:
• treatment as usual
usual treatment

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent days abstinent	percent days abstinent during 3-month active phase	3 months
Primary	Clinical Global Impression	Clinical Global Impression ratings conducted at 6 months from study entry.	6 months
Secondary	change from baseline in BASIS-24	change in Behavior and Symptom Identification Scale, self-report	3 months
Secondary	change from baseline in Rosenberg self-esteem scale	change in self report of self-esteem	6 months
Secondary	change from baseline in New General Self-Efficacy Scale	change in self-report of self-efficacy	6 months
Secondary	change in WHOQOL BREF	change in self-report of quality of life	6 months