Impact of Work Activity on SUD Outcomes

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT04969081
Collaborator
(none)
140
1
2
71.9
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: referral to work focused program
  • Other: treatment as usual
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (Outcomes Assessor)
Masking Description:
Assessors will be blind to randomization status.
Primary Purpose:
Treatment
Official Title:
Augmenting Early Phase Substance Use Treatment With Therapeutic Work Activity to Improve Clinical Outcomes: a New Indication for an Old Intervention
Actual Study Start Date :
Jan 3, 2022
Anticipated Primary Completion Date :
Dec 31, 2026
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

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

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

Other: treatment as usual
usual treatment

Outcome Measures

Primary Outcome Measures

  1. percent days abstinent [3 months]

    percent days abstinent during 3-month active phase

  2. Clinical Global Impression [6 months]

    Clinical Global Impression ratings conducted at 6 months from study entry.

Secondary Outcome Measures

  1. change from baseline in BASIS-24 [3 months]

    change in Behavior and Symptom Identification Scale, self-report

  2. change from baseline in Rosenberg self-esteem scale [6 months]

    change in self report of self-esteem

  3. change from baseline in New General Self-Efficacy Scale [6 months]

    change in self-report of self-efficacy

  4. change in WHOQOL BREF [6 months]

    change in self-report of quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Connecticut Healthcare System West Haven Campus, West Haven, CT West Haven Connecticut United States 06516

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Joanna M. Fiszdon, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT04969081
Other Study ID Numbers:
  • D3493-R
First Posted:
Jul 20, 2021
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2022