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Impact of Work Activity on SUD Outcomes

Primary Purpose

Substance-related Disorders

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

referral to work focused program

treatment as usual

About this trial

This is an interventional treatment trial for Substance-related Disorders focused on measuring substance-related disorders, rehabilitation, vocational

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

treatment as usual

treatment as usual plus referral to work focused program

Arm Description

usual substance use treatment

usual substance use treatment plus referral to a competitive or non-competitive work-focused program

Outcomes

Primary Outcome Measures

percent days abstinent

percent days abstinent during 3-month active phase

Clinical Global Impression

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

Secondary Outcome Measures

change from baseline in BASIS-24

change in Behavior and Symptom Identification Scale, self-report

change from baseline in Rosenberg self-esteem scale

change in self report of self-esteem

change from baseline in New General Self-Efficacy Scale

change in self-report of self-efficacy

change in WHOQOL BREF

change in self-report of quality of life

Full Information

NCT ID

NCT04969081

First Posted

July 1, 2021

Last Updated

December 9, 2022

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT04969081

Brief Title

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

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 3, 2022 (Actual)

Primary Completion Date

December 31, 2027 (Anticipated)

Study Completion Date

December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance-related Disorders

Keywords

substance-related disorders, rehabilitation, vocational

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Outcomes Assessor

Masking Description

Assessors will be blind to randomization status.

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment as usual

Arm Type

Active Comparator

Arm Description

usual substance use treatment

Arm Title

treatment as usual plus referral to work focused program

Arm Type

Experimental

Arm Description

usual substance use treatment plus referral to a competitive or non-competitive work-focused program

Intervention Type

Behavioral

Intervention Name(s)

referral to work focused program

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

treatment as usual

Intervention Description

usual treatment

Primary Outcome Measure Information:

Title

percent days abstinent

Description

percent days abstinent during 3-month active phase

Time Frame

3 months

Title

Clinical Global Impression

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

change from baseline in BASIS-24

Description

change in Behavior and Symptom Identification Scale, self-report

Time Frame

3 months

Title

change from baseline in Rosenberg self-esteem scale

Description

change in self report of self-esteem

Time Frame

6 months

Title

change from baseline in New General Self-Efficacy Scale

Description

change in self-report of self-efficacy

Time Frame

6 months

Title

change in WHOQOL BREF

Description

change in self-report of quality of life

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joanna M Fiszdon, PhD

Phone

(203) 932-5711

Ext

2231

joanna.fiszdon@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Morris D Bell, PhD

Phone

(203) 932-5711

Ext

2281

Morris.Bell@yale.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joanna M. Fiszdon, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joanna M Fiszdon, PhD

Phone

203-932-5711

Ext

2231

joanna.fiszdon@va.gov

First Name & Middle Initial & Last Name & Degree

Morris D Bell, PhD

Phone

(203) 932-5711

Ext

2281

Morris.Bell@yale.edu

First Name & Middle Initial & Last Name & Degree

Joanna M. Fiszdon, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified, anonymized dataset will be created. This dataset may be shared with other investigators, upon written request, under a data use agreement prohibiting the recipient from identifying or re-de-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The data sharing agreement will also restrict redistribution to third parties and proper acknowledgment of the data source. These datasets will be shared per guidelines provided by VACHS Information Security Officer.

IPD Sharing Time Frame

After study completion

IPD Sharing Access Criteria

After study completion for no less than 7 years.

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Impact of Work Activity on SUD Outcomes

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