From Addiction to Employment.

Substance Use Disorders Clinical Trial

— IPS-SUD  

Official title:

From Addiction to Employment. Effectiveness of Employment Support During Treatment for Substance Use Disorders. The Individual Placement and Support (IPS-SUD) Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04289415
• Other study ID #: 54204
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 28, 2032

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with substance use disorders have low employment rates and are to a large extent on the outside of the ordinary labor market. Individual Placement and Support (IPS) is an evidence based method developed to aid persons with severe mental disorders in obtaining ordinary work. IPS has been used clinically in the addiction field, but has been subject to little research. The trial "From addiction to employment" is a randomized controlled trial to investigate the effect of an IPS intervention on employment outcome among substance use disorder patients in specialized health care treatment in Oslo, Norway. The study is conducted at the Department for Substance Use Disorder Treatment at Oslo University Hospital. The trial begins to include patients March 1st 2020 and will include for two years, until February 28th 2022.

Description:

The target population in this project is patients in SUD treatment who wish to gain employment. The goal of the study is to determine the effectiveness of IPS in helping persons with SUD obtain ordinary employment. A pragmatic, two-arm, parallel, superiority, randomized controlled trial will be conducted. The project is financed through innovation funding from the South Eastern Norway Regional Health Authority, the Norwegian Directorate of Health and internal resources from OUS. Participants will be allocated randomly to either an employment specialist whom they will have individual contact with for the coming 13 months or shorter (intervention), or to a self-help and four-sessions work shop intervention (control comparison). The intervention fidelity will be assessed by external evaluators according to the Norwegian translation of the IPS Fidelity Scale. Patients will be recruited to the study over a period of two years, and followed for 18 months my data collection and up until 10 years in national registries.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 28, 2032
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• In treatment, unemployed, want to obtain ordinary, competitive employment

Exclusion Criteria:

• coercive treatment that disables the patient to engage in the intervention

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Individual Placement and Support
Employment specialist will work together with the participants in accordance to the method IPS in order to help the participant obtain competitive employment

Locations

Country	Name	City	State
Norway	Department for Substance Use Treatment, Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Directorate of Health, South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Current employment status and employment during the period	Information obtained from the State Register of Employers and Employees	From inclusion in the trial and up until 10 years after inclusion in the trial
Other	Health Economic Cost-Benefit Assessment	The assessment will include contacts with the specialized health care system (information from the National Patient Registry), contacts with the community and municipal health care and substance use treatment system (information obtained from the Municipal Patient and User Registry), reception of welfare benefits (information obtained from the FD-trygd Database) and employment (information obtained from the State Register of Employers and Employees)	From inclusion in the trial and up until 10 years after inclusion in the trial
Primary	Any employment	At least 1 day of competitive employment	From inclusion in the trial to 18 month after inclusion in the trial
Secondary	Total time worked	Number of days/hours worked	From inclusion in the trial to 18 month after inclusion in the trial
Secondary	Time to employment	Time from inclusion in the trial to first employment	From inclusion in the trial to 18 month after inclusion in the trial
Secondary	Number of jobs	Number of different jobs kept	From inclusion in the trial to 18 month after inclusion in the trial
Secondary	Job duration	Duration of longest employment	From inclusion in the trial to 18 month after inclusion in the trial
Secondary	Employment relevant activity	Whether the participant is engaged in education, training or other job-preparing activity	From inclusion in the trial to 18 month after inclusion in the trial
Secondary	Mental distress	Information obtained from the Hospital Anxiety and Depression Scale (minumum score is 0, maximum score is 42, higher score means worse outcome)	From inclusion in the trial and at different time points up until 12 month after inclusion in the trial
Secondary	Past month substance use	Information obtained from the European Addiction Severity Index	From inclusion in the trial and at different time points up until 12 month after inclusion in the trial
Secondary	Participants' quality of life	Information obtained from the EQ-5D-5L	From inclusion in the trial and at different time points up until 12 month after inclusion in the trial
Secondary	Participants' work related quality of life	Information obtained from the Work and Social Adjustment Scale (minimum score is 0, maximum score is 40, higher score means more impairment)	From inclusion in the trial and at different time points up until 12 month after inclusion in the trial