From Addiction to Employment. (IPS-SUD)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Substance Use Disorders
• Intervention / Treatment: Behavioral: Individual Placement and Support

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Department for Substance Use Treatment, Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individual Placement and Support; The intervention used in this study will be a time-limited version of IPS. The employment specialist offers up until nine months job-search support and four months in-work support, giving a total of 13 months job-related support. If a participant succeeds in obtaining work before nine months has passed the remaining job-search support months may be transferred to in-work support time. In the follow-up time while seeking employment, the employment specialists will work with the participants to identify skills and aspirations, establish contact with potential employers and ensure economic advice and help with benefits planning. The in-work support involves individual and regular contact with the participant and the employer. All participants who receive this intervention will do so in addition to their clinical treatment. The treatment provider and the employment specialist should cooperate and clarify roles together with the patient.	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
Active Comparator: Selv help kit and work shop; The participants in the control intervention will be offered a self-help tool kit and a following introduction course to help participants see what their opportunities are, and specific tips on how to get further help. The course will last three hours a session over four days, with the offer of an individual one hour follow up session with the course leader when the course is over. The goal of the control group intervention is to enable the participants to make use of the services offered at the ordinary labor and welfare service.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any employment	At least 1 day of competitive employment	From inclusion in the trial to 18 month after inclusion in the trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total time worked	Number of days/hours worked	From inclusion in the trial to 18 month after inclusion in the trial
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
Number of jobs	Number of different jobs kept	From inclusion in the trial to 18 month after inclusion in the trial
Job duration	Duration of longest employment	From inclusion in the trial to 18 month after inclusion in the trial
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: South-Eastern Norway Regional Health Authority; Norwegian Directorate of Health
• Investigators: Principal Investigator: Eline Rognli, PhD, Oslo University Hospital

Publications and helpful links

General Publications

• Rognli EB, Aas EM, Drake RE, Marsden J, Anders P, Bond GR, Lystad JU, Reme SE, Arnevik EA. The effect evaluation of Individual Placement and Support (IPS) for patients with substance use disorders: study protocol for a randomized controlled trial of IPS versus enhanced self-help. Trials. 2021 Oct 15;22(1):705. doi: 10.1186/s13063-021-05673-z.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): February 28, 2032

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 54204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No