From Addiction to Employment.

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Substance Use Disorders

Intervention / Treatment
-----------------
* Behavioral: Individual Placement and Support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In treatment, unemployed, want to obtain ordinary, competitive employment Exclusion Criteria: coercive treatment that disables the patient to engage in the intervention

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic, two-arm, parallel, superiority, randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual Placement and Support<br>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<br>* Employment specialist will work together with the participants in accordance to the method IPS in order to help the participant obtain competitive employment<br>|
| Active Comparator: Selv help kit and work shop<br>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<br>* Employment specialist will work together with the participants in accordance to the method IPS in order to help the participant obtain competitive employment<br>|

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 |