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From Addiction to Employment. (IPS-SUD)

Primary Purpose

Substance Use Disorders

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Individual Placement and Support
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department for Substance Use Treatment, Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individual Placement and Support

Selv help kit and work shop

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Any employment
At least 1 day of competitive employment

Secondary Outcome Measures

Total time worked
Number of days/hours worked
Time to employment
Time from inclusion in the trial to first employment
Number of jobs
Number of different jobs kept
Job duration
Duration of longest employment
Employment relevant activity
Whether the participant is engaged in education, training or other job-preparing activity
Mental distress
Information obtained from the Hospital Anxiety and Depression Scale (minumum score is 0, maximum score is 42, higher score means worse outcome)
Past month substance use
Information obtained from the European Addiction Severity Index
Participants' quality of life
Information obtained from the EQ-5D-5L
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)

Full Information

First Posted
February 25, 2020
Last Updated
September 14, 2023
Sponsor
Oslo University Hospital
Collaborators
South-Eastern Norway Regional Health Authority, Norwegian Directorate of Health
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1. Study Identification

Unique Protocol Identification Number
NCT04289415
Brief Title
From Addiction to Employment.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 28, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
South-Eastern Norway Regional Health Authority, Norwegian Directorate of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic, two-arm, parallel, superiority, randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual Placement and Support
Arm Type
Experimental
Arm Description
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.
Arm Title
Selv help kit and work shop
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual Placement and Support
Intervention Description
Employment specialist will work together with the participants in accordance to the method IPS in order to help the participant obtain competitive employment
Primary Outcome Measure Information:
Title
Any employment
Description
At least 1 day of competitive employment
Time Frame
From inclusion in the trial to 18 month after inclusion in the trial
Secondary Outcome Measure Information:
Title
Total time worked
Description
Number of days/hours worked
Time Frame
From inclusion in the trial to 18 month after inclusion in the trial
Title
Time to employment
Description
Time from inclusion in the trial to first employment
Time Frame
From inclusion in the trial to 18 month after inclusion in the trial
Title
Number of jobs
Description
Number of different jobs kept
Time Frame
From inclusion in the trial to 18 month after inclusion in the trial
Title
Job duration
Description
Duration of longest employment
Time Frame
From inclusion in the trial to 18 month after inclusion in the trial
Title
Employment relevant activity
Description
Whether the participant is engaged in education, training or other job-preparing activity
Time Frame
From inclusion in the trial to 18 month after inclusion in the trial
Title
Mental distress
Description
Information obtained from the Hospital Anxiety and Depression Scale (minumum score is 0, maximum score is 42, higher score means worse outcome)
Time Frame
From inclusion in the trial and at different time points up until 12 month after inclusion in the trial
Title
Past month substance use
Description
Information obtained from the European Addiction Severity Index
Time Frame
From inclusion in the trial and at different time points up until 12 month after inclusion in the trial
Title
Participants' quality of life
Description
Information obtained from the EQ-5D-5L
Time Frame
From inclusion in the trial and at different time points up until 12 month after inclusion in the trial
Title
Participants' work related quality of life
Description
Information obtained from the Work and Social Adjustment Scale (minimum score is 0, maximum score is 40, higher score means more impairment)
Time Frame
From inclusion in the trial and at different time points up until 12 month after inclusion in the trial
Other Pre-specified Outcome Measures:
Title
Current employment status and employment during the period
Description
Information obtained from the State Register of Employers and Employees
Time Frame
From inclusion in the trial and up until 10 years after inclusion in the trial
Title
Health Economic Cost-Benefit Assessment
Description
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)
Time Frame
From inclusion in the trial and up until 10 years after inclusion in the trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eline Rognli, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department for Substance Use Treatment, Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34654464
Citation
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.
Results Reference
derived

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From Addiction to Employment.

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