IPS-SUD: From Addiction to Employment.

Sponsor
Oslo University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04289415
Collaborator
South-Eastern Norway Regional Health Authority (Other), Norwegian Directorate of Health (Other)
200
1
2
143.9
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Individual Placement and Support
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pragmatic, two-arm, parallel, superiority, randomised controlled trialPragmatic, two-arm, parallel, superiority, randomised controlled trial
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
From Addiction to Employment. Effectiveness of Employment Support During Treatment for Substance Use Disorders. The Individual Placement and Support (IPS-SUD) Trial.
Actual Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Feb 28, 2032

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Any employment [From inclusion in the trial to 18 month after inclusion in the trial]

    At least 1 day of competitive employment

Secondary Outcome Measures

  1. Total time worked [From inclusion in the trial to 18 month after inclusion in the trial]

    Number of days/hours worked

  2. Time to employment [From inclusion in the trial to 18 month after inclusion in the trial]

    Time from inclusion in the trial to first employment

  3. Number of jobs [From inclusion in the trial to 18 month after inclusion in the trial]

    Number of different jobs kept

  4. Job duration [From inclusion in the trial to 18 month after inclusion in the trial]

    Duration of longest employment

  5. Employment relevant activity [From inclusion in the trial to 18 month after inclusion in the trial]

    Whether the participant is engaged in education, training or other job-preparing activity

  6. Mental distress [From inclusion in the trial and at different time points up until 12 month after inclusion in the trial]

    Information obtained from the Hospital Anxiety and Depression Scale (minumum score is 0, maximum score is 42, higher score means worse outcome)

  7. Past month substance use [From inclusion in the trial and at different time points up until 12 month after inclusion in the trial]

    Information obtained from the European Addiction Severity Index

  8. Participants' quality of life [From inclusion in the trial and at different time points up until 12 month after inclusion in the trial]

    Information obtained from the EQ-5D-5L

  9. Participants' work related quality of life [From inclusion in the trial and at different time points up until 12 month after inclusion in the trial]

    Information obtained from the Work and Social Adjustment Scale (minimum score is 0, maximum score is 40, higher score means more impairment)

Other Outcome Measures

  1. Current employment status and employment during the period [From inclusion in the trial and up until 10 years after inclusion in the trial]

    Information obtained from the State Register of Employers and Employees

  2. Health Economic Cost-Benefit Assessment [From inclusion in the trial and up until 10 years after inclusion in the trial]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • In treatment, unemployed, want to obtain ordinary, competitive employment
Exclusion Criteria:
  • coercive treatment that disables the patient to engage in the intervention

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department for Substance Use Treatment, Oslo University Hospital Oslo Norway 0424

Sponsors and Collaborators

  • Oslo University Hospital
  • South-Eastern Norway Regional Health Authority
  • Norwegian Directorate of Health

Investigators

  • Principal Investigator: Eline Rognli, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eline Borger Rognli, Researcher, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT04289415
Other Study ID Numbers:
  • 54204
First Posted:
Feb 28, 2020
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2022