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Active, Not Recruiting

NCT Number: NCT04289415

From Addiction to Employment.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Substance Use Treatment, Oslo University Hospital

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Individual Placement and Support

Behavioral

Employment specialist will work together with the participants in accordance to the method IPS in order to help the participant obtain competitive employment

Primary outcomes

  1. Any employment

    Time frame: From inclusion in the trial to 18 month after inclusion in the trial

    At least 1 day of competitive employment

Secondary outcomes

  1. Total time worked

    Time frame: From inclusion in the trial to 18 month after inclusion in the trial

    Number of days/hours worked

  2. Time to employment

    Time frame: 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

    Time frame: From inclusion in the trial to 18 month after inclusion in the trial

    Number of different jobs kept

  4. Job duration

    Time frame: From inclusion in the trial to 18 month after inclusion in the trial

    Duration of longest employment

  5. Employment relevant activity

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Current employment status and employment during the period

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Directorate of Health
  • South-Eastern Norway Regional Health Authority

Registry information

Official study title

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

Acronym: IPS-SUD

Important dates

Study start
2020
Primary completion
2024
Study completion
2032
First posted
Feb 28, 2020
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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