Clinical trial NCT04289415: From Addiction to Employment.
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
name: Norwegian Directorate of Health
First posted: 2020-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, two-arm, parallel, superiority, randomised controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Any employment
timeFrame: From inclusion in the trial to 18 month after inclusion in the trial
Secondary outcomes:
measure: Total time worked
timeFrame: From inclusion in the trial to 18 month after inclusion in the trial
measure: Time to employment
timeFrame: From inclusion in the trial to 18 month after inclusion in the trial
measure: Number of jobs
timeFrame: From inclusion in the trial to 18 month after inclusion in the trial
measure: Job duration
timeFrame: From inclusion in the trial to 18 month after inclusion in the trial
measure: Employment relevant activity
timeFrame: From inclusion in the trial to 18 month after inclusion in the trial
measure: Mental distress
timeFrame: From inclusion in the trial and at different time points up until 12 month after inclusion in the trial
measure: Past month substance use
timeFrame: From inclusion in the trial and at different time points up until 12 month after inclusion in the trial
measure: Participants' quality of life
timeFrame: From inclusion in the trial and at different time points up until 12 month after inclusion in the trial
measure: Participants' work related quality of life
timeFrame: From inclusion in the trial and at different time points up until 12 month after inclusion in the trial
Other outcomes:
measure: Current employment status and employment during the period
timeFrame: From inclusion in the trial and up until 10 years after inclusion in the trial
measure: Health Economic Cost-Benefit Assessment
timeFrame: From inclusion in the trial and up until 10 years after inclusion in the trial
Locations:
city: Oslo
country: Norway
facility: Department for Substance Use Treatment, Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Eline Rognli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.