NCT04289415

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
71mo left

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Mar 2020Feb 2032

First Submitted

Initial submission to the registry

February 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2032

Expected
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

4.2 years

First QC Date

February 25, 2020

Last Update Submit

April 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Any employment

    At least 1 day of competitive employment

    From inclusion in the trial to 18 month after inclusion in the trial

Secondary Outcomes (9)

  • Total time worked

    From inclusion in the trial to 18 month after inclusion in the trial

  • Time to employment

    From inclusion in the trial to 18 month after inclusion in the trial

  • Number of jobs

    From inclusion in the trial to 18 month after inclusion in the trial

  • Job duration

    From inclusion in the trial to 18 month after inclusion in the trial

  • Employment relevant activity

    From inclusion in the trial to 18 month after inclusion in the trial

  • +4 more secondary outcomes

Other Outcomes (2)

  • Current employment status and employment during the period

    From inclusion in the trial and up until 10 years after inclusion in the trial

  • Health Economic Cost-Benefit Assessment

    From inclusion in the trial and up until 10 years after inclusion in the trial

Study Arms (2)

Individual Placement and Support

EXPERIMENTAL

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

Selv help kit and work shop

ACTIVE COMPARATOR

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

Interventions

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

Individual Placement and SupportSelv help kit and work shop

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Substance Use Treatment, Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Eline Rognli, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Pragmatic, two-arm, parallel, superiority, randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 28, 2020

Study Start

March 1, 2020

Primary Completion

May 15, 2024

Study Completion (Estimated)

February 28, 2032

Last Updated

April 4, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations