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Substance Use DisordersIPS-SUDNCT04289415

From Addiction to Employment.

A study testing Individual Placement and Support in people with Substance Use Disorders, run by Oslo University Hospital at 1 site in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Substance Use Disorders
What is being tested?
Individual Placement and Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteNorway
Study dates
1 Mar 2020to 28 Feb 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Department for Substance Use Treatment, Oslo University Hospital

    Oslo, 0424

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
Individual Placement and Support
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individual Placement and SupportBehavioural

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

Study groups in NCT04289415
Study groupRoleWhat they receive
Individual Placement and SupportExperimentalThe 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.
Receives: Behavioral: Individual Placement and Support
Selv help kit and work shopActive comparatorThe 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.
Receives: Behavioral: Individual Placement and Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Any employment

    At least 1 day of competitive employment

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

Secondary outcomes (9)

  1. Total time worked

    Number of days/hours worked

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

  2. Time to employment

    Time from inclusion in the trial to first employment

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

  3. Number of jobs

    Number of different jobs kept

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

  4. Job duration

    Duration of longest employment

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

  5. Employment relevant activity

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

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

  6. Mental distress

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

    Measured: From inclusion in the trial and at different time points up until 12 month after inclusion in the trial

  7. Past month substance use

    Information obtained from the European Addiction Severity Index

    Measured: From inclusion in the trial and at different time points up until 12 month after inclusion in the trial

  8. Participants' quality of life

    Information obtained from the EQ-5D-5L

    Measured: From inclusion in the trial and at different time points up until 12 month after inclusion in the trial

  9. 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)

    Measured: From inclusion in the trial and at different time points up until 12 month after inclusion in the trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2020
  2. Study start1 Mar 2020
  3. Primary completion15 May 2024 (estimated)
  4. Study completion28 Feb 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pragmatic, two-arm, parallel, superiority, randomised controlled trial
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04289415
Sponsor's protocol ID
54204
Acronym
IPS-SUD
Status last verified
Apr 2024
First submitted
25 Feb 2020
Last updated
4 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34654464

Questions about this trial

What is this clinical trial studying?

A study testing Individual Placement and Support in people with Substance Use Disorders, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any employment (time frame: From inclusion in the trial to 18 month after inclusion in the trial). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04289415, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.

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