NCT02697656

Brief Summary

Individual Placement and support (IPS) is an evidence-based approach originally developed to help people with severe mental disorders to obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is well documented, but has never previously been tested for patients with chronic pain. In fact, employment support is rarely provided in pain clinics, despite an increasing focus on integrating work and health in all patient treatment (OECD, 2013). The aim of this study is to investigate the effectiveness of IPS as an integrated part of the interdisciplinary treatment for patients with chronic pain in a hospital outpatient clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

5.1 years

First QC Date

January 18, 2016

Last Update Submit

June 8, 2021

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Competitive employment

    Hours/days/weeks worked in competitive employment the last 12 months

    At 12-months follow-up

Secondary Outcomes (3)

  • Health-related quality of life

    6 and 12 months follow-up

  • Pain-related disability

    6 and 12 months follow-up

  • Pain intensity

    6 and 12 months follow-up

Study Arms (2)

Treatment as usual + self-help

ACTIVE COMPARATOR

Interdisciplinary treatment as usual at the outpatient pain clinic + an additional self-help binder with resources about pain management and employment advice.

Behavioral: Self-helpBehavioral: Treatment as usual

Treatment as usual + IPS

EXPERIMENTAL

Individual job support (IPS) as an integrated part of the interdisciplinary treatment at the outpatient pain clinic.

Behavioral: IPSBehavioral: Treatment as usual

Interventions

IPSBEHAVIORAL

Individualized job support provided by an employment specialist

Treatment as usual + IPS
Self-helpBEHAVIORAL

Self-help resources on obtaining employment and coping with chronic pain

Treatment as usual + self-help
Treatment as usualBEHAVIORAL

Transdisciplinary treatment at the pain clinic. This includes medical, psychological and physiotherapy treatment.

Treatment as usual + IPSTreatment as usual + self-help

Eligibility Criteria

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

You may qualify if:

  • Patients referred to the pain clinic and eligible for interdisciplinary treatment
  • Not currently working (long-term sick leave, disability pension or unemployed)
  • Expressed desire to work

You may not qualify if:

  • Living too far away from the pain clinic (outside of Oslo)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silje Endresen Reme

Oslo, Norway

Location

Related Publications (4)

  • Bond GR, Drake RE. Making the case for IPS supported employment. Adm Policy Ment Health. 2014 Jan;41(1):69-73. doi: 10.1007/s10488-012-0444-6.

    PMID: 23161326BACKGROUND

  • Bond GR, Drake RE, Becker DR. An update on randomized controlled trials of evidence-based supported employment. Psychiatr Rehabil J. 2008 Spring;31(4):280-90. doi: 10.2975/31.4.2008.280.290.

    PMID: 18407876BACKGROUND

  • Sveinsdottir V, Jacobsen HB, Ljosaa TM, Linnemorken LTB, Knutzen T, Ghiasvand R, Reme SE. The Individual Placement and Support (IPS) in Pain Trial: A Randomized Controlled Trial of IPS for Patients with Chronic Pain Conditions. Pain Med. 2022 Sep 30;23(10):1757-1766. doi: 10.1093/pm/pnac032.

    PMID: 35234931DERIVED

  • Linnemorken LTB, Sveinsdottir V, Knutzen T, Rodevand L, Hernaes KH, Reme SE. Protocol for the Individual Placement and Support (IPS) in Pain Trial: A randomized controlled trial investigating the effectiveness of IPS for patients with chronic pain. BMC Musculoskelet Disord. 2018 Feb 13;19(1):47. doi: 10.1186/s12891-018-1962-5.

    PMID: 29433493DERIVED

Related Links

MeSH Terms

Conditions

Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Silje E Reme, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2016

First Posted

March 3, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 11, 2021

Record last verified: 2021-06

Locations

NO(1)