NCT01926574

Brief Summary

Long-term sick-listing from work has considerable impact on social function, on the families of the sick-listed persons, the companies they work for, and society as a whole. Hence, the need for documented effective vocational rehabilitation programs is pressing. Vocational rehabilitation services described in the scientific literature have been specific to one single or a specific group of medical conditions (e.g.low back pain). In contrast, most people on sick leave have several health complaints, and many of the factors influencing sick leave are shared regardless of disorder (e.g. social surroundings, workplace environment), calling for rehabilitation programs that can be employed for both musculoskeletal-, unspecific- and common mental disorders. Aim of this study is to investigate whether a group based rehabilitation program for musculoskeletal, mental or unspecific complaints can facilitate return-to-work (RTW), thereby testing two multicomponent return-to-work RTW rehabilitation programs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

2.4 years

First QC Date

August 19, 2013

Last Update Submit

April 6, 2021

Conditions

Sick LeaveOccupational Health

Keywords

absenteeismrehabilitationreturn to work

Outcome Measures

Primary Outcomes (2)

  • time until full sustainable return-to-work (RTW)

    return-to-work i.e. for at least 4 weeks without relapse

    1 year

  • Total number of sickness absence days

    after enrollment in the study (i.e. after pre-screening)

    1 year

Secondary Outcomes (11)

  • Sickness absence days

    3 years

  • sickness absence days

    5 years

  • Health related quality of life

    1 year

  • Subjective health complaints

    1 year

  • Physical activity

    1 year

  • +6 more secondary outcomes

Other Outcomes (1)

  • Health economics from the societal perspective

    1 year

Study Arms (4)

long rehabilitation

EXPERIMENTAL

a 3.5-week, in-patient rehabilitation program, organized as a 7-hour workday with weekends off, simulating a close to normal summer work-week in Norway, and mainly group-based with maximum 8 participants per group. Focus on mental training (aimed at increasing motivation and self-efficacy), physical training and work-related problem solving.

Behavioral: long rehabilitation program

short rehabilitation

EXPERIMENTAL

4+4 full days of rehabilitation at Hysnes Rehabilitation Center, separated by 2 weeks living at home. Group-based with 8 participants per group, focus on mental training (aimed at increasing motivation and self-efficacy), physical training and work-related problem solving. A workplace visit will be included in addition to the 4 + 4 rehabilitation days, if considered relevant.

Behavioral: short rehabilitation program

Acceptance and commitment therapy

ACTIVE COMPARATOR

6 dynamic processes (committed action, self-as-context, presence in the moment, values, defusion and acceptance) are targeted both in group-sessions and individual meetings. Only the psychological part of the experimental interventions is applied, in an outpatient setting.

Behavioral: Acceptance and commitment therapy (ACT)

Untouched

NO INTERVENTION

this group will be followed in registers at group level and not be aware of their participation in the study

Interventions

long rehabilitation programBEHAVIORAL
long rehabilitation
short rehabilitation programBEHAVIORAL
short rehabilitation
Acceptance and commitment therapy (ACT)BEHAVIORAL
Acceptance and commitment therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • living in the counties of Trøndelag
  • on sick leave 2-12 months
  • current sick leave status of 50% - 100%
  • ICPC-2 (International Classification of Primary Care, Second edition) diagnosis within the L (musculoskeletal), P (psychiatric) or A (unspecific disorders) categories

You may not qualify if:

  • alcohol or drug abuse
  • serious somatic or psychological disorders
  • a specific disorder requiring specialized treatment
  • pregnancy
  • currently participating in another treatment program
  • insufficient Norwegian speaking or writing skills to participate in group session and fill out questionnaires
  • scheduled for surgery within the next 6 months
  • serious problems with functioning in a group setting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hysnes Rehabilitation Centre

Rissa, Norway

Location

St. Olavs University Hospital

Trondheim, Norway

Location

Related Publications (6)

  • Fimland MS, Vasseljen O, Gismervik S, Rise MB, Halsteinli V, Jacobsen HB, Borchgrevink PC, Tenggren H, Johnsen R. Occupational rehabilitation programs for musculoskeletal pain and common mental health disorders: study protocol of a randomized controlled trial. BMC Public Health. 2014 Apr 16;14:368. doi: 10.1186/1471-2458-14-368.

    PMID: 24735616BACKGROUND

  • Aasdahl L, Pape K, Vasseljen O, Johnsen R, Gismervik S, Halsteinli V, Fleten N, Nielsen CV, Fimland MS. Effect of Inpatient Multicomponent Occupational Rehabilitation Versus Less Comprehensive Outpatient Rehabilitation on Sickness Absence in Persons with Musculoskeletal- or Mental Health Disorders: A Randomized Clinical Trial. J Occup Rehabil. 2018 Mar;28(1):170-179. doi: 10.1007/s10926-017-9708-z.

    PMID: 28401441RESULT

  • Nordstoga AL, Mork PJ, Steiro Fimland M. Improved cardiorespiratory fitness after occupational rehabilitation in merged diagnostic groups. Ann Occup Environ Med. 2018 Feb 28;30:16. doi: 10.1186/s40557-018-0227-y. eCollection 2018.

    PMID: 29507732RESULT

  • Aasdahl L, Pape K, Vasseljen O, Johnsen R, Fimland MS. Improved Expectations About Length of Sick Leave During Occupational Rehabilitation Is Associated with Increased Work Participation. J Occup Rehabil. 2019 Sep;29(3):475-482. doi: 10.1007/s10926-018-9808-4.

    PMID: 30151631RESULT

  • Aasdahl L, Pape K, Vasseljen O, Johnsen R, Gismervik S, Jensen C, Fimland MS. Effects of Inpatient Multicomponent Occupational Rehabilitation versus Less Comprehensive Outpatient Rehabilitation on Somatic and Mental Health: Secondary Outcomes of a Randomized Clinical Trial. J Occup Rehabil. 2017 Sep;27(3):456-466. doi: 10.1007/s10926-016-9679-5.

    PMID: 27815771RESULT

  • Skagseth M, Fimland MS, Ivar Lund Nilsen T, Aasdahl L. Physical activity after inpatient occupational rehabilitation: Secondary outcomes of two randomized controlled trials. Scand J Med Sci Sports. 2020 Feb;30(2):339-348. doi: 10.1111/sms.13577. Epub 2019 Oct 30.

    PMID: 31609021RESULT

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Roar Johnsen, phd prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

January 1, 2022

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

NO(2)