NCT03348410

Brief Summary

GESAM is a randomized controlled intervention study that addressed women and men on long-term sick leave in Uppsala County. Participants which are on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance will be offered to participate in an intervention. Those how give informed consent will be randomly assigned one of the following groups: 1) informing and motivating intervention with insurance officer 2) control group. The main purpose of the study is to facilitate the return to work (preventing a return to the public health insurance) during the project period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2019

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

November 16, 2017

Last Update Submit

October 16, 2020

Conditions

Long Term Sick LeaveAbsent-mindedness

Outcome Measures

Primary Outcomes (1)

  • Return to work (RTW)

    Return to work measured as time to participation in the labor force

    One year

Study Arms (2)

Intervention

EXPERIMENTAL

Motivational interviewing

Behavioral: Motivational interviewing

Control

NO INTERVENTION

Control group

Interventions

Motivational interviewingBEHAVIORAL

Motivational interviewing with insurance officer

Intervention

Eligibility Criteria

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

You may qualify if:

  • On sick leave
  • Risk of losing sick leave compensation

You may not qualify if:

  • Major mental illness (schizophrenia, bipolar disorder type I, severe social dysfunction/personality disorder)
  • Cancer disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala university

Uppsala, SE-75122, Sweden

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ingrid Anderzén, PHD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 20, 2017

Study Start

November 14, 2017

Primary Completion

November 14, 2019

Study Completion

December 14, 2019

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)