Assessment of Activity Limitations, a Basis for Understanding the Need for Sickness Certificate and Rehabilitation

NCT05772494 | Active Not Recruiting

• 1 other identifier: FK 2022/012285
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In Sweden mental disorders have the highest proportion of sickness absence and sickness spells. One cause for this is proposed as the lack of knowledge on which activity limitations that have an impact on the ability to return to work. Further, there is a knowledge gap concerning the effect of which early measures from the health system, assessments and early rehabilitation interventions, that enables return to work. Such early measures have been proposed to have a more multidimensional perspective, than to solely focus on specific tasks during a work situation. The aim of the current project is to examine the effect of an early assessment of activity limitations, made by occupational therapists within specialized psychiatric care, at the time for the next prolonged sickness certification. The assessment will be included in the sickness certificate, and results will be compared between the intervention group and a control group. The results are calculated for differences on treatment measures, prevalence of questions from the Social Insurance Agency and changes in the patterns for sick leave spells. Further, the prevalence of activity limitations and the sick listed participants assessments of the effect of the intervention will be presented. The results are expected to lead to more adequate interventions for the individual regarding support to return to work, better routines for assessment and rehabilitation within the health care system, which in turn can facilitate decisions for sickness benefits and further have an impact on the long sick leave spells concerning mental disorders.

Conditions

Sick Leave

Keywords

Sick leave; Mental disorders; Occupational Therapy; Activity limitations

Outcome Measures

Primary Outcomes (3)

• Health care treatments

  Differences in types of healthcare treatment options between intervention and control group. Comparisons will be made between intervention and control group with regard to registered codes for intervention and codes for professionals responsible for treatment options. Descriptive calculations and comparisons will be made on differences in types of as well as changes in treatment measures within the notified time frame.

  6 months after inclusion

• Changes in sick leave patterns

  Differences in number of sick leave periods, full-time or part-time or number of sick leave spells between intervention and control group.

  6 months after inclusion

• Number of questions from the Social Insurance Agency (SIA)

  Differences in number of clarifying questions from SIA between intervention and control group.

  6 months after inclusion

Secondary Outcomes (1)

• Participants self-assessed effects of being part of the project

  6 months after inclusion

Study Arms (2)

Assessment of activity limitation

EXPERIMENTAL

Assessment and analysis of activity limitation by occupational therapist using 2 registered instruments (SDO and DOA).

Other: Assessment of activity limitations, SDO and DOA

Control group: treatment as usual

ACTIVE COMPARATOR

Assessment of activity limitations according to usual routines

Other: Control group

Interventions

Assessment of activity limitations, SDO and DOA OTHER

The assessment is made with two instruments (DOA, SDO), and finally the occupational therapist includes the analysis and summary of activity limitations to the sickness certificate. For comparative reasons the participant will answer to a sociodemographic questionnaire focusing on work situation and sick leave

Also known as: Satisfaction with Daily Occupations (SDO), A Dialogue About Ability Realted to Work (DOA)

Assessment of activity limitation

Control group OTHER

All assessments concerning activity limitations are made using usual routines, primarily by the sick-listing physician. For comparative reasons the participant will answer to a sociodemographic questionnaire focusing on work situation and sick leave

Control group: treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients registered at the chosen psychiatric care centers, in need for their second or third sickness certificate within the unit.

You may not qualify if:

• Patients with specific diagnosis belonging to another unit within the psychiatric organization.
• Patients assessed as being in an acute vulnerable situation where the planned intervention could negatively influence the situation e.g. having suicidal thoughts, or having such language difficulties that an interpreter is needed (which could complicate the understanding of the meaning of the intervention and cause unnecessary worries).

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Göteborg University, Institute of Neuroscience and Physiology

Gothenburg, 40530, Sweden

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Christina Andersson

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The participants are consecutively assigned to either intervention or control group depending on the time for the next prolonged sick leave period. Participants in the intervention group are invited to an assessment session with an occupational therapist focusing on limitations and enablers in activities related to pre-requisites for returning to work. Participants in the control group receive assessments for sickness certificate according to ordinary routines.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 16, 2023
• Study Start: April 3, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)