Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-28 @ 8:31 PM
Study NCT ID:
NCT04975750
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2021-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Problem Solving Intervention Involving Employees at Risk of Sick Leave Due to Common Mental Disorders
Sponsor:
Karolinska Institutet
Organization:
Study Overview
Official Title:
Early Prevention of Sick Leave at the Workplace: Design of a Cluster-randomized Controlled Trial of a Problem-solving Intervention Among Employees With Common Mental Disorders
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIME
Brief Summary:
The overall aim of this randomized controlled trial is to evaluate the effectiveness of a problem-solving intervention for the prevention of sick leave among employees with early signs of CMDs. The intervention is delivered by first-line managers and a 30% reduction in sick leave days is expected in the experimental condition compared to treatment-as-usual, during the 12- months follow-up.
Detailed Description:
The overall aim of this randomized controlled trial is to evaluate the effectiveness of a problem-solving intervention for the prevention of sick leave among employees with early signs of CMDs. The intervention is delivered by first-line managers and a 30% reduction in sick leave days is expected in the experimental condition compared to treatment-as-usual, during the 12- months follow-up.
In an alongside process evaluation on the intervention's core activities, i.e. identification of early signs of CMDs, training of first-line managers in problem-solving and communication, we will:
* evaluate whether and to what extent it was possible for the first-line managers to adhere to the intervention's protocol,
* investigate the association between the intervention's core activities and number of sick leave days,
* identify the facilitators and barriers to the intervention among first-line managers and employees and,
* explore the first-line manager's organizational resources supporting their general managerial work.
The study will be conducted in private sector companies, among first-line managers and blue-collar workers. The outcomes will be evaluated on both cluster- and individual participant level.
In an alongside process evaluation on the intervention's core activities, i.e. identification of early signs of CMDs, training of first-line managers in problem-solving and communication, we will:
* evaluate whether and to what extent it was possible for the first-line managers to adhere to the intervention's protocol,
* investigate the association between the intervention's core activities and number of sick leave days,
* identify the facilitators and barriers to the intervention among first-line managers and employees and,
* explore the first-line manager's organizational resources supporting their general managerial work.
The study will be conducted in private sector companies, among first-line managers and blue-collar workers. The outcomes will be evaluated on both cluster- and individual participant level.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: