NCT03346395: PROSA

A Problem Solving Based Intervention for Facilitating Return-to-work Among People Suffering From Common Mental Disorders

Completed NA Last updated 18 January 2023

What this trial tests

NA trial testing Problem solving based intervention in Depression in 197 participants. Completed in 17 January 2023.

Timeline

11 January 2018

Primary endpoint
31 December 2022

17 January 2023

Quick facts

Lead sponsor	Karolinska Institutet
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	197
Start date	11 January 2018
Primary completion	31 December 2022
Estimated completion	17 January 2023
Sites	2 locations across Sweden

Drugs / interventions tested

• Problem solving based intervention
• Care as usual — full drug profile →

Conditions studied

• Depression — all drugs for Depression →
• Anxiety Disorders — all drugs for Anxiety Disorders →
• Adjustment Disorders — all drugs for Adjustment Disorders →
• Common Mental Disorder — all drugs for Common Mental Disorder →

Sponsor

Karolinska Institutet

Who can join

Adults 18 to 59, any sex, with Depression or Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Problem solving based intervention involving the workplace has shown promising effects on return-to-work among persons with common mental disorders. A key element is cooperation between the person on sick leave, the participant's employer and health care professionals. The aim of the present study is to evaluate the effects of a problem solving based intervention in the Swedish primary health care system on an employed population on sick leave due to common mental disorders. Cluster randomized controlled trial. The investigators hypothesize that:

Participants who have undergone the work-related problem solving based intervention will have fewer total days on sick leave than the participants who receive treatment as usual at 18 months.

Participants who receive the work-related problem solving based intervention will have fewer recurrent periods of sick leave than the participants who receive treatment as usual at 18 months.

Participants who receive the work-related problem solving therapy intervention will score better on the secondary outcomes than the participants in the control group.

Population: Employed, aged 18 - 59, on short-term sick leave (min. 2 - max. 12 weeks) due to common mental disorders.

Intervention: Work-related problem solving based intervention in addition to treatment as usual. The intervention will be given by rehabilitation coordinators on max. five occasions and includes: making an inventory of problems and/or opportunities related to return-to-work; identifying the support needed to implement the solutions; a meeting with the person on sick leave, his/her employer and the rehabilitation coordinator to discuss solutions; making an action plan and evaluation.

Control: The control group will receive care as usual (i.e. cognitive behavioral therapy and/or medical treatment, and meeting with a rehabilitation coordinator if this is a part of care as usual at the primary health care centre). A total of 220 persons on sick leave and 30 rehabilitation coordinators will be included.

Primary outcome: total number of days on sick leave at 18 months after baseline. A parallel process evaluation will be conducted to examine: to what extent it is possible to implement problem-solving therapy according to the protocol; the relationship between the key elements of problem-solving intervention and the effect outcome; how the participants perceive the intervention.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA).
   Björk Brämberg E, Holmgren K, Bültmann U, Gyllensten H, et al · · 2018 · cited 25× · PMID 30021545 · DOI 10.1186/s12889-018-5816-8
2. Recruiting in intervention studies: challenges and solutions.
   Axén I, Björk Brämberg E, Galaasen Bakken A, Kwak L. · · 2021 · cited 21× · PMID 33495262 · DOI 10.1136/bmjopen-2020-044702
3. Is a Problem-Solving Intervention with Workplace Involvement for Employees on Sickness Absence Due to Common Mental Disorders More Effective, than Care as Usual, in Reducing Sickness Absence Days? Results of a Cluster-Randomised Controlled Trial in Primary Health Care.
   Karlsson I, Frantz A, Axén I, Bergström G, et al · · 2025 · cited 5× · PMID 39110387 · DOI 10.1007/s10926-024-10229-4
4. Predictors of sickness absence among employees with common mental disorders in Sweden- a longitudinal study.
   Frantz A, Toropova A, Axén I, Bergström G, et al · · 2025 · PMID 39901173 · DOI 10.1186/s12889-025-21563-4