Clinical trial NCT03346395: A Problem Solving Based Intervention for Facilitating Return-to-work Among People Suffering From Common Mental Disorders
Official title: A Problem Solving Based Intervention in Primary Health Care for Facilitating Return-to-work Among People Suffering From Common Mental Disorders - a Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety Disorders
Adjustment Disorders
Common Mental Disorder
Keywords: Adjustment disorders
Anxiety disorders
Depression
Mental disorders
Interventional study
Primary health care
Problem solving
Randomized controlled trial
Return to work
Sick leave
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swedish Council for Working Life and Social Research
First posted: 2017-11-17
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* employed women and men aged 18-59, short-term sick leave (i.e. a minimum of 2 weeks and a maximum of 12 weeks) due to mild to moderate depression, anxiety or adjustment disorder (F 32, F 41, F 43) as the primary reason for sick leave, diagnosed by a general practitioner (GP) or physician according to the Swedish version of international statistical classification of diseases and related health problems - tenth revision (ICD-10) contact with a GP or physician at a primary health care center in the vestra gotaland region.

Exclusion Criteria:

* Severe depression, other severe mental disorders, i.e. psychotic or bipolar disorders; pregnancy, somatic complaints or disorders that will influence work ability; not able to read, write and understand Swedish.

Primary outcomes:
measure: Change in total registered sickness absenteeism in number of days from baseline during the 18 month follow-up.
timeFrame: At baseline and 18 months after baseline.
Secondary outcomes:
measure: Change from baseline in registered part-time sickness absenteeism during the 18 months follow-up
timeFrame: From baseline to 18 months after baseline.
measure: Change from baseline in return to work during a period of 18 months.
timeFrame: From baseline to 18 months after baseline.
measure: Episodes of sickness absenteeism after full-time return to work
timeFrame: From baseline during 18 months follow-up.
measure: Change in total registered sick leave from baseline to 36 month follow-up.
timeFrame: Change in total registered sick leave from baseline to 36 month follow-up.
measure: Possible interaction effects
timeFrame: Change from baseline and 6, 12 and 18 months after study inclusion.
measure: Self-reported short-term sickness absenteeism
timeFrame: From baseline to 12 months after baseline.
measure: Change from baseline in self-reported part-time sickness absenteeism during the 12 months follow-up
timeFrame: From baseline to 12 months after baseline.
measure: Change from baseline in return to work during a period of 12 months.
timeFrame: From baseline to 12 months after baseline.
measure: Episodes of self-reported sickness absenteeism after full-time return to work.
timeFrame: From baseline during 12 months follow-up.
measure: Reduction of symptoms related to common mental disorders Hospital Anxiety and Depression scale
timeFrame: Baseline and 6 and 12 months after study inclusion.
measure: Reduction of symptoms related to common mental disorders Self-reported exhaustion
timeFrame: Baseline and 6 and 12 months after study inclusion.
measure: Reduction of symptoms related to common mental disorders Karolinska Sleep Questionnaire
timeFrame: Baseline and 6 and 12 months after study inclusion.
measure: Sickness presenteeism
timeFrame: Baseline and after 6 and 12 months after study inclusion.
measure: Work ability index (WAI)
timeFrame: Baseline and 6 and 12 months after study inclusion.
measure: Work performance impairment due to health problems
timeFrame: Will be assessed at baseline and once a month during a 12-month follow-up period.
measure: Work performance impairment due to problems in the working environment
timeFrame: Will be assessed at baseline and once a month during a 12-month follow-up period.
measure: Demand-control-support
timeFrame: Baseline and after 6 and 12 months after study inclusion.
measure: Return-to-work self-efficacy
timeFrame: Change from baseline and 6 and 12 months after study inclusion.
measure: Ongoing conflict with the superior
timeFrame: Change from baseline at 6 and 12 months after study inclusion.
measure: Perceived loss of control over work tasks
timeFrame: Change from baseline at 6 and 12 months after study inclusion.
measure: Conflict between employee's values and how the work actually is done
timeFrame: Change from baseline at 6 and 12 months after study inclusion.
measure: Job strain
timeFrame: Change from baseline at 6 and 12 months after study inclusion.
measure: Participants' satisfaction
timeFrame: Will be assessed at 6 months after intervention.
measure: The rehabilitation coordinators' adherence to the intervention.
timeFrame: Assessed immediately upon completion of intervention.
measure: Health related quality of life
timeFrame: Will be measured at baseline, 6 and 12 months follow-up
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Primary health care
state: Region Västra Götaland
city: Gothenburg
country: Sweden
facility: Elisabeth Björk Brämberg
state: Västra Götaland
Study officials:
affiliation: Karolinska Institute, Unit of intervention and implementation research
name: Elisabeth Björk Brämberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjork Bramberg E, Holmgren K, Bultmann U, Gyllensten H, Hagberg J, Sandman L, Bergstrom G. 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). BMC Public Health. 2018 Jul 18;18(1):889. doi: 10.1186/s12889-018-5816-8.