NCT02378272

Brief Summary

The aim of the project is to explore if a complementary addition of a care manager for depression treatment in the primary care setting has positive effects concerning reduction of the patients' depressive symptoms as well as improvement of daily function and quality of life in a short- and long-term perspective compared with the traditional Swedish primary care organization. The aim is also to evaluate the care manager function in a health economic perspective. The specific aims are to develop and evaluate an evidence-based care manager program for patients with mild to moderate depression and to compare the evidence-based care manager program to treatment as usual (TAU) in terms of their short- and long-term effects on symptom remission, treatment adherence, care satisfaction, and self-efficacy as well as to perform a cost - effectiveness analysis of the care manager program, i.e. to evaluate the effects of the program on patients' health in relation to the running costs of the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
376

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable depression

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.2 years

First QC Date

February 2, 2015

Last Update Submit

September 18, 2023

Conditions

Keywords

Care ManagerPrimary CareDepressive symptomsquality of lifereturn to work

Outcome Measures

Primary Outcomes (1)

  • Change of level of depression (Self-reported level of depressive symptoms measured by Beck Depression Inventory II)

    Self-reported level of depressive symptoms measured by Beck Depression Inventory II

    0- 6 months

Secondary Outcomes (4)

  • Sick-listing (Amount of sick-listing days during 0-6 months observation period)

    6 months

  • Change of level of job strain (Perception of job strain measured by Karasek Job Strain Model)

    0-6 months

  • Change of level of Quality of Life (Self-reported level of perceived Quality of Life measured by EQ-5D)

    0- 6 months

  • Change of level of Work Ability (Self-reported level of perceived work ability measured by Work Ability Index)

    0 - 6 months

Study Arms (2)

Care manager for depression

EXPERIMENTAL

A district nurse will apply around 15-25% of working time as care coordinator (care manager for depression) at PCC for management of care for all recruited patients with depression

Other: care manager for depression

Treatment As Usual

NO INTERVENTION

Management of recruited patients with depression continued as usually applied at PCC

Interventions

District nurse (care manager for depression) providing clinical services ( in cooperation with GP) as patient information and education on patient's preferred treatment, development of care plan, assessment of patient's depressive symptoms and regular telephone contacts.

Care manager for depression

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed mild-moderate depression,
  • years,
  • attending primary care center

You may not qualify if:

  • schizophrenia,
  • abuse/addiction,
  • psychosis,
  • bipolar syndrome,
  • suicidal ideation or earlier suicide attempt,
  • ongoing deep depression,
  • generalized anxiety syndrome,
  • not communicable in Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Primary Health Care, Sahlgrenska Academy

Gothenburg, Region Västra Götaland, 40530, Sweden

Location

Related Publications (8)

  • Bjorkelund C, Svenningsson I, Hange D, Udo C, Petersson EL, Ariai N, Nejati S, Wessman C, Wikberg C, Andre M, Wallin L, Westman J. Clinical effectiveness of care managers in collaborative care for patients with depression in Swedish primary health care: a pragmatic cluster randomized controlled trial. BMC Fam Pract. 2018 Feb 9;19(1):28. doi: 10.1186/s12875-018-0711-z.

  • Holst A, Ginter A, Bjorkelund C, Hange D, Petersson EL, Svenningsson I, Westman J, Andre M, Wikberg C, Wallin L, Moller C, Svensson M. Cost-effectiveness of a care manager collaborative care programme for patients with depression in primary care: economic evaluation of a pragmatic randomised controlled study. BMJ Open. 2018 Nov 12;8(11):e024741. doi: 10.1136/bmjopen-2018-024741.

  • Petersson EL, Hange D, Udo C, Bjorkelund C, Svenningsson I. Long-term effect of a care manager on work ability for patients with depression - the PRIM-CARE RCT. Work. 2022;72(2):601-609. doi: 10.3233/WOR-205272.

  • Holst A, Labori F, Bjorkelund C, Hange D, Svenningsson I, Petersson EL, Westman J, Moller C, Svensson M. Cost-effectiveness of a care manager collaborative care programme for patients with depression in primary care: 12-month economic evaluation of a pragmatic randomised controlled trial. Cost Eff Resour Alloc. 2021 Aug 17;19(1):52. doi: 10.1186/s12962-021-00304-5.

  • Af Winklerfelt Hammarberg S, Bjorkelund C, Nejati S, Magnil M, Hange D, Svenningsson I, Petersson EL, Andre M, Udo C, Ariai N, Wallin L, Wikberg C, Westman J. Clinical effectiveness of care managers in collaborative primary health care for patients with depression: 12- and 24-month follow-up of a pragmatic cluster randomized controlled trial. BMC Prim Care. 2022 Aug 9;23(1):198. doi: 10.1186/s12875-022-01803-x.

  • Augustsson P, Petersson EL, Bjorkelund C, Persson Kylen S, Wikberg C. Organisational and social work-environment experiences after care manager implementation: a repeated cross-sectional study in Swedish primary care. Scand J Prim Health Care. 2025 Jul 28:1-12. doi: 10.1080/02813432.2025.2538486. Online ahead of print.

  • Svenningsson I, Hange D, Udo C, Tornbom K, Bjorkelund C, Petersson EL. The care manager meeting the patients' unique needs using the care manager model-A qualitative study of experienced care managers. BMC Fam Pract. 2021 Sep 3;22(1):175. doi: 10.1186/s12875-021-01523-8.

  • Svenningsson I, Petersson EL, Udo C, Westman J, Bjorkelund C, Wallin L. Process evaluation of a cluster randomised intervention in Swedish primary care: using care managers in collaborative care to improve care quality for patients with depression. BMC Fam Pract. 2019 Jul 27;20(1):108. doi: 10.1186/s12875-019-0998-4.

MeSH Terms

Conditions

Depression

Interventions

Case Managers

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Cecilia Björkelund

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 2, 2015

First Posted

March 4, 2015

Study Start

December 1, 2014

Primary Completion

January 31, 2017

Study Completion

December 31, 2018

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations