NCT05172375

Brief Summary

Recent research has underlined that mental health of people with depression and anxiety has deteriorated over the last decades in Denmark as well as internationally, and has reached a degree where it is perceived as a global health challenge. By now, depression is the most common reason for early retirement on health grounds in Denmark. Early intervention in relation to patients with depression and anxiety is essential, as research further shows that many young people with mental health difficulties drop out of education and work. The overall purpose is to develop a shared care intervention in co-production with users, and to increase their recovery by strengthening the support and treatment using a newly developed shared care model. The study is designed as a non-randomized intervention study with a control group. Comparative analyzes will be performed with pre- and post-assessments. Patients will be recruited between August 2022 and February 2023. The patients are referred to outpatient clinics based on their home address. The two outpatient clinics should be comparable in terms of patients' diagnoses and staffing. ward. Mental health status and well-being are the primary outcomes. Self-reported questionnaires will be administered to both groups before and after the intervention. The study will be approved by the Research Ethical Committee of University of Southern Denmark and Region Zealand. The study findings will be published in peer-reviewed journals and presented at national and international conferences.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Status
unknown

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

First Submitted

Initial submission to the registry

November 11, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

November 11, 2021

Last Update Submit

August 21, 2022

Conditions

Anxiety DisordersDepressive Disorder

Keywords

Shared careMental Health servicesGeneral practiceMental health recoveryWell-being

Outcome Measures

Primary Outcomes (2)

  • Change in Mental Health Status

    Mental health status is valid and reliable indicator of the patients self-reported mental state and well-being. Mental status is assessed using the standardized Short Form Health Survey (SF-36). Its 36 items are grouped into eight domains. The summed scores for each of the eight domains were plotted on a scale from 0 (worst) to 100 (best), with higher scores indicating better health

    At baseline and after 3 months

  • Change in mental health recovery

    The patients' recovery will be assessed by the 24-item recovery assessment scale-revised (RAS-R) - a questionnaire. It is a self-report instrument measuring mental health recovery. The RAS-R thus consists of 24 items on five-level scales. These items can be added up to produce summary scales representing five dimensions of personal recovery.

    Baseline and after 3 months.

Secondary Outcomes (5)

  • Change in level of function

    Baseline and after 3 months.

  • Change in Patient Satisfaction

    Baseline and after 3 months.

  • Change in Patient Satisfaction

    Baseline and after 3 months.

  • Improvement in collaboration between general practice and mental health

    Baseline and after 3 months.

  • Improvement in collaboration between general practice and mental health

    Baseline and after 3 months.

Study Arms (2)

The Shared Care model - intervention group

EXPERIMENTAL

The patients are referred to outpatient clinics based on their home address. The two outpatient clinics should be comparable in terms of patients' diagnoses and staffing. The Shared Care model consists of the following key elements: Shared care is a collaboration between general practice and mental health services and enables a 'best of both worlds' scenario with the opportunity to provide holistic care of high quality to support the recovery process of people with mental health difficulties. The final version of the intervention can only be determined based on the results of the research steps 1+2.

Behavioral: Shared Care Model

Treatment as usual - Control group

NO INTERVENTION

The patients are referred to outpatient clinics based on their home address. The two outpatient clinics should be comparable in terms of patients' diagnoses and staffing. In the control group the patients will receive treatment as usual.

Interventions

Shared Care ModelBEHAVIORAL

The Shared Care model consists of the following key elements: Shared care is a collaboration between general practice and mental health services and enables a 'best of both worlds' scenario with the opportunity to provide holistic care of high quality to support the recovery process of people with mental health difficulties.

The Shared Care model - intervention group

Eligibility Criteria

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

You may qualify if:

  • Out patient
  • Diagnosed with: Anxiety and Depression
  • Aged 18 - 65 years

You may not qualify if:

  • Cognitive deficit
  • Patients who did not consent to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Christensen TN, Wallstrom IG, Bojesen AB, Nordentoft M, Eplov LF. Predictors of work and education among people with severe mental illness who participated in the Danish individual placement and support study: findings from a randomized clinical trial. Soc Psychiatry Psychiatr Epidemiol. 2021 Sep;56(9):1669-1677. doi: 10.1007/s00127-021-02107-8. Epub 2021 May 25.

    PMID: 34032866RESULT

  • Mojtabai R, Olfson M, Han B. National Trends in the Prevalence and Treatment of Depression in Adolescents and Young Adults. Pediatrics. 2016 Dec;138(6):e20161878. doi: 10.1542/peds.2016-1878. Epub 2016 Nov 14.

    PMID: 27940701RESULT

  • Kennedy N, Foy K, Sherazi R, McDonough M, McKeon P. Long-term social functioning after depression treated by psychiatrists: a review. Bipolar Disord. 2007 Feb-Mar;9(1-2):25-37. doi: 10.1111/j.1399-5618.2007.00326.x.

    PMID: 17391347RESULT

  • Iancu SC, Batelaan NM, Zweekhorst MB, Bunders JF, Veltman DJ, Penninx BW, van Balkom AJ. Trajectories of functioning after remission from anxiety disorders: 2-year course and outcome predictors. Psychol Med. 2014 Feb;44(3):593-605. doi: 10.1017/S0033291713001050. Epub 2013 May 10.

    PMID: 23659543RESULT

  • Rugulies R, Aust B. Work and mental health: what do we know and how can we intervene? Scand J Work Environ Health. 2019 Nov 1;45(6):529-532. doi: 10.5271/sjweh.3856. Epub 2019 Oct 16. No abstract available.

    PMID: 31616953RESULT

  • Sogaard HJ, Bech P. Psychiatric disorders in long-term sickness absence -- a population-based cross-sectional study. Scand J Public Health. 2009 Sep;37(7):682-9. doi: 10.1177/1403494809344357. Epub 2009 Aug 21.

    PMID: 19700479RESULT

  • Manthey TJ, Goscha R, Rapp C. Barriers to supported education implementation: implications for administrators and policy makers. Adm Policy Ment Health. 2015 May;42(3):245-51. doi: 10.1007/s10488-014-0583-z.

    PMID: 25145926RESULT

  • Ringeisen H, Langer Ellison M, Ryder-Burge A, Biebel K, Alikhan S, Jones E. Supported education for individuals with psychiatric disabilities: State of the practice and policy implications. Psychiatr Rehabil J. 2017 Jun;40(2):197-206. doi: 10.1037/prj0000233. Epub 2017 Feb 9.

    PMID: 28182470RESULT

  • Hunt J, Eisenberg D. Mental health problems and help-seeking behavior among college students. J Adolesc Health. 2010 Jan;46(1):3-10. doi: 10.1016/j.jadohealth.2009.08.008. Epub 2009 Oct 20.

    PMID: 20123251RESULT

  • Weitkamp K, Klein E, Midgley N. The Experience of Depression: A Qualitative Study of Adolescents With Depression Entering Psychotherapy. Glob Qual Nurs Res. 2016 May 16;3:2333393616649548. doi: 10.1177/2333393616649548. eCollection 2016 Jan-Dec.

    PMID: 28462338RESULT

  • Bauer J, Okkels N, Munk-Jorgensen P. State of psychiatry in Denmark. Int Rev Psychiatry. 2012 Aug;24(4):295-300. doi: 10.3109/09540261.2012.692321.

    PMID: 22950767RESULT

  • Marcussen M, Berring L, Horder M, Sondergaard J, Norgaard B. Development of a model for shared care between general practice and mental healthcare: a protocol for a co-production study. BMJ Open. 2022 Oct 31;12(10):e061575. doi: 10.1136/bmjopen-2022-061575.

    PMID: 36316081DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepressive Disorder

Condition Hierarchy (Ancestors)

Mental DisordersMood Disorders

Study Officials

  • Michael Marcussen, Dr.

    University of Southern Denmark (SDU), Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Marcussen, Dr.

CONTACT

+45 26369503mhmc@regionsjaelland.dk

Birgitte Nørgaard, Dr.

CONTACT

+45 24222613binorgaard@health.sdu.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study is designed as a non-randomized intervention study with pre- and post design and with a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 11, 2021

First Posted

December 29, 2021

Study Start

January 1, 2023

Primary Completion

February 28, 2023

Study Completion

December 31, 2023

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share