Standardized Assessment in Depression Treatment in Routine Psychiatric Services

March 3, 2025 updated by: Benjamin Bohman, Karolinska Institutet

Standardized Assessment in Depression Treatment in Routine Psychiatric Services: a Retrospective Medical Record Review

The goal of this observational study is to evaluate current practices in depression treatment in psychiatric services in Stockholm, Sweden.

The main questions it aims to answer are:

  • Are current practices consistent with local clinical guidelines in terms of standardized assessment and the treatments provided?
  • What are the present conditions for implementing measurement-based care in depression treatment in this setting?

Data will be collected retrospectively from medical records of patients having received psychological or pharmacological treatment for depression from 2020 to 2023. Frequency of standardized assessments (not scores) using the Montgomery-Åsberg Depression Rating Scale, the Montgomery-Åsberg Depression Rating Scale-Self Assessment, and the Patient Health Questionnaire-9 is collected, together with information on patient, clinician, and treatment characteristics.

Study Overview

Status

Completed

Conditions

Detailed Description

Measurement-based care (MBC) refers to assessing outcomes prior to and during treatment with the purpose of providing a basis for treatment decisions and planning as treatment progresses (Lewis et al., 2019). MBC typically involves routine outcome monitoring on a session-to-session basis and clinical support tools to aid in the treatment process (Scott & Lewis, 2015; Trivedi, 2020). Research shows that MBC improves outcomes om symptom measures and reduces dropout as compared to treatment as usual without MBC (de Jong et al., 2021; Rognstad et al., 2023). Central to MBC is the frequent and systematic administration of outcome measures.

In public psychiatric services in Stockholm, Sweden, local clinical guidelines of the assessment and treatment of depression have been developed (Region Stockholm, 2021). These guidelines specify what psychological and pharmacological treatments to use, and at what time intervals assessment of outcomes should be conducted, and what measures to use. However, adherence to these guidelines in clinicians have not been evaluated; thus, it is not known to what extent the guidelines are properly implemented and what the present conditions are for introducing MBC in depression treatment in this setting.

Aims and research questions

A first aim of this study is to evaluate current practices in depression treatment in public psychiatric services in Stockholm. A second aim is to assess to what extent these practices adhere to local clinical guidelines, and if practices vary according to patient, clinician, and treatment characteristics. A third aim is to assess the present conditions for implementing MBC in depression treatment in this setting. The second aim provides valuable information for future initiatives of improving the conditions for implementing MBC in routine clinical practice settings. Research questions include:

  1. Are current practices consistent with local clinical guidelines in terms of standardized assessment and the treatments provided?
  2. Do current practices vary with patient, clinician, and treatment characteristics?
  3. What are the present conditions for implementing MBC in depression treatment in this setting?

Design and procedure

This observational study employs a retrospective medical record review design. Medical records of patients initiating and completing treatment for major depression disorder between 1 January 2020 and 30 September 2023 at five general psychiatric clinics within public psychiatric outpatient services in Stockholm, Sweden are included. Specialized staff in this setting extract data on the frequency of standardized assessment, and patient, therapist, and treatment characteristics. Assessment points include at pre and post treatment as well as at specific points during treatment as specified in the local clinical guidelines.

Participants

Patients aged 18 years or older with major depressive disorder who have received psychological or pharmacological treatment.

Assessment

Frequency of standardized assessments (not scores) using the clinician-administered Montgomery-Åsberg Depression Rating Scale (MADRS; Montgomery & Åsberg, 1979), the self-reported Montgomery-Åsberg Depression Rating Scale-Self Assessment (MADRS-S; Svanborg & Åsberg, 2001), and the self-reported Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) are collected. In addition, data are collected on patient characteristics (age, gender), clinician characteristics (age, gender, profession), and treatment characteristics, including clinic, type of treatment (psychological, pharmacological), type of psychological treatment (e.g., cognitive-behavioral, psychodynamic), type of pharmacological treatment (e.g., selective serotonin reuptake inhibitors), and treatment duration. The primary outcome measure is adherence to local clinical guidelines considering frequency of standardized assessments using the MADRS. Information identifying patients or clinicians is not collected.

Data analysis

Data on adherence of frequency of standardized assessments are examined using descriptive statistics. Group differences on categorical variables are investigated using chi-square tests or Kruskal-Wallis tests, and group differences on continuous variables are analyzed using multilevel modeling, taking account the nested data structure of patients and clinicians within clinics.

References

de Jong, K., Conijn, J. M., Gallagher, R. A. V., Reshetnikova, A. S., Heij, M., & Lutz, M. C. (2021). Using progress feedback to improve outcomes and reduce drop-out, treatment duration, and deterioration: a multilevel meta-analysis. Clinical Psychology Review, 85.

Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001). The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine, 16(9), 606-13.

Lewis, C. C., Boyd, M., Puspitasari, A., Navarro, E., Howard, J., Kassab, H., Hoffman, M., Scott, K., Lyon, A., Douglas, S., Simon, G., & Kroenke, K. (2019). Implementing measurement-based care in behavioral health: a review. JAMA Psychiatry, 76(3), 324-35.

Montgomery, SA, & Åsberg, M. (1979). A new depression scale designed to be sensitive to change. British Journal of Psychiatry, 134, 382-9.

Region Stockholm (2021). Assessment and treatment of major depressive disorder. [Vårdprocesskarta för depression]. Region Stockholm, Stockholm, Sweden. Unpublished document.

Rognstad, K., Wentzel-Larsen, T., Neumer, S. P., & Kjøbli, J. (2023). A systematic review and meta-analysis of measurement feedback systems in treatment for common mental health disorders. Administration and Policy in Mental Health, 50(2), 269-82.

Scott, K., & Lewis, C. C. (2015). Using measurement-based care to enhance any treatment. Cognitive and Behavioral Practice, 22(1).

Svanborg, P., & Åsberg, M. (2001). A comparison between the Beck Depression Inventory (BDI) and the self-rating version of the Montgomery Asberg Depression Rating Scale (MADRS). Journal of Affective Disorders, 64, 203-16.

Trivedi, M. H. (2020). How can measurement-based care help improve treatment outcomes for major depressive disorder in primary care? Journal of Clinical Psychiatry, 81(2).

Study Type

Observational

Enrollment (Actual)

2173

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Stockholm Health Care Services, Region Stockholm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients of 18 years of age or older with a principal diagnosis of major depressive disorder who have initiated and completed psychological or pharmacological treatment between 1 January 2020 and 30 September 2023 at one of five general psychiatric clinics within public psychiatric outpatient services in Stockholm, Sweden.

Description

Inclusion Criteria:

  • 18 years of age or older
  • Principal diagnosis of major depressive disorder
  • Psychological or pharmacological treatment initiated and completed between 1 January 2020 and 30 September 2023 at one of five general psychiatric clinics within public psychiatric outpatient services in Stockholm, Sweden

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Åsberg Depression Rating Scale
Time Frame: Through study completion, an average of 1 year
Ten-item clinician-administered measure of depressive symptoms
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Åsberg Depression Rating Scale-Self Assessment
Time Frame: Through study completion, an average of 1 year
Nine-item self-report version of the Montgomery-Åsberg Depression Rating Scale
Through study completion, an average of 1 year
The Patient Health Questionnaire-9
Time Frame: Through study completion, an average of 1 year
Nine-item self-report measure of depressive symptoms
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2024

Primary Completion (Actual)

May 21, 2024

Study Completion (Actual)

May 21, 2024

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-BB-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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