Major Depressive DisorderNCT06332261
Standardized Assessment in Depression Treatment in Routine Psychiatric Services
An observational study of Major Depressive Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 2,173 participants
- Where
- 1 siteSweden
- Study dates
- 8 Mar 2024to 21 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the 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:
- Are current practices consistent with local clinical guidelines in terms of standardized assessment and the treatments provided?
- Do current practices vary with patient, clinician, and treatment characteristics?
- 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).
- Conditions
- Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale
Ten-item clinician-administered measure of depressive symptoms
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Montgomery-Åsberg Depression Rating Scale-Self Assessment
Nine-item self-report version of the Montgomery-Åsberg Depression Rating Scale
Measured: Through study completion, an average of 1 year
The Patient Health Questionnaire-9
Nine-item self-report measure of depressive symptoms
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start8 Mar 2024
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Benjamin Bohman, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332261
- Sponsor's protocol ID
- 2024-BB-01
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Assessment in Depression Treatment in Routine Psychiatric Services: a Retrospective Medical Record Review
- ClinicalTrials.gov ID
- NCT06332261
- Acronym / sponsor ID
- 2024-BB-01
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,173 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Are current practices consistent with local clinical guidelines in terms of standardized assessment and the treatments provided?
- Do current practices vary with patient, clinician, and treatment characteristics?
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Montgomery-Åsberg Depression Rating Scale
Time frame: Through study completion, an average of 1 year
Ten-item clinician-administered measure of depressive symptoms
2 secondary outcomes
Montgomery-Åsberg Depression Rating Scale-Self Assessment
Time frame: Through study completion, an average of 1 year
The Patient Health Questionnaire-9
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.