Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06332261 |
| Other study ID # |
2024-BB-01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 8, 2024 |
| Est. completion date |
April 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Karolinska Institutet |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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).
