Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332261
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-03-12
Brief Title:
Standardized Assessment in Depression Treatment in Routine Psychiatric Services
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Standardized Assessment in Depression Treatment in Routine Psychiatric Services a Retrospective Medical Record Review
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 eg cognitive-behavioral psychodynamic type of pharmacological treatment eg 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 169 606-13
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 763 324-35
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 502 269-82
Scott K Lewis C C 2015 Using measurement-based care to enhance any treatment Cognitive and Behavioral Practice 221
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 812
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 eg cognitive-behavioral psychodynamic type of pharmacological treatment eg 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 169 606-13
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 763 324-35
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 502 269-82
Scott K Lewis C C 2015 Using measurement-based care to enhance any treatment Cognitive and Behavioral Practice 221
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 812
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None