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Cluster Randomized Trial of Stepped Care Intervention vs. Treatment as Usual for Patients With Depression (SCM)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Active monitoring
Bibliotherapy
Online self-help
Outpatient psychotherapy
Psychiatric treatment
Combined psychotherapy and psychopharmacological treatment
Control group: treatment as usual
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, stepped care, evidence-based medicine, health services research, psychotherapy, complex intervention, guideline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >4 points on PHQ-D-9 depression scale
  • sufficient knowledge of German language
  • health situation that allows questionnaire completion

Exclusion Criteria:

  • insufficient knowledge of German language
  • health situation not allowing questionnaire completion

Sites / Locations

  • Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stepped care intervention (SCM)

Control group: treatment as usual

Arm Description

Patients within the stepped care intervention are screened by general physician using the PHQ-9 (inclusion criterion: >4 points) and diagnosed according to International Classification of Diseases (ICD-10) criteria. Patients receive differentially intensive treatment according to depression severity. Patients with mild depression receive: Step I: Active monitoring or Step II: II.a. Bibliotherapy or II.b. Online self-help ("Deprexis®") or II+: Telephone-based psychotherapy Patients with moderate depression receive: Step III: III.a. Outpatient psychotherapy or III.b. Psychopharmacological treatment Patients with severe depression receive: Step IV: Combined psychotherapy and psychopharmacological treatment, optionally in inpatient setting.

Patients in the control group are screened by their general physician using the PHQ-D-9 depression scale. Patients included in the study then receive treatment as usual from general physician or other health service providers.

Outcomes

Primary Outcome Measures

Change in depression severity (PHQ-D-9)
Change in patient-rated depression symptom severity: Patient Health Questionnaire 9, German version (PHQ-D-9; Löwe, Zipfel & Herzog, 2002)

Secondary Outcome Measures

Cost-benefit ratio (QALYs)
Cost-benefit ratio in quality-adjusted life years(QALYs)
Response/Remission/Relapse (PHQ-D-9)
Response/Remission/Relapse as computed by the difference in pre-post depression severity (PHQ-D-9)
Quality of life (EQ-5D)
Quality of life as measured by EuroQol's EQ-5D
Quality of life (SF-12)
Quality of life as measured by the 12-item Short Form Health Survey (SF-12)
Health service utilization and medication consumption
Non-standardized items regarding the amount and cost of health services utilized in the past 6 months
Self-esteem
Rosenberg self-esteem scale
Therapeutic alliance
Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ)
Anxiety symptoms (PHQ-D)
Anxiety as rated by the PHQ-D anxiety scale
Panic symptoms (PHQ-D)
Panic symptoms as measured by the PHQ-D
Somatisation (PHQ-D)
Somatisation as measured by the PHQ-D
General anxiety disorder (GAD-7)
Symptoms of general anxiety disorder measured by the GAD-7

Full Information

First Posted
November 12, 2012
Last Updated
July 10, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT01731717
Brief Title
Cluster Randomized Trial of Stepped Care Intervention vs. Treatment as Usual for Patients With Depression
Acronym
SCM
Official Title
Effektivität Und Effizienz Von Behandlungspfaden für Patienten Mit Depressiven Erkrankungen: Stepped Care Als Ansatz für Ein Leitliniengerechtes Und Integriertes Versorgungsmanagement
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main aim of the project is the implementation and evaluation of a stepped care model (SCM) for patients with depression with 6 treatment options of varying intensity and setting, including innovative technologies (e-mental health, telephone-based psychotherapy). Within this complex intervention, patients are treated by a multiprofessional network of health care providers in Hamburg, Germany. The study compares the SCM condition (intervention group) to a control group receiving treatment as usual (cluster randomization on the level of participating general practitioners). It is expected that the SCM condition will show better results regarding reduction of mental symptoms, improvement of quality of life, more efficient access to care and better cost-benefit ratio.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, stepped care, evidence-based medicine, health services research, psychotherapy, complex intervention, guideline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
737 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stepped care intervention (SCM)
Arm Type
Experimental
Arm Description
Patients within the stepped care intervention are screened by general physician using the PHQ-9 (inclusion criterion: >4 points) and diagnosed according to International Classification of Diseases (ICD-10) criteria. Patients receive differentially intensive treatment according to depression severity. Patients with mild depression receive: Step I: Active monitoring or Step II: II.a. Bibliotherapy or II.b. Online self-help ("Deprexis®") or II+: Telephone-based psychotherapy Patients with moderate depression receive: Step III: III.a. Outpatient psychotherapy or III.b. Psychopharmacological treatment Patients with severe depression receive: Step IV: Combined psychotherapy and psychopharmacological treatment, optionally in inpatient setting.
Arm Title
Control group: treatment as usual
Arm Type
Active Comparator
Arm Description
Patients in the control group are screened by their general physician using the PHQ-D-9 depression scale. Patients included in the study then receive treatment as usual from general physician or other health service providers.
Intervention Type
Behavioral
Intervention Name(s)
Active monitoring
Intervention Description
General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.
Intervention Type
Behavioral
Intervention Name(s)
Bibliotherapy
Intervention Description
Patient works with self-help book "Selbsthilfe bei Depressionen" (Görlitz, 2010) under general physician's supervision.
Intervention Type
Behavioral
Intervention Name(s)
Online self-help
Intervention Description
Patient works with online self-help program "Deprexis" under general physician's supervision.
Intervention Type
Behavioral
Intervention Name(s)
Outpatient psychotherapy
Intervention Description
Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.
Intervention Type
Procedure
Intervention Name(s)
Psychiatric treatment
Intervention Description
Patient receives treatment from psychiatrist or general physician participating in the network, this includes psychopharmacotherapy. Treatment takes place within routine care, thus psychiatrists or general physicians individually determine the type of medication and are committed to follow the recommendations of the German S3-Guideline/National Disease Management Guideline for Unipolar Depression.
Intervention Type
Behavioral
Intervention Name(s)
Combined psychotherapy and psychopharmacological treatment
Intervention Description
Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.
Intervention Type
Other
Intervention Name(s)
Control group: treatment as usual
Intervention Description
treatment as usual
Primary Outcome Measure Information:
Title
Change in depression severity (PHQ-D-9)
Description
Change in patient-rated depression symptom severity: Patient Health Questionnaire 9, German version (PHQ-D-9; Löwe, Zipfel & Herzog, 2002)
Time Frame
Baseline, 3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Cost-benefit ratio (QALYs)
Description
Cost-benefit ratio in quality-adjusted life years(QALYs)
Time Frame
Baseline, 6 months, 12 months
Title
Response/Remission/Relapse (PHQ-D-9)
Description
Response/Remission/Relapse as computed by the difference in pre-post depression severity (PHQ-D-9)
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Quality of life (EQ-5D)
Description
Quality of life as measured by EuroQol's EQ-5D
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Quality of life (SF-12)
Description
Quality of life as measured by the 12-item Short Form Health Survey (SF-12)
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
Health service utilization and medication consumption
Description
Non-standardized items regarding the amount and cost of health services utilized in the past 6 months
Time Frame
Baseline, 6 months, 12 months
Title
Self-esteem
Description
Rosenberg self-esteem scale
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Therapeutic alliance
Description
Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ)
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Anxiety symptoms (PHQ-D)
Description
Anxiety as rated by the PHQ-D anxiety scale
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Panic symptoms (PHQ-D)
Description
Panic symptoms as measured by the PHQ-D
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Somatisation (PHQ-D)
Description
Somatisation as measured by the PHQ-D
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
General anxiety disorder (GAD-7)
Description
Symptoms of general anxiety disorder measured by the GAD-7
Time Frame
Baseline, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >4 points on PHQ-D-9 depression scale sufficient knowledge of German language health situation that allows questionnaire completion Exclusion Criteria: insufficient knowledge of German language health situation not allowing questionnaire completion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Watzke, Prof. Dr.
Organizational Affiliation
Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martin Härter, Prof. Dr. Dr.
Organizational Affiliation
Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32859177
Citation
Brettschneider C, Heddaeus D, Steinmann M, Harter M, Watzke B, Konig HH. Cost-effectiveness of guideline-based stepped and collaborative care versus treatment as usual for patients with depression - a cluster-randomized trial. BMC Psychiatry. 2020 Aug 28;20(1):427. doi: 10.1186/s12888-020-02829-0.
Results Reference
derived
PubMed Identifier
25182269
Citation
Watzke B, Heddaeus D, Steinmann M, Konig HH, Wegscheider K, Schulz H, Harter M. Effectiveness and cost-effectiveness of a guideline-based stepped care model for patients with depression: study protocol of a cluster-randomized controlled trial in routine care. BMC Psychiatry. 2014 Aug 20;14:230. doi: 10.1186/s12888-014-0230-y.
Results Reference
derived
Links:
URL
http://www.psychenet.de/ueber-psychenet/teilprojekte/depression.html
Description
Project homepage

Learn more about this trial

Cluster Randomized Trial of Stepped Care Intervention vs. Treatment as Usual for Patients With Depression

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