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

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Completed

CT.gov ID

NCT01731717

Collaborator

(none)

737

Enrollment

Location

Arms

31.9

Duration (Months)

23.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Active monitoring Behavioral: Bibliotherapy Behavioral: Online self-help Behavioral: Outpatient psychotherapy Procedure: Psychiatric treatment Behavioral: Combined psychotherapy and psychopharmacological treatment Other: Control group: treatment as usual	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

737 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effektivität Und Effizienz Von Behandlungspfaden für Patienten Mit Depressiven Erkrankungen: Stepped Care Als Ansatz für Ein Leitliniengerechtes Und Integriertes Versorgungsmanagement

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stepped care intervention (SCM) 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.	Behavioral: Active monitoring General physician performs monitoring every 2 weeks using the PHQ-9 depression scale. Behavioral: Bibliotherapy Patient works with self-help book "Selbsthilfe bei Depressionen" (Görlitz, 2010) under general physician's supervision. Behavioral: Online self-help Patient works with online self-help program "Deprexis" under general physician's supervision. Behavioral: Outpatient psychotherapy Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network. Procedure: Psychiatric treatment 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. Behavioral: Combined psychotherapy and psychopharmacological treatment Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.
Active Comparator: Control group: treatment as usual 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.	Other: Control group: treatment as usual treatment as usual

Arm

Intervention/Treatment

Experimental: Stepped care intervention (SCM)

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.

Behavioral: Active monitoring

General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.

Behavioral: Bibliotherapy

Patient works with self-help book "Selbsthilfe bei Depressionen" (Görlitz, 2010) under general physician's supervision.

Behavioral: Online self-help

Patient works with online self-help program "Deprexis" under general physician's supervision.

Behavioral: Outpatient psychotherapy

Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.

Procedure: Psychiatric treatment

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.

Behavioral: Combined psychotherapy and psychopharmacological treatment

Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.

Active Comparator: Control group: treatment as usual

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.

Other: Control group: treatment as usual

treatment as usual

Outcome Measures

Primary Outcome Measures

Change in depression severity (PHQ-D-9) [Baseline, 3 months, 6 months, 12 months]
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) [Baseline, 6 months, 12 months]
Cost-benefit ratio in quality-adjusted life years(QALYs)
Response/Remission/Relapse (PHQ-D-9) [Baseline, 3 months, 6 months, 12 months]
Response/Remission/Relapse as computed by the difference in pre-post depression severity (PHQ-D-9)
Quality of life (EQ-5D) [Baseline, 3 months, 6 months, 12 months]
Quality of life as measured by EuroQol's EQ-5D
Quality of life (SF-12) [Baseline, 3 months, 6 months, 9 months]
Quality of life as measured by the 12-item Short Form Health Survey (SF-12)
Health service utilization and medication consumption [Baseline, 6 months, 12 months]
Non-standardized items regarding the amount and cost of health services utilized in the past 6 months
Self-esteem [Baseline, 3 months, 6 months, 12 months]
Rosenberg self-esteem scale
Therapeutic alliance [Baseline, 3 months, 6 months, 12 months]
Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ)
Anxiety symptoms (PHQ-D) [Baseline, 3 months, 6 months, 12 months]
Anxiety as rated by the PHQ-D anxiety scale
Panic symptoms (PHQ-D) [Baseline, 3 months, 6 months, 12 months]
Panic symptoms as measured by the PHQ-D
Somatisation (PHQ-D) [Baseline, 3 months, 6 months, 12 months]
Somatisation as measured by the PHQ-D
General anxiety disorder (GAD-7) [Baseline, 3 months, 6 months, 12 months]
Symptoms of general anxiety disorder measured by the GAD-7

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf	Hamburg		Germany	20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

Study Director: Birgit Watzke, Prof. Dr., Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
Study Director: Martin Härter, Prof. Dr. Dr., Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany