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

Purpose

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	Intervention
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression

U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:

Change in depression severity (PHQ-D-9) [ Time Frame: Baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
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) [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
Cost-benefit ratio in quality-adjusted life years(QALYs)
Response/Remission/Relapse (PHQ-D-9) [ Time Frame: Baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Response/Remission/Relapse as computed by the difference in pre-post depression severity (PHQ-D-9)
Quality of life (EQ-5D) [ Time Frame: Baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Quality of life as measured by EuroQol's EQ-5D
Quality of life (SF-12) [ Time Frame: Baseline, 3 months, 6 months, 9 months ] [ Designated as safety issue: No ]
Quality of life as measured by the 12-item Short Form Health Survey (SF-12)
Health service utilization and medication consumption [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
Non-standardized items regarding the amount and cost of health services utilized in the past 6 months
Self-esteem [ Time Frame: Baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Rosenberg self-esteem scale
Therapeutic alliance [ Time Frame: Baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ)
Anxiety symptoms (PHQ-D) [ Time Frame: Baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Anxiety as rated by the PHQ-D anxiety scale
Panic symptoms (PHQ-D) [ Time Frame: Baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Panic symptoms as measured by the PHQ-D
Somatisation (PHQ-D) [ Time Frame: Baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Somatisation as measured by the PHQ-D
General anxiety disorder (GAD-7) [ Time Frame: Baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Symptoms of general anxiety disorder measured by the GAD-7

Estimated Enrollment:	860
Study Start Date:	September 2012
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731717

Contacts

Contact: Birgit Watzke, PD Dr.	+49 (040) 7410 54883	watzke@uke.de
Contact: Maya Steinmann, Dipl.-Psych.	+49 (040) 7410 57558	m.steinmann@uke.de

Locations

Germany
Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf	Recruiting
Hamburg, Germany, 20246
Contact: Maya Steinmann, Dipl.-Psych. +49 (040) 7410 57558 m.steinmann@uke.de
Contact: Daniela Heddaeus, Dipl.-Psych. +49 (040) 7410 57558 d.heddaeus@uke.de
Principal Investigator: Birgit Watzke, PD Dr.

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

Study Director:	Birgit Watzke, PD 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

More Information

Additional Information:

Project homepage This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	PD Dr. phil. Birgit Watzke, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:	NCT01731717 History of Changes
Other Study ID Numbers:	01KQ1002B-TP7
Study First Received:	November 12, 2012
Last Updated:	November 16, 2012
Health Authority:	Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:

depression
stepped care
evidence-based medicine
health services research

psychotherapy
complex intervention
guideline

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013

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