NCT01731717

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
737

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 13, 2015

Status Verified

July 1, 2015

Enrollment Period

2.5 years

First QC Date

November 12, 2012

Last Update Submit

July 10, 2015

Conditions

Depression

Keywords

depressionstepped careevidence-based medicinehealth services researchpsychotherapycomplex interventionguideline

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (11)

  • Cost-benefit ratio (QALYs)

    Baseline, 6 months, 12 months

  • Response/Remission/Relapse (PHQ-D-9)

    Baseline, 3 months, 6 months, 12 months

  • Quality of life (EQ-5D)

    Baseline, 3 months, 6 months, 12 months

  • Quality of life (SF-12)

    Baseline, 3 months, 6 months, 9 months

  • Health service utilization and medication consumption

    Baseline, 6 months, 12 months

  • +6 more secondary outcomes

Study Arms (2)

Stepped care intervention (SCM)

EXPERIMENTAL

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 monitoringBehavioral: BibliotherapyBehavioral: Online self-helpBehavioral: Outpatient psychotherapyProcedure: Psychiatric treatmentBehavioral: Combined psychotherapy and psychopharmacological treatment

Control group: treatment as usual

ACTIVE COMPARATOR

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

Interventions

Active monitoringBEHAVIORAL

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

Stepped care intervention (SCM)
BibliotherapyBEHAVIORAL

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

Stepped care intervention (SCM)
Online self-helpBEHAVIORAL

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

Stepped care intervention (SCM)
Outpatient psychotherapyBEHAVIORAL

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

Stepped care intervention (SCM)
Psychiatric treatmentPROCEDURE

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.

Stepped care intervention (SCM)
Combined psychotherapy and psychopharmacological treatmentBEHAVIORAL

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

Stepped care intervention (SCM)
Control group: treatment as usualOTHER

treatment as usual

Control group: treatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hamburg, Hamburg, 20246, Germany

Location

Related Publications (2)

  • 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.

    PMID: 32859177DERIVED

  • 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.

    PMID: 25182269DERIVED

MeSH Terms

Conditions

Depression

Interventions

Bibliotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2012

First Posted

November 22, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

July 13, 2015

Record last verified: 2015-07

Locations

DE(1)