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Completed

NCT Number: NCT01731717

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Monitoring

Behavioral

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

Bibliotherapy

Behavioral

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

Online self-help

Behavioral

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

Outpatient psychotherapy

Behavioral

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

Psychiatric treatment

Procedure

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.

Combined psychotherapy and psychopharmacological treatment

Behavioral

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

Control group: treatment as usual

Other

treatment as usual

Primary outcomes

  1. Change in depression severity (PHQ-D-9)

    Time frame: 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 outcomes

  1. Cost-benefit ratio (QALYs)

    Time frame: Baseline, 6 months, 12 months

    Cost-benefit ratio in quality-adjusted life years(QALYs)

  2. Response/Remission/Relapse (PHQ-D-9)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Response/Remission/Relapse as computed by the difference in pre-post depression severity (PHQ-D-9)

  3. Quality of life (EQ-5D)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Quality of life as measured by EuroQol's EQ-5D

  4. Quality of life (SF-12)

    Time frame: Baseline, 3 months, 6 months, 9 months

    Quality of life as measured by the 12-item Short Form Health Survey (SF-12)

  5. Health service utilization and medication consumption

    Time frame: Baseline, 6 months, 12 months

    Non-standardized items regarding the amount and cost of health services utilized in the past 6 months

  6. Self-esteem

    Time frame: Baseline, 3 months, 6 months, 12 months

    Rosenberg self-esteem scale

  7. Therapeutic alliance

    Time frame: Baseline, 3 months, 6 months, 12 months

    Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ)

  8. Anxiety symptoms (PHQ-D)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Anxiety as rated by the PHQ-D anxiety scale

  9. Panic symptoms (PHQ-D)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Panic symptoms as measured by the PHQ-D

  10. Somatisation (PHQ-D)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Somatisation as measured by the PHQ-D

  11. General anxiety disorder (GAD-7)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Symptoms of general anxiety disorder measured by the GAD-7

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: SCM

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 22, 2012
Registry last updated
Jul 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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