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DepressionSCMNCT01731717

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

A study testing Active monitoring, Bibliotherapy and Online self-help in people with Depression, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression
What is being tested?
Active monitoring, Bibliotherapy and Online self-help
Could I receive a placebo?
No, everyone receives an active treatment
How many people
737 participants
Where
1 siteGermany
Study dates
Sep 2012to May 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Hamburg, Free and Hanseatic City of Hamburg, 20246

Other trials in Germany

About this study

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

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.

Conditions
Depression
Being tested
Active monitoring, Bibliotherapy, Online self-help, Outpatient psychotherapy, Psychiatric treatment
Keywords
depression, stepped care, evidence-based medicine, health services research, psychotherapy, complex intervention, guideline
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active monitoringBehavioural

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

  • BibliotherapyBehavioural

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

  • Online self-helpBehavioural

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

  • Outpatient psychotherapyBehavioural

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

  • Psychiatric treatmentProcedure or surgery

    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 treatmentBehavioural

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

  • Control group: treatment as usualOther

    treatment as usual

Study groups in NCT01731717
Study groupRoleWhat they receive
Stepped care intervention (SCM)ExperimentalPatients 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.
Receives: Behavioral: Active monitoring; Behavioral: Bibliotherapy; Behavioral: Online self-help; Behavioral: Outpatient psychotherapy; Procedure: Psychiatric treatment; Behavioral: Combined psychotherapy and psychopharmacological treatment
Control group: treatment as usualActive comparatorPatients 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.
Receives: Other: Control group: treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline, 3 months, 6 months, 12 months

Secondary outcomes (11)

  1. Cost-benefit ratio (QALYs)

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

    Measured: Baseline, 6 months, 12 months

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

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

    Measured: Baseline, 3 months, 6 months, 12 months

  3. Quality of life (EQ-5D)

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

    Measured: Baseline, 3 months, 6 months, 12 months

  4. Quality of life (SF-12)

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

    Measured: Baseline, 3 months, 6 months, 9 months

  5. Health service utilization and medication consumption

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

    Measured: Baseline, 6 months, 12 months

  6. Self-esteem

    Rosenberg self-esteem scale

    Measured: Baseline, 3 months, 6 months, 12 months

  7. Therapeutic alliance

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

    Measured: Baseline, 3 months, 6 months, 12 months

  8. Anxiety symptoms (PHQ-D)

    Anxiety as rated by the PHQ-D anxiety scale

    Measured: Baseline, 3 months, 6 months, 12 months

  9. Panic symptoms (PHQ-D)

    Panic symptoms as measured by the PHQ-D

    Measured: Baseline, 3 months, 6 months, 12 months

  10. Somatisation (PHQ-D)

    Somatisation as measured by the PHQ-D

    Measured: Baseline, 3 months, 6 months, 12 months

  11. General anxiety disorder (GAD-7)

    Symptoms of general anxiety disorder measured by the GAD-7

    Measured: Baseline, 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionMar 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
737 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01731717
Sponsor's protocol ID
01KQ1002B-TP7
Acronym
SCM
Status last verified
Jul 2015
First submitted
12 Nov 2012
Last updated
13 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32859177

  • 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.

    PubMed 25182269

Questions about this trial

What is this clinical trial studying?

A study testing Active monitoring, Bibliotherapy and Online self-help in people with Depression, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in depression severity (PHQ-D-9) (time frame: Baseline, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01731717, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2015.

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