CClinicalTrials.gg
CompletedNCT02044913Updated Jul 15, 2015

Randomized-controlled Trial of Aftercare-Coordination by Phone for Depression and Anxiety

An interventional study of Phone-based Aftercare-Coordination in Depression, Anxiety, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-15.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
218
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of this study is to test in a randomized controlled trial if aftercare-coordination by phone subsequent to inpatient treatment is an effective aftercare approach in the treatment of depression and anxiety.

Read the detailed description

Depression and anxiety are among the most prevalent mental health problems and are associated with a high risk of chronification. Despite the large capacities in the German health care system only a small percentage of these patients receive treatment. Relevant barriers on the pathways of patients are communication und coordination difficulties between different services and providers.The aftercare subsequent to an inpatient treatment represents one of these interfaces. Here the aim is to consolidate the treatment outcomes and to minimize the so called rebound-effect, the reduction of the positive treatment effects after the inpatient treatment. Although evidence-based treatments for depression and anxiety disorders exist, treatment effects often decrease after treatment due to the lack of an integration of different steps in care. The method of a case management-based aftercare coordination by phone could be a promising approach to overcome the interface between inpatient treatment and aftercare: case management is a patient-centered and situation-based approach which comprises systematic tracking and support of patients by a case-manager. Primary goal is to coordinate and integrate services across treatment settings. This approach can help to maintain and even improve longterm treatment outcomes.

02

Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 218 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Depressive disorder (F32.x; F33.x; F34.1) and/or Anxiety disorder (F40.0; F40.1, F41.0; F41.1) according to ICD-10

Exclusion criteria

Exclusion Criteria:

  • Concurrent outpatient psychotherapeutic treatment which will be continued after the inpatient rehabilitation treatment.
  • No knowledge of the German language
  • Risk of suicide
  • Acute psychosis or psychotic symptoms
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
218 participants (actual)

Study arms

  • Experimental
    Phone-based Aftercare-Coordination

    After inpatient treatment patients receive six phone contacts of aftercare-coordination at intervals of two weeks carried out by therapists for 12 weeks. The intervention aims at supporting the patients in coordinating their aftercare treatment which can help to maintain or even improve longterm treatment outcome.

    Behavioral: Phone-based Aftercare-Coordination

  • No intervention
    Treatment as usual

    After inpatient treatment patients receive treatment as usual within routine care.

Interventions

  • BehavioralPhone-based Aftercare-Coordination

    After inpatient treatment patients receive six phone contacts of aftercare-coordination at intervals of two weeks carried out by therapists for 12 weeks. The intervention is case-management orientated and aims at supporting the patients in finding and organising an adequate aftercare treatment.

06

What researchers measure

Primary outcomes

  1. Measure of the symptom severity - Beck Depression Inventory (BDI)

    Time frame: Change in the BDI from the beginning of the intervention to follow up (6 months after termination of the intervention)

Secondary outcomes

  1. Measure of health related quality of life - Short Form 8 Health Survey (SF-8), Measure of health related quality of life (EQ-5D)

    Time frame: Change in the SF-8 and EQ-5D from the beginning of the intervention to follow up (6 months after termination of the intervention)

  2. Proportion of patients who get routine outpatient aftercare treatment at follow up (6 months after the intervention)

    Time frame: 6 months after termination of the intervention

  3. Patient-rated acceptance and satisfaction with the intervention

    Patients rate their acceptance of the intervention and their satisfaction using non-standardized items.

    Time frame: Approximately 3 months (end of intervention)

07

Study locations

1 site
  • University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology
    Hamburg, Germany
08

References and documents

Publications

  • Kivelitz L, Schulz H, Melchior H, Watzke B. Effectiveness of case management-based aftercare coordination by phone for patients with depressive and anxiety disorders: study protocol for a randomized controlled trial. BMC Psychiatry. 2015 Apr 22;15:90. doi: 10.1186/s12888-015-0469-y. PubMed 25897757 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02044913
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Responsible party
Sponsor
First posted
Jan 24, 2014
Start date
Mar 2012
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jul 15, 2015

Study contacts

Dr. phil. Hanne Melchior
principal investigator · University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion