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

July 14, 2015 updated by: Universitätsklinikum Hamburg-Eppendorf

Randomized-controlled Trial of Aftercare-Coordination by Phone for Patients With Depression and Anxiety Subsequent to an Inpatient Treatment.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
No Intervention: Treatment as usual
After inpatient treatment patients receive treatment as usual within routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Change in the BDI from the beginning of the intervention to follow up (6 months after termination of the intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change in the SF-8 and EQ-5D from the beginning of the intervention to follow up (6 months after termination of the intervention)
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
6 months after termination of the intervention
Patient-rated acceptance and satisfaction with the intervention
Time Frame: Approximately 3 months (end of intervention)
Patients rate their acceptance of the intervention and their satisfaction using non-standardized items.
Approximately 3 months (end of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Dr. phil. Hanne Melchior, University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Estimate)

July 15, 2015

Last Update Submitted That Met QC Criteria

July 14, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0421-FSCP-Z202 (Other Grant/Funding Number: 0421-FSCP-Z202)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression, Anxiety

Clinical Trials on Phone-based Aftercare-Coordination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe