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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044913
• Other study ID #: 0421-FSCP-Z202
• Secondary ID: 0421-FSCP-Z202
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: July 14, 2015
• Start date: March 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of the symptom severity - Beck Depression Inventory (BDI)		Change in the BDI from the beginning of the intervention to follow up (6 months after termination of the intervention)	No
Secondary	Measure of health related quality of life - Short Form 8 Health Survey (SF-8), Measure of health related quality of life (EQ-5D)		Change in the SF-8 and EQ-5D from the beginning of the intervention to follow up (6 months after termination of the intervention)	No
Secondary	Proportion of patients who get routine outpatient aftercare treatment at follow up (6 months after the intervention)		6 months after termination of the intervention	No
Secondary	Patient-rated acceptance and satisfaction with the intervention	Patients rate their acceptance of the intervention and their satisfaction using non-standardized items.	Approximately 3 months (end of intervention)	No