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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: Phone-based Aftercare-Coordination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phone-based Aftercare-Coordination<br>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<br>* 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.<br>|
| No Intervention: Treatment as usual<br>After inpatient treatment patients receive treatment as usual within routine care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

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) |  | 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) |  | 6 months after termination of the intervention | 
| 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) |