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

NCT02044913 | Completed

• 1 other identifier: 0421-FSCP-Z202
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  Approximately 3 months (end of intervention)

Study Arms (2)

Phone-based Aftercare-Coordination

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

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

Interventions

Phone-based Aftercare-Coordination BEHAVIORAL

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.

Phone-based Aftercare-Coordination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

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

Hamburg, Germany

Location

Related Publications (1)

• 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.

  PMID: 25897757 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Dr. phil. Hanne Melchior

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 24, 2014
• Study Start: March 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

DE (1)