Randomized Trial of Depression Follow-up Care by Email

June 3, 2015 updated by: PD Dr. phil. Birgit Watzke, Universitätsklinikum Hamburg-Eppendorf

Randomized Trial of E-mail Follow-up Care After Cognitive Behavioural Treatment for Depression

The primary objective of this study is to test in a randomized effectiveness trial if e-mail delivered cognitive behavioural treatment is an effective follow-up care approach in the treatment of depression under clinically representative conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression belongs to the most prevalent mental disorders and often goes along with a high burden of disease. Although the efficacy and the effectiveness of psychological treatments for depressive disorders have been demonstrated, there remains the problem of maintaining the benefits achieved during the initial treatment phase. Therefore options of follow-up care have to be considered. Since access to psychotherapeutic treatments is limited and costly, internet-based interventions can offer a feasible opportunity for follow-up care in order to enhance the long-term effectiveness of psychotherapy.

Study Type

Interventional

Enrollment (Actual)

92

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, 20246
        • 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: F32.0-F32.2; F33.0-F33.2; F34.1 according to ICD-10
  • Precursory CBT
  • Internet access

Exclusion Criteria:

  • No knowledge of the German language
  • Risk of suicide
  • Acute psychosis or psychotic symptoms
  • Established concurrent in vivo CBT after discharge from inpatient CBT

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E-mail follow up care
After having terminated inpatient CBT patients receive follow up care by email for 12 weeks (on average one contact per week). The follow up care aims at supporting the patients in continuing exercises they have learned during the initial treatment phase in order to cope with depression, e.g. integrating positive activities in their all day life or monitoring the interdependence of cognition, emotion and behaviour.
Behavioral: E-mail follow up care
After having terminated inpatient CBT patients receive follow up care by email for 12 weeks (on average one contact per week). The follow up care aims at supporting the patients in continuing exercises in order to cope with depression.
Other Names:
  • internet based psychotherapy
  • web based psychotherapy
No Intervention: Treatment as usual
After having terminated inpatient CBT patients receive treatment as usual within routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of the severity of depression - Beck Depression Inventory (BDI- II)
Time Frame: Change in the BDI-II from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
Change in the BDI-II from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of health related quality of life - SF-8
Time Frame: Change in the SF-8 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care
SF-8: short version of the SF -36
Change in the SF-8 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care
GAD-7
Time Frame: Change in the GAD-7 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
Measure for generalized anxiety disorder
Change in the GAD-7 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
Depressive relapse/recurrence
Time Frame: Measured at follow up (3 months after termination of the follow-up care)
Measured at follow up (3 months after termination of the follow-up care)

Collaborators and Investigators

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

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Birgit Watzke, PhD, University Medical Center Hamburg-Eppendorf Centre of Psychosocial Medicine Department of Medical Psychology

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

September 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

October 7, 2011

First Posted (Estimate)

October 10, 2011

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRV0422/00-40-65-50-24

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.

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