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Randomized Trial of Depression Follow-up Care by Email

Primary Purpose

Depressive Disorders

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
E-mail follow up care
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorders focused on measuring follow up care, e-mail, effectiveness, depressive disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

E-mail follow up care

Treatment as usual

Arm Description

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.

After having terminated inpatient CBT patients receive treatment as usual within routine care.

Outcomes

Primary Outcome Measures

Measure of the severity of depression - Beck Depression Inventory (BDI- II)

Secondary Outcome Measures

Measure of health related quality of life - SF-8
SF-8: short version of the SF -36
GAD-7
Measure for generalized anxiety disorder
Depressive relapse/recurrence

Full Information

First Posted
October 6, 2011
Last Updated
June 3, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT01449890
Brief Title
Randomized Trial of Depression Follow-up Care by Email
Official Title
Randomized Trial of E-mail Follow-up Care After Cognitive Behavioural Treatment for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorders
Keywords
follow up care, e-mail, effectiveness, depressive disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E-mail follow up care
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
After having terminated inpatient CBT patients receive treatment as usual within routine care.
Intervention Type
Behavioral
Intervention Name(s)
E-mail follow up care
Other Intervention Name(s)
internet based psychotherapy, web based psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Measure of health related quality of life - SF-8
Description
SF-8: short version of the SF -36
Time Frame
Change in the SF-8 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care
Title
GAD-7
Description
Measure for generalized anxiety disorder
Time Frame
Change in the GAD-7 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
Title
Depressive relapse/recurrence
Time Frame
Measured at follow up (3 months after termination of the follow-up care)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Watzke, PhD
Organizational Affiliation
University Medical Center Hamburg-Eppendorf Centre of Psychosocial Medicine Department of Medical Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

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Randomized Trial of Depression Follow-up Care by Email

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