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Randomized Trial of Depression Follow-up Care by Email

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01449890
First Posted: October 10, 2011
Last Update Posted: June 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PD Dr. phil. Birgit Watzke, Universitätsklinikum Hamburg-Eppendorf
  Purpose
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.

Condition Intervention
Depressive Disorders Behavioral: E-mail follow up care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of E-mail Follow-up Care After Cognitive Behavioural Treatment for Depression

Further study details as provided by PD Dr. phil. Birgit Watzke, Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 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 Measures:
  • 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

  • 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

  • Depressive relapse/recurrence [ Time Frame: Measured at follow up (3 months after termination of the follow-up care) ]

Enrollment: 92
Study Start Date: September 2012
Study Completion Date: November 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449890


Locations
Germany
University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Birgit Watzke, PhD University Medical Center Hamburg-Eppendorf Centre of Psychosocial Medicine Department of Medical Psychology
  More Information

Responsible Party: PD Dr. phil. Birgit Watzke, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01449890     History of Changes
Other Study ID Numbers: DRV0422/00-40-65-50-24
First Submitted: October 6, 2011
First Posted: October 10, 2011
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by PD Dr. phil. Birgit Watzke, Universitätsklinikum Hamburg-Eppendorf:
follow up care
e-mail
effectiveness
depressive disorders

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders