Randomized Trial of Depression Follow-up Care by Email

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Information provided by (Responsible Party):
PD Dr. phil. Birgit Watzke, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01449890
First received: October 6, 2011
Last updated: January 18, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of E-mail Follow-up Care After Cognitive Behavioural Treatment for Depression

Resource links provided by NLM:


Further study details as provided by 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) ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Measure for generalized anxiety disorder

  • Depressive relapse/recurrence [ Time Frame: Measured at follow up (3 months after termination of the follow-up care) ] [ Designated as safety issue: No ]

Estimated Enrollment: 306
Study Start Date: September 2012
Estimated Study Completion Date: November 2013
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449890

Contacts
Contact: Martin Ceynowa ++49-(0)40-7410-56878 m.ceynowa@uke.de

Locations
Germany
University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology Recruiting
Hamburg, Germany, 20246
Contact: Martin Ceynowa       m.ceynowa@uke.de   
Principal Investigator: Birgit Watzke, PhD         
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

No publications provided

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
Study First Received: October 6, 2011
Last Updated: January 18, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
follow up care
e-mail
effectiveness
depressive disorders

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

ClinicalTrials.gov processed this record on July 23, 2014