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Randomized Trial of Depression Follow-up Care by Email

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ClinicalTrials.gov Identifier: NCT01449890
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
PD Dr. phil. Birgit Watzke, Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease Intervention/treatment Phase
Depressive Disorders Behavioral: E-mail follow up care Not Applicable

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  (Clinical Trial)
Actual Enrollment : 92 participants
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
Study Start Date : September 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

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


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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

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

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 Posted: October 10, 2011    Key Record Dates
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