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Completed

NCT Number: NCT01449890

Randomized Trial of Depression Follow-up Care by Email

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.

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Key information

Conditions

Depressive Disorders Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-mail follow up care

Behavioral

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 10, 2011
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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