Randomized Trial of Depression Follow-up Care by Email

Depressive Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449890
• Other study ID #: DRV0422/00-40-65-50-24
• Status: Completed
• Phase: N/A
• First received: October 6, 2011
• Last updated: June 3, 2015
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: June 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorders

Intervention

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.

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of the severity of depression - Beck Depression Inventory (BDI- II)		Change in the BDI-II from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)	No
Secondary	Measure of health related quality of life - SF-8	SF-8: short version of the SF -36	Change in the SF-8 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care	No
Secondary	GAD-7	Measure for generalized anxiety disorder	Change in the GAD-7 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)	No
Secondary	Depressive relapse/recurrence		Measured at follow up (3 months after termination of the follow-up care)	No