Randomized Trial of Depression Follow-up Care by Email

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Completed

CT.gov ID

NCT01449890

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Sep 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

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)]

Secondary Outcome Measures

Measure of health related quality of life - SF-8 [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 [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 [Measured at follow up (3 months after termination of the follow-up care)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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