NCT01449890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

October 6, 2011

Last Update Submit

June 3, 2015

Conditions

Keywords

follow up caree-maileffectivenessdepressive disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • GAD-7

    Change in the GAD-7 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)

  • Depressive relapse/recurrence

    Measured at follow up (3 months after termination of the follow-up care)

Study Arms (2)

E-mail follow up care

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

After having terminated inpatient CBT patients receive treatment as usual within routine care.

Interventions

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.

Also known as: internet based psychotherapy, web based psychotherapy
E-mail follow up care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Depressive disorder: F32.0-F32.2; F33.0-F33.2; F34.1 according to ICD-10
  • Precursory CBT
  • Internet access

You may not qualify if:

  • No knowledge of the German language
  • Risk of suicide
  • Acute psychosis or psychotic symptoms
  • Established concurrent in vivo CBT after discharge from inpatient CBT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hamburg, Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • Birgit Watzke, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 10, 2011

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Study Completion

November 1, 2013

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations