NCT01226238

Brief Summary

Patients with major depression who are on a waiting list for psychotherapy usually suffer from considerable symptoms. Online self-help is one potential way to alleviate this suffering. The investigators want to study if patients awaiting psychotherapy benefit from online-self help. The investigators therefore randomly assign patients to either online self-help or no intervention and assess their depressive symptoms on a regular basis. The investigators hypothesize that online self-help will be superior to no intervention in alleviating depressive symptoms in depressed patients awaiting psychotherapy.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

October 20, 2010

Last Update Submit

June 25, 2014

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Depressive Symptomatology

    up to 16 weeks

Secondary Outcomes (1)

  • Depressive Symptomatology

    6 weeks, up to 10 months

Study Arms (2)

Online self-help

EXPERIMENTAL

Provision of online self-help while waiting for psychotherapy

Other: Online self-help

Waiting list alone

NO INTERVENTION

Waiting for psychotherapy alone

Interventions

Online self-helpOTHER

Provision of online self-help

Online self-help

Eligibility Criteria

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

You may qualify if:

  • Major Depressive Disorder
  • stable medication
  • yrs. or older

You may not qualify if:

  • current psychotherapy
  • acute suicidality
  • unavailability of internet connection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MVZ Falkenried

Hamburg, Germany

Location

Related Publications (1)

  • Klein JP, Roniger A, Schweiger U, Spath C, Brodbeck J. The association of childhood trauma and personality disorders with chronic depression: A cross-sectional study in depressed outpatients. J Clin Psychiatry. 2015 Jun;76(6):e794-801. doi: 10.4088/JCP.14m09158.

    PMID: 26132688DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 22, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

DE(1)