Condition category
Mental and Behavioural Disorders
Date applied
17/04/2009
Date assigned
22/04/2009
Last edited
22/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mario Weiss

ORCID ID

Contact details

Holstenwall 7
Hamburg
20355
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An integrative online self-help program (Deprexis®) versus waitlist control for adults with depressive symptoms: a randomised parallel group controlled trial

Acronym

Study hypothesis

Using an integrative online-self-help programme (Deprexis®) as an add-on to treatment as usual will reduce depressive symptoms and improve social functioning more than remaining on a waitlist and continuing to receive treatment as usual.

Ethics approval

Local ethics committee ("Modellvorhaben Arzneimittelmanagement", Hesse Ministry of Health) approved on the 29th January 2007

Study design

Randomised parallel group controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depressive symptoms

Intervention

The Deprexis® program consists of ten interactive modules, plus one introductory and one summary module, which can be completed at the users own speed and frequency during a period of nine weeks. The program focuses on changing unhelpful thoughts, increasing activities that convey a sense of mastery and pleasure, improving social skills, practicing relaxation exercises and increasing a sense of acceptance/mindfulness. The program is based on standard cognitive-behavioural self-help and psychotherapy treatment literature. The delivery of content is individualised to match users preferences and needs, based on their responses in an initial program module. The program does not permit users to enter text; instead, users navigate through the program by choosing from various response options that are continuously presented to them. The program is delivered via the internet and is protected by individually assigned passwords.

The control group did not receive access to the program during the first nine weeks of the study (the waiting period for the control group). During this waiting period, they were permitted to continue whatever treatment they were receiving (e.g., psychotherapy, antidepressant medication or both). After the initial waiting period, the control group also received access to the Deprexis® program for a duration of nine weeks.

Both groups were followed for six months after termination of program usage.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Depressive symptom level, measured with the German version of the Beck Depression Inventory (BDI).

For both the initial treatment group and the control (delayed treatment) group, data were collected at baseline, 9 weeks and 18 weeks. Additionally, participants in the control group completed questionnaires 9 weeks after completing the program (for those in the initial treatment group, this 9-week post-treatment timepoint coincided with the 18-week assessment point mentioned above). Both groups also completed questionnaires 6 months after their respective program usage termination.

Secondary outcome measures

1. Work and Social Adjustment Scale (German translation)
2. Subjective usefulness of the program, as measured by individually designed items

For both the initial treatment group and the control (delayed treatment) group, data were collected at baseline, 9 weeks and 18 weeks. Additionally, participants in the control group completed questionnaires 9 weeks after completing the program (for those in the initial treatment group, this 9-week post-treatment timepoint coincided with the 18-week assessment point mentioned above). Both groups also completed questionnaires 6 months after their respective program usage termination.

Overall trial start date

01/02/2007

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or older, either sex
2. Indicate agreement with an electronic consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 at post-treatment

Participant exclusion criteria

Does not meet with inclusion criteria

Recruitment start date

01/02/2007

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Holstenwall 7
Hamburg
20355
Germany

Sponsor information

Organisation

GAIA AG (Germany)

Sponsor details

Holstenwall 7
Hamburg
20355
Germany

Sponsor type

Industry

Website

http://www.gaia-group.com

Funders

Funder type

Industry

Funder name

GAIA AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes