An integrative online self-help program (Deprexis®) versus waitlist control for adults with depressive symptoms

ISRCTN	ISRCTN64953693
DOI	https://doi.org/10.1186/ISRCTN64953693
Secondary identifying numbers	N/A

Submission date: 17/04/2009
Registration date: 22/04/2009
Last edited: 22/04/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mario Weiss
Scientific

Holstenwall 7
Hamburg
20355
Germany

Study information

Study design	Randomised parallel group controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	An integrative online self-help program (Deprexis®) versus waitlist control for adults with depressive symptoms: a randomised parallel group controlled trial
Study objectives	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(s)	Local ethics committee ("Modellvorhaben Arzneimittelmanagement", Hesse Ministry of Health) approved on the 29th January 2007
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/02/2007
Completion date	30/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200 at post-treatment
Key inclusion criteria	1. Aged 18 years or older, either sex 2. Indicate agreement with an electronic consent form
Key exclusion criteria	Does not meet with inclusion criteria
Date of first enrolment	01/02/2007
Date of final enrolment	30/06/2008

Locations

Countries of recruitment

Germany

Study participating centre

Holstenwall 7

Hamburg
20355
Germany

Sponsor information

GAIA AG (Germany)
Industry

Holstenwall 7
Hamburg
20355
Germany

Website	http://www.gaia-group.com
"ROR"	https://ror.org/04rmmk750

Funders

Funder type

Industry

GAIA AG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan