Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Ms E H Warmerdam
ORCID ID
Contact details
VU University Medical Center
FPP
Department of Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
+31 (0)20 598 8959
eh.warmerdam@psy.vu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR804
Study information
Scientific title
Acronym
DOC
Study hypothesis
Cognitive behaviour therapy and self-examination therapy are both more effective in reducing depressive complaints than a waiting list control group.
Ethics approval
Received from the local ethics committee (Medisch Ethische Toetingscommissie of the VUMC) on the 7th September 2007 (ref: 2006/168).
Study design
Randomised, parallel group, controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Depressive symptoms
Intervention
The cognitive-behavioural intervention is called Color your life (Kleur je leven). This intervention consists of eight lessons (one lesson a week). Four weeks later, the ninth lesson takes place. The intervention focuses on increasing pleasurable activities, increasing social skills and decreasing dysfunctional cognitions.
Self examination therapy is based on problem solving therapy. We use the Dutch version, called 'Alles onder controle'. This intervention takes five weeks. During this intervention participants determine what matters to them, think less negatively about things that do not matter to them, invest their energy in things that are important to them (by using problem-solving strategies) and accept situations they cannot change.
Both interventions are computer-based.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Depressive symptom level will be measured with the Center for Epidemiological Studies Depression Scale (CES-D).
Secondary outcome measures
1. Quality of life is measured by the Euroqol Questionnaire
2. Anxiety symptoms are measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
3. Dysfunctional cognitions are measured by the Dysfunctional Attitude Scale (DAS)
4. Worrying is measured by the Penn State Worry Questionnaire (PSWQ)
5. Problem solving skills are measured by the Social Problem Solving Skills-Revised (SPSI-R)
6. Mastery is measured by the Mastery Scale
7. Absence at work and use of healthcare are measured by the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P)
Overall trial start date
01/10/2006
Overall trial end date
01/10/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Score of 16 or higher on the Center for Epidemiological Studies Depression scale (CES-D).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
Does not comply with the above inclusion criteria
Recruitment start date
01/10/2006
Recruitment end date
01/10/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center, FPP
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Department of Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Vrije University Medical Centre (VUMC) (The Netherlands)
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
Basic results (scientific)
Publication list
1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18093331
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21169166
Publication citations
-
Results
Warmerdam L, Smit F, van Straten A, Riper H, Cuijpers P, Cost-utility and cost-effectiveness of internet-based treatment for adults with depressive symptoms: randomized trial., J. Med. Internet Res., 2010, 12, 5, e53, doi: 10.2196/jmir.1436.
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Warmerdam L, van Straten A, Cuijpers P, Internet-based treatment for adults with depressive symptoms: the protocol of a randomized controlled trial., BMC Psychiatry, 2007, 7, 72, doi: 10.1186/1471-244X-7-72.