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Cognitive behaviour therapy versus self-examination therapy with depressive symptomatology
ISRCTN ISRCTN16823487
DOI 10.1186/ISRCTN16823487
ClinicalTrials.gov identifier
EudraCT number
Public title Cognitive behaviour therapy versus self-examination therapy with depressive symptomatology
Scientific title
Acronym DOC
Serial number at source NTR804
Study hypothesis Cognitive behaviour therapy and self-examination therapy are both more effective in reducing depressive complaints than a waiting list control group.
Lay summary
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
Countries of recruitment Netherlands
Disease/condition/study domain Depressive symptoms
Participants - inclusion criteria Score of 16 or higher on the Center for Epidemiological Studies Depression scale (CES-D).
Participants - exclusion criteria Does not comply with the above inclusion criteria
Anticipated start date 01/10/2006
Anticipated end date 01/10/2007
Status of trial Completed
Patient information material
Target number of participants 300
Interventions 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.
Primary outcome measure(s) Depressive symptom level will be measured with the Center for Epidemiological Studies Depression Scale (CES-D).
Secondary outcome measure(s) 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)
Sources of funding Vrije University Medical Centre (VUMC) (The Netherlands)
Trial website http://www.psy.vu.nl/depressiviteitondercontrole
Publications 1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18093331
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21169166
Contact name Ms  E H  Warmerdam
  Address VU University Medical Center, FPP
Department of Clinical Psychology
Van der Boechorststraat 1
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Tel +31 (0)20 598 8959
  Email eh.warmerdam@psy.vu.nl
Sponsor Vrije University Medical Centre (VUMC) (The Netherlands)
  Address Department of Clinical Psychology
Van der Boechorststraat 1
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Sponsor website: http://www.vumc.nl/
Date applied 28/12/2006
Last edited 21/04/2011
Date ISRCTN assigned 28/12/2006
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