Cognitive behaviour therapy versus self-examination therapy with depressive symptomatology

ISRCTN ISRCTN16823487
DOI https://doi.org/10.1186/ISRCTN16823487
Secondary identifying numbers NTR804
Submission date
28/12/2006
Registration date
28/12/2006
Last edited
21/04/2011
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

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Ms E H Warmerdam
Scientific

VU University Medical Center, FPP
Department of Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands

Phone +31 (0)20 598 8959
Email eh.warmerdam@psy.vu.nl

Study information

Study designRandomised, parallel group, controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymDOC
Study objectivesCognitive behaviour therapy and self-examination therapy are both more effective in reducing depressive complaints than a waiting list control group.
Ethics approval(s)Received from the local ethics committee (Medisch Ethische Toetingscommissie of the VUMC) on the 7th September 2007 (ref: 2006/168).
Health condition(s) or problem(s) studiedDepressive symptoms
InterventionThe 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 typeOther
Primary outcome measureDepressive symptom level will be measured with the Center for Epidemiological Studies Depression Scale (CES-D).
Secondary outcome measures1. 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 study start date01/10/2006
Completion date01/10/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants300
Key inclusion criteriaScore of 16 or higher on the Center for Epidemiological Studies Depression scale (CES-D).
Key exclusion criteriaDoes not comply with the above inclusion criteria
Date of first enrolment01/10/2006
Date of final enrolment01/10/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU University Medical Center, FPP
Amsterdam
1081 BT
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre

Department of Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands

Website http://www.vumc.nl/
ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

Hospital/treatment centre

Vrije University Medical Centre (VUMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 19/12/2007 Yes No
Results article results 19/12/2010 Yes No