Cognitive behaviour therapy versus self-examination therapy with depressive symptomatology

ISRCTN	ISRCTN16823487
DOI	https://doi.org/10.1186/ISRCTN16823487
Protocol serial number	NTR804
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funder	Vrije University Medical Centre (VUMC) (The Netherlands)

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

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

Primary study design	Interventional
Study design	Randomised, parallel group, controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DOC
Study objectives	Cognitive 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) studied	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
Primary outcome measure(s)	Depressive symptom level will be measured with the Center for Epidemiological Studies Depression Scale (CES-D).
Key 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)
Completion date	01/10/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	300
Key inclusion criteria	Score of 16 or higher on the Center for Epidemiological Studies Depression scale (CES-D).
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	01/10/2006
Date of final enrolment	01/10/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Center, FPP

Amsterdam
1081 BT
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/12/2010		Yes	No
Protocol article	protocol	19/12/2007		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes