Condition category
Mental and Behavioural Disorders
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
21/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.psy.vu.nl/depressiviteitondercontrole

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 measures

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

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

http://www.vumc.nl/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes