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
Contact information
Ms E H Warmerdam
Scientific
Scientific
VU University Medical Center, FPP
Department of Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 598 8959 |
|---|---|
| eh.warmerdam@psy.vu.nl |
Study information
| Study design | Randomised, parallel group, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/10/2006 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
1081 BT
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
| Website | http://www.vumc.nl/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
