| - candidate number | 2312 |
| - NTR Number | NTR804 |
| - ISRCTN | ISRCTN16823487 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 7-nov-2006 |
| - Secondary IDs | N/A |
| - Public Title | Cognitive behaviour therapy versus Self-examination therapy with depressive symptomatology. |
| - Scientific Title | Cognitive behaviour therapy versus Self-examination therapy with depressive symptomatology. |
| - ACRONYM | DOC |
| - hypothesis | Cognitive behaviour therapy and Self-examination therapy are both more effective in reducing depressive complaints than a waiting list control group. |
| - Healt Condition(s) or Problem(s) studied | Depressive symptoms |
| - Inclusion criteria | Score of 16 or higher on the Center for Epidemiological Studies Depression scale (CES-D). |
| - Exclusion criteria | N/A |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Not applicable |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-okt-2006 |
| - planned closingdate | 1-okt-2007 |
| - Target number of participants | 300 |
| - Interventions | The cognitive-behavioural intervention is called Color your life (Kleur je leven). This intervention consists of 8 lessons (1 lesson a week). Four weeks later, the 9th 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 5 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 | Depressive symptom level will be measured with the Center for Epidemiological Studies Depression scale (CES-D). |
| - Secondary outcome | 1. Quality of life is measured by the Euroqol; 2. Anxiety symptoms are measured by the anxiety subschale 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 TIC-P. |
| - Timepoints | N/A |
| - Trial web site | http://www.psy.vu.nl/depressiviteitondercontrole |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Drs. E.H. Warmerdam |
| - CONTACT for SCIENTIFIC QUERIES | Drs. E.H. Warmerdam |
| - Sponsor/Initiator | VU University Medical Center, Department of Clinical Psychology |
| - Funding (Source(s) of Monetary or Material Support) | VU University Medical Center, Department of Clinical Psychology |
| - Publications | N/A |
| - Brief summary | Depression is highly prevalent: More than 15% of the adult population under 65 had major depression in their history according to DSM-III-R criteria. Minimal interventions are effective in the treatment for depression. The purpose of this study is to investigate the efficacy of two minimal interventions with adults reporting elevated depressive symptoms. The two interventions are cognitive-behavioural therapy (Color your life) and self-examination therapy. People will be recruited through advertisements in local newspapers and websites. Inclusion criterion is a score of 16 or higher on the Center for Epidemiological Studies Depression scale (CES-D). Participants are assigned on a random basis to the two treatment conditions and a delayed-treatment condition. Both interventions are delivered through computer administration. During the interventions respondents receive support by email. Respondents in the delayed-treatment condition receive the interventions three months later. Data are collected at baseline and at 5 weeks, 8 weeks, 12 weeks and 9 months after baseline. Data are collected by email. |
| - Main changes (audit trail) | |
| - RECORD | 7-nov-2006 - 5-jan-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl