|- candidate number||5383|
|- NTR Number||NTR1689|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-feb-2009|
|- Secondary IDs||12051.0003 ZonMW|
|- Public Title||Reducing suicidal thoughts: a web-based self-help intervention.|
|- Scientific Title||Reducing suicidal ideation. Effectiveness of a web-based self-help intervention: A randomised controlled trial.|
|- hypothesis||This study aims at testing the effectiveness of a web-based self-help intervention for people with mild to moderate suicidal thoughts. |
|- Healt Condition(s) or Problem(s) studied||Suicide, Personal injury, Suicidal thoughts, Attempted suicide |
|- Inclusion criteria||1. 18 years and over;|
2. Mild to moderate suicidal thoughts.
|- Exclusion criteria||1. No suicidal thoughts;|
2. Severe suicidal thoughts;
3. Severe depression.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2009|
|- planned closingdate||1-nov-2009|
|- Target number of participants||260|
|- Interventions||The self-help intervention is based on CBT and consists of 6 lessons. By means of exercises participants learn to gain control over, and reduce, their suicidal thoughts. Besides this, attention is given to emotion regulation, future perspectives and self-esteem. |
|- Primary outcome||The reduction in frequency and intensity of suicidal thoughts.|
|- Secondary outcome||1. The increase in number of people that seeks professional help;|
2. Reduction in feelings of hopelessness, anxiety, depression, insomnia and worrying.
|- Timepoints||Measure are taken at three timepoints: pre- and post the intervention, and at follow-up after 3 months. At all timepoints, the following self-report questionnaires are administered:|
1. Beck Suicidal Ideation Scale, self-report;
2. Beck Depression Inventory;
3. Beck Hopelessness Scale;
4. Hospital and Anxiety and Depression Scale (only the Anxiety subscale);
5. Penn State Worry Questionnaire;
7. Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness;
8. Loneliness Scale.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc B.A.J. Spijker, van |
|- CONTACT for SCIENTIFIC QUERIES||MSc B.A.J. Spijker, van |
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Suicide, attempted suicide and suicidal thoughts are a major problem in Dutch society. Face-to-face treatments often consist of Cognitive Behavioural Therapy (CBT), Dialectical Behavioural Therapy (DBT) or Problem Solving Treatment (PST). However, about 50% of the people who die by suicide are not in contact with mental health care services at that moment, and many have never been treated. Even when patients are being treated for depression or other emotional disorders, many do not disclose their suicidal thoughts to their care provider. This may be out of shame, due to fear of stigma or to not having faith in (mental) health care. Web-based self-help might be a promising new way to reach people with this serious mental health problem who would not be reached otherwise. In this study, a recently developed self-help intervention will be evaluated in a RCT.
The 260 participants will be recruited in the Netherlands.
|- Main changes (audit trail)|
|- RECORD||26-feb-2009 - 14-sep-2009|