|- candidate number||7950|
|- NTR Number||NTR2303|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-apr-2010|
|- Secondary IDs||WC2010-021 VU University Medical Centre|
|- Public Title||Self-help course with guidance on the Internet for Turkish migrants with depression.|
|- Scientific Title||Guided self-help course on the Internet for Turkish migrants with depression: a randomised controlled trial.|
|- ACRONYM||AOC-TR for Turkish migrants with depression.|
|- hypothesis||The culturally adapted version of the web-based guided self-help intervention Alles Onder Controle(in Dutch and Turkish) will reduce symptoms of depression among Turkish adults living in the Netherlands.|
|- Healt Condition(s) or Problem(s) studied||Depressive symptoms, Anxiety, Quality of life, Somatic symptoms, Acculturation|
|- Inclusion criteria||1. Aged 18 years or older;|
2. Depressive symptoms (CES-D score >= 16);
3. Turkish ethnicity (which will be based if the participant or at least on of his/her parents is born in Turkey);
4. Having access to a PC and the Internet and an e-mail address;
5. Provide informed consent.
|- Exclusion criteria||The exclusion criterion is having active suicidal ideations or plans (M.I.N.I. score > low risk).|
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2010|
|- planned closingdate||1-sep-2011|
|- Target number of participants||200|
|- Interventions||The intervention we will evaluate is the adapted version of the original website Alles Onder Controle, a brief problem solving intervention based on Self-Examination Therapy: Alles Onder Controle TR (in Dutch) and Her Şey Kontrol Altında (in Turkish).
The course is available in two languages and both are adapted by a Turkish psychologist in collaboration with the VU University and the Trimbos-institute, by:
1. Cultural sensitivity in the languages and presentation concerning psychological problems;
2. Use of cultural specific cases and problems that are recognizable for the target group concerned;
3. Cultural specific examples of persons with similar problems.
The intervention consists of 5 sessions and takes 5 weeks in total. During that period the respondents indicate what they think is important in their lives, they make a list of their “problems and worries” and they categorize their problems into three groups: unimportant (not related to what they think is important in their lives), important and solvable (these problems are solved by a systematic problem-solving approach consisting of 6 steps), or important but unsolvable (for example having lost someone by death, having a chronic general medical disease; for these problems they make a plan how to live with it). At the end of the course, the participant will receive a certificate for successfully completing the course. The participants are supported by a trained coach, who gives feedback to the homework assignments of the participants in brief, weekly e-mails.
|- Primary outcome||To investigate the effectiveness of a culturally adapted and internet-based guided self-help intervention among Turkish migrants, in terms of reduction of depressive symptoms (CES-D). All assessments take place online.|
|- Secondary outcome||1. Somatic symptoms (SCL-90R);|
2. Symptoms of anxiety (HADS);
3. Acculturation (LAS);
5. Quality of life (EuroQol-5D).
All assessments take place online.
|- Timepoints||1. T0: Baseline measurement;|
2. T1: Post-treatment'
3. T2: 4 months follow up (after baseline).
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| B. Ünlü|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Pim Cuijpers|
|- Sponsor/Initiator ||VU University Medical Center, Trimbos-institute - Netherlands Institute of Mental Health and Addiction|
(Source(s) of Monetary or Material Support)
|VU University Medical Center, Trimbos Institute - Netherlands Institute of Mental Health and Addiction|
|- Brief summary||The Turkish population living in the Netherlands has a high prevalence of psychological complaints and experiences a high threshold for seeking professional help for these problems. Seeking help through the Internet can bridge these barriers. This project aims to evaluate the effectiveness of "Alles Onder Controle TR" (in Dutch and Turkish), a web-based guided self-help intervention for depressed Turkish migrants.|
This study will investigate the effectiveness of a culturally adapted and internet-based guided self-help intervention among Turkish migrants, in terms of reduction of depressive symptoms (CES-D). As a secondary objective, the underlying mechanisms of change will be measured in terms of somatic symptoms, anxiety, acculturation, satisfaction and the quality of life.
This study is a randomized controlled trial with two conditions:
1. Web-based guided self-help intervention (experimental group);
2. The wait-list control group (access to the intervention after 4 months).
|- Main changes (audit trail)|
|- RECORD||19-apr-2010 - 7-jul-2010|