|- candidate number||8705|
|- NTR Number||NTR2621|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-nov-2010|
|- Secondary IDs||NL33917.097.11 METC METiGG|
|- Public Title||Beating the Blues.|
|- Scientific Title||Comparing computerized cognitive behavioural therapy with limited therapist support to face-to-face therapy based on cognitive behavioural techniques in a randomized trial.|
|- hypothesis||On the basis of the available literature, we hypothesize that the clinical and cost effectiveness of computerized cognitive-behavioural therapy with limited therapist support is not inferior (by an amount of delta = 0.2) to face-to-face therapy based on cognitive behavioural techniques. |
|- Healt Condition(s) or Problem(s) studied||Anxiety, (Sub)clinical depression|
|- Inclusion criteria||All clients of Mentaal Beter in the age range of 18 to 65 with a score between 14 and 28 on the BDI-II-NL (Van der Does, 2002) will be asked to participate in the study. The minimal duration of the depressive complaints needs to be at least two months. The participants also need to be native Dutch speakers and to have access to internet and e-mail at home. |
|- Exclusion criteria||These participants will only be asked to participate in the study when they receive no other psychological treatment for their depressive complaints. Furthermore, the presence of suicide ideation, severe co-morbid diagnoses (in particular current psychosis and organic mental disorders) and substance abuse are not allowed. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2011|
|- planned closingdate||1-jun-2015|
|- Target number of participants||374|
|- Interventions||The CCBT program that is going to be used in this study is Beating the Blues (BtB). BtB is based on cognitive-behavioural techniques and consists of an introductory video and eight computerized sessions, lasting around fifty minutes. The sessions are (inter)active and based on cognitive behavioural techniques, clarified with the help of animations and case-studies. Each session ends with a summary and several homework assignments. Furthermore, both the therapist and the client receive a progress report after each session. The complete program minimally takes eight weeks. The client is encouraged to go through one session each week, and to schedule all of the sessions in his or her diary beforehand. During the BtB program, the therapists meet their client three times in face-to-face sessions of 45 minutes each:|
1. Before the program - for an intake;
2. After the fourth session - for motivation and support;
3. After the program - for an evaluation.
The alternative to CCBT in this study is face-to-face therapy based on cognitive-behavioural techniques. The face-to-face therapy lasts minimally eight and maximally sixteen weeks, with eight to nine sessions of 45 minutes each. The client is supposed to do home work assignments after each session. In order to ensure that the therapists indeed do apply cognitive-behavioural techniques, a random selection of five percent of the sessions will be video-taped. These videos will be analyzed for their cognitive-behavioural content by independent therapists.
|- Primary outcome||The main study parameter is the presence/ severity of depressive symptoms as measured with the Beck Depression Inventory (BDI-II-NL). Other clinical and economic questionnaires (CORE-34, PHQ-9, BADS, DAS, WSAS, EQ-5D/VAS, TiC-P) will be used to back up the main study parameter. More specifically, they will be used to answer the research questions about (cost) effectiveness.|
|- Secondary outcome||The secondary study parameters are:|
1. Client acceptability ratings, as measured with the AQ (long and short versions);
2. Presence/ severity of anxiety symptoms, as measured with the anxiety subscale of the CORE-34 and with the GAD-7.
Age, sex, social economic status and ethnical background will be used as prognostic factors.
|- Timepoints||1. Baseline;|
4. Six-month follow-up;
5. Twelve-month follow-up.
|- Trial web site||http://www.mentaalbeter.nl/onderzoekbtb|
|- CONTACT FOR PUBLIC QUERIES|| Esther Parigger|
|- CONTACT for SCIENTIFIC QUERIES|| Esther Parigger|
|- Sponsor/Initiator ||Interhealth|
(Source(s) of Monetary or Material Support)
|- Brief summary||This study compares computerized cognitive behavioural therapy with limited therapist support to face-to-face therapy based on cognitive behavioural techniques in a (non-inferiority) randomized trial. The study will focus will be on clinical and cost effectiveness.|
|- Main changes (audit trail)|
|- RECORD||25-nov-2010 - 10-jun-2012|