|- candidate number||8612|
|- NTR Number||NTR2590|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-nov-2010|
|- Secondary IDs||P09.146 / NL29380.058.09 METC Leiden University Medical Centre (LUMC)|
|- Public Title||Kort & Krachtig onderzoek (in Dutch).|
|- Scientific Title||Kort & Krachtig (in Dutch): A (cost) effectiveness study of brief interventions for mood and anxiety disorders: brief Routine Outcome Monitoring (ROM), intake & therapy.|
|- ACRONYM||Kort & Krachtig (in Dutch)|
|- hypothesis||The (cost)-effectiveness of brief therapy compared with treatment as usual (TAU) in the treatment of mild depression and anxiety disorders has not yet been determined. In this study a brief cognitive behavioural therapy (CBT) and/or pharmacotherapy is compared with TAU at five Dutch out-patient Mental Healthcare Centersí of Rivierduinen (MHCs).
Since ROM is more or less daily clinical practice in Dutch mental health care, additionally, the advantage of a brief ROM, giving minimalised ROM feedback, is investigated in this study.
1. Is a brief CBT or pharmacotherapy as effective as TAU in patients suffering from depressive and/or anxiety disorders?
2. Is a brief CBT or pharmacotherapy more cost effective as TAU in patients suffering from depressive and/or anxiety disorders?
Exploratory, the satisfaction of patients and clinicians about this short and powerful method (= Kort & Krachtig) is compared with those on the conventional treatment (TAU).
|- Healt Condition(s) or Problem(s) studied||Anxiety, Mood disorders|
|- Inclusion criteria||1. Male or female adolescents;|
2. Adolescent between the ages of 18 and 65 year (inclusive) at the time of randomization;
3. Adolescent main complaint: anxiety and/or mood disorder;
4. Proper understanding of the Dutch language.
|- Exclusion criteria||1. Adolescents with main complaints other than anxiety and depression;|
2. Adolescents with psychotic or bipolar traits;
3. Adolescents with suicidal or homicidal risk;
4. No proper understanding of the Dutch language;
5. Social disfunctioning.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2010|
|- planned closingdate||18-mei-2013|
|- Target number of participants||500|
|- Interventions||Intervention: Brief Cognitive Behavioural Therapy (CBT) and/or pharmacotherapy (SSRI).
The brief CBT protocol is characterized by a quick onset and a maximum number of sessions (maximum 7 sessions within 7 weeks). The brief CBT protocol is based upon existing and already used CBT protocols.
The brief farmacotherapy intervention is characterized by treating patients with a selective serotonin reuptake inhibitor (SSRI) in 4 sessions within 7 weeks. The protocol is based upon already existing and used farmacotherapy treatment protocols.
Active control: Treatment As Usual (TAU).
Active control group receives routine primary care: Treatment As Usual (TAU). TAU is not formalised. Based on therapistsí professional experience, characteristics of the patient, a therapy is assigned from a wide range of therapeutic options. As a result the treatment, the intensity, as well as the setting (individual, group e.d.) varies.
|- Primary outcome||Effectiveness of the intervention is investigated by the main questionnaires:|
1. Web Screening Questionnaire (WSQ);
2. Brief Symptom Inventionary (BSI) as conducted by Routine Outcome Monitoring (ROM).
|- Secondary outcome||Secondary, cost-effectiveness is investigated by an open question version of the questionnaire Trimbos/iMTA Questionnaire for Cost associated with Psychiatric Illness (TIC-P).|
Additionally patient and clinicians satisfaction about the intervention is compared with treatment as usual by these main questionnaires.
|- Timepoints||Primary and secondary outcomes are measured by ROM at four time points:|
1. At baseline;
2. Post treatment;
3. 6 months post- treatment;
4. 12 months post- treatment.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Mw. Drs. D. Meuldijk|
|- CONTACT for SCIENTIFIC QUERIES||Mw. Drs. D. Meuldijk|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Kort & Krachtig (in Dutch): A (cost) effectiveness study of brief interventions for mood and anxiety disorders: brief Routine Outcome Monitoring (ROM), intake & therapy.
The (cost)-effectiveness of brief therapy compared with treatment as usual (TAU) in the treatment of mild depression and anxiety disorders, has not yet been determined. In this study a brief cognitive behavioural therapy (CBT) and/or pharmacotherapy (SSRI) is compared with TAU at five out-patient Mental Healthcare Centersí of Rivierduinen (MHCs) in the Netherlands. Additionally, to collect data on the effectiveness of treatment, the advantage of a brief ROM is investigated.
The ultimate goal of this study is to develop a as (cost) effective and shortest possible ROM, intake and therapy for the treatment of mild depression and anxiety disorders.
|- Main changes (audit trail)|
|- RECORD||2-nov-2010 - 19-nov-2010|