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Kort & Krachtig onderzoek (in Dutch).


- candidate number8612
- NTR NumberNTR2590
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-nov-2010
- Secondary IDsP09.146 / NL29380.058.09 METC Leiden University Medical Centre (LUMC)
- Public TitleKort & Krachtig onderzoek (in Dutch).
- Scientific TitleKort & Krachtig (in Dutch): A (cost) effectiveness study of brief interventions for mood and anxiety disorders: brief Routine Outcome Monitoring (ROM), intake & therapy.
- ACRONYMKort & Krachtig (in Dutch)
- hypothesisThe (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.

Hypothesis:
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) studiedAnxiety, Mood disorders
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2010
- planned closingdate18-mei-2013
- Target number of participants500
- InterventionsIntervention: 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 outcomeEffectiveness 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 outcomeSecondary, 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.
- TimepointsPrimary 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 siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMw. Drs. D. Meuldijk
- CONTACT for SCIENTIFIC QUERIESMw. Drs. D. Meuldijk
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Rivierduinen, Leiden
- PublicationsN/A
- Brief summaryKort & 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)
- RECORD2-nov-2010 - 19-nov-2010


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