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van CCT (UK)

van CCT (UK)

Cognitive Remediation Therapy (CRT) for eating disorders and obsessive compulsive disorders.

- candidate number14419
- NTR NumberNTR3865
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-feb-2013
- Secondary IDs43751 ABR
- Public TitleCognitive Remediation Therapy (CRT) for eating disorders and obsessive compulsive disorders.
- Scientific TitleThe (cost) effectiveness of Cognitive Remediation Therapy (CRT) as a treatment enhancer in eating disorders and obsessive compulsive disorders.
- hypothesisPatients who have received CRT will have more symptom reduction anda better quality of life after TAU than patients who have not received CRT. Furthermore we hypothesise that CRT will be cost-effective.
- Healt Condition(s) or Problem(s) studiedObsessive-compulsive disorder (OCD), Anorexia nervosa
- Inclusion criteriaED patients:
The ED patients encompass primarily patients with Anorexia nervosa (including those patients that meet some but not all of the diagnostic criteria for AN who are diagnosed as Eating Disorders Not Otherwise Specified ( (clinically referred to as AN) as established by medical experts and verified with the Structured Clinical Interview on axis I DSM V diagnoses (SCID-I; for a structural diagnosis)/ assessed with the aid of the Eating Disorder Examination Interview.

OCD patients:
The OCD patients encompass OCD patients of all symptom dimensions (Leckman, Grice, Boardman et al., 1997), as established by medical experts and verified with the Structured Clinical Interview on axis I DSM IV diagnoses (SCID-I; for a structural diagnosis) and should have a Yale- Brown Obsessive-compulsive scale (Goodman, Price, Rasmussen et al., 1989a,1989b) severity score of > 16.
- Exclusion criteriaPatients with neurological illness (epilepsia, Parkinson’s disease), co-morbid severe psychiatric disorders (severe major depressive disorder, current psychosis, dependence and abuse of alcohol, drugs), mental deficiency (IQ < 80) and inability to adequately read or speak Dutch will be excluded. Use of anti-depressants will be permitted, provided that dosages are kept constant during the experimental part of the study. Benzodiazepine use will be accepted only when used as sleep medication, since benzodiazepine use might hamper the effect of cognitive treatments.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2013
- planned closingdate30-apr-2014
- Target number of participants130
- InterventionsCondition 1: Cognitive Remediation Therapy (CRT):
CRT consists of ten individual sessions (45 minutes each), given within six weeks. These CRT sessions are delivered by trained professionals (therapists, clinical nurses). CRT uses a range of cognitive (paper and pencil) exercises that are specifically aimed at improving cognitive flexibility and increasing global information processing as opposed to detail-oriented processing. Also CRT aims to improve the awareness of ongoing thinking patterns. Reflection about thinking styles during these cognitive exercises is a crucial part of CRT. Patients are also encouraged to find out how these thinking styles affect their daily life and from about the sixth session onwards, the cognitive exercises are linked to real life behavioral tasks. These behavioral tasks are designed to allow patients to practice skills in daily life, thereby introducing more flexible behavior in their everyday life.

Condition 2: Supportive Counseling therapy (SC):
The placebo treatment condition will entail 10 bi-weekly individual sessions of 45 minutes duration, delivered by psychologists or trained nurses. In the first treatment session the rationale of nondirective supportive counseling will be explained. The subsequent SC sessions will entail 1) education about mental disorders in general, 2) general problem solving skills, and uncondiotnal support. Further, the patients are encouraged to keep a diary of current problems and mood scales (with similar load as for the assignments in CRT). If the patient raises an issue with respect to his/ her mental illness, treatment goal to be achieved, inter relational issues or psychosocial situation, no explanations nor any direct advice is given.
- Primary outcome1. Symptom reduction;
2. Quality of life;
3. Costeffectiveness.
- Secondary outcomeCognitive flexibility.
- TimepointsT0: Baseline;
T1: Post-intervention (8 weeks after T0);
T2: 4-month follow-up (4 months after T1).
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Altrecht GGZ
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryObsessive Compulsive Disorders (OCD) and Eating disorders (ED) are –according to the WHO - among the most incapacitating and costly of all mental disorders. Cognitive behavior treatment and/or medication have proven to be only moderately successful in both disorders in between 40% and 60% of patients, leaving much room for more effective treatment algorithms. A striking underlying deficit shared by both disorders is patients' cognitive inflexibility, a trait that is likely to hamper treatment engagement and ability to benefit from treatment. New promising evidence indicates that Cognitive Remediation Therapy (CRT), an easy-to-use technique, successfully enhances flexible thinking styles, and therefore enhances benefit from symptom-based therapies, and improvement of quality of life. Although not investigated directly, CRT-like strategies have also been effective in enhancing symptom reduction in OCD. The objectives of this study are: 1) To investigate the treatment enhancing effect of CRT in ED and OCD (i.e to what extent does CRT lead to shorter duration of treatment, increased symptom reduction and quality of life, reduced dropout rates?); 2) To investigate cost effectiveness and budget impact of CRT on treatment of ED and OCD; 3)To investigate neurocognitive markers of treatment enhancement by CRT in OCD and ED, i.e. which characteristics determine for which patients augmentation with CRT is most beneficial in clinical practice? Study design: This placebo-controlled multicenter trial involves 64 adult patients with ED, and 64 patients with OCD, randomized to 10 bi-weekly sessions with either CRT or a placebo control condition, followed by TAU which will involve ao weekly sessions of 60-90 minutes CBT. Treatment effect will be analysed using linear mixed model analyses including calculations of clinically significant change. A Markov modeling approach will be applied for the economic evaluation. Cost utility analyses will be performed from a societal perspective estimating the cost per QALY. The budget impact analysis will be conducted from a payers and societal perspective. Disorder-specific symptom severity (EDEQ; YBOCS severity scale), Quality of Life (EQ-5D), cognitive flexibility (D-flex), healthcare use costs, budget impact, and loss of work productivity will be assessed at baseline, post CRT, and after 4 months TAU.
- Main changes (audit trail)
- RECORD20-feb-2013 - 18-dec-2013

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