search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Processes and Outcomes of Cognitive Therapy vs. Cognitive Therapy + Exposure for Eating Disorders: Study protocol for a Randomized Controlled Trial


- candidate number27729
- NTR NumberNTR6597
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-aug-2017
- Secondary IDsNL 17291.068.07 METC
- Public TitleProcesses and Outcomes of Cognitive Therapy vs. Cognitive Therapy + Exposure for Eating Disorders: Study protocol for a Randomized Controlled Trial
- Scientific TitleProcesses and Outcomes of Cognitive Therapy vs. Cognitive Therapy + Exposure for Eating Disorders: Study protocol for a Randomized Controlled Trial
- ACRONYM-
- hypothesisCT + (Cue) Exposure is more effective than Pure CT (both in short- and long-term).
- Healt Condition(s) or Problem(s) studiedEating disorders, Eating Disorders Not Otherwise Specified
- Inclusion criteriaAdults with Eating Disorders BN/ED-NOS as primary diagnosis.
- Exclusion criteriaBMI < 18; primary diagnosis other than ED; elevated acute suicide risk, concomitant psychological treatment; drugs and alcohol abuse/dependence; insufficient knowledge of the Dutch language; mental retardation (IQ < 80).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate1-mrt-2018
- Target number of participants106
- InterventionsCognitive Therapy Cognitive Therapy + (Cue) Exposure
- Primary outcomeSeverity of specific Eating Disorder pathology (including body satisfaction/esteem); Meeting/not meeting DSM criteria for any of the Eating Disorders.
- Secondary outcomeCraving; Self-control; Impulsivity; Irrational thinking; Attention bias for negatively perceived body parts and high caloric food; Personality problems/disorders; Self-esteem; Mood; General well-being/psychopathology; Body Mass Index (BMI) and Various potential (treatment specific / non-specific) process measures
- TimepointsIntake; pre- and post-treatment; prior to-, during- and after each therapy session; and at 1, 6, 12 and 24 months follow-up.
- Trial web sitewww.eetonderzoek.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Lotte Lemmens
- CONTACT for SCIENTIFIC QUERIESDr. Lotte Lemmens
- Sponsor/Initiator Maastricht University
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University
- Publications-
- Brief summaryCognitive Behavioural Therapy (CBT) has shown to be an effective treatment for various Eating Disorders. However, since approximately 30% of patients do not (or insufficiently) respond to treatment there is room for improvement. When taking a closer look at the protocols that are currently being used in clinical practice, it can be concluded that existing protocols often have a relatively strong focus on diet management. More emphasis on the cognitive aspects of CBT might make treatment more effective. Furthermore, there are indications that specific exposure elements (e.g. cue exposure, forbidden foods exposure, and positive body exposure) might be effective as well. Combining cognitive interventions with these exposure exercises might therefore also increase treatment effects. These ideas were leading ground for designing the current RCT. In this study, 106 adults with an Eating Disorder (BN, BED, and ED NOS) will receive psychotherapy (CT or CT + Exposure) in an outpatient mental health clinic in the Netherlands. Treatment consists of 20 individual sessions of 60 minutes (3 pre-sessions, 16 treatment sessions, 1 booster session). Primary outcome is severity of eating disorder pathology. Secondary outcomes include self-esteem, body satisfaction, mood, general psychological distress, craving, impulsivity and BMI. In addition, measures of various potential mechanisms of change are included. Assessments are taken at baseline, pre- and post-treatment, prior to-, during- and after each therapy session, and at 1, 6, 12 and 24 months follow-up. By including repeated measures of clinical outcomes and multiple potential process measures over the course of 2.5 years, we aim to examine both the clinical effects (acute and long-term) of both interventions, as well as the causal pathways that lead to therapeutic change.
- Main changes (audit trail)
- RECORD9-aug-2017 - 19-aug-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl