No registrations found.
ID
Source
Brief title
Health condition
Eating Disorders; Bulimia Nervosa; Eating Disorder Not Otherwise Specified / Eetstoornissen; Boulimia Nervosa; Eetstoornis niet anderszins omschreven.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Severity of specific Eating Disorder pathology (including body satisfaction/esteem); Meeting/not meeting DSM criteria for any of the Eating Disorders.
Secondary outcome
Craving; 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
Background summary
Cognitive 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.
Study objective
CT + (Cue) Exposure is more effective than Pure CT (both in short- and long-term).
Study design
Intake; pre- and post-treatment; prior to-, during- and after each therapy session; and at 1, 6, 12 and 24 months follow-up.
Intervention
Cognitive Therapy
Cognitive Therapy + (Cue) Exposure
Lotte Lemmens
Maastricht University, Faculty of Psychology and Neuroscience, Department of Clinical Psychological Science
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881874
Lotte.Lemmens@maastrichtuniversity.nl
Lotte Lemmens
Maastricht University, Faculty of Psychology and Neuroscience, Department of Clinical Psychological Science
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881874
Lotte.Lemmens@maastrichtuniversity.nl
Inclusion criteria
Adults with Eating Disorders BN/ED-NOS as primary diagnosis.
Exclusion criteria
BMI < 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).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6420 |
| NTR-old | NTR6597 |
| CCMO | NL17291.068.07 |
| OMON | NL-OMON44125 |