The goal of this study is to learn whether:The above described CBT according to protocol is more effective than CT according to protocol without behavioral interventions (binge cue exposure with respons prevention and body exposure including…
ID
Source
Brief title
Condition
- Eating disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Specific eating psychopathology using the interview Eating Disorder
Examination
- Body dissatisfaction and Body Checking ( ASI-R short, EDI Body Image
subscale, Body Checking Scale)
- Eating Behaviour (DEBQ and Power of Food Scale (PFS)).
- Self-esteem (RSE)
- Mood (depression, positive and negative affect) ( Beck Depression's
Inventory-II and PANAS; Positive and Negative Affect Schedule)
- Body Mass Index (BMI)
Secondary outcome
process variables each session:
- Positive and Negative Affect (PANAS)
- Urge to eat (VAS)
- Belief in idiosyncratic irrational cognitions (VAS)
- Anxiety to lose control about eating (VAS)
- Body loathing (VAS)
- general well-being (VAS)
process variables VM & NM:
- Personality Disorder (interview SCID-II)
- Impulsivity (inhibition capacity) (Stop Signal Task - computer)
secundary (VM, NM, FU's):
- Dichotomous Thinking (DTS)
- General Psychopathology (BSI)
- Treatment credibility (3 items)
- Treatment integrity
Background summary
Cognitive Behaviour Therapy (CBT: a therapy with components from cognitive
therapy (CT) as well as behaviour therapy components (BT)) currently is the
treatment of choice for bulimia nervosa (BN) and eating disorders not otherwise
specified (EDNOS). CBT is the treatment of choice because it is, until now, the
most effective therapy for eating disorders, in particular BN and EDNOS. There
is, however, room for improvement; this (international form of) CBT ends up in
a considerable improvement in about 2/3 of the patients, but in the long run
1/3 of the CBT treated patients still fulfills the criteria of an eating
disorder, although often a more mild eating disorder. Based on our experimental
studies we developed a new CBT taking maintenance models for binge eating and
body dissatisfaction that are empirically supported as a starting point. The C
of CBT is the cognitive therapy that is succesfully provided for years in the
adults care unit (VZK) of the RIAGG Maastricht. The B includes exposure in two
forms: 1) exposure to binge eating cues with response prevention (no binge, no
eating), and 2) body exposure with attention retraining. The new CBT is a
combination of cognitive interventions with exposure interventions. Based on
our experience and earlier research data as well, we expect the gradual
exposure to binge cues leading to a prompt reduction of binge frequency, soon
after the start of treatment. We further expect the body exposure + attentional
retraining leading to a sharp decline in body dissatisfaction. The research
question is whether this new CBT is more effective than pure CT without
behavioral interventions.
Study objective
The goal of this study is to learn whether:
The above described CBT according to protocol is more effective than CT
according to protocol without behavioral interventions (binge cue exposure with
respons prevention and body exposure including attention reallocation
training).
Study design
This study is a randomised clinical trial (open trial).
Intervention
The intervention consists of 16 sessions cognitive treatment (CT) or 16
sessions cognitive behavioral treatment (CBT). Each session lasts 60 minutes.
In the CT and CBT homework will be assigned (completing 'thought' diaries and
doing behavioral experiments). The homework will cost about 15 - 30 minutes a
day, 5 days a week.
Study burden and risks
Participants do not run any risk. Participation takes time (completion of
questionnaires, participation in interviews and performing a computer task).
The research participation takes about 13 to 14 hours over 1,5 years. According
to the researchers this is acceptable considering the research question and
anticipated answers.
Universiteitssingel 40
Maastricht 6229ER
NL
Universiteitssingel 40
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosis Bulimia Nervosa (BN) or Eating Disorder Not Otherwise Specified (EDNOS - bulimic subtype) according to DSM-IV (APA, 1994)
2. BMI between 18 en 30
3. sex: female
4. age: between 18 and 40 years
Exclusion criteria
1. A primary Axis-1 diagnosis other than eating disorders (eating disorder should be the primary diagnosis)
2. BMI < 18, BMI > 30
3. Anorexia Nervosa
4. Simultaneous other treatment for psychopathology
5. IQ less than 80
6. Not able to speak and/ or write Dutch
7. Acute danger of suicide
8. Alcohol- and/or drug use that requires a first treatment
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL17291.068.07 |
| OMON | NL-OMON27127 |