GSH CBT-E is an internet-based guided self-help intervention. Objective of this study is to investigate the effectiveness of GSH CBT-E in comparison with a waiting list condition on frequency of binge eating (BE). Secondary objective is to measure…
ID
Source
Brief title
Condition
- Eating disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is to compare the efficacy of GSH CBT-E on the amount
of binge free days pre- and post-treatment. Primary parameter will be measured
through the Eating Disorder Examination (EDE) and Eating Disorder Examination
Questionnaire (EDE-Q). All questionnaires will be assessed at start and end of
treatment. In week 5, 24 and 36 the EDE-Q will also be conducted.
Secondary outcome
Secondary parameter is eating disorder pathology pre and post treatment.
Tertiary parameter are cost effectiveness of GSH CBT-E, quality life and
clinical impairment. Secondary parameter will be measured through the Eating
Disorder Examination (EDE) and Eating Disorder Examination Questionnaire
(EDE-Q). Secondary parameters will also be measured 4 weeks after start of
treatment and at 3 and 6 months follow up through the EDE-Q. Tertiary
parameters will be measured through the questionnaire on Costs associated with
Psychiatric illness (TiC-P), the Quality of life questionnaire (EQ-5D-5L), the
Clinical Impairment Assessment (CIA) and Working Alliance Inventory (WAI). All
questionnaires will be assessed at start and end of treatment. In week 5 the
EDE-Q and CIA will be conducted. During week 24 and 36 only the EDE-Q,
EQ-5D-5L, TiC-P, and CIA will be conducted. Followed module will serve as a
moderator.
Background summary
Self-help (SH) interventions based on CBT have proven effective for the
treatment of eating disorders in the past when compared to waiting lists.
Cognitive behaviour therapy enhanced (CBT-E) has proven to be effective in
order to treat eating disorders. However it still remains unknown if a guided
self-help (GSH) version of CBT-E (GSH CBT-E) intervention is effective in
treatment of binge eating disorder in comparison to a waiting list condition.
Therefore an online guided self-help treatment is developed. This treatment is
based on CBT-E (GSH CBT-E). It*s hypothesized that GSH CBT-E is superior to the
waiting list condition.
Study objective
GSH CBT-E is an internet-based guided self-help intervention. Objective of this
study is to investigate the effectiveness of GSH CBT-E in comparison with a
waiting list condition on frequency of binge eating (BE). Secondary objective
is to measure eating disorder pathology. Tertiary objective is to measure cost-
effectiveness of GSH CBT-E, quality of life, clinical impairment and
therapeutic alliance.
Study design
Effectiveness of GSH CBT-E in comparison with a waiting list condition will be
measured through a Randomized Controlled Trial (RCT). This RCT will be
conducted in a routine healthcare practice. 180 participants will participate
in this study. Parameters will be measured at start of treatment (week 0), week
5, end of treatment (week 12) and at week 24 and week 36. Week 24 and 36 are
follow up measurements.
Intervention
GSH CBT-E is a guided self-help version of CBT-E based on the self help-book
*Overcoming Binge Eating*. Treatment period is 12 weeks. Once a week there will
be a therapy session of 20 minutes. All sessions will be conducted by phone.
Study burden and risks
Participants burden is expected to be as following:
Burden during *treatment as usual*:
Initial session: 75 minutes
Advisory session: 30 minutes
Conduct of questionnaires: maximum of 3x30 minutes= maximum of 90 minutes
Behandeltijd: 12x 20 minuten= 240 minuten
Total burden during *treatment as usual*: 435 minutes
Extra burden due to study participation:
Conduct of interview: 2x 60 minutes= 120 minutes
2x follow up measurement: 2x maximum 30 minutes= 60 minutes
Totale extra burden: 180 minutes
Total burden of *treatment as usual* and study participation: 180+435= 615
minutes
Klaprozenweg 111
Amsterdam 1033 NN
NL
Klaprozenweg 111
Amsterdam 1033 NN
NL
Listed location countries
Age
Inclusion criteria
1. Binge Eating Disorder or Other Specified Eating Disorder (OSFED), most
similar to Binge Eating disorder diagnosis
2. Age >= 18
3. 19.5 <= BMI < 40
4. Moderately proficient in Dutch
5. Willing to provide contact details including (mobile)phone number
6. Referral letter from their general practitioner (GP)
7. Internet access
8. Computer/tablet at home and willingness to use this for treatment and
research purposes
9. Ability to buy *Overcoming binge eating* written by Christopher Fairburn. In
case the participant is not able to buy the book, Novarum will provide an
exemplar during treatment.
10. Informed consent regarding the study provided by the patient
11. Medication that might influence eating behavior such as, Lithium,
Mitrazepine and anti- psychotic stimulants
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Acute psychosis
2. Acute depression
3. Suicidal ideation
4. Self induced vomiting as compensatory behavior
5. Receivement of treatment for ED during the past months
6. Pregnancy
7. Expected absence during treatment period
8. Bariatric surgery
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69598.100.19 |