This study compares the efficacy of guided self-help CBT-E with to screen-to-screen CBT-E in terms of robust remission at end of treatment and during follow up. Robust remission will be defined as eating disorder pathology below a clinical cut-off…
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 relative treatment efficacy of
guided self-help CBT-E versus screen-to-screen CBT-E, reported as robust
remission pre- and post-treatment and during follow-up. The primary parameter
will be measured through the Eating Disorder Examination (EDE) and Eating
Disorder Examination Questionnaire (EDE-Q) at start and end of treatment and 60
weeks follow up, during follow up, 20, weeks post treatment (week 40) by the
EDE-Q.
Secondary outcome
Secondary parameters are the efficacy with regard to clinical impairment and
quality of life of guided self-help CBT-E in comparison with screen-to-screen
CBT-E after treatment and during follow-up and, to investigate the moderating
effect of severity of body dissatisfaction and the association of early
menarche and body dissatisfaction. Secondary parameters involving quality of
life, clinical impairment and body dissatisfaction will be measured at start
and end of treatment, during follow up (20, 60 weeks post treatment) by the
EQ-5D-NL, Clinical Impairment Assessment (CIA) and, Body Shape Questionnaire
(BSQ). The association between body dissatisfaction and early menarche will be
measured at start of treatment. Other parameters are the moderating effects of
therapeutic alliance between both conditions and the compare cost- efficacy.
Therapeutic alliance will be measured by the Working Alliance Inventory and
costs by the questionnaire on Costs associated with Psychiatric illness (TiC-P)
during week 5, 12 and at end of treatment.
Background summary
Cognitive Behavioral Therapy- Enhanced (CBT-E) is an evidence based and
effective treatment for all eating disorders. Offering treatment remotely has
several advantages for the patient such as removal of geographical barriers,
sessions can be held within the patients safe environment, they can communicate
with their therapist wherever they are, and reduced travel costs and travel
time. The Covid-19 pandemic increased the urgence of offering specialized
treatment remotely and several outpatient centers introduced potential
adaptations to their existing levels of care, including CBT-E. There is a lack
of studies examining remote versions of CBT-E and no study has directly
compared efficacy of guided self-help CBT-E with screen-to-screen CBT-E and
investigated the effect of treatment dose. At Novarum center for eating
disorders in the Netherlands both CBT-E treatments will be offered online. One
treatment protocol will be developed involving a screen-to-screen version of
CBT-E (screen-to-screen CBT-E) and another one involves a guided self-help
treatment protocol (guided self-help CBT-E). It*s hypothesized that
screen-to-screen CBT-E is superior to guided self-help CBT-E and, that guided
self-help CBT-E is superior in terms of cost-efficacy.
Study objective
This study compares the efficacy of guided self-help CBT-E with to
screen-to-screen CBT-E in terms of robust remission at end of treatment and
during follow up. Robust remission will be defined as eating disorder pathology
below a clinical cut-off and no binge eating pathology. Secondary objective is
to measure the efficacy with regard to clinical impairment and quality of life
of guided self-help CBT-E in comparison with screen-to-screen CBT-E group after
treatment and during follow-up and, to investigate the moderating effect of
severity of body dissatisfaction and the covariating effect of early menarche,
as early menarche is expected to be associated with body dissatisfaction.
Study design
A single center randomized controlled trial assessing the effects of the newly
developed screen-to-screen CBT-E compared with guided self-help CBT-E. Both
treatments are based on Cognitive Behavioral Therapy- Enhanced treatment
protocol and will be offered online. Stratification will take place based on
BMI group; 19.5 <= BMI <= 35 or 35< BMI <= 40.
180 participants (142= without correction) will participate in this study.
Parameters will be measured at start of treatment (week 0), week 5, end of
treatment (week 12 for guided self-help, week 20 for screen-to-screen CBT-E),
follow up measurements are 20and 60 weeks after end of treatment.
Intervention
Cognitive Behavorial Therapy-Enhanced (CBT-E) is an evidenced based treatment
for eating disorders. Treatment period is 20 weeks, including 20 sessions of 50
minutes each. The first 4 weeks will involve 8 sessions, weeks 5- 14 involve
weekly sessions and week 15-20 involves bi- weekly sessions. Sessions will be
conducted in a screen-to-screen setting. Guided self-help CBT-E is an online
guided self-help version of CBT-E based on the self-help book *Overcoming Binge
Eating*. Treatment period is 12 weeks and patients will complete exercises at
an online treatment platform on a daily basis. Once a week they will have a
therapy session of 20 minutes offered through video call.
Study burden and risks
Participants burden is expected to be limited since they receive either
screen-to-screen CBT-E or guided self-help CBT-E which is less extensive.
Participants will be requested to complete questionnaires at baseline, during
and at end of treatment which will be used as treatment evaluation and are
therefore also included without study participation. Completion of the
self-report follow up measures will be 30 minutes each, 60 minutes in total to
complete all follow-up measures. Completion of the interviews will take 3 times
45-60 minutes. In total a burden of maximum 180 minutes for each participant in
comparison with treatment without study participation. There are minimal risks
associated with participation in this study as the medical device is classified
as a class 1 medical device.
Laan van de Helende Meesters 2
Amstelveen 1186 AM
NL
Laan van de Helende Meesters 2
Amstelveen 1186 AM
NL
Listed location countries
Age
Inclusion criteria
1. binge eating disorder or other specified feeding or eating disorder (OSFED)
binge eating disorder classification
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 read *Overcoming binge eating* written by Christopher Fairburn
10. Informed consent regarding the study provided by the patient
Exclusion criteria
1. Acute psychosis, assesed via SCID 5
2. Acute depression, assesed via SCID 5
3. Suicidal ideation, assesed via SCID 5
4. Anorexia Nervosa or Bulimia Nervosa
5. Treatment for an eating disorder during the past 6 months
6. Pregnancy
7. Expected absence during treatment period
8. Medication that might influence eating behavior such as, Lithium,
Mitrazepine and anti-psychotic stimulants
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL76368.100.21 |