It is hypothesized that GSH CBT-E is superior to the waiting list condition with regard to a decrease in eating disorder pathology and clinical impairment. GSH CBT-E is also expected to be superior to the waiting list with regard to increase in the…
ID
Bron
Verkorte titel
Aandoening
Binge eating disorder, other specified eating disorder BED
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measure will be difference in eating disorder pathology, operationalized as the amount of days binge eating occurred, post treatment versus the waiting list control condition.
Achtergrond van het onderzoek
Binge eating disorder is characterized by recurrent episodes of binge eating accompanied by a sense of lack of control. Of the different treatments available, Cognitive Behavior Therapy-Enhanced (CBT-Enhanced) and guided self- help treatment are recommended. As online treatment offers several additional advantages, we have developed a CBT-Enhanced online guided self-help intervention. The aim of this study is to determine whether this intervention reduces eating disorder pathology and increases the amount of binge free days in male and female adults classified with binge eating disorder or other specified eating disorder BED, compared to an untreated waiting list condition. The experimental condition is hypothesized to be superior to the waiting list condition.
The efficacy of an online guided self-help intervention for binge eating disorder will be assessed by conducting a randomized controlled trial. The trial will target male and female adult binge eating disorder patients with a BMI between 19.5 and 40, referred to a specialized eating disorder treatment center. Dual arm allotment will be performed in a 1:1 ratio stratified for BMI above or below 30. Randomization will be blinded to the online intervention (n = 90), or to the control waiting list condition (n = 90). Blinded assessments will be administered at baseline, week 5, at end-of-treatment, and at 12 and 24 weeks follow-up. The primary outcome will be eating disorder pathology, operationalized as number of days on which binge eating occurred. Secondary outcome measures will target other be differences in other eating disorder pathology, clinical impairment due to the eating disorder and quality of life, while therapeutic alliance, demographic characteristics and followed treatment module will serve as effect moderators. Direct treatment costs of the intervention will also be evaluated. Recruitment, assessment and first therapy sessions will start in September 2019.
An online Guided Self-Help Cognitive Behavior Therapy- Enhanced intervention for individuals classified with binge eating disorder or other specified eating disorder. Efficacy will be examined through a Randomized Controlled Trial.
Doel van het onderzoek
It is hypothesized that GSH CBT-E is superior to the waiting list condition with regard to a decrease in eating disorder pathology and clinical impairment. GSH CBT-E is also expected to be superior to the waiting list with regard to increase in the number of binge free days and quality of life.
Onderzoeksopzet
The control group will start treatment after a waiting list period of 12 weeks, the same duration as the intervention. After baseline (T0), assessments will take place four times during and after treatment: at week 5, which is the evaluation-point of treatment for GSH CBT-E (T1); at the end of treatment for GSH CBT-E/ start of treatment for waiting list control group (week 12, T2); at 12 weeks after treatment for GSH CBT-E/ End of treatment for the waiting list condition (week 24, T3); and at 24 weeks after treatment for GSH CBT-E/, 12 weeks after treatment for waiting list control group (week 36, T4).
Onderzoeksproduct en/of interventie
GSH CBT-E is a 12 week program. Patients have to start reading information online, to monitor their eating behavior, and to schedule, once a week, weighing, and, twice a week, self- evaluation sessions. A few days after start of treatment, patients will have a 20 minutes phone session with their therapist. To ensure consistency between therapists, these phone sessions are pre-scripted. During the first 4 weeks, patients will have to monitor their eating behavior, including their thoughts and feelings and establish a regular eating pattern. They will also introduce alternative activities for binge eating and work on problem-solving skills. During week 5, they will fill out assessment questionnaires, sent to them by a link, and their progress will be assessed, by both themselves and their therapist. This session will enable them to decide whether to add a module on body evaluation or eating rules during week 6-11 in addition to monitoring, regular eating, alternatives for binge eating and problem solving (figure 2). Before the 12th session patients will have to fill out the questionnaires. Results will be discussed during session 12, when they will also discuss what to do to prevent set-backs. The post treatment EDE will be conducted by phone. GSH CBT-E treatment will not be altered or interfered with during the study. As GSH CBT-E is a 100% guided self- help treatment without face to face sessions, sessions will only be conducted by phone.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
(1) a DSM- 5 BED or OFSED most similar to BED classification;
(2) age at least 18;
(3) a BMI between 19.5 and 40;
(4) moderate proficiency in Dutch and ability to read pPart one of the Dutch translation of Overcoming Binge Eating, by Christopher Fairburn (2013) , which involves psychoeducation;
(5) willingness to provide contact details, including phone number, internet access, possession of a computer or tablet, and willingness to use it for treatment and research purposes.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
(1) acute psychosis, assessed via Structural Clinical Interview by the DSM 5 (SCID -5) (First, Williams, Karg & Spitzer, 2016);
(2) acute depression, assessed via SCID -5;
(3) suicidal ideation, assessed via SCID -5 or
(4) self-induced vomiting as compensatory behavior, as reported at initial session or EDE-interview at baseline. Other exclusion criteria are:
(5) having received eating disorder treatment during the past 6 months,
(6) being pregnant
(7) reported use of medication with the potential to influence eating behavior such as, Lithium, Mitrazepine and anti- psychotic stimulants.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7994 |
Ander register | METC MEC-U : R19.035 |