Online Cognitive Behavioral Therapy-Enhanced: Guided self-help versus screen to screen for Binge Eating Disorder, A Randomized Controlled Trial

Online Cognitive Behavioral Therapy-Enhanced: Guided self-help versus screen to screen for Binge Eating Disorder, A Randomized Controlled Trial - Online guided self-help versus screen tot screen for Binge Eating Disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51181

Enrollment

180

Registered

2021-05-25

Start date

2021-11-19

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating Disorder eating disorder

Interventions

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 inv

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. binge eating disorder or other specified feeding or eating disorder (OSFED) binge eating disorder classification 2. Age >= 18 3. 19.5

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)