Clinical trial NCT06012045: Enhanced Cue Exposure Therapy for Negative Emotional Eating
Official title: A Randomized Controlled Trial of Enhanced Cue Exposure Therapy for Negative Emotional Eating
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disordered Eating Behaviors
Binge Eating
Keywords: emotional eating
eating disorders
obesity
exposure and response prevention
behavioral therapy
randomized controlled trial
violation of expectancy
inhibitory learning
habituation
mechanism of change
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study aims to evaluate the efficacy of Enhanced Cue Exposure Therapy (E-CET) in reducing negative emotional eating (NEE), compared to an active control intervention, behavioral lifestyle intervention (BLI), in a parallel-group, participant-blinded, randomized controlled trial. The secondary aim is to evaluate whether changes in conditioned stimulus-unconditioned stimulus (CS-US) expectancies mediate the changes in NEE.

Detailed description: Participants will be randomly assigned to either the experimental treatment or control BLI group. Participants in the experimental group will receive 6 weeks of E-CET treatment and those in the control group will receive 6 weeks of behavioral counselling integrating behavioral strategies for making changes related to diet and exercise. Outcomes will be assessed at baseline, posttreatment, and 3- and 12-month follow-ups.

Research question 1:

Is E-CET an efficacious intervention for reducing NEE?

Hypothesis 1:

E-CET will lead to greater reductions in NEE at posttreatment and follow-up compared to BLI.

Research question 2:

Does E-CET work via the violation of the CS-US expectancies?

Hypothesis 2:

Changes in the believability of CS-US expectancies will mediate the treatment effects of E-CET on NEE.

Eligibility criteria: Inclusion Criteria:

* aged 18 or over
* a score \>3.25 on the emotional eating subscale of the Dutch Eating Behavioural Questionnaire lasting for three months or longer
* confirmed to have, on average, two or more NEE episodes per week using ecological momentary assessments (EMAs)

Exclusion Criteria:

* active suicidal intent or plan
* psychiatric illnesses except mood disorders, anxiety disorders, and eating disorders because mood and anxiety disorders and symptoms are common in those with NEE
* currently receiving psychotherapy, or adjusting to changing psychiatric medication
* substance abuse
* any conditions or circumstances that prevent the participant from receiving all treatment sessions

Primary outcomes:
measure: Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)
timeFrame: 14 months (up to 12-month follow-up)
measure: Number of EMA-measured NEE episodes
timeFrame: 14 months (up to 12-month follow-up)
Secondary outcomes:
measure: Changes in NEE
timeFrame: 14 months (up to 12-month follow-up)
measure: Changes in caloric consumption
timeFrame: 14 months (up to 12-month follow-up)
measure: Changes in external eating measured by the external eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)
timeFrame: 14 months (up to 12-month follow-up)
measure: Changes in eating disorder symptoms measured by the Eating Disorder Examination Questionnaire-Short (EDE-QS)
timeFrame: 14 months (up to 12-month follow-up)
measure: Changes in body weight
timeFrame: 14 months (up to 12-month follow-up)
measure: Changes in mood measured using the Depression, Anxiety and Stress Scale-21 (DASS-21)
timeFrame: 14 months (up to 12-month follow-up)
measure: Changes in quality of life measured using the Satisfaction with Life Scale (SWLS)
timeFrame: 14 months (up to 12-month follow-up)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Wai Sze Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References: