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NCT Number: NCT06012045

Enhanced Cue Exposure Therapy for Negative Emotional Eating

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.

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Key information

Conditions

Disordered Eating Behaviors Behavior Binge Eating Body Weight Bulimia Chemically-Induced Disorders Disordered Eating Behavior Emotional Eating Feeding Behavior Feeding and Eating Disorders Hyperphagia Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Wai Sze Chan, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Cue Exposure Therapy

Behavioral

The E-CET will consist of six weekly sessions and will be delivered by a clinical psychology trainee in person. Session #1 will be used to introduce to the participant the rationale and procedures of E-CET to establish therapeutic alliance, agreement on treatment goals and tasks, and to collect information on idiosyncratic CS-US expectancies to be targeted in exposures. Sessions #2 to #5 will be in vivo exposures. The interventionist will prompt the participant to evaluate the CS-US expectancy to facilitate the violation of the CS-US expectancy maintaining NEE. Between-session homework exposures will be planned and conducted by the participant in their naturalistic environment. They will also be reviewed at the beginning of the following session to consolidate learning. The final session will consist of consolidation of treatment gains and relapse prevention.

behavioral lifestyle intervention

Behavioral

The BLI will consist of six weekly sessions of behavioral counselling integrating behavioral strategies for participants to make dietary changes. These behavioral strategies will include education about healthy and balanced diets, goal-setting, problem-solving, and relaxation. A manualized protocol developed by the PI's team for previous studies in the local community will be used.

Primary outcomes

  1. Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)

    Time frame: 14 months (up to 12-month follow-up)

    The subscale consists of 13 items assessing the tendency to eat in response to negative emotions, on a 5-point Likert scale from 1 (never) to 5 (very often). The cutoff point of >3.25 is used to indicate negative emotional eating tendencies. Higher scores indicate greater tendency and severity.

  2. Number of EMA-measured NEE episodes

    Time frame: 14 months (up to 12-month follow-up)

    Participants will respond to fixed-interval prompts asking whether they have engaged in NEE in the assessment period. The sum of all the reported episodes during the seven days will be computed to indicate the frequency of NEE per week.

Secondary outcomes

  1. Changes in NEE

    Time frame: 14 months (up to 12-month follow-up)

    It will be indexed by the association between negative emotionality and caloric consumption measured in three days a week. Negative emotionality will be measured using the four fixed interval prompts per day. Participants will be asked to select the negative emotions applied to them at the moment and rate the intensity of the selected negative emotions on a visual analog scale from 0 (not at all) to 100 (very intense). Caloric consumption will be measured by the 24-hour dietary recall interview conducted for three days a week. Stronger associations will indicate greater NEE.

  2. Changes in caloric consumption

    Time frame: 14 months (up to 12-month follow-up)

    It will be measured by the 24-hour dietary recall interview conducted for three days a week. Nutrition information on food intake (calories, protein, carbohydrates, fat, dietary fibre, sugar, and sodium) will be processed by trained research assistants.

  3. Changes in external eating measured by the external eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)

    Time frame: 14 months (up to 12-month follow-up)

    The subscale consists of 10 items assessing the tendency to eat in response to external cues on a 5-point Likert scale from 1 (never) to 5 (very often). Higher scores indicate greater frequencies of disordered eating.

  4. Changes in eating disorder symptoms measured by the Eating Disorder Examination Questionnaire-Short (EDE-QS)

    Time frame: 14 months (up to 12-month follow-up)

    It consists of 12 items assessing the symptoms of eating disorders for the preceding seven days rated on a 4-point Likert scale from 0 (0 days) to 3 (6-7 days). Higher global scores indicate greater eating disorder symptoms.

  5. Changes in body weight

    Time frame: 14 months (up to 12-month follow-up)

    It will be measured in the laboratory using a digital weighing scale.

  6. Changes in mood measured using the Depression, Anxiety and Stress Scale-21 (DASS-21)

    Time frame: 14 months (up to 12-month follow-up)

    The scale consists of 21 items rated on 0 (not at all) to 3 (very much) Likert scales assessing symptoms of anxiety, depression, and stress.

  7. Changes in quality of life measured using the Satisfaction with Life Scale (SWLS)

    Time frame: 14 months (up to 12-month follow-up)

    It is a 5-item scale measuring subjective life satisfaction on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher total scores indicate greater life satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Wai Sze Chan, PhD

CONTACT

[email protected]

+85239172295

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

A Randomized Controlled Trial of Enhanced Cue Exposure Therapy for Negative Emotional Eating

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 25, 2023
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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