Enhanced Cue Exposure Therapy for Negative Emotional Eating
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Cue Exposure Therapy
BehavioralThe 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
BehavioralThe 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.
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: Enhanced Cue Exposure TherapyExperimental treatment 1 intervention
Group B: Behavioral Lifestyle InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)
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.
Time frame
14 months (up to 12-month follow-up)2
Number of EMA-measured NEE episodes
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.
Time frame
14 months (up to 12-month follow-up)Secondary outcomes
1
Changes in NEE
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.
Time frame
14 months (up to 12-month follow-up)2
Changes in caloric consumption
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.
Time frame
14 months (up to 12-month follow-up)3
Changes in external eating measured by the external eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)
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.
Time frame
14 months (up to 12-month follow-up)4
Changes in eating disorder symptoms measured by the Eating Disorder Examination Questionnaire-Short (EDE-QS)
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.
Time frame
14 months (up to 12-month follow-up)Sponsors and contacts
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Source ClinicalTrials.gov