Enhanced Cue Exposure Therapy for Negative Emotional Eating

Browse trials for

• Bulimia 173
• Emotional Eating 40
• Feeding and Eating Disorders 645
• Obesity 11,522
• Substance-Related Disorders 2,238

Keywords

• emotional eating
• eating disorders
• obesity
• exposure and response prevention
• behavioral therapy
• randomized controlled trial
• violation of expectancy
• inhibitory learning
• habituation
• mechanism of change

Bulimia

173 studies on the registry are indexed under Bulimia; 33 are open to participants now.

This study's planned enrollment of 138 is above the median of 60 across 143 interventional studies indexed under Bulimia.

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study arms

• Experimental
  Enhanced Cue Exposure Therapy

  This is the experimental arm. Participants will receive the 6-session enhanced cue exposure therapy.

  Behavioral: Enhanced Cue Exposure Therapy

• Active comparator
  Behavioral Lifestyle Intervention

  This is the active control arm. Participants will receive the 6-session behavioral lifestyle intervention.

  Behavioral: Behavioral Lifestyle Intervention

Interventions

• BehavioralEnhanced Cue Exposure Therapy

  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.

• BehavioralBehavioral Lifestyle Intervention

  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)

   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)

5. Changes in body weight

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

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

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

   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.

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

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

   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.

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

Individual participant data

Plan to share: Yes — De-identified individual patient data may be shared upon request for research purposes.

Supporting information: Study protocol, Statistical analysis plan, Analytic code

Time frame: De-identified data will become available indefinitely

Access criteria: Requests to share data will be evaluated by the principal investigator