Ten Session Intervention in the Treatment of Disordered Eating: A Randomised Controlled Pilot and Feasibility Study (ED10)
- Conditions
- disordered eatingeating disordersdepressionanxietystressquality of lifePublic Health - Other public healthMental Health - Eating disorders
- Registration Number
- ACTRN12623000985684
- Lead Sponsor
- a Trobe University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
Age - 18 years or older
Disordered eating - Diagnosis of bulimia nervosa (BN), binge-eating disorder (BED), other-specified feeding or eating disorder (OSFED), unspecified feeding or eating disorder (UFED), based on EDE 17.0D assessment
Medical monitoring- Participant has a GP who is aware of participant’s disordered eating. Both participant and GP are willing to conduct medical monitoring during the trial. At a minimum, medical monitoring will include a medical assessment prior to study commencement, and at any point at which (i) the treating clinician deems it appropriate (e.g., where there are indicators of medical risk or instability) or (ii) the GP deems it necessary. Consent is provided by the participant for treating clinicians to share clinical information with their nominated GP and any other members of their treating team (e.g., dietician, psychiatrist) and for the GP to share clinical information with the treating clinician.
Suicide risk - No thoughts of suicide or self-harm, OR Irregular or fleeting thoughts of suicide or self-harm without intent or plan. Self-harm does not include binge eating, purging, laxative use or excessive exercise occurring as a symptom of disordered eating.
Medically Stable- Blood pressure, heart rate, Biochemistry including electrolytes indicate medical stability as assessed by the GP. No current rapid weight loss
Purging behaviour - Low frequency. Fewer than 3 instances per day
Psychological risk - No comorbid severe mental health disorder (e.g., depression, anxiety symptoms in the severe to extremely severe range) OR Symptoms likely to interfere with engagement in treatment (e.g., active psychosis)
Recent hospital admission - No eating disorder or other psychiatric (including self-harm) related hospital admission in previous 12 months.
Drug and alcohol- No drug and alcohol issues
BMI - >17.5kg/m2
Weight loss - No significant rapid weight loss in previous 3 to 6 months
Structure/supervision required for eating/weight gain - Must demonstrate some level of independent eating
Social and clinical supports - Present (e.g., stable and safe housing, supportive family/friends/or living arrangements)
* Age - under 18 years
* Disordered eating - Diagnosis of anorexia nervosa (AN). No diagnosis of an eating disorder
* Medical monitoring - Participant does not want GP involved or unable to establish regular GP monitoring.
* Suicide risk - Regular thoughts or intent of suicide or self-harm, OR Current plan OR Previous attempts OR Serious and intentional self-harm
* Medically stable - Medically unstable i.e. Blood pressure, heart rate, electrolytes, cardiac function indicate medical instability or risk as assessed by the GP, OR Rapid weight loss (current), severe emaciation, OR Severe unstable medical comorbidity (e.g., unstable diabetes)
* Purging behaviour - Purging after every food/fluid intake equal to or more than three instances per day. Haematemesis
* Psychological risk - Acute comorbid mental health disorder. Depression, Anxiety or Stress in the Severe category (DASS21). Symptoms of psychosis.
* Recent hospital admission - Long eating disorder or psychiatric (including self-harm) related admission history with minimal recovery OR Eating disorder or psychiatric (including self-harm) related hospital admission in previous 12 months.
* Drug and alcohol - Current active or untreated drug and alcohol use
* BMI - BMI less than 17.5kg/m2
* Weight loss - Experienced rapid weight loss across the past 3 to 6 months (e.g., a weight loss of more than 10-15% of total body mass in 3 – 6 months)
* Structure/supervision required for eating/weight gain - Supervision required at all meals
* Social and clinical supports - Not present
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method