None listed
Conditions
Brief summary
This research project is based at Eating Disorders Victoria (EDV) and embeds a master of clinical psychology placement program for postgraduate psychology students within a research program examining evidence-based eating disorder assessment and treatment. (Master Research Agreement attached) This is a pilot and feasibility RCT with two primary aims: (i) to explore the viability of running a full RCT to compare treatment efficacy and cost effectiveness of a stepped-care model of eating disorder treatment, specifically comparing two interventions; Cognitive Behaviour Therapy (CBT-E) and Guided Self Help (GSH); and (ii) to explore the feasibility of providing specialised training in eating disorder treatment and access to treatment via a community-university partnership that embeds professional psychology training in an ongoing research and treatment program. It is expected that eating disorder symptoms will be significantly reduced from pre- to post-treatment in both CBT-E and GSH. It is also expected that those allocated to the CBT-E group will have significantly lower eating disorder symptoms post-treatment compared to those allocated to GSH.
Interventions
Extended/Enhanced Cognitive Behavioural Therapy (CBT-E)
CBT-E is an evidence-based, transdiagnostic treatment for eating disorders that can be applied to all diagnostic categories of eating disorders including anorexia nervosa, bulimia nervosa, and binge eating disorder and other disordered eating presentations (C. G. Fairburn, 2008). The general protocol is described in ‘Cognitive Behavior Therapy and Eating Disorders’ (C. G. Fairburn, 2008) and will be followed in this study. CBT-E consists of
Extended/Enhanced Cognitive Behavioural Therapy (CBT-E) CBT-E is an evidence-based, transdiagnostic treatment for eating disorders that can be applied to all diagnostic categories of eating disorders including anorexia nervosa, bulimia nervosa, and binge eating disorder and other disordered eating presentations (C. G. Fairburn, 2008). The general protocol is described in ‘Cognitive Behavior Therapy and Eating Disorders’ (C. G. Fairburn, 2008) and will be followed in this study. CBT-E consists of a 20-session course of treatment offered over 20 weeks covering four distinct therapeutic stages - starting well (building rapport, regular eating), taking stock (identifying barriers to treatment), addressing maintaining factors (checking behaviours), and ending well (ways of maintaining progress). Each session runs for 50-60 minutes. At the end of treatment, the CBT-E group will have received 20 sessions over 20 weeks (i.e., weekly sessions). Provisional psychologists will be delivering treatment under the supervision of multiple experienced clinical psychologists. Treatment will be delivered primarily face-to-face, but participants will have the option of telehealth. Treatment adherence will be monitored and documented closely by the treating clinician (a provisional psychologist), including session attendance, and will be a check=in topic for supervision sessions with the clinician's supervisor. Provisional psychologists will receive training over the course of the month before beginning to see clients. This involves attending training with their clinical supervisor (i.e., Kim Haebich and/or Annemarie Hindle) and experts in the field (e.g., Tracey Wade) on delivering CBT-E and GSH, as well as watching recordings of additional psychotherapy training from these same individuals. Training modes will mostly be online, however, some clinical supervision with their primary supervision (KH) will be face to face.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 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)
Exclusion criteria
* 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 or = than three instances per day. Haematemesis * Psychological risk - Acute comorbid mental health disorder. Depression, Anxiety or Stress in 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
Outcome results
None listed