None listed
Conditions
Brief summary
This research project will be based at La Trobe University Albury-Wodonga (LTU-AW) and Eating Disorders Victoria (EDV) and embeds a professional 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 two brief eating disorder interventions; Ten Session Cognitive Behaviour Therapy (CBT-T) and Ten session Guided Self Help (GSH-T), 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-T and GSH-T. It is also expected that those allocated to the CBT-T group will have significantly lower eating disorder symptoms post-treatment compared to those allocated to GSH-T.
Interventions
The intervention treatment will be ten session Cognitive Behaviour Therapy (CBT-T) compared to ten session guided self-help (GSH-T).
Baseline:
Assessment interviews:
• Semi-structured clinical interview based on that recommended by C. G. Fairburn (2008)
• Eating Disorder Examination 17.0D (EDE 17.0D; C. G. Fairburn, 2008), a structured, investigator-based clinical interview that generates DSM-5 eating disorder diagnoses.
Questionnaires:
• Demographic items: This questionnaire was developed for
The intervention treatment will be ten session Cognitive Behaviour Therapy (CBT-T) compared to ten session guided self-help (GSH-T). Baseline: Assessment interviews: • Semi-structured clinical interview based on that recommended by C. G. Fairburn (2008) • Eating Disorder Examination 17.0D (EDE 17.0D; C. G. Fairburn, 2008), a structured, investigator-based clinical interview that generates DSM-5 eating disorder diagnoses. Questionnaires: • Demographic items: This questionnaire was developed for the purpose of this study. It includes information about height and weight, family structure, education, employment, weight, eating and activity history. • Depression Anxiety and Stress Scale Short Form (DASS-21; Lovibond & Lovibond, 1995): This 21-item scale measures the participant’s negative emotional states, specifically depression, anxiety and stress. Each item is rated on a scale from ‘did not apply to me at all’ to ‘applied to me very much, or most of the time’. • Eating Disorder Examination Questionnaire (6.0) (EDE-Q 6.0; Fairburn & Beglin, 2008) is a 28-item scale that measures behavioural components of disordered eating. A global score and four subscales can be derived: (a) restraint (b) eating concerns (c) weight concerns, and (d) shape concerns. • Clinical Impairment Assessment Questionnaire 3.0 (CIA: Bohn & Fairburn, 2008): A 16-item scale designed to assess severity of psychosocial impairment due to eating disorder features. • Assessment of Quality of Life 8D (AQOL 8D; Richardson et al., 2014): A 35-item health-related multi-attribute utility quality of life instrument assessing attributes of independent living, happiness, mental health, coping, relationships, self-worth, pain, and senses. • Client measure o Client outcome measure, satisfaction with treatment: ~40 items asks clients about their experience, specific to treatment modality (I.e., there are two separate measures with items specific to GSH-T and CBT-T). This measure also includes qualitative, open-ended questions. o Measure intervention/appropriateness: This 9-item measure created for this project includes a range of items asking about the weekly measures length/appropriateness, and the quality, content, and length of sessions (3-point Likert scale). Measure also includes qualitative, open-ended questions. Mid-treatment assessment: Participants will repeat the DASS-21, EDE-Q6, CIA, AQOL 8D Weekly monitoring: Participants will complete the Kessler 10 and brief EDE-Q • Brief Eating Disorder Examination Questionnaire (Brief EDE-Q6; Fairburn & Beglin, 2008): A brief 8 item version of the EDE-Q6 assessing frequency of eating disorder behaviours. • Kessler 10 (K10; Kessler et al., 2002): A 10-item scale assessing level of psychological distress. Items are rated on a 5-point scale of 1 (All the time) to 5 (None of the time). • Client measure intervention/appropriateness End of treatment: • Participants will complete the EDE clinical interview and the DASS-21, EDE-Q6, CIA, AQOL 8D. • Client experience / satisfaction: Clients will complete the Client Rating Scale and outcome measure, as well as the measure/intervention appropriateness Follow up (6m, 12m, 18, 24m): Participants will complete the DASS-21, EDEQ, CIA, AQOL 8D. These measures will be delivered via REDCap and completed online by participants. The intervention will be delivered by provisional psychologists on placement at La Trobe University as part of their Masters of Professional Psychology (MPP) program, under the supervision of two experienced clinical psychologists. Treatment will be delivered via telehealth consults or on campus at La Trobe University's Wodonga campus. Each treatment group will have 10 sessions, ideally in sequential weeks, but there is some flexibility and reasonable adjustments where the treatment window can be as long at 15 weeks, where if participants are sick or have genuine reasons for missing sessions, they will not be excluded from receiving treatment. However, three consecutive weeks of cancellations will result in treatment ceasing. The sessions will last 60 minutes for CBT-T, and 30 minutes for GSH-T. Intervention will occur via telehealth or on campus at La Trobe University's Wodonga campus. Strategies to monitor treatment adherence are indicated above in measures and will be monitored by the treating clinician. Treatment fidelity will be monitored in weekly supervision.
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 - >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 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
Outcome results
None listed