None listed
Conditions
Brief summary
This study will compare Cognitive Behaviour Therapy (CBT) with Non-specific Supportive Clinical Management (NSCM), in a chronic anorexia nervosa (C-AN) sample. Subjects will include 90 females over the age of 18, meeting the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM IV) criteria for AN for more than seven years (even if there have been periods of recovery). Individuals will be randomly assigned to either CBT or NSCM and will receive 30 treatment sessions over 6 months. All patients will be monitored for six months after the end of treatment. Assessments will occur at the start of treatment, 15 weeks into treatment, end of treatment, and six months after treatment. Interpretation of Results This study aims to compare outcomes between individuals with chronic anorexia (C-AN) who receive CBT and those who receive NSCM. It is hypothesised that these treatments will influence an individual's quality of life, level of depression and social isolation. It is also thought that there will be changes in an individual's core eating disorder pathology, in their motivation for change and a reduction in the use of medical services. This innovative project will provide the world's first information about potentially effective treatments for chronic anorexia nervosa. It will be the largest study ever conducted on C-AN anywhere in the world.
Interventions
This study will compare the established therapy, Cognitive Behaviour Therapy (CBT), with the most promising therapy to emerge in the recent anorexia nervosa (AN) literature, Non-specific Supportive Clinical Management (NSCM), in a chronic anorexia nervosa (C-AN) sample. To accomplish these aims, 90 females over the age of 18, meeting the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM IV) criteria for AN for more than seven years will be randomly assigned to one of two manualised treatment conditions, CBT or NSCM. Both treatments will involve 30 individual treatment sessions over 6 months. All patients will be monitored for six months after the end of treatment. Assessments will occur at baseline, 15 weeks into treatment, end of treatment, and six months post-treatment. The primary outcome will be the change in measures assessing chronicity, i.e., Quality of Life (QoL), depression and social isolation. The secondary outcomes will include change in core eating disorder (ED) pathology, motivation for change and use of medical services (the number of hospital days, GP and specialist visits). NSCM fosters a therapeutic relationship that promotes adherence to treatment, without imposing assumptions about change; it includes education, care and support for change, without necessitating it. The treatment does not aim to restore weight, but supports patients in making any changes that will improve QoL and physical well-being, including, but not exclusively, weight change. CBT actively targets food and weight increases by having the patient challenge Eating Disorder (ED) behaviours and underlying maladaptive cognitions around food, body, weight and shape. CBT is an active treatment aimed at acheiving some weight gain and the reumption of normal eating habits by challenging underlying beliefs and thoughts through cognitive restructuring and behaviour change. This trial will involve two treatments sites and one data management site. Treatment Site 1: University of Sydney, School of Psychology Treatment Site 2: University of London, St George's School of Medicine Data Management Site: University of Chicago, Pritzker School of Medicine This innovative project will provide the world's first information about potentially effective treatments for this highly debilitated group who have proved very difficult for professionals to treat thus far. It will be the largest study ever conducted on C-AN anywhere in the world.
Sponsors
Study design
Eligibility
Inclusion criteria
Subjects will meet the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th Edition) criteria for AN for more that 7 years (even if there have been periods of recovery). Females over the age of 18. Subjects up to a Body Mass Index (BMI) of 18.5 can participate as long as menstruation has not returned. Underweight patients who meet all criteria bar that for amenorrhea can participate. All subjects will have provided informed consent prior to their inclusion in the study.
Exclusion criteria
Current manic episode or psychosis, current alcohol or substance abuse or dependence, currently engaged in psychotherapy or self-help treatment modalities for the eating disorder and not willing to forego these for the duration of their participation in the trial, significant current medical or neurological illness (including seizure disorder), with the exception of nutrition-related alterations that impacts on weight, plans to move beyond commuting distance from the study site in the following 12 months, does not live within commuting distance to the study site.