TMS and Body Image Treatment for Anorexia Nervosa

Study Overview
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Brief Summary
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To evaluate if TMS together with a body image intervention is an efficacious treatment for anorexia nervosa compared to treatment as usual.

Official Title
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TMS Treatment for Anorexia Nervosa: Effects on Body Image Processing and Clinical Outcome Measures

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Device: Transcranial magnetic stimulation
* Behavioral: Body Image Intervention
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being enrolled as a patient at the eating disorder unit of the Child and adolescent psychiatric clinic and Psychiatric clinic in Linköping Having a DSM-5 diagnosis of anorexia nervosa, atypical anorexia (restrictive type) Being at least 18 years of age Having a BMI of 20 or under. Being free of psychotropic medications or on stable (at least three months on the same dose) medication. Exclusion Criteria: Clinical diagnosis of schizophrenia or psychotic disorder Clinical diagnosis of bipolar disorder Alcohol/drug dependence Ongoing treatment with antipsychotics or tricyclic antidepressants Previous severe head injury Birth before 33 weeks of gestation Hearing impairment Earlier epilepsy or seizures of other causes Having severe claustrophobia Being pregnant Having a cognitive disability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as usual<br>Participants will receive treatment as usual at the eating disorder unit at the Child and adolescent psychiatric clinic and at the Psychiatric clinic during 4 weeks. | Behavioral: Treatment as usual<br>* Treatment as usual at the eating disorder unit, Child and adolescent psychiatric clinic and Psychiatric clinic is delivered during 4 weeks<br>|
| Experimental: TMS and body image intervention<br>Participants will receive TMS and a body image intervention daily 5 times/week during 4 weeks | Device: Transcranial magnetic stimulation<br>* TMS (theta burst) will be administered consisting of bursts containing 3 pulses at 50 Hz and an intensity of 80% motor threshold repeated at 200 ms intervals (i.e., at 5 Hz) and a 10 s between burst triplet interval for a total for 190 s (600 pulses). The intervention will be given daily 5 times/week during 4 weeks.<br>Behavioral: Body Image Intervention<br>* Body image interventions delivered directly after TMS will include body exercises that target disturbed body image and psychoeducation about the body. Together with a therapist the participants with anorexia nervosa will explore and estimate their body size through feedback.<br>|
| Sham Comparator: sham TMS and body image intervention<br>Participants will receive sham TMS and a body image intervention Daily 5 times/week during 4 weeks | Behavioral: Body Image Intervention<br>* Body image interventions delivered directly after TMS will include body exercises that target disturbed body image and psychoeducation about the body. Together with a therapist the participants with anorexia nervosa will explore and estimate their body size through feedback.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Disorder Examination Questionnaire (EDE-Q) | EDE-Q measures symptoms of eating disorder. It contains at total of 36 items. 23 of these are rated on a Likert scale between 0-6 and contains 4 subscales: Restraint (ranging from 0-30); Eating concern (ranging from 0-30); shape concern (ranging from 0-48); weight concern (ranging from 0-30). Higher scores indicating more difficulties with eating disorder. In addition, 11 open ended questions concern binge eating and compensating behaviors. | Change from baseline at 4 weeks and at 6 months | 
| Body Attitude Test (BAT) | BAT measures attitudes toward one own body. It contains a total of 20 items that are rated on a Likert scale between 0-5. Total scores range from 0-100. Higher scores indicate more problems with body attitude. | Change from baseline at 4 weeks and at 6 months | 
| Body Shape Questionnaire (BSQ) | BSQ measures dissatisfaction with one's own body/figure. It contains a total of 34 items, which are rated on a Likert scale ranging from 1-6. total scores range from 34-204, with higher scores indicating more dissatisfaction. | Change from baseline at 4 weeks and at 6 months | 
| Figure Rating Scale | Figure Rating Scale measures body image and estimation of one's own body size. Each figure presents nine schematic silhouettes, ranging from extreme thinness (1) to extreme obesity (9). For research purposes, participants are asked to self-select the silhouette that best indicates his or her current body size (ranging from 1-9) and the silhouette that reflects his or her ideal body size (ranging from 1-9). | Change from baseline at 4 weeks and at 6 months | 
| Body Mass Index (BMI) | Body Mass Index is a person's weight in kilograms divided by the square of height in meters and is an indication of under- or overweight in adults. | Change from baseline at 4 weeks and at 6 months |