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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual | Active Comparator | 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. |
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| TMS and body image intervention | Experimental | Participants will receive TMS and a body image intervention daily 5 times/week during 4 weeks |
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| sham TMS and body image intervention | Sham Comparator | Participants will receive sham TMS and a body image intervention Daily 5 times/week during 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial magnetic stimulation | Device | 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. |
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Extrastriatal body area (EBA) activation during fMRI | Change from baseline at 4 weeks and at 6 months | |
| Extrastriatal body area (EBA) connectivity during resting state fMRI | Change from baseline at 4 weeks and at 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria A Zetterqvist, PhD | Contact | +46 101034339 | maria.zetterqvist@liu.se | |
| Rebecca Böhme, PhD | Contact | rebecca.bohme@liu.se |
| Name | Affiliation | Role |
|---|---|---|
| Maria A Zetterqvist, PhD | Region Östergötland/Linköping university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Östergötland BUP-kliniken | Recruiting | Linköping | 581 85 | Sweden |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
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| Body Image Intervention | Behavioral | 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. |
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| Treatment as usual | Behavioral | Treatment as usual at the eating disorder unit, Child and adolescent psychiatric clinic and Psychiatric clinic is delivered during 4 weeks |
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| Change from baseline at 4 weeks and at 6 months |