TMS and Body Image Treatment for Anorexia Nervosa

Not Applicable

Recruiting

• Conditions: Anorexia Nervosa
• Interventions: Device: Transcranial magnetic stimulation; Behavioral: Body Image Intervention; Behavioral: Treatment as usual

• Registration Number: NCT04213820
• Lead Sponsor: Region Östergötland

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-25
• Study First Submitted: 2019-12-27
• Study First Submitted QC: 2019-12-27
• Study First Posted: 2019-12-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-29
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMS and body image intervention	Transcranial magnetic stimulation	Participants will receive TMS and a body image intervention daily 5 times/week during 4 weeks
sham TMS and body image intervention	Body Image Intervention	Participants will receive sham TMS and a body image intervention Daily 5 times/week during 4 weeks
Treatment as usual	Treatment as usual	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.
TMS and body image intervention	Body Image Intervention	Participants will receive TMS and a body image intervention daily 5 times/week during 4 weeks

Primary Outcome Measures

Name	Time	Method
Body Attitude Test (BAT)	Change from baseline at 4 weeks and at 6 months	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.
Body Mass Index (BMI)	Change from baseline at 4 weeks and at 6 months	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.
Figure Rating Scale	Change from baseline at 4 weeks and at 6 months	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).
Eating Disorder Examination Questionnaire (EDE-Q)	Change from baseline at 4 weeks and at 6 months	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.
Body Shape Questionnaire (BSQ)	Change from baseline at 4 weeks and at 6 months	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.

Trial Locations

Locations (1)

Region Östergötland BUP-kliniken; 🇸🇪 Linköping, Sweden