TMS and Body Image Treatment for Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04213820
• Other study ID #: 2019-02821
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: February 2024

Study information

• Verified date: August 2023
• Source: Region Östergötland
• Contact: Maria A Zetterqvist, PhD
• Phone: +46 101034339
• Email: maria.zetterqvist[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Device:
• Transcranial magnetic stimulation
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.

Behavioral:
• Body Image Intervention
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.
• Treatment as usual
Treatment as usual at the eating disorder unit, Child and adolescent psychiatric clinic and Psychiatric clinic is delivered during 4 weeks

Locations

Country	Name	City	State
Sweden	Region Östergötland BUP-kliniken	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Region Östergötland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Extrastriatal body area (EBA) activation during fMRI		Change from baseline at 4 weeks and at 6 months
Other	Extrastriatal body area (EBA) connectivity during resting state fMRI		Change from baseline at 4 weeks and at 6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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