TMS and Body Image Treatment for Anorexia Nervosa

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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria A Zetterqvist, PhD; Phone Number: +46 101034339; Email: maria.zetterqvist@liu.se
• Study Contact Backup: Name: Rebecca Böhme, PhD; Email: rebecca.bohme@liu.se

Study Locations

• Sweden
  • Linköping, Sweden, 581 85
    • Recruiting
    • Region Östergötland BUP-kliniken
    • Contact: Maria A Zetterqvist, PhD; Phone Number: +46 101034339; Email: maria.zetterqvist@liu.se
    • Contact: Rebecca Böhme, PhD; Email: rebecca.bohme@liu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Treatment as usual; Treatment as usual at the eating disorder unit, Child and adolescent psychiatric clinic and Psychiatric clinic is delivered during 4 weeks
Experimental: TMS and body image intervention; Participants will receive TMS and a body image intervention daily 5 times/week during 4 weeks	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.
Sham Comparator: sham TMS and body image intervention; Participants will receive sham TMS and a body image intervention 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Region Östergötland
• Investigators: Principal Investigator: Maria A Zetterqvist, PhD, Region Ostergotland/Linkoping University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: December 27, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 2019-02821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No