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TMS and Body Image Treatment for Anorexia Nervosa

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04213820
Enrollment
40
Registered
2019-12-30
Start date
2019-09-25
Completion date
2024-02-29
Last updated
2023-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

Brief summary

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

Interventions

DEVICETranscranial 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.

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.

BEHAVIORALTreatment as usual

Treatment as usual at the eating disorder unit, Child and adolescent psychiatric clinic and Psychiatric clinic is delivered during 4 weeks

Sponsors

Region Östergötland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Body Attitude Test (BAT)Change from baseline at 4 weeks and at 6 monthsBAT 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.
Figure Rating ScaleChange from baseline at 4 weeks and at 6 monthsFigure 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).
Body Mass Index (BMI)Change from baseline at 4 weeks and at 6 monthsBody 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.
Eating Disorder Examination Questionnaire (EDE-Q)Change from baseline at 4 weeks and at 6 monthsEDE-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 monthsBSQ 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.

Other

MeasureTime frame
Extrastriatal body area (EBA) connectivity during resting state fMRIChange from baseline at 4 weeks and at 6 months
Extrastriatal body area (EBA) activation during fMRIChange from baseline at 4 weeks and at 6 months

Countries

Sweden

Contacts

Primary ContactMaria A Zetterqvist, PhD
maria.zetterqvist@liu.se+46 101034339
Backup ContactRebecca Böhme, PhD
rebecca.bohme@liu.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026