NCT04213820

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

4.4 years

First QC Date

December 27, 2019

Last Update Submit

August 25, 2023

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • 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

Study Arms (3)

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.

Behavioral: Treatment as usual

TMS and body image intervention

EXPERIMENTAL

Participants will receive TMS and a body image intervention daily 5 times/week during 4 weeks

Device: Transcranial magnetic stimulationBehavioral: Body Image Intervention

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

Behavioral: Body Image Intervention

Interventions

Transcranial magnetic stimulationDEVICE

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.

TMS and body image intervention
Body Image InterventionBEHAVIORAL

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.

TMS and body image interventionsham TMS and body image intervention
Treatment as usualBEHAVIORAL

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

Treatment as usual

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Östergötland BUP-kliniken

Linköping, 581 85, Sweden

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Transcranial Magnetic StimulationTherapeutics

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy

Study Officials

  • Maria A Zetterqvist, PhD

    Region Östergötland/Linköping university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria A Zetterqvist, PhD

CONTACT

+46 101034339maria.zetterqvist@liu.se

Rebecca Böhme, PhD

CONTACT

rebecca.bohme@liu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2019

First Posted

December 30, 2019

Study Start

September 25, 2019

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)