TMS and Body Image Treatment for Anorexia Nervosa

Sponsor
Region Östergötland (Other)
Overall Status
Recruiting
CT.gov ID
NCT04213820
Collaborator
(none)
40
1
3
38.2
1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial magnetic stimulation
  • Behavioral: Body Image Intervention
  • Behavioral: Treatment as usual
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
TMS Treatment for Anorexia Nervosa: Effects on Body Image Processing and Clinical Outcome Measures
Actual Study Start Date :
Sep 25, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Other Outcome Measures

  1. Extrastriatal body area (EBA) activation during fMRI [Change from baseline at 4 weeks and at 6 months]

  2. Extrastriatal body area (EBA) connectivity during resting state fMRI [Change from baseline at 4 weeks and at 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Region Östergötland BUP-kliniken Linköping Sweden 581 85

Sponsors and Collaborators

  • Region Östergötland

Investigators

  • Principal Investigator: Maria A Zetterqvist, PhD, Region Östergötland/Linköping university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Zetterqvist, Principal Investigator, Region Östergötland
ClinicalTrials.gov Identifier:
NCT04213820
Other Study ID Numbers:
  • 2019-02821
First Posted:
Dec 30, 2019
Last Update Posted:
Jan 5, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2022