TMS and Body Image Treatment for Anorexia Nervosa

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Transcranial magnetic stimulation

Body Image Intervention

Treatment as usual

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Region Östergötland BUP-klinikenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Sham Comparator

Arm Label

Treatment as usual

TMS and body image intervention

sham TMS and body image intervention

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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).

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04213820

First Posted

December 27, 2019

Last Updated

August 25, 2023

Sponsor

Region Östergötland

1. Study Identification

Unique Protocol Identification Number

NCT04213820

Brief Title

TMS and Body Image Treatment for Anorexia Nervosa

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 25, 2019 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Region Östergötland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia Nervosa

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment as usual

Arm Type

Active Comparator

Arm Description

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.

Arm Title

TMS and body image intervention

Arm Type

Experimental

Arm Description

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

Arm Title

sham TMS and body image intervention

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Transcranial magnetic stimulation

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Body Image Intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Treatment as usual

Intervention Description

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

Primary Outcome Measure Information:

Title

Eating Disorder Examination Questionnaire (EDE-Q)

Description

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.

Time Frame