TMS and Body Image Treatment for Anorexia Nervosa

NCT ID: NCT04213820

Last Updated: 2023-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-25

Study Completion Date

2024-02-29

Brief Summary

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

Detailed Description

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Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

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

TMS and body image intervention

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

Group Type EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type DEVICE

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 Intervention

Intervention Type BEHAVIORAL

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 TMS and body image intervention

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

Group Type SHAM_COMPARATOR

Body Image Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Region Östergötland

OTHER

Sponsor Role lead

Responsible Party

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Maria Zetterqvist

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria A Zetterqvist, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Östergötland/Linköping university

Locations

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Region Östergötland BUP-kliniken

Linköping, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Maria A Zetterqvist, PhD

Role: CONTACT

+46 101034339

Rebecca Böhme, PhD

Role: CONTACT

Facility Contacts

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Maria A Zetterqvist, PhD

Role: primary

+46 101034339

Rebecca Böhme, PhD

Role: backup

Other Identifiers

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2019-02821

Identifier Type: -

Identifier Source: org_study_id

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