Examination of the physiological changes of the body and brain during one session of acupuncture-based exposure (ABE) vs. treatment with NADA ear acupuncture in patients with PTSD compared to healthy subjects: A randomized controlled trial

Phase 2

Recruiting

• Conditions: F43.1; Post-traumatic stress disorder

• Registration Number: DRKS00028469
• Lead Sponsor: Klinik und Poliklinik für Psychiatrie und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Right-handed
Sufficient knowledge of the German language
Group-specific criteria:
a) Healthy
Physical and mental health
(collected via structured interview)

b) Patients
Type I PTSD (ICD-10: F43.1

Exclusion Criteria

Skin aging that prevents EEG derivation
Hepatitis B or C positive
Severe internal disease
Severe neurological disease with brain involvement
Epilepsy
Specific needle phobia
Pregnancy
Heavy smoker
Large tattoos or scarred skin
Regular use of certain medications: Continuous medication with benzodiazepines
Group-specific criteria:
(a) Healthy individuals

Presence of psychiatric or neurological diseases

Psychiatric or psychotherapeutic treatment in the last 10 years.

b) Patients
Taking psychotropic drugs

Comorbidity with:
- Other Axis I disorder (exclusion via M.I.N.I.).
- borderline personality disorder

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is a significantly greater reduction in amygdal activity in EEG activim in patients* with PTSD in the intervention group (ABE) compared with the control group (NADA) in the t-test for dependent samples.