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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

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 - SNAP study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028469
Enrollment
80
Registered
2022-07-14
Start date
2022-03-25
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F43.1

Interventions

Group 1: Intervention group (ABE): Participants receive a single 45 min treatment session following the ABE protocol: Includes conversation-guided trauma exposure using individualized acupuncture ther

Sponsors

Klinik und Poliklinik für Psychiatrie und Psychotherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Secondary endpoints are: 2. patients* with PTSD show compared to healthy control subjects before treatment: - an increased activity of the amygdala (measured by LORETA-EEG) (confirmatory) - increased sympathetic tone (measured by HRV) - increased values on the rating scales 3. by a single treatment with ABE, patients with PTSD show: - a decrease in amygdal activity measured by LORETA-EEG - a shift in HRV from sympathicotonic values to parasympathicotonic values - an improvement in PTSD-specific symptoms as measured by the IES-R as well as the SUDs. 4. by a single treatment with NADA, patients with PTSD show - a decrease in amygdal activity measured by LORETA-EEG - a shift in HRV from sympathicotonic values to parasympathicotonic values - an improvement in PTSD-specific symptoms as measured by the IES-R and SUDs. 5. by a single treatment with ABE, patients* with PTSD show compared to a single treatment with NADA: - a greater shift in HRV from sympathicotonic to parasympathicotonic values - greater improvement in PTSD-specific symptoms as measured by the IES-R and SUDs - a greater decrease in amygdal activity as measured by LORETA-EEG. 6. during the single treatment with ABE, treatment phase-specific changes in HRV occur. -Increase in heart rate after and already during the imagination phase. -Decrease in heart rate after phases 1 ("somatics"), 2 ("psychosomatics") and 3 ("psyche"). -shift from sympathicotonic to parasympathicotonic values in the course of treatment (comparison start-end) 7. the further data collected by means of questionnaires (depressive symptomatology, childhood traumatization) are evaluated exploratively with regard to possible modulating influences on the above-mentioned hypotheses.

Countries

Germany

Contacts

Public ContactJonas Hohmann

Klinik und Poliklinik für Psychiatrie und Psychotherapie

J.Hohmann@med.uni-muenchen.de+49 15164507760

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026