Pilot Study on Auricular Acupuncture in Hospitalized Adults With Borderline Personality Disorder

NCT07476300 | Not Yet Recruiting DMC

• 2 other identifiers: CERVD 2026-INTERFACE
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to evaluate the feasibility and preliminary effectiveness of a brief auricular acupuncture program delivered by mental health nurses as a complementary therapy for adults hospitalized with borderline personality disorder (BPD). The main questions it aims to answer are:

• Is participation in the five-session auricular acupuncture program feasible (in terms of attendance) for hospitalized adults with borderline personality disorder?
• Does the auricular acupuncture intervention show potential benefits on emotional regulation, anxiety, sleep quality, and overall clinical status? 15 hospitalized adults with BPD will receive 5 individual ear acupuncture sessions, over a 9-day period, based on the National Acupuncture Detoxification Association (N.A.D.A.) protocol in addition to treatment as usual. Participants will complete brief questionnaires at several time points. The findings will inform the feasibility of the study procedures and guide the development of a future larger-scale clinical trial.

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality Disorder; Acupuncture; Complementary and Alternative Medicine; Psychiatric patients; Hospitalized patients; Feasibility Study; Pilot study; Mental Health Nursing

Outcome Measures

Primary Outcomes (1)

• Feasibility of the study design

  The primary objective is to evaluate the feasibility of the study design, defined as the attendance to the ear acupuncture sessions (n, %). Feasibility will be deemed satisfactory if 75% of the participants attend at least 4 out of 5 of the planned acupuncture sessions. A proportion lower than 75% will be considered unsatisfactory.

  Participant attendance will be recorded at each scheduled study visit corresponding to acupuncture sessions (Day 0 [baseline], Days 2, 4, 6, and 8) in a study worksheet completed by the nurse administering the intervention.

Secondary Outcomes (9)

• Impulsive aggression

  Collected at 10 time points: Day 0 (baseline incl. acupuncture n°1); Days 2, 4, 6, and 8 (acupuncture sessions n°2 to 5); Days 1, 3, 5, and 7 (24-hour intervals between sessions); and Day 11 (follow-up, 2 days after program completion).

• Anxiety

  Collected at 10 time points: Day 0 (baseline incl. acupuncture n°1); Days 2, 4, 6, and 8 (acupuncture sessions n°2 to 5); Days 1, 3, 5, and 7 (24-hour intervals between sessions); and Day 11 (follow-up, 2 days after program completion).

• Deliberate self-harm

  Collected at 10 time points: Day 0 (baseline incl. acupuncture n°1); Days 2, 4, 6, and 8 (acupuncture sessions n°2 to 5); Days 1, 3, 5, and 7 (24-hour intervals between sessions); and Day 11 (follow-up, 2 days after program completion).

• Relaxation state

  Collected at 6 time points: Day 0 (baseline incl. acupuncture n°1); Days 2, 4, 6, and 8 (acupuncture sessions n°2 to 5); and Day 11 (follow-up, 2 days after program completion).

• Sleep quality

  Collected at 10 time points: Day 0 (baseline incl. acupuncture n°1); Days 2, 4, 6, and 8 (acupuncture sessions n°2 to 5); Days 1, 3, 5, and 7 (24-hour intervals between sessions); and Day 11 (follow-up, 2 days after program completion).

Study Arms (1)

Auricular acupuncture

EXPERIMENTAL

Single-arm intervention consisting of five individual auricular acupuncture sessions based on the National Acupuncture Detoxification Association (N.A.D.A) protocol, delivered by trained mental health nurses in addition to treatment as usual.

Procedure: Auricular acupuncture program based on the N.A.D.A. protocol

Interventions

Auricular acupuncture program based on the N.A.D.A. protocol PROCEDURE

Participants receive a brief, standardized auricular acupuncture intervention based on the National Acupuncture Detoxification Association (N.A.D.A.) protocol. The intervention consists of five individual ear acupuncture sessions delivered over nine days, with approximately 24 hours between sessions. Sessions are conducted in the participant's hospital room between 4:00 p.m. and 8:00 p.m. by mental health nurses certified as N.A.D.A. practitioners. Sterile, single-use needles are inserted at three to five standardized auricular points and retained for approximately 30 to 45 minutes. All participants continue to receive treatment as usual throughout the study period. Participants may pause or discontinue the intervention at any time without consequences.

Auricular acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Currently hospitalized in a psychiatric unit at the Prangins site of Lausanne University Hospital (CHUV)
• Diagnosed with borderline personality disorder, as documented in the medical record
• Able to speak and understand French
• Able to communicate verbally
• Clinically stable enough to participate, as determined by the healthcare team
• Able to understand the study information and provide written informed consent

You may not qualify if:

• Presence of severe clinical instability, such as: marked agitation, high risk of suicide, risk of harm to others
• Inability to provide informed consent (for example, due to impaired judgment or legal protective measures)
• Currently hospitalized in a seclusion or isolation room
• Expected discharge from hospital before completion of the five acupuncture sessions
• Current treatment with anticoagulant (blood-thinning) medications
• Current treatment with immunosuppressive medications
• Currently receiving acupuncture treatment for any reason
• Received acupuncture within the past three months for anxiety, emotional regulation, relaxation, or sleep problems
• Participation in intensive behavioral therapy programs outside usual care that target similar outcomes
• Presence of skin lesions, irritation, or infection on the ears
• Severe fear of needles
• Inability to remain still during acupuncture sessions

Sponsors & Collaborators

• Jenny Gentizon: lead
• Manuel Simon: collaborator
• Julien Elowe: collaborator
• Luca Scuderi: collaborator

Study Sites (1)

Psychiatric hospitalization units at the Prangins site of the Lausanne University Hospital (CHUV)

Lausanne, Canton of Vaud, Switzerland

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Central Study Contacts

Jenny Gentizon, Ph.D

CONTACT

+41795568033; jenny.gentizon@chuv.ch

Manuel Simon, MSc

CONTACT

+41795566398; Manuel.Simon@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse PhD, Principal Investigator, Nurse Researcher with a focus on medication-related problems and Senior Lecturer in advanced practice nursing at the Master's level.

Model Details: A quasi-experimental pilot study using a single arm based on a pretest-posttest design

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 17, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)