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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJenny Gentizon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Auricular acupunctureExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
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

1

Impulsive aggression

Impulsive aggression will be assessed with the Brøset Violence Checklist (BVC). The BVC, a clinician-rated scale, assesses three characteristics (confusion, irritability and boisterousness) and three behaviours (verbal threats, physical threats and attack on objects) of patients as absent (score 0) or present (score 1). Each item is scored independently and then a sum total obtained. A sum of 0 suggests that the risk of violence is small, whereas a score between 2 and 6 (the maximum) indicates high risk of violence and immediate need for preventive measures. So, it is hypothesized that a client displaying more than two of these behaviors carries a high potential of becoming violent within the subsequent 24-h period. Means and standard deviations (M; sd) or medians and interquartile ranges (Mdn; IQR) will be used to present the scores.

Time frame
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).
2

Anxiety

Anxiety will be assessed using the Hamilton Anxiety Rating Scale (HAM-A) (14 items). The HAM-A evaluates the severity of anxiety symptoms across psychological and somatic (biopsychosocial) dimensions, including sleep disturbances, muscular tension, and autonomic symptoms. Each item is rated on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe). The total score ranges from 0 to 56, with higher scores indicating greater anxiety severity. A total score ≥ 20 will be considered indicative of clinically significant anxiety. Means and standard deviations (M; sd) or medians and interquartile ranges (Mdn; IQR) will be used to present the scores.

Time frame
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).
3

Deliberate self-harm

Deliberate self-harm will be assessed using the Deliberate Self-Harm Inventory (DSHI) (17 items). This self-report instrument evaluates various forms of self-injurious behavior, including their frequency, severity, duration, and type. For each behavior, participants indicate whether they have engaged in it (Yes = 1; No = 0). A total score is calculated by summing endorsed behaviors, with higher scores reflecting greater engagement in deliberate self-harm. Means and standard deviations (M; sd) or medians and interquartile ranges (Mdn; IQR) will be used to present the scores.

Time frame
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).
4

Relaxation state

Relaxation state will be measured using the Relaxation State Questionnaire (RSQ) (10 items). This self-report scale assesses subjective states of relaxation using a 5-point Likert scale ranging from 1 (do not agree at all) to 5 (totally agree). The questionnaire comprises four subscales: Muscle Relaxation, Cardiovascular Relaxation, General Relaxation, and Sleepiness. Items 1, 2, 3, and 10 are reverse scores. Higher total and subscale scores indicate greater levels of perceived relaxation. Means and standard deviations (M; sd) or medians and interquartile ranges (Mdn; IQR) will be used to present the scores.

Time frame
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).

Other outcomes

Sponsors and contacts

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Jenny Gentizon

Lead sponsor

University of Lausanne Hospitals

Sponsor institution

Manuel Simon

Collaborator

Julien Elowe

Collaborator

Luca Scuderi

Collaborator

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