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

Feasibility and Preliminary Effectiveness of a Nurse-led Auricular Acupuncture Intervention as a Complementary Therapy to Usual Treatments: A Pilot Study in Adults Hospitalized in Psychiatric Units With Borderline Personality Disorder

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Procedure: Auricular acupuncture program based on the N.A.D.A. protocol

Detailed Description

The study "ACUPSY" is a single-center, quasi-experimental, single-arm pilot trial conducted in a French-speaking university hospital in Switzerland, designed to evaluate the feasibility and preliminary effectiveness of a brief auricular acupuncture intervention delivered by trained mental health nurses as a complement to treatment as usual (TAU) for adults hospitalized with borderline personality disorder (BPD).

Background and rationale Borderline personality disorder is associated with severe emotional and impulse dysregulation, high psychiatric comorbidity, and elevated risk of suicide. Despite relatively high reported levels of satisfaction (66-88%) and perceived helpfulness (64-90%) of mental health services, substantial variability exists across service types, diagnostic groups, and care settings. Among individuals with BPD, previous studies have identified significant unmet needs in symptom management, treatment satisfaction, and quality of life, with patients frequently reporting difficulty coping with persistent and severe symptoms.

Improving mental health care for individuals with BPD may benefit from the integration of empirically supported complementary therapies. This approach aligns with the growing interest among both patients and healthcare professionals in complementary and alternative medicine (CAM) for mental health care.

Acupuncture has demonstrated potential benefits in mental health settings, particularly for anxiety, depression, sleep disturbances, substance use, and emotional distress. The National Acupuncture Detoxification Association (N.A.D.A.) protocol is a standardized and accessible form of auricular acupuncture targeting three to five specific ear points and is widely used in behavioral health settings. However, the feasibility and potential benefits of brief auricular acupuncture interventions during psychiatric hospitalization for individuals with BPD remain unexplored.

This pilot study aims to generate preliminary evidence on feasibility and potential clinical effects to inform the design of a future larger-scale trial.

Study design The study uses a single-arm, pretest-posttest design. Fifteen adults diagnosed with BPD and hospitalized in psychiatric units at the Prangins site of the Lausanne University Hospital (CHUV) will be recruited using convenience sampling.

All participants receive the auricular acupuncture intervention in addition to TAU. There is no control group.

Intervention The intervention consists of a standardized auricular acupuncture program based on the N.A.D.A. protocol.

Participants receive five individual ear acupuncture sessions over a nine-day period, with 24 hours between consecutive sessions. Sessions are scheduled between 4:00 p.m. and 8:00 p.m. and are conducted in the participant's hospital room.

Each session is delivered by a mental health nurse certified as a N.A.D.A. practitioner. Sterile, single-use needles are inserted at five standardized auricular points bilaterally, according to the protocol. Each acupuncture session last 45 minutes.

Treatment as usual All participants continue to receive standard inpatient psychiatric care throughout the study period. TAU includes supportive psychotherapeutic approaches as well as symptom-focused pharmacological treatment, and multidisciplinary care provided by psychiatrists, nurses, physical therapists, occupational therapists, and social workers.

Participation in the study does not modify or restrict access to standard treatments.

Study procedures and data collection Following informed consent and baseline assessment (Day 0), participants complete a series of study visits and assessments across multiple predefined time points (Day 0 to Day 8 + Day 11).

The study includes six visits during the hospital stay:

• Five intervention visits corresponding to acupuncture sessions (Day 0, 2, 4, 6, 8, with a 24-interval between each sessions)
• One follow-up visit two days after completion of the intervention (Day 11, two days after the end of the program) Participants also complete brief self-administered questionnaires during the intervals between acupuncture sessions. Questionnaires may be completed independently on paper or with assistance from the study nurse if needed.

Baseline assessments include sociodemographic and health-related information. Repeated measures assess emotional regulation, anxiety, self-harm behaviours, relaxation, sleep quality, treatment satisfaction, clinical severity, and psychotropic medication use.

Attendance at each acupuncture session is recorded and serves as the primary outcome (feasibility). Additional feasibility indicators include recruitment rate, retention rate, questionnaire completion, and acceptability of procedures.

Safety monitoring The intervention is classified as minimal risk (category A). Sessions are conducted exclusively by certified nurses trained in the N.A.D.A. protocol.

Before and after each session, the nurse assesses for bruising, bleeding, localized pain, infection, vasovagal reactions, or other discomfort. Appropriate measures, including cold packs, antiseptic application, session adjustment, or discontinuation, may be applied if needed.

Participants have access to a call button during sessions and may pause or stop the intervention at any time without consequences.

All adverse events are documented. If a participant's mental health deteriorates (e.g., increased distress, agitation, or anxiety), the principal investigator may suspend participation and, with consent, inform the treating psychiatrist.

Recruitment and consent Potential participants are identified and pre-screened by the clinical team. Eligibility is then confirmed by a trained study nurse independent from the psychiatric units.

Participants receive oral and written study information and provide written informed consent before enrolment. Participation is voluntary, and participants may withdraw at any time without impact on their medical care.

Compensation Participants receive a CHF 20 Swiss francs gift card in a grocery store at the end of each study visit, for a maximum total compensation of CHF 120 Swiss francs. No costs are incurred by participants or their health insurers.

Data management and confidentiality Study data are collected using standardized case report forms and stored in a secure REDCap database. Participants are assigned unique identification codes. Personal identifying information is stored separately from study data.Data handling complies with Swiss data protection regulations and Good Clinical Practice guidelines.

Statistical considerations As a pilot study, the sample size is based on feasibility considerations rather than formal power calculation. The study aims to include 13 hospitalized patients with borderline personality disorder. Allowing an anticipated dropout rate of approximately 15%, a total of 15 participants will be recruited.

Statistical analyses will be primarily descriptive and exploratory. Feasibility outcomes will be summarized using attendance rates, retention rates, and questionnaire completion rates. Continuous variables will be described using means and standard deviations or medians and interquartile ranges, as appropriate, while categorical variables will be summarized using frequencies and percentages.

Changes in clinical outcomes over time will be explored using within-subject comparisons across measurement time points. Depending on data distribution, appropriate parametric or non-parametric methods will be applied (e.g., paired t-tests or Wilcoxon signed-rank tests). When relevant, exploratory longitudinal analyses may be conducted to examine trends across repeated measurements.

Missing data patterns and dropout rates will be examined and reported. No formal hypothesis testing or adjustment for multiple comparisons is planned, as the study is not powered for confirmatory analyses.

Results will be used to refine study procedures, assess outcome measure sensitivity, and inform sample size estimation and design considerations for a future randomized controlled trial.

Dissemination Study findings may be presented at scientific conferences and published in peer-reviewed journals. Only aggregated data will be reported. Individual participants will not be identifiable in publications.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenny Gentizon, Ph.D; Phone Number: +41795568033; Email: jenny.gentizon@chuv.ch
• Study Contact Backup: Name: Manuel Simon, MSc; Phone Number: +41795566398; Email: Manuel.Simon@chuv.ch

Study Locations

• Switzerland
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland
      • Psychiatric hospitalization units at the Prangins site of the Lausanne University Hospital (CHUV)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• 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

Exclusion criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Auricular acupuncture; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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.	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	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.	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	Sleep quality will be evaluated using the Groningen Sleep Quality Scale (GSQS) (15 items). This brief questionnaire assesses subjective sleep quality for the previous night (recall period: last night) using a true/false response format. One point is assigned for each response indicating poor sleep (i.e., "True" for items 2, 3, 4, 5, 6, 7, 9, 11, 13, 14, 15 and "False" for items 8, 10, 12). The first item is not included in the total score. Total scores range from 0 to 14, with higher scores indicating poorer sleep quality. A score ≥ 6 suggests poor sleep quality for the previous night, whereas scores between 0 and 2 indicate good, restorative sleep. Means and standard deviations (M; sd) or medians and interquartile ranges (Mdn; IQR) will be used to present the scores.	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).
Satisfaction with the treatment	Satisfaction with treatment will be assessed using the Client Assessment of Treatment Scale - Inpatient Version (CAT) (7 items). This brief instrument measures patients' satisfaction with and perceived appropriateness of their inpatient treatment. Each item is rated on a 100-mm visual analogue scale ranging from 0 ("not at all") to 10 ("yes, entirely"). A total score is computed by summing item scores, with higher scores indicating greater satisfaction with treatment. Means and standard deviations (M; sd) or medians and interquartile ranges (Mdn; IQR) will be used to present the scores.	Collected at 3 time points: Day 0 (baseline incl. acupuncture n°1); Day 6 (4th acupuncture session); and Day 11 (follow-up, 2 days after program completion).
Clinical severity	Clinical severity and improvement will be evaluated by clinicians using the Clinical Global Impressions Scale (CGI) (2 items). The CGI consists of two components: CGI-Severity (CGI-S) assesses overall illness severity on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).; CGI-Improvement (CGI-I) evaluates change relative to baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse since initiation of treatment/admission). Ratings should reflect the clinician's overall impression based on observations over the preceding 7 days. Lower scores indicate lower symptom severity (CGI-S) and greater clinical improvement (CGI-I). Means and standard deviations (M; sd) or medians and interquartile ranges (Mdn; IQR) will be used to present the scores.	Collected at 3 time points: Day 0 (baseline incl. acupuncture n°1); Day 6 (4th acupuncture session); and Day 11 (follow-up, 2 days after program completion).
Psychotropic medications	Use of psychotropic medications will be recorded based on the patient's electronic health record. The total number of psychotropic medications will be calculated based on the number of psychotropic agents prescribed on the day of each data collection time point. Medications will be categorized according to the Anatomical Therapeutic Chemical (ATC) classification system as follows: benzodiazepines (N03AE, N05BA, N05CD), benzodiazepine-related drugs (N05CF), antipsychotics (N05A), antidepressants (N06A), antiepileptics (N03A), and opioid analgesics (N02A). Data will be reported as absolute and relative frequencies (n; %).	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).
Other aspects of feasibility	Other aspects of feasibility concerning the study design will be evaluated: Recruitment rate (proportion of eligible participants who consent to participate), (n; %); Dropout rate and reasons for discontinuation (n; %); Data completeness (proportion of missing data) (n; %); Occurrence of adverse events (proportion of any unfavorable or unintended sign, symptom, or medical or psychological occurrence temporally associated with the acupuncture intervention, whether or not it is considered related to the intervention) (n; %); Duration of each acupuncture session, in minutes (M; sd or Mdn; IQR)	- Recruitment rate, dropout rate, data completeness and the occurrence of adverse events will be collected throughout the study period. - Duration of each acupuncture session will be collected at Day 0, 2, 4, 6, and 8 (acupuncture sessions n°1 to 5).

Collaborators and Investigators

• Sponsor: Jenny Gentizon
• Collaborators: Manuel Simon; Julien Elowe; Luca Scuderi

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Acupuncture; Borderline Personality Disorder; Pilot study; Complementary and Alternative Medicine; Feasibility Study; Hospitalized patients; Psychiatric patients; Mental Health Nursing
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: CERVD 2026-; INTERFACE (Other Grant/Funding Number: University of Lausanne)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregated study results will be made publicly available through scientific publications and presentations. Data handling complies with Swiss data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No