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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Feasibility of the study design
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Auricular acupuncture program based on the N.A.D.A. protocol (Procedure)
结局指标
主要结局
Feasibility of the study design
时间窗: 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.
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.
次要结局
- 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).)
- Satisfaction with the treatment(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(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(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(- 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).)
研究者
Jenny Gentizon
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.
University of Lausanne Hospitals