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临床试验/NCT06563466
NCT06563466招募中不适用

PEGASUS - Improving Treatment for Patients With Emotionally Unstable Personality Disorder

University Hospital Bispebjerg and Frederiksberg2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Level of functioning

研究概览

简要总结

The purpose of the PEGASUS study is to conduct a pilot trial to test the feasibility and acceptability of the PEGASUS intervention, adding a case manager and family-based interventions meetings to the existing psychiatric integrated care-models known as "Treatment Packages" in Denmark. We will conduct a randomized, assessor-blinded parallel-groups superiority clinical trial, testing the PEGASUS intervention for emotionally unstable personality disorder "EUPD", borderline type (borderline personality disorder) compared to "Treatment as Usual" before moving on to testing in a full-scale trial. Participants will be assessed at baseline and 9 month post baseline at study conclusion

详细描述

Background and rationale:

Unmet needs for patients diagnosed with emotionally unstable personality disorder (borderline personality disorder).

People with emotionally unstable personality disorder, borderline type, also known as borderline personality disorder (BPD) have substantial degrees of impairment (in educational, work, family, and social functioning) even after treatment, and they contribute very substantially to the burden of psychiatric disorders on a population level. When treatment in primary care is insufficient, these patients should be referred to psychiatric integrated care-models known as "treatment packages" in the secondary psychiatric healthcare sector. The treatment packages were introduced in Denmark in 2013. More than half of patients finishing a treatment package may still have symptoms, and it is also a clinical experience and hypothesis, that many patients will continue to receive more than one treatment package either for the same disorder or for different disorders. Furthermore, the level of functioning, particularly in BPD, often remains impaired despite symptomatic relief.

Family members are often both the first and the last line of defense, as they are the people whom the patient will contact 24/7, whenever there is an obstacle or a crisis related to the mental disorder. The lives of the family members are severely affected, as they may live in constant worry for their mentally ill relative, and they may need to be ready to throw everything else aside, when there is a crisis. Moreover, they will also often play the role as self-taught lawyers or case managers to help the patient to get the necessary treatment and to avoid severe social adversities.

Enhanced treatment, case management and involvement of families Over the last 25 years we have learned a great deal about the benefits of providing additional support for people with early psychosis. Our OPUS trial resulted in more than 40 publications, and has been highly cited (2700 citations, February 2023 (Web of Science)). We have learned from the OPUS trial, that prompt and skilled treatment for those with recent onset psychosis can improve health outcomes. The most important elements in the experimental OPUS-treatment were involvement of families and affiliation with a case manager. The results of the OPUS trial have been replicated in many countries, and there is now solid evidence for "Early Intervention Services", summarized in a meta-analysis and a recent Cochrane Review. A next obvious research question is, whether the same clinical approaches and treatment elements could be helpful for other mental health conditions. In a recent Australian study it was shown, that caregivers of young people with borderline personality features experience adversities similar to, or greater than, that reported by caregivers of young people with other severe illnesses. Currently, except from a single trial carried out with young people with BPD, and few trials investigating the effect of psychoeducation or group therapy with relatives, we lack an evidence base to know, if comparable comprehensive treatment packages can help the patients with BPD and their families.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The investigators, outcome assessor and statistician will be blinded. Because of the nature of this study, it will not be possible to blind the participant or therapists providing the intervention.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participating Patients
  • Inclusion Criteria:
  • Must be able to give an informed written consent.
  • Must be newly accepted in the pre-planned BPD treatment packages.
  • ≥18 years of age.
  • Agreeing to involvement of one or two informal caregivers, families, or close friends ("Relatives").
  • Capable of reading and understanding Danish.

排除标准

  • Note that to get accepted into a treatment package for BPD, patients must not fulfill the criteria for a F20 diagnosis or the criteria for alcohol or substance abuse or harmful use.
  • Participating Relatives:
  • Inclusion Criteria:
  • Must be able to give an informed written consent.
  • ≥18 years of age.
  • Capable of reading and understanding Danish.
  • Exclusion criteria: None

研究组 & 干预措施

Treatment as usual (TAU)

Active Comparator

Patients with BPD are offered group-based treatment and individual therapy according to the standardized healthcare delivery models, known as the "psychiatric treatment package" for borderline personality disorder. The treatment package complies with the description agreed upon in common documents endorsed by all Danish Regions. The content of the treatment package includes psychotherapeutic treatment, according to the evidence based diagnose-specific manuals, and consultations with a psychiatrist. In this study this specifically includes, a treatment program consisting of dialectic behavioral treatment (DBT), delivered according to the manuals by Linehan, 1993 and Linehan, 2015.

干预措施: Treatment as usual (Other)

The experimental intervention PEGASUS

Experimental

Patients in PEGASUS will, in addition to TAU, be offered to be affiliated with a case manager and to have their families involved in family-based interventions. Duration of the intervention will be nine months.

The case manager will be a trained professional, who will be able to be a guiding figure and when needed, be able to help the patient contacting different authorities. The case manager can support the patient in solving everyday life problems, and will be an occupational therapist, a nurse, or a social worker. The case manager will offer the patients nine extra individual sessions during their treatment course.

The format of the family-based interventions will be two psychoeducational workshops with 6 to 8 families invited and six multifamily group meetings, in which the patient and one or two relatives can participate. Theories behind Psychoeducational Multifamily Groups, Compassion Cultivation Training and Family Connections (FC, Hoffman et al., 2007) will be drawn upon.

干预措施: The experimental intervention PEGASUS (Other)

结局指标

主要结局

Level of functioning

时间窗: Study inclusion and at 9 months at study completion

WHODAS 2.0, 36-item interviewer-administered version (WHO's Disability Assessment Schedule). Measured in patients.

次要结局

  • Change in quality of relation between patient and relatives(Study inclusion and at 9 months at study completion)
  • Presences of suicidal ideations(Study inclusion and at 9 months at study completion)
  • Symptom relief(Study inclusion and at 9 months at study completion)
  • Well-being(Study inclusion and at 9 months at study completion)
  • Satisfaction and acceptability of treatment(At study conclusion)
  • Patient Recorded Outcome Measures (PROM)(Study inclusion and at 9 months at study completion. Measured in patients)
  • Ability to apply therapeutic tools learnt in therapy to everyday life situations.(At study inclusion and 9 months later at study conclusion)
  • Perceived burden by relatives(Study inclusion and at 9 months at study completion)

研究者

发起方
University Hospital Bispebjerg and Frederiksberg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carsten Hjorthøj

Associate Professor

University Hospital Bispebjerg and Frederiksberg

研究点 (2)

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