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临床试验/NCT05358925
NCT05358925已完成不适用

Online Psychoeducational Videos and Digital Assessments as a Method for Broadening Access to Care for Borderline Personality Disorder

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2023年6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
已完成
入组人数
83
试验地点
1
主要终点
Borderline Symptom List 23 (BSL-23)

研究概览

简要总结

In this study, 100 adults who were recently diagnosed with borderline personality disorder (BPD) will be randomized to either receive educational videos about BPD or educational videos about other topics. All participants in both conditions will complete daily surveys about their emotions and social interactions, and they will respond to surveys and complete cognitive tests at 4 different time points. Some participants will receive feedback about their cognitive test performance, and others will not. The investigators are interested in learning about how accurate education about BPD and enhanced knowledge about cognitive abilities might help people manage their BPD symptoms. The investigators expect that participants who received psychoeducation about BPD will have lower levels of BPD and depressive symptoms than other participants, and that participants who received feedback on their cognitive tests will also have lower symptoms.

详细描述

In this study, 100 adults who were diagnosed with BPD within the past three months will be randomly assigned to receive psychoeducational videos (4-10 minutes each) about the development, symptoms, naturalistic trajectory, and treatment of BPD (2/3 of participants) or matched-length videos about non-BPD, health-related topics (1/3 of participants). One video will be delivered every business day for two weeks. Participants will respond to 5-minute surveys on their recent social interactions, their feelings of threat, connectedness, and aloneness, and will complete a 1-minute version of the Continuous Performance Test (CPT) and Digit Symbol Matching Test, every day for 30 days. Participants will complete additional full-length surveys and cognitive tests at 4 time points: baseline (Day 1), Time 2 (day 15), Time 3 (Day 30), and Follow-up (day 60). The primary outcome is BPD symptom severity, and the secondary outcome is depressive symptom severity. The investigators expect that BPD-focused psychoeducation and personalized neuropsychological feedback will each lead to separate, measurable reductions in BPD and depressive symptom severity. The investigators also expect that the relationship between psychoeducation and symptom reduction will be mediated by increased knowledge about BPD, and that the relationship between neuropsychological feedback and symptom reduction will be mediated by increased cognitive control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

盲法说明

While the investigators will not explicitly inform participants of their condition, it will be apparent based on the content of the videos they receive and whether or not they receive feedback.

The investigators and study staff will be aware of condition assignments in order to facilitate the delivery of the appropriate videos and the neuropsychological feedback.

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

  • reliable access to a smartphone with a data plan for the duration of the study
  • ability to speak and understand English
  • age 18 years or older
  • diagnosis of BPD within the past 6 months
  • awake and able to complete EMA surveys between 9:00am and 9:00pm on most days
  • located within the United States

排除标准

  • cognitive disability that impedes ability to participate in the study
  • current psychiatric symptoms that interfere with the individual's ability to provide consent or complete the research procedures (e.g., acute mania, acute psychosis, eating disorder threatening medical stability).

研究组 & 干预措施

BPD Videos and Feedback

Experimental

Ten daily 4-10 minute psychoeducational videos about BPD and personalized feedback about performance on neuropsychological tasks.

干预措施: Psychoeducational Videos (Other)

BPD Videos and Feedback

Experimental

Ten daily 4-10 minute psychoeducational videos about BPD and personalized feedback about performance on neuropsychological tasks.

干预措施: Neuropsychological Feedback (Other)

BPD Videos and No Feedback

Experimental

Ten daily 4-10 minute psychoeducational videos about BPD.

干预措施: Psychoeducational Videos (Other)

Non-BPD Videos and No Feedback

Sham Comparator

Ten daily 4-10 minute educational videos about health-related topics other than BPD.

干预措施: Non-BPD-related Educational Videos (Other)

结局指标

主要结局

Borderline Symptom List 23 (BSL-23)

时间窗: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)

Change (increase or decrease) in BSL-23 mean score (average score across all 23 items) at time 2, time 3, and follow-up, as compared to baseline. Minimum score = 0, maximum score = 4. A higher score indicates more severe BPD symptoms.

次要结局

  • Patient Health Questionnaire (PHQ-9)(Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lois W. Choi-Kain, MD

Director, Gunderson Personality Disorder; Associate Professor of Psychiatry

Mclean Hospital

研究点 (1)

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