跳至主要内容
临床试验/NCT05215392
NCT05215392Unknown不适用

A Smartphone Application of "Family Connections" to Increase the Use of Skills and the Improving of Psychological Symptoms in Relatives of People With Borderline Personality Disorder: a Protocol Study for a Randomized Controlled Trial.

Universitat Jaume I2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
116
试验地点
2
主要终点
Burden Assessment Scale (BAS; Horwitz & Reinhard, 1992)

研究概览

简要总结

The aims of our study are the following: (a) testing the effectiveness of a combined intervention: "Family Connections" program with a smartphone app versus the same intervention supported by a paper-based manual, (b) studying the feasibility and acceptance of both conditions and (c) evaluating the perceptions and opinions of families about both interventions.

详细描述

Family members of patients with borderline personality disorder (BPD) often experience high levels of suffering, anxiety, stress, burden and helplessness. The treatment program with the most empirical support is "Family Connections". It is one of the first programs specifically designed to help relatives of patients with BPD. The program is an adaptation of multiple strategies of Dialectical Behavioral Therapy. The results of these studies and their subsequent replications showed an improvement in family attitudes and perceived burden. Two of the technologies with very promising developments are Ecological Momentary Assessment and Ecological Momentary Intervention, that can act on each other. A large number of smartphone apps for people with psychological problems focus on the provision of instructions, adaptive self-help strategies, alarms, electronic diaries or emotional state ratings. The Family Connections app proposed in this article consists of a smartphone app built using EMA and EMI technologies.The aims of our study are the following: (a) testing the effectiveness of a combined intervention: "Family Connections" program with a smartphone app versus the same intervention supported by a paper-based manual, (b) studying the feasibility and acceptance of both conditions and (c) evaluating the perceptions and opinions of families about both interventions.

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 (Participant, Investigator)

盲法说明

Double (Participant, Investigator)

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

  • Having a family member diagnosed with borderline personality disorder.
  • Being 18 years of age or older.
  • Knowing and understanding the Spanish language.
  • Having a smartphone with Internet connection.
  • Completing the informed consent.

排除标准

  • 未提供

结局指标

主要结局

Burden Assessment Scale (BAS; Horwitz & Reinhard, 1992)

时间窗: Changes will be assessed from pre-treatment to immediately after the intervention (3 months)

Burden Assessment Scale (BAS) consists of 19 items and it assess the caregivers' objective and subjective burden within the past six months. Items are rated on a 4-point Likert scale ranging from 1(nothing) to 4 (a lot), and higher values indicate stronger burden. Internal reliability of the scale ranged from .89 to .91 and it shows adequated validity (Reinhard, Gubman, Horwitz \& Minsky, 1994).

次要结局

  • Depression, Anxiety and Stress (DASS-21; Lovibond & Lovibond, 1995)(Changes will be assessed from pre-treatment to immediately after the intervention (3 months))
  • Family Empowerment (FES; Koren, DeChillo & Friesen, 1992)(Changes will be assessed from pre-treatment to immediately after the intervention (3 months))
  • Resilience (CD-RISC; Connor & Davidson, 2003)(Changes will be assessed from pre-treatment to immediately after the intervention (3 months))

研究者

发起方
Universitat Jaume I
申办方类型
Other
责任方
Sponsor

研究点 (2)

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