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临床试验/NCT04809610
NCT04809610Unknown不适用

Effectiveness of the Internet Attachment-Based Compassion Therapy (iABCT) to Improve the Quality of Life and Well-being in a Population With Chronic Medical Illness.

University of Valencia1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
68
试验地点
1
主要终点
Changes in quality of life

研究概览

简要总结

Compassion-Based Interventions are increasingly relevant as a potentially beneficial way to support people with chronic medical conditions and improve different outcomes related with the management of the disease. Online interventions The purpose of this study is to evaluate the effectiveness of the internet version of the attachment-based compassion therapy for improving quality of life in a population with chronic medical illness.

详细描述

Our participants will be randomized to one of the following two conditions: 1) the Internet version of the attachment-based compassion therapy, and 2) Waiting list (WL) control group.

The corresponding evaluations of the outcomes will be carried out at different moments of the process: baseline, and a three- and six-month follow-up.

This study will use the internet version of attachment-based compassion therapy (iABCT) for improving the quality of life in a population with chronic medical illness.

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
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

  • •Age > 18 years;
  • •ability to understand and read Spanish;
  • •access to a computer with the Internet; and
  • •fulfill criteria for diagnosis of one of the following chronic medical conditions: diabetes, inflammatory bowel disease, fibromyalgia, low-back chronic pain, migraines, and other conditions.

排除标准

  • •Terminal disease;
  • •severe psychiatric disorders comorbidities (schizophrenia, substance dependence, bipolar disorder, psychotic illness) or severe neurologic or medical condition; and
  • •receiving psychological treatment or mindfulness training at the time of recruitment.

研究组 & 干预措施

Intervention group: Internet attachment-based compassion therapy (iABCT).

Experimental

The iABCT is a self-applied program based on the attachment theory and the use of compassion meditations. It is composed of 8 modules that have been reformulated to be completely self-applied and include text, images, illustrations, videos, audio with guided meditations, exercises, and homework. Downloadable PDF files will be made available so that users can review them offline. Each module has been optimized to have a duration of 60 and 90 minutes approximately. The entire intervention is estimated to be completed in eight weeks.

干预措施: Internet attachment-based compassion therapy (iABCT). (Behavioral)

Control group: Waiting list control group.

No Intervention

Participants in this condition will be informed that they will have access to the intervention at 3 months (after the intervention group).

结局指标

主要结局

Changes in quality of life

时间窗: Baseline (week 0), 3-month follow-up, 6-month follow-up

EuroQol (EQ-5D; Badia et al., 1999). It is a self-report measures composed by five dimensions of functionality in daily-life and three levels of severity (1-3). A higher score in this scale indicates higher severity on the different areas of functioning in daily life.

Changes in wellbeing

时间窗: Baseline (week 0), 3-month follow-up, 6-month follow-up

Pemberton Happiness Index (PHI; Hervás and Vázquez, 2013). The scale includes eleven items related to different domains of remembered well-being (general, hedonic, eudaimonic, and social well-being) and ten items related to experienced well-being (i.e., positive and negative emotional events that possibly happened the day before); the sum of these items produces a combined well-being index that range from 0 to 10. Higher levels indicate higher levels of wellbeing.

次要结局

  • Compassion and self-compassion(Baseline (week 0), 3-month follow-up, 6-month follow-up)
  • Self-care and healthy behaviors(Baseline (week 0), 3-month follow-up, 6-month follow-up)
  • Self-criticism(Baseline (week 0), 3-month follow-up, 6-month follow-up)
  • Semi-structured qualitative interview(3-month follow-up (only intervention group), 6-month follow-up (only WL control group))
  • Specific illness interference(Baseline (week 0), 3-month follow-up, 6-month follow-up)
  • Symptomatology(Baseline (week 0), 3-month follow-up, 6-month follow-up)
  • Social support(Baseline (week 0), 3-month follow-up, 6-month follow-up)
  • Client's satisfaction(3-month follow up (only intervention group), 6-month follow-up (only WL control group))
  • Attachmetn styles(Baseline (week 0), 3-month follow-up, 6-month follow-up)
  • Illness perception(Baseline (week 0), 3-month follow-up, 6-month follow-up)
  • Difficulties of the compassion practice(3-month follow-up (only intervention group), 6-month follow-up (only WL control group))
  • Usability and client acceptance(3-month follow-up (only intervention group), 6-month follow-up (only WL control group))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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