跳至主要内容
临床试验/NCT02444312
NCT02444312已完成不适用

A Randomised Controlled Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study Protocol

University of Limerick0 个研究点目标入组 88 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
主要终点
Benefit Finding (Adapted version of the 17-item Benefit Finding Scale; Antoni et al., 2001)

研究概览

简要总结

A randomised controlled trial that will compare the effects of a brief benefit -finding writing intervention with an active control condition on quality of life and psychological health among informal caregivers.

详细描述

A double-blind, randomized controlled parallel group study design with an equal 1:1 allocation ratio will be employed. This study will compare the effect of a brief benefit finding writing intervention with a control condition among caregivers. Caregivers currently caring for people with mental and physical disabilities will be randomised into a two-week, a) a benefit writing group or b) a control writing group. Caregivers will complete self-report measures relating to their care-recipient and themselves (e.g., illness type, and sociodemographics) and psychometric measures of benefit finding (primary outcome), psychological distress and quality of life(secondary outcomes). These will be assessed via online software at baseline, immediate post-test and at 3 month follow-up. Additionally, expectations and fidelity indices will be assessed and qualitative commentary on participation experiences gathered.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

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

  • Must be over the age of 18
  • Must identify as caring for a family member, friend or relative
  • Must be living in Ireland

排除标准

  • If the person cared for is living in institutional care

结局指标

主要结局

Benefit Finding (Adapted version of the 17-item Benefit Finding Scale; Antoni et al., 2001)

时间窗: Baseline, immediate post-intervention (two weeks), and 3 months

Used to assess change in benefit-finding levels over the course of the intervention and follow-up

次要结局

  • Psychological Distress (Hospital and Anxiety Depression Scale; Zigmond & Snaith, 1983)(Baseline, immediate post-intervention (two weeks), and 3 months)
  • Caregiver Quality of Life (40 item Adult Carer Quality of Life Questionnaire; Joseph, Becker, Elwick, & Silburn, 2012)(Baseline, immediate post-intervention (two weeks), and 3 months)

研究者

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

Brenda O'Connell

Ms. Brenda O'Connell

University of Limerick

相似试验

已完成
不适用
Ongoing 2b/3a inhibition In Myocardial infarction Evaluation.
NL-OMON20108950
已完成
不适用
A Randomized Controlled Trial of the Usefulness of Double Balloon Enteroscopy and Single Balloon Enteroscopy for Small Intestinal DiseaseSmall Intestinal Disease
JPRN-UMIN000000954Department of Gastroenterology,The University of Tokyo Hospital, Tokyo, Japan200
已完成
不适用
Effects of Lactobacillus Reuteri Plus Vitamin D3 in Children With Atopic DermatitisAtopic Dermatitis
NCT02945683Noos S.r.l.88
招募中
不适用
A controlled study examining CBT for bereaved children.The death of a loved one in childhood and adolescence is a risk factor for distress and dysfunction. This event has been associated with increased emotional problems including elevated depression, anxiety, and posttraumatic stress, as well as somatic complaints and behavioural problems (Dowdney, 2008Kaplow, Layne, & Pynoos, 2012). An estimated 5% to 10% of children, experience clinically significant psychiatric problems following loss, including major depression, posttraumatic stress-disorder (PTSD), and Prolonged Grief Disorder (PGD) (Melhem, Moritz, Walker, Shear, & Brent, 2007Melhem, Porta, Shamseddeen, Walker, & Brent, 2011).PGD encompasses several symptoms including separation distress, preoccupation with thoughts about the lost person, a sense of purposelessness about the future, numbness, bitterness, difficulties accepting the loss and difficulty moving on with life without the lost person (Prigerson et al., 2009Shear et al., 2011). Although PGD has mostly been studied among adults, a growing body of empirical studies has shown that children and adolescents can develop PGD symptoms, that can be reliably assessed, are distinct from normal grief, depression and anxiety, including PTSD, and are predictive of significant concomitant internalizing and externalizing problems (Brown & Goodman, 2005Dillen, Fontaine, & Verhofstadt-Denève, 2008Spuij, Prinzie et al., 2012Spuij, Reitz et al., 2012). Evidence that, in a small percentage of people, acute grief reactions turn into chronic debilitating distress, blocking reestablishment of normal routines, will likely lead to the inclusion of two bereavement-related disorders in the DSM-5, namely Adjustment Disorder Related to Bereavement, located in its main text, and Persistent Complex Bereavement-Related Disorder, located in its appendix (APA, 2000APA, 2012for discussions see Boelen & Prigerson, 2012Kaplow et al., 2012Wakefield, 2012).
NL-OMON25798niversiteit UtrechtFaculteit Sociale WetenschappenDepartement Kinder- en JeugdstudiesPostbus 801403508 TC UTRECHTNederland160
招募中
不适用
Randomised controlled trial to evaluate the effects of tele-monitoring weight in oncology and COPD patients.OncologyCOPD MalnutritionWeightInfectionsComplications
NL-OMON24869Medizorg BVNutricia NetherlandsAbbott NutritionMedizorgLoodsboot 73991 CJ HoutenTel. +31 30 2804271 Nutricia NetherlandsAlbert Einsteinlaan 202719 EP Zoetermeer+31 79 3539000 Abbott NutritionWegalaan 92132 JD Hoofddorp+31 88 8222487168