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临床试验/NCT05477758
NCT05477758进行中(未招募)不适用

The Impact of Pain on Depression Outcomes of Older Adults in Behavioural Activation: An Exploratory Secondary Data Analysis

Teesside University1 个研究点 分布在 1 个国家目标入组 1,522 人开始时间: 2022年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,522
试验地点
1
主要终点
SF-12 (Short Form- 12)

研究概览

简要总结

This study is a secondary data analysis of three of largest Randomised Controlled Trials (RCTs) of behavioural activation (BA) for older people with depression in the United Kingdom (UK) primary care. The analysis will aim to explore the impact of pain on depression outcomes of older people receiving BA and potentially identify sub-groups of people who may not respond as well to treatment.

详细描述

Previous findings have indicated that pain might be an important barrier in depression treatment both with antidepressant medication and in a United States (US) collaborative care model using problem solving therapy and antidepressant medication. It is unknown, however, if pain impacts depression outcomes of older adults in a collaborative care (CC) framework focusing on a brief psychological intervention of BA. Collectively CASPER, CASPER PLUS (+) and SHARD are three of the largest pragmatic, multi-centre randomised controlled trials (RCT) of BA for older adults in UK primary care with low mood and depression. The purpose of this secondary data analysis is, therefore, to explore if pain moderates (modifies) the effect of BA on depression outcomes in older adults, potentially identifying subgroups of older adults who may not respond as well to BA.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

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

入选标准

  • Patients who participated in CASPER, CASPER + or SHARD study

排除标准

  • Anyone who did not consent into one of the three studies above

结局指标

主要结局

SF-12 (Short Form- 12)

时间窗: Baseline

The instrument is a generic health status measure consisting of 12 questions measuring 8 domains. Question 8 referring to bodily pain will be used for the moderation analysis. The tool has a likhert scale of 1-5 with 5 denotating worse pain.

EQ-5D (Euroqual Group)

时间窗: Baseline

The EQ-5D consists of 5 questions assessing the various quality of life dimensions including mobility, self-care, usual activities, Pain/Discomfort and Anxiety/Depression. Each dimension is rated on three levels: no problem (score=1) some problems (score=2) and extreme problems (score=3). Question 4 relating to pain/discomfort will be used as a second indicator for the pain moderator.

PhQ-9 (Patient Health Questionnaire- 9

时间窗: 4 months

5 point likert scale ranging from 0 to 27. Higher points denote worse depression. The instrument is used for screening, diagnosing, monitoring and measuring the severity of depression in primary care.

次要结局

未报告次要终点

研究者

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

Alexandra Carne

Chief Investigator

Teesside University

研究点 (1)

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