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临床试验/NCT02459028
NCT02459028已完成2 期

A Phase II, Community-based, Single-blinded, Randomized Controlled, Parallel-group Trial to Assess the Effects of a Tailored Positive Psychology Intervention on Chronic Pain and Well-being in Individuals With Spinal Cord Injury

Swiss Paraplegic Research, Nottwil2 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
168
试验地点
2
主要终点
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Mid-treatment

研究概览

简要总结

Background:

Chronic pain is one of the most burdensome potential consequences of a physical disability, such as spinal cord injury (SCI). Estimates of the incidence of chronic pain in SCI range between 65 - 80%. A recent pilot-study of a computer-based tailored positive psychology intervention showed a significant reduction in pain intensity, pain interference, pain catastrophizing and depression and an enhancement of subjective well-being and control over pain in persons with chronic pain secondary to a physical disability.

Study Objective:

Objective 1: To determine the efficacy of a tailored positive psychology intervention (T3P) in a community-based, single-blind, randomized, controlled, parallel group trial on subjective well-being and pain in individuals with chronic pain secondary to SCI.

Hypothesis 1: T3P will result in (1) greater immediate and long-lasting increase in subjective well-being, and perceived control over pain and (2) greater immediate and long-lasting decrease in depression, pain intensity, pain interference and catastrophizing, relative to an active control treatment.

Specific aim 1: To increase the understanding of the mechanisms underlying T3P by determining potential mediation effects.

Hypothesis 2: (1) Pain catastrophizing and pain control mediate the effect of T3P on pain intensity, and (2) positive and negative affect mediate the effect of T3P on life satisfaction and depression.

Objective 2: To identify for whom T3P is most effective by exploring potential moderator effects.

Study Design:

The proposed study is a single-blind, randomized, controlled trial with a parallel group design to determine the effects and mechanisms of T3P in a Swiss community sample of persons with chronic pain secondary to SCI.

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
Single (Participant)

入排标准

年龄范围
16 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Registered in Swiss Spinal Cord Injury Cohort Study (SwiSCI)
  • Individuals who experience an average disability-related pain intensity of ≥ 4 on a 0-10 numeric rating scale in the past week
  • Individuals who experience pain at least half the days in the past four weeks, and
  • Individuals are able to speak, read and write German

排除标准

  • Individuals who report current participation in any psychotherapy (e.g. psychotherapy, hypnosis, biofeedback) once a month or more often
  • Individuals who report hospitalization for psychiatric reasons within the past year
  • Individuals with a severe cognitive impairment defined as one or more errors on a Six-Item Screening

结局指标

主要结局

Change from baseline in Pain Numeric Rating Scale (pain intensity) at Mid-treatment

时间窗: Mid-treatment (at 4 weeks)

Pain Numeric Rating Scale (0-10)

Change from baseline in Pain Numeric Rating Scale (pain intensity) at Follow-up

时间窗: Follow-up (at 20 weeks or at 3 months after post-treatment)

Pain Numeric Rating Scale (0-10)

Change from baseline in Pain Numeric Rating Scale (pain intensity)

时间窗: Baseline (Pre-treatment)

Pain Numeric Rating Scale (0-10)

Change from baseline in Pain Numeric Rating Scale (pain intensity) at Post-treatment

时间窗: Post-treatment (at 8 weeks)

Pain Numeric Rating Scale (0-10)

次要结局

未报告次要终点

研究者

发起方
Swiss Paraplegic Research, Nottwil
申办方类型
Network
责任方
Sponsor

研究点 (2)

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