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临床试验/NCT05527691
NCT05527691已完成不适用

Testing SupportGroove: a Novel Mhealth Intervention for Couples Coping with Spinal Cord Injury

University of Utah4 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2022年10月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
4
主要终点
Revised Dyadic Adjustment Scale

研究概览

简要总结

The purpose of this study is to test the preliminary effects of an 8-week mobile application-based program (SupportGroove) developed for persons with spinal cord injury and their romantic partners.

详细描述

Eligible couples who provide informed consent will be enrolled in the study and will be randomized to either immediately start the 8-week SupportGroove program or be waitlisted for 8-weeks before starting the program. While actively participating in the program, couples will use the app to engage in daily "quests" (positive psychology-based activities to be completed on their own or as a couple). Both partners in the participating couple complete self-report assessments at baseline (0 weeks), 8 weeks, 16 weeks, and 28 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
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

入选标准

  • cohabitating romantic couples where one partner has sustained a spinal cord injury at least 3 months prior to enrolling in the study
  • be able to read and understand printed English instructions
  • have a smartphone, tablet, or personal computer with internet access

排除标准

  • the partner has a spinal cord injury or other major neurological condition
  • either partner is unable to read and understand printed English instructions
  • either partner does not consent to participate in the study

研究组 & 干预措施

SupportGroove

Experimental

8-week intervention that is remotely delivered through a mobile app, consisting of daily "quests" (positive psychology-based activities) completed individually and as a couple.

干预措施: SupportGroove (Behavioral)

Waitlist control

No Intervention

Participants will be waitlisted for 8 weeks.

结局指标

主要结局

Revised Dyadic Adjustment Scale

时间窗: 28 weeks

14-items assessing couple satisfaction and how each partner within the couple perceives their relationship; rated on a scale from 0-5; score range from 0-70, higher scores = better adjustment/greater relationship satisfaction /better outcome

Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form

时间窗: 28 weeks

10-items assessing state resilience; rated from 1-5 (never-always); score range from 19-50, higher score = more resilient /better outcome

Patient Health Questionnaire-9

时间窗: 28 weeks

9-item depression measure; rated from 0-3 (not at all-nearly every day); score range from 0-27, higher scores = more depressed /worse outcome

Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing

时间窗: 28 weeks

10-items assessing aspects of well-being; rated from 1-5 (never-always); score range from 10-50, higher score = greater well-being /better outcome

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 Terrill

Associate Professor, Occupational Recreational Therapy

University of Utah

研究点 (4)

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