跳至主要内容
临床试验/NCT04845542
NCT04845542进行中(未招募)不适用

Testing Efficacy of an Intervention to Promote Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)

University of Utah1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
400
试验地点
1
主要终点
PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

研究概览

简要总结

Affecting nearly 800,000 people in the US every year, stroke is a leading cause of long-term disability, and has serious consequences for stroke survivors and their carepartners. Our project uses a scientifically rigorous efficacy study to evaluate a remotely delivered 8-week dyadic (couples-based) positive psychology intervention to reduce emotional distress in stroke survivors and their carepartners. If successful, couples may be better emotionally equipped to cope with the sequelae of stroke, and have better rehabilitation outcomes and quality of life.

详细描述

The impact of stroke is shared between the stroke survivor and their spousal/partner caregiver (carepartner). An estimated 30-50% of stroke survivors and carepartners experience depressive or anxiety symptoms that negatively affect rehabilitation outcomes and quality of life. Yet, interventions to support couples post-stroke are largely insufficient or inaccessible. To address this need, we developed a novel remotely-delivered dyadic intervention to promote Resilience in Stroke survivor-carepartner Dyads (ReStoreD), in which couples learn and practice goal-setting, communication strategies, and positive psychology activities like expressing gratitude, finding meaning, and fostering connections. Preliminary pilot study results were promising, showing reduced depressive symptoms and increased resilience in participants. The purpose of the current study is to conduct a Stage II efficacy trial of the 8-week ReStoreD intervention with a sample of 200 dyads (n=400) consisting of one individual who has sustained an ischemic or hemorrhagic stroke between 3 months and 3 years prior to enrollment and a cohabitating carepartner. Using a fully-powered, randomized waitlist-control design, we will determine efficacy of ReStoreD to reduce emotional distress in both dyad members (Aim 1). We will also examine effects of ReStoreD on secondary outcomes (resilience, relationship quality, stress-related stroke, meaningful activity engagement) as potential mediators (Aim 2), and explore moderators to determine whether certain subgroups respond better to the intervention (Aim 3). All participants will complete standardized, validated assessments at baseline, 8 weeks, 16 weeks, and 6-month follow up. All aspects of the study, including intervention activities and assessments, are conducted remotely, online.

This is the first rigorously designed efficacy trial to test a positive psychology intervention for stroke survivors and their carepartners. When the aims of this study are realized, we will 1) have a remotely-delivered, dyadic intervention to support couples post-stroke; 2) have a better understanding of the mechanisms involved in the intervention's effect on emotional distress, and can use this information to inform future interventions; and 3) be able to identify a more specific target population for whom the intervention works best. Ultimately, if found efficacious, this intervention will offer sustainable and accessible support for couples who are coping with stroke to improve rehabilitation outcomes and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Community-dwelling cohabitating couple where one partner has a had an ischemic or hemorrhagic stroke
  • The stroke must have occurred between 3 months and 3 years prior to enrollment
  • The adult couple must have been living together since before the stroke and for at least 6 months prior to enrollment
  • One or both partners must report some anxiety and/or depressive symptoms
  • Participants must be able to read, understand, and follow instructions, and be able to provide their own consent

排除标准

  • Either dyad partner has significant aphasia (difficulties with speech), visual, psychiatric, and/or significant cognitive impairment that would limit their ability to participate in the intervention in a meaningful way

研究组 & 干预措施

ReStoreD

Experimental

8-week intervention that is remotely delivered, consisting of psychoeducation and positive psychology activities. Participants complete two activities individually and two together each week.

干预措施: ReStoreD (Behavioral)

Waitlist-control

No Intervention

Participants will be waitlisted for 8 weeks.

结局指标

主要结局

PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

时间窗: 6 months

8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress

PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

时间窗: Baseline

8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress

PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

时间窗: 8 weeks

8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress

PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

时间窗: 16 weeks

8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress

次要结局

  • PROMIS-Psychosocial Illness Impact Scale-short form(6-months)
  • Connor-Davidson Resilience Scale (CD-RISC)(6 months)
  • Dyadic Coping Inventory (DCI)-short(6 months)
  • Zarit Burden Inventory-Short(6 months)
  • Meaningful Activity Participation Assessment (MAPA)(6 months)
  • Dyadic Relationship Scale(6 months)
  • Connor-Davidson Resilience Scale (CD-RISC)(baseline)
  • Connor-Davidson Resilience Scale (CD-RISC)(8 weeks)
  • Connor-Davidson Resilience Scale (CD-RISC)(16 weeks)
  • Dyadic Coping Inventory (DCI)-short(baseline)
  • Dyadic Coping Inventory (DCI)-short(8 weeks)
  • Dyadic Coping Inventory (DCI)-short(16 weeks)
  • Dyadic Relationship Scale(baseline)
  • Dyadic Relationship Scale(8 weeks)
  • Dyadic Relationship Scale(16 weeks)
  • PROMIS-Psychosocial Illness Impact Scale-short form(baseline)
  • PROMIS-Psychosocial Illness Impact Scale-short form(8 weeks)
  • PROMIS-Psychosocial Illness Impact Scale-short form(16 weeks)
  • Zarit Burden Inventory-Short(baseline)
  • Zarit Burden Inventory-Short(8 weeks)
  • Zarit Burden Inventory-Short(16 weeks)
  • Meaningful Activity Participation Assessment (MAPA)(baseline)
  • Meaningful Activity Participation Assessment (MAPA)(8 weeks)
  • Meaningful Activity Participation Assessment (MAPA)(16 weeks)

研究者

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

Alexandra Terrill

Associate Professor

University of Utah

研究点 (1)

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