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临床试验/NCT05725161
NCT05725161已完成不适用

Acceptance and Commitment Therapy Supplemented With Psychoeducation for Improving Mental Health of Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Change from baseline to immediately after the intervention and 2 month follow-up on the Patient Health Questionnaire-9

研究概览

简要总结

This randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy (ACT) on mental health outcomes in individuals living with spinal cord injuries (SCI). A total of 34 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group. The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing. The wait-list group will receive ACT sessions after the study period ends. We will provide psychoeducation materials related to SCI as supplemental resources to both groups. Mental health outcomes using self-reported questionnaires will be collected at pretest, posttest, and 2-month follow-up. Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in mental health outcomes (e.g., depression) and ACT processes (e.g., psychological flexibility) at posttest and 2-month follow-up, compared to the wait-list control group provided with psychoeducation materials alone. Interviews will be conducted at posttest to explore the participants' experiences in ACT.

详细描述

This randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy (ACT) on mental health outcomes in individuals living with spinal cord injuries (SCI). A total of 34 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group. The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing. The wait-list group will receive ACT sessions after the study period ends. We will provide psychoeducation materials related to SCI as supplemental resources to both groups. Mental health outcomes using self-reported questionnaires will be collected at pretest, posttest, and 2-month follow-up. Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in depression (primary outcome), secondary mental health outcomes (e.g., anxiety, stress, and grief), and ACT processes (e.g., psychological flexibility) at posttest and 2-month follow-up, compared to the wait-list control group provided with psychoeducation materials alone. Interviews will be conducted at posttest to explore the participants' experiences in ACT.

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 (Investigator)

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 adults (aged 18 years or older) living with spinal cord injuries sustained within 5 years
  • having at least mild depression measured by the Patient Health Questionnaire-9
  • having a computer or a smartphone and internet access at home

排除标准

  • having cognitive deficits or language barriers that might impede study participation
  • having suicidal attempts within 6 months;
  • having a prior experience with acceptance and commitment therapy

结局指标

主要结局

Change from baseline to immediately after the intervention and 2 month follow-up on the Patient Health Questionnaire-9

时间窗: Change from baseline to immediately after the intervention and 2 month follow-up

The Patient Health Questionnaire-9 is a 9-item questionnaire assessing depressive symptoms on a scale of 0 to 3. Scores range from 0 to 27. Higher scores indicate greater symptomatology in depression.

次要结局

  • Change from baseline to immediately after the intervention and 2 month follow-up on the Perceived Stress Scale(Change from baseline to immediately after the intervention and 2 month follow-up)
  • Change from baseline to immediately after the intervention and 2 month follow-up on the Generalized Anxiety Disorder-7(Change from baseline to immediately after the intervention and 2 month follow-up)
  • Change from baseline to immediately after the intervention and 2 month follow-up on the World Health Organization Quality of Life - Psychological health component(Change from baseline to immediately after the intervention and 2 month follow-up)
  • Change from baseline to immediately after the intervention and 2 month follow-up on the Self-Compassion Scale- Short Form(Change from baseline to immediately after the intervention and 2 month follow-up)
  • Change from baseline to immediately after the intervention and 2 month follow-up on the Cognitive Fusion Questionnaire(Change from baseline to immediately after the intervention and 2 month follow-up)
  • Change from baseline to immediately after the intervention and 2 month follow-up on the Spinal Cord Injury-Quality of Life (SCI-QOL) Grief and Loss Short form(Change from baseline to immediately after the intervention and 2 month follow-up)
  • Change from baseline to immediately after the intervention and 2 month follow-up on the SCI-QOL Resilience Short form(Change from baseline to immediately after the intervention and 2 month follow-up)
  • Change from baseline to immediately after the intervention and 2 month follow-up on the Action and Acceptance Questionnaire-II(Change from baseline to immediately after the intervention and 2 month follow-up)
  • Change from baseline to immediately after the intervention and 2-month follow-up on the Engaged Living Scale(Change from baseline to immediately after the intervention and 2 month follow-up)

研究者

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

Areum Han

Associate Professor

University of Alabama at Birmingham

研究点 (2)

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