RCT of Stress Management and Mindfulness Intervention for Patients With Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- PROMIS-57
研究概览
简要总结
The purpose of this research is to determine whether a new stress management and mindfulness program can improve quality of life in individuals with sickle cell disease. The program is based on a number of empirically supported treatments including techniques from cognitive-behavioral therapy like overcoming motivational barriers to self-care, learning to see things as accurately as possible, practicing assertive communication, relaxation exercises like deep slow breathing, mindfulness meditation, and other stress management strategies.
详细描述
After consenting and completing the baseline measures, participants will be assigned (like flipping a coin) to the immediate treatment group or the control group. The immediate treatment group will participate in the intervention for six weeks while the control group waits. At the end of six weeks, both groups will complete the measures again, and then the control group will have a chance to participate in the intervention. See table below for the timeline of the study for each group.
Study Stage Immediate Intervention Group Waitlist Control Group
- Baseline Measures - Complete online demographic, mood, and symptom questionnaires
- May skip any questions
- Study team emails to confirm participation Same as Immediate Group
- Randomization (like flipping a coin) Receive email stating you were assigned to the Immediate Group and will begin the program right away Receive email stating you were assigned to the Waitlist Group and will begin the program after 6 weeks Weeks 1-6 Attend six weekly 1-hour group sessions (in person on the campus of the University of Pennsylvania in room 450 of the NBS building located at 425 S. University Avenue or via Zoom) Waiting period (no sessions yet) End of Week 6 Complete symptom measures again and provide feedback on the program Complete symptom measures at the end of the waiting period Weeks 7-12 No additional sessions during this time Attend six weekly 1-hour group sessions (in person in NBS 450 or via Zoom) End of Week 12 - Complete symptom measures again and provide feedback on the program Final Follow-Up (3 months after completing the program) Complete the symptom questionnaires one last time Complete the symptom questionnaires one last time
Intervention: The intervention is a stress management and mindfulness-based program developed and led by Dr. Melissa Hunt, who is a licensed clinical psychologist with expertise in chronic health conditions and mindfulness interventions. She will be assisted by four research coordinators who are undergraduate psychology majors at the University of Pennsylvania. Participants will also have access to an app called Blackfulness. It is a mindfulness meditation app designed specifically for black people. The in person sessions will take place in person at The Neural and Behavioral Sciences (NBS) Building (425 S University Ave, Philadelphia, PA 19104) Room 450. Remote sessions will take place virtually via Zoom video conferencing. People who elect the in person sessions may choose to attend some sessions remotely if weather or health necessitates it.
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
- 否
入选标准
- •18 years of age or older.
- •Diagnosed with sickle cell disease.
- •Live within 90 minutes of Philadelphia
排除标准
- •- Severe depression or suicidality
研究组 & 干预措施
Immediate Treatment
6 week intervention focused on: How psychological stress affects health and SCD pain crises Deep diaphragmatic breathing and basic relaxation skills to lower stress and improve pain management CBT techniques to rethink situations, reduce stress, and respond less reactively Practice identifying unhelpful thoughts and replacing them with more balanced ones Self-Care & Barriers to Change Learn ways to build more wellness activities into daily life.
Navigating the ER & Medical Encounters. Learn effective ways to communicate with doctors and nurses unfamiliar with SCD Mindfulness Meditation
干预措施: Stress Management and Mindfulness Intervention for Patients with Sickle Cell Disease (Behavioral)
Waitlist Control
Participants in the waitlist control will receive no treatment for 6 weeks. After completing the follow-up measures, they will be crossed over to active treatment.
结局指标
主要结局
PROMIS-57
时间窗: Baseline, 6 weeks, 3 month follow-up
PROMIS-57 Profile (PROMIS Health Organization, 2020) offers a broad assessment of health-related quality of life (HRQoL) across multiple domains such as physical function, anxiety, depression, fatigue, and sleep disturbance
ASCQ-Me
时间窗: Baseline, 6 weeks and 3 month follow-up
Quality of life in adults with SCD is comprehensively measured by the ASCQ-Me tool (ASCQ-Me User's Manual, American Institutes for Research, 2017), covering emotional distress, pain impact, and sleep disturbances, and validated for use in both clinical and research settings. We will be using the Pain Impact Scale (ASCQ-Me v2.0 Pain Impact - American Institutes for Research, 2017) which assesses how much pain limits daily activities and overall function.
次要结局
- Beck Depression Inventory(Baseline, 6 weeks and 3 month follow-up)
研究者
Melissa Hunt, PhD
Associate Director of Clinical Training
University of Pennsylvania