Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Feasibility (patient perspective)
研究概览
简要总结
The purpose of this study to to assess the feasibility, acceptability, and satisfaction of a telehealth cognitive behavioral stress management (CBSM) intervention among adults with cystic fibrosis (CF) who exhibit elevated anxiety and/or depression symptoms.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Fluent in English
- •Diagnosed with Cystic Fibrosis
- •Colorado resident
- •Access to personal device (smart phone, computer, tablet) with 1) reliable internet connection, and 2) a built-in web camera and microphone or the capability to install a study-provided web camera and microphone
- •Regular access to a private location with sufficient lighting that is free from distractions or intrusions to use during telehealth sessions
- •Access to private email to complete surveys
- •Mild anxiety and/or depression symptoms (i.e., a score of 5 or higher on the Generalized Anxiety Disorder 7 Item Scale (GAD-7) and/or the Patient Health Questionnaire 9 Item Scale (PHQ-9))
排除标准
- •Currently receiving therapy or counseling with an outside provider for a mental health condition
- •Currently in treatment for alcohol or substance abuse
- •Unstable medical condition (not including cystic fibrosis)
- •Neurological disease
- •Pregnant women
- •Active suicidal intent or plan (a score of 1 or higher on the Suicide Severity Scale)
结局指标
主要结局
Feasibility (patient perspective)
时间窗: Week 0 (baseline)
Assess the feasibility of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using participation rates (i.e., number of people interested and consented into the study).
Feasibility (clinician perspective)
时间窗: Week 8
Assess the feasibility of telehealth-delivered Cognitive Behavioral Stress Management from the clinician perspective using the Structured Assessment of Feasibility (SAFE; 16 items). The first 8 items provide information about barriers to implementation and the second 8 items provide information about enablers to implementation. It is recommended that no overall summary score be used, as this scale is designed to highlight barriers and facilitators that future programs should consider if they decide to continue or begin implementing this intervention.
Acceptability (patient perspective 2 of 2)
时间窗: Week 8
Assess the acceptability of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using the Acceptability Scale (12 items; 5 = strongly agree, 1 = strongly disagree), which was adapted specifically for this study. A mean acceptability score will be computed from these 12 items.
Satisfaction (patient perspective 1 of 2)
时间窗: Week 8
Assess the satisfaction of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective. Satisfaction measured using the Satisfaction Scale (8 items; 5 = strongly agree, 1 = strongly disagree), which was adapted specifically for this study. A mean satisfaction score will be computed from the 8 items.
Acceptability (patient perspective 1 of 2)
时间窗: Week 8
Assess the acceptability of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using participation rates (i.e., telehealth sessions completed, dropouts).
Satisfaction (patient perspective 2 of 2)
时间窗: Week 8
Assess the satisfaction of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using 4 open-ended questions designed specifically for this study. A qualitative summary will be provided based on responses to the open ended questions.
次要结局
- Anxiety symptom improvement(Week 0, 2, 4, 6, 8, 20)
- Depression symptom improvement(Week 0, 2, 4, 6, 8, 20)
研究者
Christina Bathgate
Licensed Clinical Psychologist
National Jewish Health