Dysphonia, Distress, and Perceived Control: Technology Based Assessment and Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Perceived Control
研究概览
简要总结
The purpose of this study is to pilot test a version of the intervention that has been tailored for participants with dysphonia. The study seeks to determine if the adapted intervention: a) increases perceived control over voice-related stressors and b) decreases stress and distress resulting from voice problems. The study will also explore the usability and acceptability of the program. The goal is to help people with voice problems achieve better voice and quality of life outcomes.
详细描述
In the investigator's voice clinic, a high prevalence of severe distress has been identified. Distress and voice handicap were positively correlated, and perceived control moderated the relationship. Perceived control is associated with less distress in a variety of medical conditions, has an impact beyond that of coping and personality, and can be increased via targeted intervention.
This is a randomized controlled trial. Participants will be randomly assigned to one of the two groups. Both groups involve completing surveys and receiving information online about voice problem.
Participants complete an initial baseline assessment focused on voice function and emotions, including items from the Perceived Control Scale, Voice Handicap Index-10, Perceived Stress Scale, Brief Symptom Inventory-18. Finally, the participants will complete some brief feedback questions about the material.
Next, twice a week for up to three weeks participants will complete check-ins from the online program. Participants in the intervention arm will complete self-guided exercises and brief assessment questions. Participants in the information-only arm will complete mini knowledge quizzes.
All participants will complete brief a post-intervention assessment parallel to the baseline assessment. Lastly, they will have an opportunity to provide final feedback on their experience.
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 (Participant)
盲法说明
Participants are not aware of which treatment arm they are assigned.
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
- •Patients who are seen at the Otolaryngology Clinic (University of Minnesota Health Clinics and Surgery Center, or Fairview Hospital Maple Grove or Southdale) with Muscle Tension Dysphonia
- •Patients between 18-80 years of age experiencing a voice problem
- •Scored high (>10) on the Voice Handicap Index (VHI-10)
- •Has the ability to complete informed consent process
- •Interested in using an online program/intervention
- •Has reliable access to internet
排除标准
- •Patients who have clinical need for concurrent treatment will be excluded to decrease confounding introduced by having multiple simultaneous interventions. This may include:
- •Concurrent laryngeal lesion requiring immediate operative or other intervention
- •Concurrent participation in speech therapy
- •Concurrent need for new medications that may directly affect voice-related symptoms
- •Participant has a Speech Language Pathology visit scheduled in two weeks or less from when they will start the program (if applicable)
- •Unable to read English (as determined by their ability to complete the clinic intake forms)
- •Female and pregnant
- •Unable to provide informed consent (e.g., patients with dementia)
结局指标
主要结局
Perceived Control
时间窗: 2 weeks
Change from baseline assessment using a questionnaire, Perceived Present Control-8 (PPC-8). The PPC-8 questionnaire has 8 questions about perceptions of present control over their voice problem, assessed on a 4-point Likert-type scale, with scores of 1-4 (1=Strongly Disagree, 2=Disagree Somewhat, 3=Agree Somewhat, 4=Strongly Agree). Total scores range from 1-32. Higher scores indicate more perceived control over the patient's voice problems.
次要结局
- Voice Handicap(2 weeks)
- Perceived Stress(2 Weeks)
- Psychological Symptoms(2 weeks)