The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Anxiety and Depression in Men Experiencing Infertility
研究概览
简要总结
The purpose of this study is to determine if the use of a new app, FertiStrong, is associated with decreased levels of anxiety and depression in men who have infertility or whose partner has infertility.
详细描述
Individuals who are experiencing infertility report high levels of anxiety and depression. A recent study (1) documented that both men and women involved in the treatment of infertility expressed emotional distress. Research on the female partner of an infertile couple documents that psychological interventions, especially those with a cognitive-behavior therapy (CBT) focus, are associated with significant decreases in levels of anxiety and depression (2). Subsequent research has also shown that both members of the infertile couple definitively underutilize the psychological services offered to them. Thus, new ways to provide psychological relief to these individuals is needed. This has lead to the development of a new app, FertiStrong. This app is targeted at men- either men with infertility or men whose partner has infertility.
Study Requirements:
- Study participants will be asked to complete an on-line questionnaire.
- Once completed, the study participant will be randomly assigned to one of two groups. One group will be provided the mobile app to use for 30 days. The second group will be provided the app after 30 days.
- After the 30 day period, each group will be asked to complete a follow-up questionnaire. Each questionnaire will take approximately 15-20 minutes to compete.
Men who are directly seeking care or whose partners is seeking care at any Fertility Center of Illinois location are invited to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participant assignment will be masked for data analysis
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All men who are receiving care, or whose partner is receiving care, at Fertility Centers of Illinois during the study period.
排除标准
- •Does not have daily access to a smart phone
- •Does not read or understand English
研究组 & 干预措施
Treatment Group
Participants who are in the intervention group will receive the FertiStrong app downloading instructions as soon as they have been randomized. They will have access to this app for a period of 30 days during the intervention phase of the study.
干预措施: FertiStrong App (Behavioral)
Control Group
Participants in the control group will not have access to the FertiStrong app for the first 30 days. After a period of 30 days, participants will be provided downloading instructions to this app.
结局指标
主要结局
Anxiety and Depression in Men Experiencing Infertility
时间窗: 6 months post study completion
Evaluation of pre and post Hospital Anxiety and Depression Scores
次要结局
- Stress Levels in Men Experiencing Infertility(6 months post study completion)