Effects of a Cardiac and Psychosocial Rehabilitation Program on Depression, Anxiety, Self-Efficacy, Quality of Life, and Exercise Capacity in Young Adults With Fontan Circulation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Depression Score Assessed by the Hospital Anxiety and Depression Scale (HADS-
研究概览
简要总结
Helping Young Adults With Fontan Circulation Feel Better and Stay Active What is the study about? This study looked at how a special program could help young adults with Fontan circulation feel better mentally and physically. People with this condition often struggle with anxiety, depression, and low energy. The study tested a Cardiac and Psychosocial Rehabilitation (CPR) program, which included counseling and exercise training to improve their well-being.
Who participated?
38 young adults (ages 18-23) with Fontan circulation
They were divided into three groups:
CPR Group - received counseling (Cognitive Behavioral Therapy, CBT) and a home exercise program CR Group - did only the home exercise program Control Group - continued with their usual care What did the study find?
- Less anxiety and depression - The CPR group had the biggest improvement in mental health.
- Better self-confidence (self-efficacy) - Participants felt more capable of handling challenges.
- Higher quality of life - They felt happier and more engaged in daily life. ❌ No major changes in exercise ability - While they became more active, their heart fitness levels did not change much.
What does this mean for patients and families?
Mental health support is just as important as physical care for young adults with Fontan circulation.
A combination of counseling and exercise is better than exercise alone for reducing stress and anxiety.
Regular safe exercise should still be encouraged for better long-term health.
For healthcare providers:
This study supports adding psychological care (CBT) to standard cardiac rehabilitation.
More research is needed to optimize home-based exercise programs for Fontan patients.
Final message:
If you or a loved one has Fontan circulation, taking care of mental health is just as important as heart health. A program that includes counseling and exercise may help improve both!
详细描述
"All relevant information has been entered in the appropriate sections of the study record."
This ensures there is no unnecessary duplication while keeping the record clear and organized.
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
- None
盲法说明
"Not Applicable - This is an open-label study."
入排标准
- 年龄范围
- 18 Years 至 23 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 23 years more than one year after Fontan surgery
- •Had no surgery planned during study participation
- •Had scores ≥ 8 for the anxiety (HADS-A) and/or depression (HADS-D) HADS subscales (Bjelland, Dahl, Haug, & Neckelmann, 2002; Holdgaard et al., 2023).
- •Could read and complete the consent form and questionnaire, and participate in a Korean-language group
排除标准
- •Undergoing psychotherapy during study participation
- •Had significant cognitive impairment, psychosis, or personality disorder noted in their medical record
- •Had scores ≥ 11 for HADS-D and > 17 for the Beck Depression Inventory (BDI) as evaluated by a psychiatrist or had been identified with severe depression or other serious psychiatric diagnoses (Kovacs et al., 2022; Marquez et al., 2020).
- •Exhibited indications for the restriction of exercise of greater-than-moderate intensity based on recommendations from the American Heart Association (Franklin et al., 2020; Longmuir et al., 2013)
研究组 & 干预措施
CPR group; Cardiac and Psychosocial Rehabilitation
Cognitive Behavioral Therapy (CBT)-based psychosocial rehabilitation program with a structured Home-Based Cardiac Rehabilitation (CR) program
干预措施: CPR; (Cardiac and Psychosocial Rehabilitation) with Cardiac Rehabilitation (Behavioral)
CR group; Home-Based Cardiac Rehabilitation
8-week Home-Based Cardiac Rehabilitation (CR) program
干预措施: CR; Home-Based Cardiac Rehabilitation (Behavioral)
Control group; usual care
control group received usual care without any additional interventions
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Change in Depression Score Assessed by the Hospital Anxiety and Depression Scale (HADS-
时间窗: Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
Depression will be measured using the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D). The HADS-D consists of 7 items, each scored from 0 to 3, with a total score ranging from 0 to 21. Higher scores indicate greater depressive symptoms. The primary outcome will be assessed at three time points: pre-intervention, post-intervention (week 8), and follow-up (week 12)
次要结局
- Change in Anxiety Score Assessed by the Hospital Anxiety and Depression Scale (HADS-A)(Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up))
- Change in Self-Efficacy Score Assessed by the General Self-Efficacy Scale (GSE)(Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up))
- Change in Quality of Life Score Assessed by the Linear Analog Scale (LAS)(Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up))
- Change in Heart Rate Variability (HRV) Assessed by Electrocardiographic Monitoring(Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up))
- Change in Exercise Capacity Assessed by Cardiopulmonary Exercise Testing (CPET)(Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up))
- Change in Physical Activity Level Assessed by the International Physical Activity Questionnaire (IPAQ) Short Form(Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up))
研究者
June Huh
Professor of Pediatric Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Samsung Medical Center