The Effectiveness and Efficacy of an Online Group Cognitive Behavioral Psychotherapy in Patients With Cystic Fibrosis and Caregivers in Comparison to Control Groups by the Hellenic Cystic Fibrosis Association A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- SRSDA
研究概览
简要总结
An online group cognitive behavioral psychotherapeutic program will be offered to patients with cystic fibrosis and to caregivers by the Hellenic Cystic Fibrosis Association. These 2 above therapy groups will be compared with control groups in a randomized controlled trial
详细描述
A therapy group of patients with cystic fibrosis, who participate on the online group cognitive behavioral psychotherapeutic program will be compared with a control group of patients with cystic fibrosis, who participate in an online group supportive psychotherapeutic program. Both of the groups participate on 13 sessions once a week.
A therapy group of caregivers, who participate on the online group cognitive behavioral psychotherapeutic program will be compared with a control group of caregivers, who participate in an online group supportive psychotherapeutic program. Both of the groups participate on 13 sessions once a week.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70
- •Members of the Hellenic Cystic Fibrosis Association
- •Willingness to participate on 13 sessions via Zoom
排除标准
- •Age over 70
- •Not members of the Hellenic Cystic Fibrosis Association
- •Not able to participate on 13 sessions via Zoom
研究组 & 干预措施
Therapy group A patients with Cystic Fibrosis
Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions.
3 participants
干预措施: Group A An online group cognitive behavioral psychotherapy in 13 sessions via Zoom (Behavioral)
Control group B Patients with cystic fibrosis
Participation on an online group supportive psychotherapy via Zoom in 13 sessions.
2 participants
干预措施: Group B An online group supportive psychotherapy in 13 sessions via Zoom (Behavioral)
Therapy group C caregivers of patients with cystic fibrosis
Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions.
2 participants
干预措施: Group C An online group cognitive behavioral psychotherapy in 13 sessions via Zoom (Behavioral)
Contol group D caregivers of patients with cystic fibrosis
Participation on an online group supportive psychotherapy via Zoom in 13 sessions.
2 participants
干预措施: Group D An online group supportive psychotherapy in 13 sessions via Zoom (Behavioral)
结局指标
主要结局
SRSDA
时间窗: Follow-up up to 24 weeks
It measures Depression. Minimum 0 Maximum over 14. Low scores better
SCL-90-R
时间窗: Follow-up up to 24 weeks
It evaluates psychopathology. T\>60 means psychopathology. Low scores better
U Uncertainty questionnaire
时间窗: Follow up up to 24 weeks
It evaluates social skills and assertiveness.: fear of criticism (psychopathology in \>35), fear of contact (psychopathology in \>41) , assertiveness (psychopathology in \<26) , difficulty of saying no (psychopathology in \>28) , guilt and decency (psychopathology in \>9)
Hamilton Depression Scale
时间窗: Follow up up to 24 weeks
It measures depression. Minimum 0, maximum 23. Low scores better.
WHODAS total
时间窗: Follow up up to 24 weeks
It measures functional outcome. Minimum 0, maximum 100. low scores better.
RAS-DS total
时间窗: Follow up up to 24 weeks
Recovery. It measures recovery. Minimum 0, maximum 152. High scores better.
SCL-90-R
时间窗: Preintervention
It evaluates psychopathology. T\>60 means psychopathology. Low scores better
SCL-90-R
时间窗: Immediately after the intervention
It evaluates psychopathology. T\>60 means psychopathology. Low scores better
SRSDA
时间窗: Preintervention
It measures Depression. Minimum 0 Maximum over 14. Low scores better
SRSDA
时间窗: Immediately after intervention
It measures Depression. Minimum 0 Maximum over 14. Low scores better
U Uncertainty questionnaire
时间窗: Preintervention
It evaluates social skills and assertiveness.: fear of criticism (psychopathology in \>35), fear of contact (psychopathology in \>41) , assertiveness (psychopathology in \<26) , difficulty of saying no (psychopathology in \>28) , guilt and decency (psychopathology in \>9)
U Uncertainty questionnaire
时间窗: Immediately after the intervention
It evaluates social skills and assertiveness.: fear of criticism (psychopathology in \>35), fear of contact (psychopathology in \>41) , assertiveness (psychopathology in \<26) , difficulty of saying no (psychopathology in \>28) , guilt and decency (psychopathology in \>9)
Hamilton Depression Scale
时间窗: Preintervention
It measures depression. Minimum 0, maximum 23. Low scores better.
Hamilton Depression Scale
时间窗: Immediately after the intervention
It measures depression. Minimum 0, maximum 23. Low scores better.
WHODAS total
时间窗: Preintervention
It measures functional outcome. Minimum 0, maximum 100. low scores better.
WHODAS total
时间窗: Immediately after the intervention
It measures functional outcome. Minimum 0, maximum 100. low scores better.
RAS-DS total
时间窗: Preintervention
Recovery. It measures recovery. Minimum 0, maximum 152. High scores better.
RAS-DS total
时间窗: Immediately after intervention
Recovery. It measures recovery. Minimum 0, maximum 152. High scores better.
次要结局
未报告次要终点
研究者
Dr. Stavroula Rakitzi
PhD, Clinical psychologist and cognitive behavioral psychotherapist
Rakitzi, Stavroula