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临床试验 NCT07255131 (RAKITZIHCFA) 针对Depression - Major Depressive Disorder，Anxiety Chronic，焦虑，功能性结果，恢复，Obsessive Compulsive Disorders，Assertiveness目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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The Effectiveness and Efficacy of an Online Cognitive Behavioral Psychotherapeutic Program (RAKITZIHCFA)
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临床试验NCT07255131 (RAKITZIHCFA)是一项针对Depression - Major Depressive Disorder，Anxiety Chronic，焦虑，功能性结果，恢复，Obsessive Compulsive Disorders，Assertiveness的干预性研究试验，目前试验状态为招募中。试验始于2025年9月26日，计划招募52名患者。该研究由Rakitzi, Stavroula主导，预计于2028年12月20日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年11月28日。
简要概括
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.
官方标题
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
疾病
Depression - Major Depressive DisorderAnxiety Chronic焦虑功能性结果恢复Obsessive Compulsive DisordersAssertiveness出版物
关于此临床试验发表的科学文章和研究论文：- Rakitzi, S., Spinou, A., & Giannaki, K. (2025). The effectiveness of an online-group cognitive behavioral psychotherapy in Hellenic Cystic Fibrosis Association for patients and caregivers. Journal of rational emotive and cognitive behavior therapy. DOI: 10.1007/s10942-025-00611-3
- Rakitzi, S. (2023). Clinical psychology and cognitive behavioral psychotherapy. Recovery in mental health. Springer.
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- Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.
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- HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
- Fountoulakis KN, Iacovides A, Kleanthous S, Samolis S, Gougoulias K, St Kaprinis G, Bech P. The Greek translation of the symptoms rating scale for depression and anxiety: preliminary results of the validation study. BMC Psychiatry. 2003 Dec 10;3:21. doi: 10.1186/1471-244X-3-21.
- Fiedler, P. (2005). Verhaltenstherapie in Gruppen. Beltz.
- Cohen, J. (1988). Statistical Power Analyses for the Behavioural Sciences. Erlbaum.
- Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. Springer-Verlag.
- Αntoniou, V., Εfthimiou, Κ., & Μilona, Κ.(2015). Social anxiety and assertiveness. A structured group cognitive behavioral program. IETHS.
其他研究标识符
- RAKITZIHCFA
- RAKITZI CYSTIC FIBROSIS
- HELLENIC CYSTIC FIBROSIS ASSOC (其他标识符) (HELLENIC CYSTIC FIBROSIS ASSOCIATION & DR. STAVROULA RAKITZI)
NCT编号
实际开始日期
2025-09-26
最近更新发布
2025-11-28
预计完成日期
2028-12-20
计划入组人数
52
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Cystic Fibrosis
Group cognitive behavioral psychotherapy
Group cognitive behavioral psychotherapy
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Therapy group A patients with Cystic Fibrosis Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions. | Group a an Online Group Cognitive Behavioral Psychotherapy in 13 Sessions Via Zoom An online group cognitive behavioral psychotherapy will be offered via Zoom in 13 sessions to the therapy Group A, to patients with cystic fibrosis |
阳性对照Control group B Patients with cystic fibrosis Participation on an online group supportive psychotherapy via Zoom in 13 sessions. | Group B an Online Group Supportive Psychotherapy in 13 Sessions Via Zoom An online group supportive psychotherapy will be offered via Zoom in 13 sessions to the control group Group B, to patients with cystic fibrosis |
实验性Therapy group C caregivers of patients with cystic fibrosis Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions. | Group C an Online Group Cognitive Behavioral Psychotherapy in 13 Sessions Via Zoom An online group cognitive behavioral psychotherapy will be offered via Zoom in 13 sessions to the therapy group C, to caregivers of patients with cystic fibrosis |
阳性对照Contol group D caregivers of patients with cystic fibrosis Participation on an online group supportive psychotherapy via Zoom in 13 sessions. | Group D an Online Group Supportive Psychotherapy in 13 Sessions Via Zoom An online group supportive psychotherapy will be offered via Zoom in 13 sessions to the control Group D, to caregivers of patients with cystic fibrosis |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
SCL-90-R | It evaluates psychopathology. T\>60 means psychopathology. Low scores better | Preintervention |
SCL-90-R | It evaluates psychopathology. T\>60 means psychopathology. Low scores better | Immediately after the intervention |
SCL-90-R | It evaluates psychopathology. T\>60 means psychopathology. Low scores better | Follow-up up to 24 weeks |
SRSDA | It measures Depression. Minimum 0 Maximum over 14. Low scores better | Preintervention |
SRSDA | It measures Depression. Minimum 0 Maximum over 14. Low scores better | Immediately after intervention |
SRSDA | It measures Depression. Minimum 0 Maximum over 14. Low scores better | Follow-up up to 24 weeks |
SRSDA | It measures anxiety. Minimum 0 Maximum over 10. Low scores better | Preintervention |
SRSDA | It measures anxiety. Minimum 0 Maximum over 10. Low scores better | Immediately after intervention |
SRSDA | It measures anxiety. Minimum 0 Maximum over 10. Low scores better | Follow-up up to 24 weeks |
U Uncertainty questionnaire | 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) | Preintervention |
U Uncertainty questionnaire | 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) | Immediately after the intervention |
U Uncertainty questionnaire | 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) | Follow up up to 24 weeks |
Hamilton Depression Scale | It measures depression. Minimum 0, maximum 23. Low scores better. | Preintervention |
Hamilton Depression Scale | It measures depression. Minimum 0, maximum 23. Low scores better. | Immediately after the intervention |
Hamilton Depression Scale | It measures depression. Minimum 0, maximum 23. Low scores better. | Follow up up to 24 weeks |
WHODAS total | It measures functional outcome. Minimum 0, maximum 100. low scores better. | Preintervention |
WHODAS total | It measures functional outcome. Minimum 0, maximum 100. low scores better. | Immediately after the intervention |
WHODAS total | It measures functional outcome. Minimum 0, maximum 100. low scores better. | Follow up up to 24 weeks |
RAS-DS total | Recovery. It measures recovery. Minimum 0, maximum 152. High scores better. | Preintervention |
RAS-DS total | Recovery. It measures recovery. Minimum 0, maximum 152. High scores better. | Immediately after intervention |
RAS-DS total | Recovery. It measures recovery. Minimum 0, maximum 152. High scores better. | Follow up up to 24 weeks |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Age 18-70
- Members of the Hellenic Cystic Fibrosis Association
- Willingness to participate on 13 sessions via Zoom
- Age over 70
- Not members of the Hellenic Cystic Fibrosis Association
- Not able to participate on 13 sessions via Zoom
Rakitzi, Stavroula研究责任方
Dr. Stavroula Rakitzi, 主要研究者, PhD, Clinical psychologist and cognitive behavioral psychotherapist, Rakitzi, Stavroula
研究中心联系人
联系人: Dr. Stavroula Rakitzi, PhD, +306989766935, [email protected]
联系人: Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc, +306944255853, [email protected]
1 位于 1 个国家/地区的研究中心
Private practice, ILISION 34 15771 Athens Greece, Athens, 15771, Greece
Dr. Stavroula Rakitzi, PhD, 联系人, +306989766935, [email protected]
Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc, 联系人, +306944255853, [email protected]
招募中