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临床试验/NCT07837440
NCT07837440已完成不适用

Effectiveness of a Structured Psychoeducational Intervention on Anxiety, Depression, Cognitive Avoidance, and Sense of Coherence in Women With Cancer

Ardakan University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Change from Baseline in Anxiety Score

研究概览

简要总结

This study evaluates the effectiveness of a structured psychoeducational intervention on anxiety, depression, cognitive avoidance, and sense of coherence in women with cancer. In this randomized controlled trial, 40 women with cancer were assigned to either an intervention group or a control group. The intervention group received 6 weekly structured psychoeducational sessions (90 minutes each) focusing on stress management, cognitive restructuring, and emotional regulation. The control group received standard care. All four outcomes (anxiety, depression, cognitive avoidance, and sense of coherence) were assessed at baseline, after the 6-week intervention, and at a 2-month follow-up using the Hospital Anxiety and Depression Scale (HADS), Cognitive Avoidance Questionnaire (CAQ), and Sense of Coherence Scale (SOC-13).The study aims to provide evidence for integrating psychoeducational support into routine cancer care to improve mental health outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Minimum age of 20 years
  • •Diagnosis of cancer in stages 1 or 2 confirmed by a physician
  • •Having completed at least one course of cancer treatment
  • •Not currently receiving any other psychological treatment or intervention
  • •Minimum literacy (ability to read and write)
  • •Written informed consent to participate in the study

排除标准

  • •Unwillingness to continue participation
  • •Absence from more than two sessions
  • •Receiving other psychological interventions concurrently with cancer treatment
  • •Major psychiatric or cognitive disorder that prevents providing informed consent and participating in the study
  • •Death of the patient

研究组 & 干预措施

Intervention Group

Experimental

Participants in this group receive 6 weekly structured psychoeducational sessions (90 minutes each) focusing on stress management, cognitive restructuring, and emotional regulation.

干预措施: Structured Psychoeducational Intervention (Behavioral)

Control Group

No Intervention

Participants in this group receive standard care without any psychoeducational intervention.

结局指标

主要结局

Change from Baseline in Anxiety Score

时间窗: Baseline, 6 weeks, and 2-month follow-up

Anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale.

Change from Baseline in Depression Score

时间窗: Baseline, 6 weeks, and 2-month follow-up

Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) - Depression Subscale.

Change from Baseline in Cognitive Avoidance Score

时间窗: Baseline, 6 weeks, and 2-month follow-up

Cognitive avoidance will be assessed using the Cognitive Avoidance Questionnaire (CAQ).

Change from Baseline in Sense of Coherence Score

时间窗: Baseline, 6 weeks, and 2-month follow-up

Sense of coherence will be assessed using the Sense of Coherence Scale (SOC-13).

次要结局

未报告次要终点

研究者

发起方
Ardakan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeinab Mollaeifar

Student

Ardakan University

研究点 (1)

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