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临床试验/NCT07588724
NCT07588724已完成不适用

Effectiveness of Cognitive Behavioral Therapy on Psychological Distress and Problem-Solving Skills in Women With Vaginismus: A Randomized Controlled Trial

Delta University for Science and Technology1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3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
入组人数
60
试验地点
1
主要终点
Psychological Distress

研究概览

简要总结

This randomized controlled trial aimed to evaluate the effectiveness of a structured cognitive behavioral therapy (CBT) intervention on psychological distress and problem-solving skills among women with vaginismus. Sixty women diagnosed with vaginismus were randomly assigned to either an intervention group receiving CBT or a control group receiving routine care. Psychological distress and problem-solving skills were assessed before and after the intervention using the Depression Anxiety Stress Scale (DASS-21) and the Problem-Solving Inventory (PSI). The study examined the effectiveness of CBT in reducing psychological distress and improving adaptive coping and problem-solving abilities among affected women.

详细描述

Vaginismus is associated with considerable psychological distress, emotional difficulties, and impaired interpersonal relationships. Cognitive behavioral therapy (CBT) has demonstrated effectiveness in reducing anxiety, maladaptive cognitions, and emotional distress in various psychological and sexual disorders. However, limited evidence is available regarding the effectiveness of CBT interventions among women with vaginismus in Arab populations.

This study used a randomized controlled trial design to evaluate the effectiveness of a structured CBT intervention program on psychological distress and problem-solving skills among women with vaginismus attending outpatient obstetrics and gynecology clinics in Port Said Governorate, Egypt. Participants were randomly allocated into an intervention group and a control group.

The intervention program consisted of structured CBT sessions integrating cognitive restructuring, relaxation techniques, adaptive coping strategies, and problem-solving training. The intervention was delivered over three months through structured sessions lasting approximately 60-90 minutes.

Primary outcomes included psychological distress measured using the Depression Anxiety Stress Scale (DASS-21). Secondary outcomes included problem-solving skills measured using the Problem-Solving Inventory (PSI). Baseline and post-intervention assessments were conducted to evaluate the effectiveness of the intervention.

The study aimed to provide evidence regarding the effectiveness and cultural applicability of CBT interventions for women with vaginismus within Arab healthcare settings.

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

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women diagnosed with vaginismus.
  • Age between 20 and 50 years.
  • Ability to communicate and participate in the intervention sessions.
  • Willingness to participate and provide written informed consent.

排除标准

  • Presence of severe psychiatric disorders or cognitive impairment.
  • Current participation in another psychological intervention program.
  • Presence of severe medical conditions that may interfere with participation in the study.
  • Refusal to participate or inability to complete the intervention sessions.

研究组 & 干预措施

Control Group

No Intervention

Participants in this group received routine care and attended non-therapeutic discussion sessions without receiving the structured cognitive behavioral therapy intervention.

Cognitive Behavioral Therapy Group

Experimental

Participants in this group received a structured cognitive behavioral therapy (CBT) intervention program integrating cognitive restructuring, relaxation techniques, adaptive coping strategies, and problem-solving training. The intervention was delivered through structured sessions over a three-month period.

干预措施: Cognitive Behavioral Therapy (Behavioral)

结局指标

主要结局

Psychological Distress

时间窗: Baseline and 3 months post-intervention

Psychological distress was measured using the Depression Anxiety Stress Scale-21 (DASS-21). Total scores range from 0 to 63, with higher scores indicating greater psychological distress and worse psychological outcomes among women with vaginismus.

次要结局

  • Problem-Solving Skills(Baseline and 3 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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