Skip to main content
OpenTrials
Completed

NCT Number: NCT07588724

Effectiveness of Cognitive Behavioral Therapy on Psychological Distress and Problem-Solving Skills in Women With Vaginismus

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vaginismus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Mental Disorders Psychological Distress Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Vaginal Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dar Sehet Elmaraa Hospital

Port Said, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

The intervention consisted of a structured cognitive behavioral therapy (CBT) program designed for women with vaginismus. The program integrated cognitive restructuring, relaxation techniques, adaptive coping strategies, and problem-solving training. Sessions were delivered over a three-month period through structured interactive sessions lasting approximately 60-90 minutes.

Other names: CBT

Primary outcomes

  1. Psychological Distress

    Time frame: 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.

Secondary outcomes

  1. Problem-Solving Skills

    Time frame: Baseline and 3 months post-intervention

    Problem-solving skills were measured using the Problem-Solving Inventory (PSI). Total scores range from 32 to 192, with higher scores indicating poorer perceived problem-solving ability and lower scores indicating better problem-solving skills.

    Time

Sponsors and collaborators

Lead sponsor

Delta University for Science and Technology

Other

Collaborators

  • Fayoum University
  • Misr University for Science and Technology
  • Port Said University

Registry information

Official study title

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

Acronym: CBT-VAG

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 15, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.