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

May 14, 2026 updated by: Delta University for Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Port Said, Egypt
        • Dar Sehet Elmaraa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Therapy Group
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.
Behavioral: Cognitive Behavioral Therapy
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
No Intervention: Control Group
Participants in this group received routine care and attended non-therapeutic discussion sessions without receiving the structured cognitive behavioral therapy intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Delta University for Science and Technology

Collaborators

Fayoum University
Misr University for Science and Technology
Port Said University

Investigators

  • Principal Investigator: Basma W Elrefay, PhD, Faculty of Nursing, Port Said University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

May 9, 2026

First Submitted That Met QC Criteria

May 9, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSU-CBT-VAG-2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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