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

NCT07588724 | Completed

• 1 other identifier: PSU-CBT-VAG-2024-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychological Distress; Vaginismus

Keywords

Cognitive Behavioral Therapy; Vaginismus; Psychological Distress; Depression Anxiety Stress Scale; Problem-Solving Skills

Outcome Measures

Primary Outcomes (1)

• Psychological Distress

  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 Outcomes (1)

• Problem-Solving Skills

  Baseline and 3 months post-intervention

Study Arms (2)

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.

Behavioral: Cognitive Behavioral Therapy

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.

Interventions

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.

Also known as: CBT

Cognitive Behavioral Therapy Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Delta University for Science and Technology: lead
• Fayoum University: collaborator
• Port Said University: collaborator
• Misr University for Science and Technology: collaborator

Study Sites (1)

Dar Sehet Elmaraa Hospital

Port Said, Egypt

Location

MeSH Terms

Conditions

Vaginismus

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Basma W Elrefay, PhD

  Faculty of Nursing, Port Said University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned to either a cognitive behavioral therapy (CBT) intervention group or a control group receiving routine care. The intervention group received a structured CBT program integrating cognitive restructuring, relaxation techniques, and problem-solving training, while the control group received routine care and non-therapeutic discussion sessions. Outcomes were assessed before and after the intervention to evaluate changes in psychological distress and problem-solving skills among women with vaginismus.

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 15, 2026
• Study Start: March 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)