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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07588724
Acronym
CBT-VAG
Enrollment
60
Registered
2026-05-15
Start date
2024-03-01
Completion date
2024-06-30
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Distress, Vaginismus

Keywords

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

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.

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.

Interventions

BEHAVIORALCognitive 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.

Sponsors

Delta University for Science and Technology
Lead SponsorOTHER
Fayoum University
CollaboratorOTHER
Port Said University
CollaboratorOTHER
Misr University for Science and Technology
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Psychological DistressBaseline and 3 months post-interventionPsychological 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

MeasureTime frameDescription
Problem-Solving SkillsBaseline and 3 months post-interventionProblem-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

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORBasma W Elrefay, PhD

Faculty of Nursing, Port Said University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026