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

Delta University for Science and Technology

Status: Completed

Conditions: Vaginismus; Psychological Distress

Treatments: Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07588724

PSU-CBT-VAG-2024-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Cognitive Behavioral Therapy Group

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy

Control Group

No Intervention group

Description:

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