VaginismusCBT-VAGNCT07588724
Effectiveness of Cognitive Behavioral Therapy on Psychological Distress and Problem-Solving Skills in Women With Vaginismus
A study testing Cognitive Behavioral Therapy in people with Vaginismus and Psychological Distress, run by Delta University for Science and Technology at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Vaginismus, Psychological Distress
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vaginismus, Psychological Distress
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Cognitive Behavioral Therapy, Vaginismus, Psychological Distress, Depression Anxiety Stress Scale, Problem-Solving Skills
- Medical subject headings
- Vaginismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months post-intervention
Secondary outcomes (1)
Problem-Solving Skills
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
Measured: Baseline and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Mar 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginismusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Fayoum University, Port Said University, Misr University for Science and Technology
- Responsible party
- Sponsor
- Investigators
- Basma W Elrefay, PhD, Principal investigator, Faculty of Nursing, Port Said University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588724
- Sponsor's protocol ID
- PSU-CBT-VAG-2024-01
- Acronym
- CBT-VAG
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cognitive Behavioral Therapy on Psychological Distress and Problem-Solving Skills in Women With Vaginismus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07588724
- Acronym / sponsor ID
- CBT-VAG / PSU-CBT-VAG-2024-01
- Conditions
- Vaginismus, Psychological Distress
- Keywords
- Cognitive Behavioral Therapy, Vaginismus, Psychological Distress, Depression Anxiety Stress Scale, Problem-Solving Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Collaborators
- Fayoum University, Port Said University, Misr University for Science and Technology
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy Group | Experimental | Behavioral: Cognitive Behavioral TherapyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBTThe 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. | Behavioural | Cognitive Behavioral Therapy Group |
Primary outcome
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.
1 secondary outcome
Problem-Solving Skills
Time frame: Baseline and 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basma W Elrefay, PhD principal investigator
Faculty of Nursing, Port Said University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Vaginismus and Psychological Distress, run by Delta University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Distress (time frame: Baseline and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.