Cognitive Behavioral Therapy to Medical Treatment on Functional Ability of Patients With Vestibular MigraineNCT07849283
Efficacy of Cognitive Behavioral Therapy at Vestibular Migraine
A study testing •Group A: Patients will receive Medical treatment only: Beta-blockers (Propranolol) , Calcium channel blockers and Group B: Cognitive Behavioral Therapy (CBT) +Medical treatment in people with Cognitive Behavioral Therapy to Medical Treatment on Functional Ability of Patients With Vestibular Migraine, run by Sohag University at 1 site in Egypt.
Trial summary
The management of vestibular migraine is multifaceted and includes both pharmacological and non-pharmacological approaches. Aim of work Evaluate the efficacy of adding Cognitive Behavioral Therapy (CBT) to standardized Medical treatment on improving functional ability of Vestibular Migraine. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Behavioral Therapy to Medical Treatment on Functional Ability of Patients With Vestibular Migraine
- What is being tested?
- •Group A: Patients will receive Medical treatment only: Beta-blockers (Propranolol) , Calcium channel blockers and Group B: Cognitive Behavioral Therapy (CBT) +Medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-60 years. Patients with a confirmed diagnosis of Vestibular Migraine according to ICHD-3 (Not better accounted by another vestibular disorder or another disease) Psychological state: Patients with stable general and psychological condition.
Who cannot join
- Age: below 18, above 60 years Other Vestibular Disorders as Ménière's disease, Benign Paroxysmal Positional Vertigo, Vestibular neuritis and Central neurological disorder Systemic or Other Causes Orthostatic hypotension Anxiety/panic disorders Drug-induced dizziness Psychological state: Patients with active psychiatric disorders requiring immediate intervention.
- Pregnancy, lactating woman and Cognitive impairment patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University
Sohag
Reham Kamel residant at audio vestibular unite, 01110629145, aa.rehamkamel0@gmail.com
About this study
Official title: Efficacy of Adding Cognitive Behavioral Therapy to Medical Treatment on Functional Ability of Patients With Vestibular Migraine
The management of vestibular migraine is multifaceted and includes both pharmacological and non-pharmacological approaches. Aim of work Evaluate the efficacy of adding Cognitive Behavioral Therapy (CBT) to standardized Medical treatment on improving functional ability of Vestibular Migraine.
- Being tested
- •Group A: Patients will receive Medical treatment only: Beta-blockers (Propranolol) , Calcium channel blockers, Group B: Cognitive Behavioral Therapy (CBT) +Medical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
•Group A: Patients will receive Medical treatment only: Beta-blockers (Propranolol) , Calcium channel blockersDrug
Group A: Patients will receive Medical treatment only:
beta blocker :20 mg twice daily ca channel blocker:5 mg once daily
Group B: Cognitive Behavioral Therapy (CBT) +Medical treatmentDrug
Structured CBT program consisting of 6-8 sessions over 8 weeks .
Session 1:
Psychoeducation about Vestibular Migraine
Session 2:
Progressive muscle relaxation and mini relaxation
Session 3:
Increasing pleasant activities and coping with fear
Session 4:
Cognitive Restructuring
Session 5:
Trigger management and skill review.
Session 6:
Impact of thoughts and feelings (stress management and calm statements)
Session 7:
Skill review and self -monitoring process
Session 8:
Summery and review (if needed)
| Study group | Role | What they receive |
|---|---|---|
| Group A: Patients will receive Medical treatment only | Active comparator | Not described Receives: Drug: •Group A: Patients will receive Medical treatment only: Beta-blockers (Propranolol) , Calcium channel blockers |
| Group B: Cognitive Behavioral Therapy (CBT) +Medical treatment | Active comparator | • Patients will receive Medical treatment +CBT Beta-blockers (Propranolol) Calcium channel blockers Structured CBT program consisting of 6-8 sessions over 8 weeks .
Session 1:
Psychoeducation about Vestibular Migraine
Session 2:
Progressive muscle relaxation and mini relaxation
Session 3:
Increasing pleasant activities and coping with fear
Session 4:
Cognitive Restructuring
Session 5:
Trigger management and skill review.
Session 6:
Impact of thoughts and feelings (stress management and calm statements)
Session 7:
Skill review and self -monitoring process
Session 8:
Summery and review (if needed) Receives: Drug: Group B: Cognitive Behavioral Therapy (CBT) +Medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
improving in Functional Ability of patients with vestibular migraine
1-DHI score Dizziness Handicap Inventory (DHI) is a 25-item self-assessment scale used to evaluate the self-perceived handicapping effects imposed by dizziness. The total score ranges from 0 to 100, where 0 indicates no handicap and 100 indicates severe handicap.
Measured: 1-Baseline and at 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 posted30 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Behavioral Therapy to Medical Treatment on Functional Ability of Patients With Vestibular MigraineStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Kamal Lotfy Gad, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849283
- Sponsor's protocol ID
- Soh-Med-26-9-3MS
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Cognitive Behavioral Therapy to Medical Treatment on Functional Ability of Patients With Vestibular Migraine
- ClinicalTrials.gov ID
- NCT07849283
- Acronym / sponsor ID
- Soh-Med-26-9-3MS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Sep 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.
The management of vestibular migraine is multifaceted and includes both pharmacological and non-pharmacological approaches. Aim of work Evaluate the efficacy of adding Cognitive Behavioral Therapy (CBT) to standardized Medical treatment on improving functional ability of Vestibular Migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Patients will receive Medical treatment only | Active comparator | Drug: •Group A: Patients will receive Medical treatment only: Beta-blockers (Propranolol) , Calcium channel blockers |
| Group B: Cognitive Behavioral Therapy (CBT) +Medical treatment | Active comparator | Drug: Group B: Cognitive Behavioral Therapy (CBT) +Medical treatment• Patients will receive Medical treatment +CBT Beta-blockers (Propranolol) Calcium channel blockers Structured CBT program consisting of 6-8 sessions over 8 weeks . Session 1: Psychoeducation about Vestibular Migraine Session 2: Progressive muscle relaxation and mini relaxation Session 3: Increasing pleasant activities and coping with fear Session 4: Cognitive Restructuring Session 5: Trigger management and skill review. Session 6: Impact of thoughts and feelings (stress management and calm statements) Session 7: Skill review and self -monitoring process Session 8: Summery and review (if needed) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age: 18-60 years. Patients with a confirmed diagnosis of Vestibular Migraine according to ICHD-3 (Not better accounted by another vestibular disorder or another disease) Psychological state: Patients with stable general and psychological condition.
Key exclusion criteria (2 listed)
- Age: below 18, above 60 years Other Vestibular Disorders as Ménière's disease, Benign Paroxysmal Positional Vertigo, Vestibular neuritis and Central neurological disorder Systemic or Other Causes Orthostatic hypotension Anxiety/panic disorders Drug-induced dizziness Psychological state: Patients with active psychiatric disorders requiring immediate intervention.
- Pregnancy, lactating woman and Cognitive impairment patient
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 |
|---|---|---|
| •Group A: Patients will receive Medical treatment only: Beta-blockers (Propranolol) , Calcium channel blockersGroup A: Patients will receive Medical treatment only: beta blocker :20 mg twice daily ca channel blocker:5 mg once daily | Drug | Group A: Patients will receive Medical treatment only |
| Group B: Cognitive Behavioral Therapy (CBT) +Medical treatmentStructured CBT program consisting of 6-8 sessions over 8 weeks . Session 1: Psychoeducation about Vestibular Migraine Session 2: Progressive muscle relaxation and mini relaxation Session 3: Increasing pleasant activities and coping with fear Session 4: Cognitive Restructuring Session 5: Trigger management and skill review. Session 6: Impact of thoughts and feelings (stress management and calm statements) Session 7: Skill review and self -monitoring process Session 8: Summery and review (if needed) | Drug | Group B: Cognitive Behavioral Therapy (CBT) +Medical treatment |
Primary outcome
improving in Functional Ability of patients with vestibular migraine
Time frame: 1-Baseline and at 3 months post-intervention
1-DHI score Dizziness Handicap Inventory (DHI) is a 25-item self-assessment scale used to evaluate the self-perceived handicapping effects imposed by dizziness. The total score ranges from 0 to 100, where 0 indicates no handicap and 100 indicates severe handicap.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing •Group A: Patients will receive Medical treatment only: Beta-blockers (Propranolol) , Calcium channel blockers and Group B: Cognitive Behavioral Therapy (CBT) +Medical treatment in people with Cognitive Behavioral Therapy to Medical Treatment on Functional Ability of Patients With Vestibular Migraine, run by Sohag University 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 7 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reham Kamel residant doctor at audio vestibular unite (01110629145, aa.rehamkamel0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improving in Functional Ability of patients with vestibular migraine (time frame: 1-Baseline and at 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 7 Oct 2026.