Eye Movement Desensitization and Reprocessing InterventionEMDRNCT05836181
The Effect of Eye Movement Desensitization and Reprocessing Intervention in Hypertension Patient.
A study testing Eye Movement Desensitization and Reprocessing in people with Eye Movement Desensitization and Reprocessing Intervention and Blood Pressure, run by Miao-Yi Chen at 1 site in Taiwan.
Trial summary
Eye Movement Desensitization and Reprocessing intervention may improve anxiety, depression, systolic blood pressure and heart rate variability in patients with hypertension. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Eye Movement Desensitization and Reprocessing Intervention, Blood Pressure, Heart Rate Variability
- What is being tested?
- Eye Movement Desensitization and Reprocessing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2014to 28 Dec 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age of 20-80 years,
- diagnosed with primary hypertension as in SBP ≥130 mmHg or DBP ≥80 mmHg,
- and able to read and understand Chinese or Taiwanese and willing to participate in this study,
Who cannot join
- . Secondary hypertension
- . Hypertension Crisis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Eye Movement Desensitization and Reprocessing Reducing Anxiety, Depressive Symptoms, Blood Pressure, and Heart Rate Variability in Primary Hypertension： A Randomized Controlled Clinical Trial
Eye Movement Desensitization and Reprocessing intervention may improve anxiety, depression, systolic blood pressure and heart rate variability in patients with hypertension.
- Conditions
- Eye Movement Desensitization and Reprocessing Intervention, Blood Pressure, Heart Rate Variability, Anxiety
- Being tested
- Eye Movement Desensitization and Reprocessing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and ReprocessingBehavioural
Effects of Eye Movement Desensitization and Reprocessing on Anxiety, Depression, Quality of Life, Blood Pressure and Heart Rate Variability in Patients with Hypertension.
| Study group | Role | What they receive |
|---|---|---|
| Eye Movement Desensitization and Reprocessing intervention | Experimental | The goal of EMDR is to help manage physical and mental unpleasant experiences due to hypertension. The intervention group received EMDR therapy included eight phases, each lasting 60-90 minutes, and the intervention consisted of four weekly. In this study, a Nurse practitioner trained in EMDR performs an intervention in an outpatient clinic's quiet, empty room. Receives: Behavioral: Eye Movement Desensitization and Reprocessing |
| Eye Movement Desensitization and Reprocessing control | No intervention | The control group received routine care and treatment as usual. They did not receive EMDR intervention or counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
HADS-A score
Measured: Six month
depression symptoms
CESD Scale
Measured: Six month
Secondary outcomes (1)
Blood pressure
Blood pressure
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Feb 2014
- Primary completion10 Dec 2016
- Study completion28 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye Movement Desensitization and Reprocessing InterventionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miao-Yi Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Miao-Yi Chen, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836181
- Sponsor's protocol ID
- TSGHNDMC
- Acronym
- EMDR
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eye Movement Desensitization and Reprocessing Reducing Anxiety, Depressive Symptoms, Blood Pressure, and Heart Rate Variability in Primary Hypertension： A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05836181
- Acronym / sponsor ID
- EMDR / TSGHNDMC
- Conditions
- Eye Movement Desensitization and Reprocessing Intervention, Blood Pressure, Heart Rate Variability, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Miao-Yi ChenUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 10 Dec 2016 (actual)
- Study completion
- 28 Dec 2016 (actual)
- First posted
- 1 May 2023 (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.
Eye Movement Desensitization and Reprocessing intervention may improve anxiety, depression, systolic blood pressure and heart rate variability in patients with hypertension.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye Movement Desensitization and Reprocessing intervention | Experimental | Behavioral: Eye Movement Desensitization and ReprocessingThe goal of EMDR is to help manage physical and mental unpleasant experiences due to hypertension. The intervention group received EMDR therapy included eight phases, each lasting 60-90 minutes, and the intervention consisted of four weekly. In this study, a Nurse practitioner trained in EMDR performs an intervention in an outpatient clinic's quiet, empty room. |
| Eye Movement Desensitization and Reprocessing control | No intervention | –The control group received routine care and treatment as usual. They did not receive EMDR intervention or counseling. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age of 20-80 years,
- diagnosed with primary hypertension as in SBP ≥130 mmHg or DBP ≥80 mmHg,
- and able to read and understand Chinese or Taiwanese and willing to participate in this study,
Key exclusion criteria (2 listed)
- . Secondary hypertension
- . Hypertension Crisis.
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 |
|---|---|---|
| Eye Movement Desensitization and ReprocessingEffects of Eye Movement Desensitization and Reprocessing on Anxiety, Depression, Quality of Life, Blood Pressure and Heart Rate Variability in Patients with Hypertension. | Behavioural | Eye Movement Desensitization and Reprocessing intervention |
Primary outcome
Anxiety
Time frame: Six month
HADS-A score
depression symptoms
Time frame: Six month
CESD Scale
1 secondary outcome
Blood pressure
Time frame: Six month
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 1 May 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing in people with Eye Movement Desensitization and Reprocessing Intervention and Blood Pressure, run by Miao-Yi Chen at 1 site in Taiwan.
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 3 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: finished, as of the sponsor's last update on 1 May 2023. 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 Taiwan. 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?
Anxiety (time frame: Six month). The study lists 2 primary outcomes in all. 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 1 May 2023.