Postpartum DepressionNCT04355091
Emotional Freedom Techniques (EFT) and Postpartum Depression
A study testing Emotional Freedom Techniques (EFT) in people with Postpartum Depression, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Hypothesis 1: Pregnant women in the EFT group will have a lower test score from Edinburgh Postpartum Depression Scale, and a follow-up score of three months and six months after the last application date, compared to the control group. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Emotional Freedom Techniques (EFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 30 Apr 2020
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- To be in the 18-49 age range
- To be at least a primary school graduate
- To be pregnant between 13-30 weeks
- Not having a risky pregnancy,
- Having spontaneous pregnancy,
- Having a single and live fetus
- Not having a chronic serious physical illness or disability
- The absence of infection, wound, scar in the tapping area
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpaşa
Istanbul, Eyalet/Yerleşke
About this study
Official title: Effect of Emotional Freedom Techniques (EFT) on Postpartum Depression
Hypothesis 1: Pregnant women in the EFT group will have a lower test score from Edinburgh Postpartum Depression Scale, and a follow-up score of three months and six months after the last application date, compared to the control group.
Hypothesis 2: In the post-test of pregnant women in the EFT group, three months and six months after the last application date, the optimistic, self-confident and social support approach methods used to deal with stress will increase, and the helpless and submissive approach styles will decrease compared to the control group.
Hypothesis 3: Pregnant women in the EFT group will have a lower test score from the State-Trait Anxiety Inventory, and a follow-up score of three months and six months after the last application date, compared to the control group.
Read the detailed description
In addition to being a natural life event for women, pregnancy is also a period in which significant biological and psychosocial changes are experienced, and the risk of encountering many factors that may create anxiety and stress. While many women easily adapt to these changes occurring with pregnancy and childbirth, some women may develop various levels of mental illness. It is reported that the majority of depression, one of the mental illnesses, occurs in women aged 18-44, including fertility processes such as pregnancy, childbirth, and puerperium. A meta-analysis on the subject indicates that the rate of depression increases in pregnancy and postpartum period.
Depression during pregnancy can cause serious effects for all family members. Pregnancy depression which is not managed well, damages the developing fetüs due to problems such as poorly managed pregnancy depression, substance abuse, insufficient prenatal care, and suicide attempt. It also causes an increased level of cortisol, which can lead to insulin resistance and, if not compensated, gestational diabetes may occur. In this process, elevated norepinephrine and cortisol reduce blood flow to the uterus, causing very serious obstetric and neonatal consequences both on pregnant and fetus, and pregnancy-related adverse events such as HT and preeclampsia are also increasing. Postpartum depression is the most negative result of untreated depression during pregnancy.
In the initial treatment of pregnancy depression and postpartum depression, good psychosocial evaluation, activation of support systems and the combined use of integrated therapies are the most ideal options. Treatment options for postpartum depression are psychotherapy (interpersonal relationships therapy and cognitive - behavioral therapy), drug therapy and non-pharmacology applications. While it is recommended to apply psychotherapy and non-pharmacological approaches as the first choice in mild depression, the use of pharmacological treatments (antidepressants) stands out in moderate and severe depression.
One of the psychotherapeutic techniques, whose numbers have increased rapidly in recent years, is "Emotional Freedom Techniques (EFT)". EFT; It combines cognitive therapy, acceptance and stability therapy, and acupuncture point stimulation, and is based on manual stimulation of acupuncture points specific to Shiatsu or other acupressure massage forms, rather than using acupuncture needles.Manual pressure on acupuncture sites has been found to be as effective as acupuncture needling technique.It is an initiative that can be applied by individuals and midwives easily after receiving the necessary education all over the world.
EFT has a comprehensive research bibliography that includes successful treatment of various psychological conditions such as depression, anxiety, phobias, and post-traumatic stress disorder. The duration of treatment in these studies varies from one to ten sessions. Feinstein states that in EFT studies that include a follow-up assessment, participants maintain their profit and the rehabilitation period varies between 3 months and 2 years.
Considering all these data, it is necessary to focus primarily on the prenatal period in order to develop preventive and therapeutic interventions. In the literature, scientific studies evaluating the effectiveness of EFT on depression are included, but only one study has been reached in which EFT is applied during pregnancy, and this study is related to stress and endurance. In addition, with this study, an important step will be taken to include an easy-to-apply, inexpensive therapeutic method such as pregnancy and postpartum depression treatments, and evidence will be sought to ensure that all professionals dealing with women's health, especially midwifery, use this technique.
The aim of the study is to evaluate the effect of EFT on postpartum depression.
- Conditions
- Postpartum Depression
- Being tested
- Emotional Freedom Techniques (EFT)
- Keywords
- postpartum depression, pregnancy, stress
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Freedom Techniques (EFT)Behavioural
It combines cognitive therapy, acceptance and stability therapy, and acupuncture point stimulation, and is based on manual stimulation of acupuncture points specific to Shiatsu or other acupressure massage forms, rather than using acupuncture needles.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The pregnant women in this group will be informed about the application of EFT with a written material.
The pregnant women who have undergone EFT will be interviewed a week or two after the application, and how they feel and whether the problem still disturbs him. If a new issue is reported, similar actions will be repeated for this new issue. The number of EFT sessions was decided based on the condition of the pregnant woman. After all EFT sessions are completed, a re-evaluation (post-test) of Edinburgh Postpartum Depression Scale, Stress Coping Scale and State-Trait Anxiety Inventory will be done.
The same participants will be asked to apply the other inventories and the postpartum interview form if she had birth three months and six months after the last application (follow-up). In the follow-up study performed three months after the last application, EFT will be applied to the pregnant women in need. Receives: Behavioral: Emotional Freedom Techniques (EFT) |
| control group | No intervention | The participants in this group will be talked about the problems they should have in routine midwifery care, the problems they encounter during pregnancy or postpartum period and the subjects they want to receive information. If necessary, suggestions will be made for problems related to pregnancy, postpartum period or newborn care. Again, with these participants, after the depression risk determination (pre-test), after the interviews ended (post-test), three months and six months after the last application, Edinburgh Postpar All Depression Scale, Stressful Life Events List, Stress Coping Scale. If the pregnant woman has given birth, State-Trait Anxiety Inventory and postnatal interview form will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Edinburgh Postpartum Depression Scale scores at 6 months
The scale consists of 10 items. Items are evaluated in 4-point Likert format and scored between 0-3. The lowest score that can be obtained from the scale is 0, the highest score is 30. Each item is scored as 0,1,2,3 in the scale.
In the evaluation of 3,5,6,7,8,9,10 items, the scoring is reversed (3,2,1,0). Individuals with a total scale score higher than the cut-off point are considered a risk group for depression. The cut-off score was taken as 12 in this study.
Measured: Baseline and 6 months
Secondary outcomes (2)
Stress Coping Styles Scale
This scale is used to determine the coping mechanisms used by the participants in the face of stressful situations.It consists of 30 items and 5 sub-dimensions.
High scores from each of the five subscales identified indicate an increase in the use of coping style expressed by that subscale. These subscales and the items are as follows:
- Self-Confident Approach: 8, 10, 14, 16, 20, 23, 26,
- Optimistic Approach: 2, 4, 6, 12 18,,
- Helpless Approach: 3, 7, 11, 19, 22, 25, 27, 28,
- Submissive Approach: 5, 13, 15, 17, 21, 24,
- Contacting Social Support: 1, 9, 29, 30. Items 1 and 9 in the scale are reversed. Subgroup scores are obtained by dividing the score from each sub-dimension by the number of items.
Measured: Change from baseline in stress coping styles at 6 months
State-Trait Anxiety Inventory
This scale consists of a total of forty items; the "State Anxiety Scale" consisting of twenty items and the "Trait Anxiety Scale" consisting of twenty items. There are two types of expressions in the scales: direct and reversed. Direct expressions express negative emotions, and reversed expressions express positive emotions. There are ten (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20th) reversed statements on the state anxiety scale. On the trait anxiety scale, there are seven (1, 6, 7, 10, 13, 16, 19th items) reversed. The total score value obtained from each scale is between minimum 20 and maximum 80. The total score of the reverse expressions is subtracted from the total score obtained for direct expressions. A predetermined and constant value is added to this number. This is 50 for state anxiety and 35 for trait anxiety. The most recent value is the individual's anxiety score. A high score indicates a high anxiety level, a small score indicates a low anxiety level.
Measured: Change from baseline in State-Trait Anxiety scores at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Jul 2019
- Primary completion1 Sep 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In order to determine the risk of depression, the Edinburgh Postpartum Depression Scale (EPDS) will be administered to the pregnant women. Pregnant women who receive 12 ≥ points from the EPDS will be included in the randomization process. Subsequently, the tests will be applied to experimental and control groups. EFT will be applied to women in the experimental group. One or two weeks after the application, it will be discussed again and questioned how she feels, whether that problem still disturbs her. The number of EFT sessions can be increased or decreased depending on the condition of the woman (the average number of sessions reported in the studies ranges from 2-10). After all EFT sessions are completed, three months and six months after the last application, post-tests will be done. the control group will receive routine midwifery care. The post-tests will be done by the control group after three months and six months
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neriman Guducu, Istanbul University - Cerrahpasa
- Investigators
- Neslihan Ozcan, Professor, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355091
- Sponsor's protocol ID
- 99984023-302.99-
- Status last verified
- Aug 2020
- First submitted
- 6 Apr 2020
- Last updated
- 10 Aug 2020
- 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 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Emotional Freedom Techniques (EFT) on Postpartum Depression
- ClinicalTrials.gov ID
- NCT04355091
- Acronym / sponsor ID
- 99984023-302.99-
- Conditions
- Postpartum Depression
- Keywords
- postpartum depression, pregnancy, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 21 Apr 2020 (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.
Hypothesis 1: Pregnant women in the EFT group will have a lower test score from Edinburgh Postpartum Depression Scale, and a follow-up score of three months and six months after the last application date, compared to the control group.
Hypothesis 2: In the post-test of pregnant women in the EFT group, three months and six months after the last application date, the optimistic, self-confident and social support approach methods used to deal with stress will increase, and the helpless and submissive approach styles will decrease compared to the control group.
Hypothesis 3: Pregnant women in the EFT group will have a lower test score from the State-Trait Anxiety Inventory, and a follow-up score of three months and six months after the last application date, compared to the control group.
Detailed description
In addition to being a natural life event for women, pregnancy is also a period in which significant biological and psychosocial changes are experienced, and the risk of encountering many factors that may create anxiety and stress. While many women easily adapt to these changes occurring with pregnancy and childbirth, some women may develop various levels of mental illness. It is reported that the majority of depression, one of the mental illnesses, occurs in women aged 18-44, including fertility processes such as pregnancy, childbirth, and puerperium. A meta-analysis on the subject indicates that the rate of depression increases in pregnancy and postpartum period.
Depression during pregnancy can cause serious effects for all family members. Pregnancy depression which is not managed well, damages the developing fetüs due to problems such as poorly managed pregnancy depression, substance abuse, insufficient prenatal care, and suicide attempt. It also causes an increased level of cortisol, which can lead to insulin resistance and, if not compensated, gestational diabetes may occur. In this process, elevated norepinephrine and cortisol reduce blood flow to the uterus, causing very serious obstetric and neonatal consequences both on pregnant and fetus, and pregnancy-related adverse events such as HT and preeclampsia are also increasing. Postpartum depression is the most negative result of untreated depression during pregnancy.
In the initial treatment of pregnancy depression and postpartum depression, good psychosocial evaluation, activation of support systems and the combined use of integrated therapies are the most ideal options. Treatment options for postpartum depression are psychotherapy (interpersonal relationships therapy and cognitive - behavioral therapy), drug therapy and non-pharmacology applications. While it is recommended to apply psychotherapy and non-pharmacological approaches as the first choice in mild depression, the use of pharmacological treatments (antidepressants) stands out in moderate and severe depression.
One of the psychotherapeutic techniques, whose numbers have increased rapidly in recent years, is "Emotional Freedom Techniques (EFT)". EFT; It combines cognitive therapy, acceptance and stability therapy, and acupuncture point stimulation, and is based on manual stimulation of acupuncture points specific to Shiatsu or other acupressure massage forms, rather than using acupuncture needles.Manual pressure on acupuncture sites has been found to be as effective as acupuncture needling technique.It is an initiative that can be applied by individuals and midwives easily after receiving the necessary education all over the world.
EFT has a comprehensive research bibliography that includes successful treatment of various psychological conditions such as depression, anxiety, phobias, and post-traumatic stress disorder. The duration of treatment in these studies varies from one to ten sessions. Feinstein states that in EFT studies that include a follow-up assessment, participants maintain their profit and the rehabilitation period varies between 3 months and 2 years.
Considering all these data, it is necessary to focus primarily on the prenatal period in order to develop preventive and therapeutic interventions. In the literature, scientific studies evaluating the effectiveness of EFT on depression are included, but only one study has been reached in which EFT is applied during pregnancy, and this study is related to stress and endurance. In addition, with this study, an important step will be taken to include an easy-to-apply, inexpensive therapeutic method such as pregnancy and postpartum depression treatments, and evidence will be sought to ensure that all professionals dealing with women's health, especially midwifery, use this technique.
The aim of the study is to evaluate the effect of EFT on postpartum depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In order to determine the risk of depression, the Edinburgh Postpartum Depression Scale (EPDS) will be administered to the pregnant women. Pregnant women who receive 12 ≥ points from the EPDS will be included in the randomization process. Subsequently, the tests will be applied to experimental and control groups. EFT will be applied to women in the experimental group. One or two weeks after the application, it will be discussed again and questioned how she feels, whether that problem still disturbs her. The number of EFT sessions can be increased or decreased depending on the condition of the woman (the average number of sessions reported in the studies ranges from 2-10). After all EFT sessions are completed, three months and six months after the last application, post-tests will be done. the control group will receive routine midwifery care. The post-tests will be done by the control group after three months and six months
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Emotional Freedom Techniques (EFT)The pregnant women in this group will be informed about the application of EFT with a written material. The pregnant women who have undergone EFT will be interviewed a week or two after the application, and how they feel and whether the problem still disturbs him. If a new issue is reported, similar actions will be repeated for this new issue. The number of EFT sessions was decided based on the condition of the pregnant woman. After all EFT sessions are completed, a re-evaluation (post-test) of Edinburgh Postpartum Depression Scale, Stress Coping Scale and State-Trait Anxiety Inventory will be done. The same participants will be asked to apply the other inventories and the postpartum interview form if she had birth three months and six months after the last application (follow-up). In the follow-up study performed three months after the last application, EFT will be applied to the pregnant women in need. |
| control group | No intervention | –The participants in this group will be talked about the problems they should have in routine midwifery care, the problems they encounter during pregnancy or postpartum period and the subjects they want to receive information. If necessary, suggestions will be made for problems related to pregnancy, postpartum period or newborn care. Again, with these participants, after the depression risk determination (pre-test), after the interviews ended (post-test), three months and six months after the last application, Edinburgh Postpar All Depression Scale, Stressful Life Events List, Stress Coping Scale. If the pregnant woman has given birth, State-Trait Anxiety Inventory and postnatal interview form will be performed. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- To be in the 18-49 age range
- To be at least a primary school graduate
- To be pregnant between 13-30 weeks
- Not having a risky pregnancy,
- Having spontaneous pregnancy,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Emotional Freedom Techniques (EFT)It combines cognitive therapy, acceptance and stability therapy, and acupuncture point stimulation, and is based on manual stimulation of acupuncture points specific to Shiatsu or other acupressure massage forms, rather than using acupuncture needles. | Behavioural | Intervention Group |
Primary outcome
Change from baseline in Edinburgh Postpartum Depression Scale scores at 6 months
Time frame: Baseline and 6 months
The scale consists of 10 items. Items are evaluated in 4-point Likert format and scored between 0-3. The lowest score that can be obtained from the scale is 0, the highest score is 30. Each item is scored as 0,1,2,3 in the scale. In the evaluation of 3,5,6,7,8,9,10 items, the scoring is reversed (3,2,1,0). Individuals with a total scale score higher than the cut-off point are considered a risk group for depression. The cut-off score was taken as 12 in this study.
2 secondary outcomes
Stress Coping Styles Scale
Time frame: Change from baseline in stress coping styles at 6 months
State-Trait Anxiety Inventory
Time frame: Change from baseline in State-Trait Anxiety scores at 6 months
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 10 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Postpartum Depression
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Not yet recruitingObservational study
AI-Enabled Wearable Monitoring for Detection of Postpartum Depression and Anxiety
Postpartum Depression (PPD), Postpartum Anxiety
Recruiting
Methyl Donor-Rich Diet in the Postpartum Period
Postpartum Depression (PPD), Breastfeeding
Active, not recruiting
Improving Maternal Mental Health & SUD Screening and Treatment
Mental Health Issue, Substance Use Disorders
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.
Neslihan Ozcan, Professor study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Freedom Techniques (EFT) in people with Postpartum Depression, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 8 inclusion and 1 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 10 Aug 2020. 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 Turkey (Türkiye). 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?
Change from baseline in Edinburgh Postpartum Depression Scale scores at 6 months (time frame: Baseline and 6 months). 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 10 Aug 2020.