Postpartum MothersNCT06490094
Impact of IBSR on Postpartum Mothers' Mental Health.
A study testing Inquiry Based Stress Reduction (IBSR) in people with Postpartum Mothers, run by Tel Aviv University at 1 site in Israel.
Trial summary
The period of pregnancy, childbirth, and the postpartum phase significantly impacts the mental health of women and their families. Mental health is crucial for overall well-being, quality of life, and is associated with healthcare costs. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Mothers
- What is being tested?
- Inquiry Based Stress Reduction (IBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Jun 2024to Jun 2025
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mothers up to two years after giving birth, between the ages of 18 and 45 (at the time of birth), without a history of mental disorders or illnesses
Who cannot join
- Mothers with a history of illness or mental disorders
- mothers who have passed more than two years since their last birth
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv University
Tel Aviv
shirly mor anavy, MPH, +972-50-7652030, shirlymor30@gmail.com
About this study
Official title: Impact of Inquiry-Based Stress Reduction (IBSR) on Postpartum Mothers' Mental Health.
The period of pregnancy, childbirth, and the postpartum phase significantly impacts the mental health of women and their families. Mental health is crucial for overall well-being, quality of life, and is associated with healthcare costs. Therefore, promoting mental health should be a top priority in public health and health promotion efforts.
The Inquiry-Based Stress Reduction (IBSR) intervention, developed by Byron Katie ("The Work"), enables participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR involves a contemplative "inquiry" process and a "turnaround," which is a method of experiencing the opposite of what the participant believes. This process equips individuals with skills for self-inquiry and management of stressful thoughts that can be easily integrated into daily life.
Based on previous research, we hypothesize that the IBSR intervention can improve postpartum mothers' mental health.
Read the detailed description
In recent years, there is growing evidence regarding the effectiveness of population-based mental health promotion interventions. Developing social and emotional skills such as improved self-esteem, sense of control and self-efficacy, self-acceptance, purpose in life, positive relationships with others, problem-solving, and coping skills has been shown to improve mental health and contribute to psychological well-being. According to the International Union for Health Promotion and Education (IUHPE, 2021), interventions to promote mental health can be classified into eight priority areas. The first priority is to promote the mental health of infants and mothers by focusing on social and emotional development and positive mental health in early childhood development services, including prenatal care, home visits, and parenting programs. The healthcare system today faces the challenge of gaining a better understanding of the mechanisms that allow women to develop and maintain positive mental health in the postpartum period and understanding how these mechanisms are sustained over time.
The Inquiry-Based Stress Reduction (IBSR) intervention, developed by Byron Katie ("The Work"), enables participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR involves a contemplative "inquiry" process and a "turnaround," which is a method of experiencing the opposite of what the participant believes. This process equips individuals with skills for self-inquiry and management of stressful thoughts that can be easily integrated into daily life. Based on previous research, we hypothesize that the IBSR intervention can improve postpartum mothers' mental health.
- Conditions
- Postpartum Mothers
- Being tested
- Inquiry Based Stress Reduction (IBSR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inquiry Based Stress Reduction (IBSR)Behavioural
The 8-week IBSR program is a clinical intervention based on "The Work" method, developed by Byron Katie and run in the US and Europe for 35 years. The IBSR intervention will involve weekly group meetings (3 hours/meeting) throughout 8 weeks. Home practice between sessions will be supported by facilitator assistants (1-hour session per week). All sessions will be standardized according to the IBSR certification program guidelines and will be assessed to maintain consistency in the program, as in previous studies. .
| Study group | Role | What they receive |
|---|---|---|
| Inquiry Based Stress Reduction | Experimental | Inquiry Based Stress Reduction (IBSR) program Receives: Behavioral: Inquiry Based Stress Reduction (IBSR) |
| Control group | No intervention | Postpartum mothers who are randomly assigned to not receive the Inquiry-Based Stress Reduction (IBSR) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)
Questionnaire
Measured: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Questionnaire
Measured: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Secondary outcomes (5)
Emotion Regulation Questionnaire (ERQ)
Questionnaire
Measured: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Connor-Davidson Resilience Scale (2-item CD-RISC)
Questionnaire
Measured: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Ryff scale- Psychological well-being (PWB)
Questionnaire
Measured: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Subjective well-being (WHO-5)
Questionnaire
Measured: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Multidimensional Scale of Perceived Social Support (MSPSS)
Questionnaire
Measured: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start9 Jun 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum MothersStudies 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
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shahar lev-ari, Tel Aviv University
- Investigators
- Shahar Lev- Ari, PhD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490094
- Sponsor's protocol ID
- IBSR Postpartum Mothers
- Status last verified
- Jun 2024
- First submitted
- 29 Jun 2024
- Last updated
- 8 Jul 2024
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inquiry-Based Stress Reduction (IBSR) on Postpartum Mothers' Mental Health.
- ClinicalTrials.gov ID
- NCT06490094
- Acronym / sponsor ID
- IBSR Postpartum Mothers
- Conditions
- Postpartum Mothers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 9 Jun 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 8 Jul 2024 (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 period of pregnancy, childbirth, and the postpartum phase significantly impacts the mental health of women and their families. Mental health is crucial for overall well-being, quality of life, and is associated with healthcare costs. Therefore, promoting mental health should be a top priority in public health and health promotion efforts.
The Inquiry-Based Stress Reduction (IBSR) intervention, developed by Byron Katie ("The Work"), enables participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR involves a contemplative "inquiry" process and a "turnaround," which is a method of experiencing the opposite of what the participant believes. This process equips individuals with skills for self-inquiry and management of stressful thoughts that can be easily integrated into daily life.
Based on previous research, we hypothesize that the IBSR intervention can improve postpartum mothers' mental health.
Detailed description
In recent years, there is growing evidence regarding the effectiveness of population-based mental health promotion interventions. Developing social and emotional skills such as improved self-esteem, sense of control and self-efficacy, self-acceptance, purpose in life, positive relationships with others, problem-solving, and coping skills has been shown to improve mental health and contribute to psychological well-being. According to the International Union for Health Promotion and Education (IUHPE, 2021), interventions to promote mental health can be classified into eight priority areas. The first priority is to promote the mental health of infants and mothers by focusing on social and emotional development and positive mental health in early childhood development services, including prenatal care, home visits, and parenting programs. The healthcare system today faces the challenge of gaining a better understanding of the mechanisms that allow women to develop and maintain positive mental health in the postpartum period and understanding how these mechanisms are sustained over time.
The Inquiry-Based Stress Reduction (IBSR) intervention, developed by Byron Katie ("The Work"), enables participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR involves a contemplative "inquiry" process and a "turnaround," which is a method of experiencing the opposite of what the participant believes. This process equips individuals with skills for self-inquiry and management of stressful thoughts that can be easily integrated into daily life. Based on previous research, we hypothesize that the IBSR intervention can improve postpartum mothers' mental health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inquiry Based Stress Reduction | Experimental | Behavioral: Inquiry Based Stress Reduction (IBSR)Inquiry Based Stress Reduction (IBSR) program |
| Control group | No intervention | –Postpartum mothers who are randomly assigned to not receive the Inquiry-Based Stress Reduction (IBSR) intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mothers up to two years after giving birth, between the ages of 18 and 45 (at the time of birth), without a history of mental disorders or illnesses
Key exclusion criteria (2 listed)
- Mothers with a history of illness or mental disorders
- mothers who have passed more than two years since their last birth
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 |
|---|---|---|
| Inquiry Based Stress Reduction (IBSR)The 8-week IBSR program is a clinical intervention based on "The Work" method, developed by Byron Katie and run in the US and Europe for 35 years. The IBSR intervention will involve weekly group meetings (3 hours/meeting) throughout 8 weeks. Home practice between sessions will be supported by facilitator assistants (1-hour session per week). All sessions will be standardized according to the IBSR certification program guidelines and will be assessed to maintain consistency in the program, as in previous studies. . | Behavioural | Inquiry Based Stress Reduction |
Primary outcome
Perceived Stress Scale (PSS)
Time frame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Questionnaire
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time frame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Questionnaire
5 secondary outcomes
Emotion Regulation Questionnaire (ERQ)
Time frame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Connor-Davidson Resilience Scale (2-item CD-RISC)
Time frame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Ryff scale- Psychological well-being (PWB)
Time frame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Subjective well-being (WHO-5)
Time frame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- 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.
Shahar Lev- Ari, PhD principal investigator
Tel Aviv 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 Inquiry Based Stress Reduction (IBSR) in people with Postpartum Mothers, run by Tel Aviv University at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahar Lev- Ari, PhD (+972-3-6409040, leva@tauex.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS) (time frame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)). 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 8 Jul 2024.