Impact of IBSR on Postpartum Mothers' Mental Health.

NCT06490094 | Recruiting

• 1 other identifier: IBSR Postpartum Mothers
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postpartum Mothers

Outcome Measures

Primary Outcomes (2)

• Perceived Stress Scale (PSS)

  Questionnaire

  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

  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)

  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)

  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)

  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)

  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)

  A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)

Other Outcomes (3)

• Primary Care PTSD DSM-5

  A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)

• exposure to the events of the war in Israel

  A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)

• Demographic and Childhood history

  A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)

Study Arms (2)

Inquiry Based Stress Reduction

EXPERIMENTAL

Inquiry Based Stress Reduction (IBSR) program

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

Interventions

Inquiry Based Stress Reduction (IBSR) BEHAVIORAL

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. .

Inquiry Based Stress Reduction

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: postpartum mothers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Mothers with a history of illness or mental disorders
• mothers who have passed more than two years since their last birth

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, Israel

RECRUITING

Study Officials

• Shahar Lev- Ari, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahar Lev- Ari, PhD

CONTACT

+972-3-6409040; leva@tauex.tau.ac.il

shirly mor-anavy, MPH

CONTACT

+972-50-7652030; shirlymor30@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Impact of Inquiry-Based Stress Reduction (IBSR) on Postpartum Mothers' Mental Health.

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 8, 2024
• Study Start: June 9, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)