Impact of IBSR on Postpartum Mothers' Mental Health.

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Mothers
• Intervention / Treatment: Behavioral: Inquiry Based Stress Reduction (IBSR)

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 Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shahar Lev- Ari, PhD; Phone Number: +972-3-6409040; Email: leva@tauex.tau.ac.il
• Study Contact Backup: Name: shirly mor-anavy, MPH; Phone Number: +972-50-7652030; Email: shirlymor30@gmail.com

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Tel Aviv University
    • Contact: shirly mor anavy, MPH; Phone Number: +972-50-7652030; Email: shirlymor30@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inquiry Based Stress Reduction; Inquiry Based Stress Reduction (IBSR) program	Behavioral: 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. .
No Intervention: Control group; Postpartum mothers who are randomly assigned to not receive the Inquiry-Based Stress Reduction (IBSR) intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion Regulation Questionnaire (ERQ)	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)
Connor-Davidson Resilience Scale (2-item CD-RISC)	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)
Ryff scale- Psychological well-being (PWB)	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)
Subjective well-being (WHO-5)	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)
Multidimensional Scale of Perceived Social Support (MSPSS)	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Care PTSD DSM-5	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)
exposure to the events of the war in Israel	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)
Demographic and Childhood history	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)

Collaborators and Investigators

• Sponsor: Tel Aviv University
• Investigators: Principal Investigator: Shahar Lev- Ari, PhD, Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 29, 2024
• First Submitted That Met QC Criteria: June 29, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: June 29, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IBSR Postpartum Mothers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No