Clinical trial NCT06490094: Impact of IBSR on Postpartum Mothers' Mental Health.
Official title: Impact of Inquiry-Based Stress Reduction (IBSR) on Postpartum Mothers' Mental Health.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Mothers
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
measure: Generalized Anxiety Disorder 7-Item Scale (GAD-7)
timeFrame: 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:
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
measure: Connor-Davidson Resilience Scale (2-item CD-RISC)
timeFrame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
measure: Ryff scale- Psychological well-being (PWB)
timeFrame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
measure: Subjective well-being (WHO-5)
timeFrame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 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:
measure: Primary Care PTSD DSM-5
timeFrame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
measure: exposure to the events of the war in Israel
timeFrame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
measure: Demographic and Childhood history
timeFrame: A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Shahar Lev- Ari, PhD
role: PRINCIPAL_INVESTIGATOR
References: