Clinical trial NCT04803344: The Effectiveness of Expressive Writing on a Sample of New Mothers
Official title: The Effectiveness of Expressive Writing Intervention on the Psychological Wellness of the Mothers One Month After the Childbirth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Distress
Health Care Utilization
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study aims to evaluate the effects of an expressive writing intervention on a sample of new mothers after the childbirth on the psychological health and on the healthcare costs. The mothers were evaluated also in a follow-up one month after the end of the expressive writing intervention.

Detailed description: Women are recruited starting from the sixth month of pregnancy; forty-one eventually agreed to participate and they were randomly assigned to two groups: an Experimental group (treated with the expressive writing task, one weeks-three months after childbirth) and a Control group (no intervention).

Psychological health is measured at three stages:

before intervention, at 8-9 months pregnant (T0); after intervention, from 1 week to 3 months after delivery (T1); and a follow-up after 1 to 3 months (T2). The assessment protocol consists of the Attachment Style Questionnaire (ASQ), the Prenatal Attachment Inventory (PAI), the Toronto Alexythimia Scale-20 (TAS-20), the Beck Depression Inventory (BDI-13), the State-Trait Anxiety Inventory (STAI-Y), the Rating Scale For Rapid Stress Assessment (VRS) and the 12-Item Short Form Survey (SF-12). The healthcare costs are collected at baseline (T0) and follow-up (T2) with a survey created ad hoc, in which participants reported the number and the type of the medical examinations, hospitalisations, prescribed drugs etc. Social and personal data are collected from the first survey.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* \> 6 months of pregnancy
* no medical complications during pregnancy

Exclusion Criteria:

* medical complication during pregnancy
* no comprehension of Italian language

Primary outcomes:
measure: Health-related quality of life
timeFrame: Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour
measure: Anxiety
timeFrame: Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour
measure: Depression
timeFrame: Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour
measure: Healthcare spending
timeFrame: Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour
measure: Stress
timeFrame: Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Dynamic and Clinical Psychology, and Health Studies, Sapienza University
Study officials:
affiliation: Sapienza university of Rome, Department of Dynamic and Clinical Psychology, and Health Studies
name: Carlo Lai, Professor
role: PRINCIPAL_INVESTIGATOR
References: