The Effectiveness of Expressive Writing on a Sample of New Mothers

The Effectiveness of Expressive Writing Intervention on the Psychological Wellness of the Mothers One Month After the Childbirth

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.

Study Overview

• Status: Completed
• Conditions: Health Care Utilization; Maternal Distress
• Intervention / Treatment: Behavioral: Expressive Writing tecnique; Behavioral: Neutral Writing

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00185
    • Department of Dynamic and Clinical Psychology, and Health Studies, Sapienza University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	Behavioral: Neutral Writing; Participants were asked to write on neutral objects or events.
Experimental: Experimental Group; After the childbirth, writing group participants has been asked to write for 3 consecutive days, 20 minutes each days, all the deepest emotions and feelings related to the pregnancy.	Behavioral: Expressive Writing tecnique; Expressive Writing (EW), is a simple, potentially inexpensive, therapeutic intervention which involves writing daily for 15-20 min over 3-4 consecutive days. EW can be completed at home without the need for facilitation, a specialist therapist or a dedicated facility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	In order to evaluate the Health-related quality of life, the 12-Item Short Form Health Survey was used. This standardized questionnaire is composed by 12 items selected from SF-36 and produces two summaries, physical (PCS) and mental (MCS) scale (Brazier and Roberts, 2004).	Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour
Anxiety	In order to evaluate the levels of anxiety, the Spielberger State-Trait Anxiety Inventory, STAI-Y, (Spielberger, 1983; Spielberger et al., 1970) was used. It is a self-report questionnaire developed to evaluate both state and trait anxiety, respectively a transitory emotional state and a personality trait considered relatively stable.	Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour
Depression	In order to evaluate the levels of depression, The 13-item short form of Beck Depression Inventory (BDI-II) was used.	Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour
Healthcare spending	In order to test the healthcare spending to all participants were asked (through a specific questionnaire built ad hoc for the specific situation) the number of medical visits, the number of hospitalizations, the number of admissions to emergency room for acute episodes, the number of hospitalizations stay days in the last year. The study hypothesized a lower number of medical visits, hospitalization's days and admissions to emergency room for those mothers who performed the expressive writing task.	Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour
Stress	In order to test the stress levels, the Valutazione Rapida dello stress (VRS) was used. The VRS is rapid self-assessment rating scale for measure of percieved stress. This scale is composed of 15 items and five areas: anxiety, depression, somatization, aggressiveness, and social support. The social support scale measures the percieved lack of social support (Tarsitani and Biondi, 1999).	Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Principal Investigator: Carlo Lai, Professor, Sapienza university of Rome, Department of Dynamic and Clinical Psychology, and Health Studies

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: URomLS_2

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