The Effectiveness of Expressive Writing on a Sample of New Mothers

Health Care Utilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04803344
• Other study ID #: URomLS_2
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: March 2021
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Care Utilization
• Maternal Distress

Intervention

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.
• Neutral Writing
Participants were asked to write on neutral objects or events.

Locations

Country	Name	City	State
Italy	Department of Dynamic and Clinical Psychology, and Health Studies, Sapienza University	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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