Skip to main content
OpenTrials
Completed

NCT Number: NCT04803344

The Effectiveness of Expressive Writing on a Sample of New Mothers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Maternal Distress Behavior Health Behavior Health Care Utilization Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dynamic and Clinical Psychology, and Health Studies, Sapienza University

Rome, 00185, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expressive Writing tecnique

Behavioral

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

Behavioral

Participants were asked to write on neutral objects or events.

Primary outcomes

  1. Health-related quality of life

    Time frame: Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour

    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).

  2. Anxiety

    Time frame: Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour

    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.

  3. Depression

    Time frame: Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour

    In order to evaluate the levels of depression, The 13-item short form of Beck Depression Inventory (BDI-II) was used.

  4. Healthcare spending

    Time frame: Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour

    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.

  5. Stress

    Time frame: Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour

    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).

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 17, 2021
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.