The Effectiveness of Expressive Writing on a Sample of New Mothers

• ClinicalTrials.gov Identifier: NCT04803344
• Recruitment Status: Completed
• First Posted: March 17, 2021
• Last Update Posted: March 17, 2021
• Sponsor: University of Roma La Sapienza
• Information provided by (Responsible Party): Carlo Lai, University of Roma La Sapienza

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Maternal Distress; Health Care Utilization	Behavioral: Expressive Writing tecnique; Behavioral: Neutral Writing	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: The Effectiveness of Expressive Writing Intervention on the Psychological Wellness of the Mothers One Month After the Childbirth
• Actual Study Start Date: April 1, 2019
• Actual Primary Completion Date: March 30, 2020
• Actual Study Completion Date: March 30, 2020

Arms and Interventions

Arm	Intervention/treatment
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.
Active Comparator: Control Group	Behavioral: Neutral Writing; Participants were asked to write on neutral objects or events.

Outcome Measures

Primary Outcome Measures :

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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: The study was conducted on new mothers
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Italy

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

Rome, Italy, 00185

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

• Principal Investigator: Carlo Lai, Professor; Sapienza university of Rome, Department of Dynamic and Clinical Psychology, and Health Studies

More Information

• Responsible Party: Carlo Lai, Associate Professor, University of Roma La Sapienza
• ClinicalTrials.gov Identifier: NCT04803344
• Other Study ID Numbers: URomLS_2
• First Posted: March 17, 2021
• Last Update Posted: March 17, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No