"Expressive Writing Psychological Health Migrants (EWPHM)
EWPHM
"Effectiveness of the Expressive Writing on the Somatization and Psychological Health of the Migrants: a Longitudinal Study"
1 other identifier
interventional
28
1 country
2
Brief Summary
Migration is a global phenomenon that produces several psychological impacts on the migrant causing psychological changes and difficulties such as the development of psychological diseases, the decrease of the life expectancy, insecurity, isolation, and poorness. These diseases create a situation of emergency that has prompted the need to intervene with specific psychological treatments. This study proposed to verify the effectiveness of expressive writing on the elaborative processes of the migratory journey's trauma. Participants were twenty-eight migrants of a reception center. A blinded randomized controlled trial was performed to divide them into three groups: an experimental sample that performed the expressive writing treatment, a neutral sample that performed the neutral description writing, and a control sample. The samples were assessed in three times through self-report measures. The administration of expressive writing is expected to improve the psychological health condition of migrants
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2017
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2018
CompletedFirst Submitted
Initial submission to the registry
March 18, 2021
CompletedFirst Posted
Study publicly available on registry
March 25, 2021
CompletedMarch 30, 2021
March 1, 2021
4 months
March 18, 2021
March 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
psychological health of the migrants assessed with Symptom Check-List Revised. A self-report questionnaire that assess the psychological and psychopathological dimensions
Specifically, the somatization and in general, the global psychological functioning. The Symptom Check-List Revised Scale was a self-report questionnaire that measures psychological and psychopathological issues in clinical and non-clinical populations. It is composed from 90 items. Higher scores show the presence of psychopathological symptomology and psychological complications. The range of scores are less 45 more 75 with cut-off 55. It is composed by different dimensions.
1 month
Secondary Outcomes (1)
Hope for the future, assessed with Beck Hopelessness Scale, self-report questionnaire
1 month
Study Arms (3)
Pennebaker's expressive writing
EXPERIMENTALThree consecutive days for 20 minutes daily of expressive writing. The topic of the traumatic traveling experience, focalizing the attention on the deeper emotions, thoughts, and feelings.
Writing about different aspects of their knowledge
ACTIVE COMPARATORThree consecutive days for 20 minutes daily of neutral writing. Different topics of own knowledge Description of the city, their room, their place where they live, or easy procedure like, how to make a coffee (or something else), their population, trying to remain free from deep emotions, thoughts, or feelings.
Control
NO INTERVENTIONNo intervention
Interventions
It focuses on the emotional aspect of the written event
Description of neutral topics with less emotional involvement
Eligibility Criteria
You may qualify if:
- age \>18 years and the refugees or asylum seekers status
You may not qualify if:
- psychiatric or neurologic diagnosis and drug abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Carlo Lai Professor PhD
Roma, Rm, 00185, Italy
Department of Dynamic and Clinical Psychology, and Health Studies, Sapienza University
Rome, 00185, Italy
Related Publications (1)
Begotaraj E, Sambucini D, Ciacchella C, Pellicano GR, Pierro L, Wamser-Nanney R, Aceto P, De Paola C, Caroppo E, Lai C. Effectiveness of the expressive writing on the psychological distress and traumatic symptoms of the migrants: A prospective study multiarm randomized controlled trial. Psychol Trauma. 2023 Jul;15(5):738-747. doi: 10.1037/tra0001308. Epub 2022 Sep 29.
PMID: 36174151DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo Lai, Professor
University of Roma La Sapienza
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 18, 2021
First Posted
March 25, 2021
Study Start
November 2, 2017
Primary Completion
March 15, 2018
Study Completion
July 30, 2018
Last Updated
March 30, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 24 months
- Access Criteria
- The sensitive data are collected in an excel database on the department of Dynamic and Clinical psychology laptop, protected by a password. Each participant is identified by a personal numerical code, to guarantee them their privacy. All the sensitive data will be accessible only by the Chief investigator, the Ph.D. student, and the sub-investigator co-responsible for the study
The data was collected and stored by the Dynamics department and clinical psychology laptop, protected by a password. The data are accessible only to the Chief Researcher, the Ph.D. student, and the secondary researcher. The study protocol will be shared with other sub-investigators involved in the study, but not sensitive data. The study report will be shared and published in a scientific journal, but the privacy of each participant will be respected according to the agreements established by the ethics committee.