Expressive writing for the reduction of psychological difficulties during the COVID-19 pandemic

ISRCTN	ISRCTN17898730
DOI	https://doi.org/10.1186/ISRCTN17898730
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	2020-20
Sponsor	Psychosocial Innovation Network
Funders	Psychosocial Innovation Network , Ministry for Education Science and Technological Development of the Republic of Serbia

Submission date: 21/04/2020
Registration date: 23/04/2020
Last edited: 27/11/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Large body of evidence suggested that expressive writing can be beneficial for different conditions, including depression, suicidal ideation, trauma coping, etc.
The study aims to provide the evidence needed for the development and implementation of online expressive writing interventions (EW intervention) in the reduction of psychological difficulties among the general population during the COVID-19 pandemic.

Who can participate?
Adults over 18 years, fluent in Serbian, normal or corrected-to-normal vision.

What does the study involve?
Participants will be randomly allocated to either perform expressive writing five times over two weeks, for 20 minutes at a time, or to continue as normal. Participants will fill in mental health questionnaires at the start of the study and after two weeks.

What are the possible benefits and risks of participating?
The possible benefits include positive effects on one's psychological condition and wellbeing and there are no risks associated with the study.

Where is the study run from?
University of Belgrade (Serbia)

When is the study starting and how long is it expected to run for?
April 2020 to December 2020

Who is funding the study?
Psychosocial Innovation Network (Serbia)

Who is the main contact?
Dr Maša Vukčević Marković, masa.vukcevic@f.bg.ac.rs
Dr Jovana Bjekić, jovana.bjekic@imi.bg.ac.rs
Dr Stefan Priebe, s.priebe@qmul.ac.uk

Contact information

Dr Maša Vukčević Marković
Scientific

Čika Ljubina 18-20
Belgrade
11000
Serbia

ORCID ID	0000-0002-1884-9948
Phone	+38 1637234658
Email	masa.vukcevic@f.bg.ac.rs

Dr Jovana Bjekić
Scientific

dr Subotica 4
PO BOX 39
Belgrade
11129
Serbia

ORCID ID	0000-0001-7413-0324
Phone	+38 1646344895
Email	jovana.bjekic@imi.bg.ac.rs

Dr Stefan Priebe
Scientific

Newham Centre for Mental Health
London
E13 8SP
United Kingdom

ORCID ID	0000-0001-9864-3394
Phone	+44 20 7540 4210
Email	s.priebe@qmul.ac.uk

Study information

Primary study design	Interventional
Study design	Between-subjects pre-test post-test randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness of an expressive writing intervention in the reduction of psychological difficulties during the COVID-19 pandemic
Study acronym	EWICOVID
Study objectives	Expressive writing intervention is more efficient in reduction of psychological difficulties in the general population during COVID-19 pandemic, in comparison to receiving treatment as usual.
Ethics approval(s)	Approved 14/04/2020, Institutional Review Board (IRB) of the Department of Psychology, Faculty of Philosophy, University of Belgrade, Serbia (no tel. provided; komocetis@f.bg.ac.rs), ref: #2020-20
Health condition(s) or problem(s) studied	Depression, anxiety, and stress-related difficulties
Intervention	The participants are randomized across experimental and control groups and blinded for group allocation. Following recruitment, the researcher who was blind to participants identities and baseline assessment results performed randomisation into groups using random number generating software. Intervention: Expressive writing (20 minutes, 5 sessions during 2 weeks), participants are instructed to write about any experiences and thoughts on their life during the pandemic. Control: Treatment as usual (TAU), i.e. informal support through families, friends, and networks (face-to-face, telephone and online) as well as support participants could get using available services in the community during the state of emergency (e.g. online counseling, hotlines, available self-help manuals)
Intervention type	Behavioural
Primary outcome measure(s)	Severity of psychological difficulties assessed by DASS 21 - depression, anxiety and stress scale, short version at pre-test and post-test (2 weeks)
Key secondary outcome measure(s)	At pre-test and post-test (2 weeks): 1. Severity of depression-related psychological difficulties, assessed by DASS 21 depression subscale 2. Severity of anxiety-related psychological difficulties is assessed by DASS 21 anxiety subscale 3. Severity of stress-related psychological difficulties is assessed by DASS 21 stress subscale 4. Well-being, assessed by the WHO wellbeing index 5. Subjective perception of capacities for handling situations related to pandemic and state of emergency, assessed by a single item 6. Subjective perception of the quality of life, measured by SQOL, the mean score of the 12 satisfaction items from Manchester Short Assessment of Quality of Life (MANSA)
Completion date	20/12/2020

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Total final enrolment	120
Key inclusion criteria	1. Over 18 years of age 2. Native, or fluent in Serbian 3. Normal or corrected-to-normal vision
Key exclusion criteria	1. A physical or mental disability, severe mental illness 2. No access to the internet and personal computer/mobile device
Date of first enrolment	07/04/2020
Date of final enrolment	14/04/2020

Locations

Countries of recruitment

Serbia

Study participating centre

University of Belgrade

Studentski trg 1
Belgrade
11000
Serbia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Type of data: quantitative data - baseline and post-treatment assessment scores. Data will become available three months post-study completion and will be available indefinitely. Access criteria: the data will be shared with all interested researches or third parties who provide a reasonable explanation for the inquiry (replication, meta-analysis, etc.). Consent from participants was obtained to share data anonymously. Anonymization is ensured even at the data collection stage since all participants are taking part online using personalized passcode (the researchers are blind to participants personal information).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/11/2020	27/11/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/11/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
23/04/2020: Trial’s existence confirmed by Institutional Review Board (IRB) of the Department of Psychology, Faculty of Philosophy, University of Belgrade, Serbia