Expressive writing for the reduction of psychological difficulties during the COVID-19 pandemic
| ISRCTN | ISRCTN17898730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17898730 |
| Secondary identifying numbers | 2020-20 |
- 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
Plain English Summary
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
Scientific
Čika Ljubina 18-20
Belgrade
11000
Serbia
 ORCID ID |
0000-0002-1884-9948 |
|---|---|
| Phone | +38 1637234658 |
| masa.vukcevic@f.bg.ac.rs |
Scientific
dr Subotica 4
PO BOX 39
Belgrade
11129
Serbia
| ORCID ID |
0000-0001-7413-0324 |
|---|---|
| Phone | +38 1646344895 |
| jovana.bjekic@imi.bg.ac.rs |
Scientific
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
| ORCID ID |
0000-0001-9864-3394 |
|---|---|
| Phone | +44 20 7540 4210 |
| s.priebe@qmul.ac.uk |
Study information
| Study design | Between-subjects pre-test post-test randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request 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 hypothesis | 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 |
| Condition | 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 | Severity of psychological difficulties assessed by DASS 21 - depression, anxiety and stress scale, short version at pre-test and post-test (2 weeks) |
| Secondary outcome measures | 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) |
| Overall study start date | 21/03/2020 |
| Overall study end date | 20/12/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 120 |
| Participant inclusion criteria | 1. Over 18 years of age 2. Native, or fluent in Serbian 3. Normal or corrected-to-normal vision |
| Participant exclusion criteria | 1. A physical or mental disability, severe mental illness 2. No access to the internet and personal computer/mobile device |
| Recruitment start date | 07/04/2020 |
| Recruitment end date | 14/04/2020 |
Locations
Countries of recruitment
- Serbia
Study participating centre
Belgrade
11000
Serbia
Sponsor information
Other
Gospodar Jevremova 48
Belgrade
11000
Serbia
| Phone | +38 1628880927 |
|---|---|
| office@psychosocialinnovation.net | |
| Website | https://psychosocialinnovation.net/en/ |
Funders
Funder type
Other
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results will be published in the peer-reviewed journal. Furthermore, the results will be presented at scientific conferences and congresses. In addition, the findings’ summary for a lay audience will be created, circulated to local and international networks dealing with mental health interventions, and disseminated through social networks. |
| 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 |
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
