Evaluating The Women’s EmotionS, Trauma, and EmpowErMent (W-ES.T.EEM) protocol: a psychological support for victims of domestic violence
| ISRCTN | ISRCTN12880309 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12880309 |
- Submission date
- 15/11/2021
- Registration date
- 20/12/2021
- Last edited
- 26/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
Background and study aims
Intimate partner violence (IPV) is a widespread phenomenon that affects the physical and mental well-being of victims, and several barriers prevented sufferers from receiving face-to-face interventions. These obstacles increased with the advent of the Coronavirus (COVID-19) pandemic, and online psychological interventions can represent a valid solution to increase the well-being of IPV victims. This study aims to develop a psycho-education clinical protocol for a single-blind randomised controlled trial (RCT) that examines the effectiveness of a web-based psychoeducational intervention for IPV victims that integrates Dialectical Behavioural Therapy and Empowerment approach.
Who can participate?
Women aged over 18 years who were victims of IPV during the COVID-19 outbreak
What does the study involve?
Participants will be randomly allocated to the W-ES.T.EEM experimental group or the treatment as usual control group. Both interventions will be administered individually to each woman and will consist of eight weekly online treatment sessions over a period of 2 months.
What are the possible benefits and risks of participating?
The results of this study could contribute to an increase in the use of online interventions to overcome social and psychological barriers that prevent victims of IPV from asking for help and psychological support.
Where is the study run from?
University of Padua (Italy)
When is the study starting and how long is it expected to run for?
April 2021 to December 2025
Who is funding the study?
University of Padua (Italy)
Who is the main contact?
Prof. Stefania Mannarini
stefania.mannarini@unipd.it
Contact information
Scientific
Via Venezia 12
Padova
35131
Italy
 ORCID ID |
0000-0002-8446-785X |
|---|---|
| Phone | +39 (0)498276630 |
| stefania.mannarini@unipd.it |
Study information
| Study design | Single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | 40668_PIS.pdf |
| Scientific title | A psycho-educational support intervention for victims of domestic violence: the Women’s EmotionS, Trauma, and EmpowErMent (W-ES.T.EEM) study protocol |
| Study acronym | W-ES.T.EEM |
| Study hypothesis | Compared to the treatment as usual only condition, the W-ES.T.EEM protocol may produce a better reduction of emotion dysregulation, negative affects and symptoms related to violence, and alexithymia. Moreover, compared to the treatment as usual only condition, the W-ES.T.EEM protocol may produce a greater increase of both self-esteem and self-efficacy. |
| Ethics approval(s) | Approved 06/08/2021, Ethical Committee of the University of Padua (Comitato Etico Della Ricerca Psicologica, Dipartimenti/Sezione di Psicologia, Università degli Studi di Padova, Via Venezia 8, 35131 Padova, Italy; +39 (0)49 827 6600; comitato.etico.area17@unipd.it), ref: 4300 |
| Condition | Intimate partner violence |
| Intervention | Participants will be randomized into two different groups: 1. A psycho-educational intervention plus treatment as usual 2. Treatment as usual Both interventions will be administered individually to each woman and will consist of eight weekly online treatment sessions over a period of 2 months. The randomization scheme will be generated using the Web site Randomization.com. Due to the nature of the intervention the treatment group allocation cannot be concealed from the participants. |
| Intervention type | Behavioural |
| Primary outcome measure | Each of the following will be measured at baseline, at the end of treatment, at 3-months follow-up, at 6-month follow-up, and at 1-year follow-up: 1. Emotion regulation measured using the Difficulties Emotion Regulation Scale – SF (DERS-SF) 2. Well-being measured using the Clinical Outcomes in Routine Evaluation-Outcome Measures (CORE-OM) 3. The intensity of affects measured using the Intimate Violence and Traumatic Affect Scale (VITA) 4. Traumatic impact of the event measured using the Impact of Event Scale Revised (IES - R) 5. Self-esteem measured using the Rosenberg Self-Esteem Scale (RSES) 6. Self-efficacy measured using the Generalized Self-Efficacy Scale |
| Secondary outcome measures | Each of the following will be measured at baseline, at the end of treatment, at 3-months follow-up, at 6-month follow-up, and at 1-year follow-up: 1. The participants’ experience of violence measured using the Conflict Tactic Scale – 2 (CTS-2) 2. Violence at the time of COVID-19 measured using a self-report questionnaire built ad hoc 3. Alexithymia measured using the Toronto Alexithymia Scale – 20 (TAS-20) |
| Overall study start date | 21/04/2021 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 86 |
| Participant inclusion criteria | 1. Older than 18 years old 2. Victims of IPV since the outbreak of the COVID-19 pandemic 3. Able to speak and understand Italian 4. Female 5. Had their first contact with anti-violence centers within 2 weeks before recruitment |
| Participant exclusion criteria | Inability to understand/take part in the psychoeducation intervention due to hearing, visual, cognitive, or neurological difficulties |
| Recruitment start date | 01/01/2022 |
| Recruitment end date | 31/12/2022 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Venezia 12
Padua
35131
Italy
Sponsor information
University/education
CIRF - Interdepartmental Center for Family Research
Via Venezia 12
Padova
35131
Italy
| Phone | +39 (0)3466853503 |
|---|---|
| centro.cirf@unipd.it | |
| Website | https://www.unipd.it/en/ |
"ROR" |
https://ror.org/00240q980 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Padova, University of Padua, UNIPD
- Location
- Italy
Results and Publications
| Intention to publish date | 01/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | First - research protocol; planned publication in a high-impact journal Second - pilot study; planned publication in a high-impact journal Third - complete study; planned publication in a high-impact journal |
| IPD sharing plan | The data presented will be available on request from the corresponding author (stefania.mannarini@unipd.it). The data will be not publicly available due to privacy restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 06/08/2021 | 19/11/2021 | No | Yes | |
| Protocol article | 25/08/2022 | 26/08/2022 | Yes | No |
Additional files
Editorial Notes
26/08/2022: Publication reference added.
02/02/2022: The intention to publish date has been changed from 01/01/2022 to 01/01/2026.
19/11/2021: Trial’s existence confirmed by Ethical Committee of the University of Padua.
