Self-concept intervention among intimate partner violence victims: a multicomponent pilot program

ISRCTN	ISRCTN14216182
DOI	https://doi.org/10.1186/ISRCTN14216182
Secondary identifying numbers	2020/00418/001

Submission date: 19/01/2021
Registration date: 05/02/2021
Last edited: 12/09/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and aims
Intimate Partner Violence (IPV) affects women’s physical and mental health through direct pathways, such as injury, and indirect pathways, such as chronic health problems that arise from prolonged stress. One of the negative consequences is the negative self-concept IPV victims have. Self-concept refers to how someone thinks about, evaluates or perceives themselves.
Research has shown that exercise is essential to improve self-concept among victims of IPV. Moreover, a natural setting might help women with the process of contemplation and introspection needed along with psychological therapy.
This study aims to evaluate the effectiveness of a psychosocial multicomponent program which combines psychosocial group therapy along with adventure activities with the aim of reinforcing IPV victims’ self-concept.

Who can participate?
Women victims of IPV, aged over 18, from the region of Extremadura (Spain)

What does the study involve?
Participants are randomly allocated into two groups. The control group receive the usual assistance (psychological, economical) and resources available to the public institutions they attend. The intervention group receive the usual assistance available at the public institution they attend, and they will also attend the multicomponent program. The multicomponent program is designed as a program combining psychosocial therapy sessions and wilderness therapy sessions. These sessions will take about 4-6 hours over 8 weeks.

What are the possible benefits and risks of participating?
Potential benefits will be the improvement of participants’ self-esteem, self-concept, and general body image. The potential risks are minimal, and they are related to the participants' concerns about data confidentiality and potential physical risk performing the activities. It is important to highlight that professionals will be with women during the complete course of the therapy to minimise possible risks.

Where is the study run from?
Valle de Jerte (Cáceres, Extremadura, Spain)

When is the study starting and how long is it expected to run for?
September 2020 to August 2021

Who is funding the study?
University of Extremadura (Spain)

Who is the main contact?
Dr Gemma Sáez
gemmasaez@unex.es

Contact information

Dr Gemma Sáez
Scientific

Universidad de Extremadura
Facultad de Educación
Avda. de Elvas, s/n.
Badajoz
06011
Spain

ORCID ID	0000-0003-1605-951X
Phone	+34 (0)648550644
Email	gemmasaez@unex.es

Study information

Study design	Single-blind randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Wellness tourism in Valle del Jerte: self-concept program in victims of interpersonal violence. A natural activities pilot program based on a randomized controlled trial
Study objectives	H1: The multicomponent program will be feasible and useful in intimate partner violence victims H2. Participant in the experimental condition will increase their self-esteem compared to the control condition H3. Participant in the experimental condition will enhance their self-concept compared to the control condition H4. Participant in the experimental condition will improve their body image compared to the control condition H5. Participant in the experimental condition will increase their self-efficacy compared to the control condition Added 04/03/2022: H6: Participant in the experimental condition will decrease their depression compared to the control condition.
Ethics approval(s)	Approved 10/12/2020, bioethics and biosafety committee of the University of Extremadura (Campus Universitario, Avda de Elvas, s/n 06071 - Badajoz, Spain; +34 (0)924 28 93 05; vrinvestigacion@unex.es), ref: 187//2020
Health condition(s) or problem(s) studied	Intimate partner violence victims
Intervention	Participants will be randomly assigned to the intervention group (usual care + multicomponent program) or the control group (usual care) arm in a 1:1 ratio. Assessment points for both arms will be screening, baseline, 1 month and 3 months post-intervention. Updated 06/04/2021: Assessment points for both arms will be screening, baseline, immediately after the intervention program, 1 month and 3 months post-intervention. Usual care arm: Those randomized to the control group will receive any usual assistance (psychological, economical) and resources available to the public institutions they attend. Intervention arm: Those randomized to the intervention group will receive any usual assistance available at the public institution they attend, and they will attend the multicomponent program. The multicomponent program consists of 1 weekly 4-6 hour sessions during 8 weeks. Each session of the multicomponent program is composed of a psychosocial group intervention and wilderness adventure therapy (prescriptive use of adventure experiences in a natural setting).
Intervention type	Mixed
Primary outcome measure	Self-esteem measured using the Rosenberg scale at baseline, immediately after the intervention, 1 month later and 3 months later
Secondary outcome measures	1. Self-concept measured using AF5 Self-Concept at baseline, immediately after the intervention, 1 month later and 3 months later 2. Self-efficacy measured using the general self-efficacy scale at baseline, immediately after the intervention, 1 month later and 3 months later 3. Body image concerns measured using the Body Shape Questionnaire (BSQ) at baseline, immediately after the intervention, 1 month later and 3 months later 4. Depression measured using the Beck Depression Inventory, Second Edition (BDI-II), at baseline, immediately after the intervention, 1 month later and 3 months later 5. Attendance rate assessed by an attendance sheet which will allow the researchers to know the number of female participants from the experimental group that attended at least 80% of the intervention sessions; measured immediately after each intervention session Added 29/04/2021: 6. The main experiences of the activities developed in the experimental group, assessed using open-ended interviews at the end of the intervention
Overall study start date	28/09/2020
Completion date	16/08/2021

Eligibility

Participant type(s)	Other
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	34 (17 for each group)
Total final enrolment	33
Key inclusion criteria	1. Women 2. Aged older than 18 3. Intimate partner violence 4. From Extremadura (region where the project is carried out) 5. Read and signed the written informed consent
Key exclusion criteria	1. Women without psychopathology diagnosis (depression, mental illness (schizophrenia or bipolar disorder), personality disorders and eating disorders) 2. Physical problems that do not allow the participant to do the physical activities 3. Spanish skills not sufficient to be able to communicate effectively with the study staff
Date of first enrolment	08/03/2021
Date of final enrolment	20/03/2021

Locations

Countries of recruitment

Spain

Study participating centre

The study is distributed through public resources that have contact with IPV victims (dependent of the IMEX, Womens institute of Extremadura), as well as associations belonging to FADEMUR (Federación de Asociación de Mujeres Rurales), which helps with participant recruitment

Avda/De Portugal S/N. Pol Cepansa Nave, 1
Mérida
06800
Spain

Sponsor information

University of Extremadura
University/education

Facultad de Educación
Avda. de Elvas, s/n
Badajoz
06006
Spain

Phone	+34 (0)924 289 300
Email	vrinvestigacion@unex.es
Website	https://www.unex.es/organizacion/gobierno/vicerrectorados/viceinves
"ROR"	https://ror.org/0174shg90

Funders

Funder type

Government

Research Iniciation Proyect, subprogram Diputación de Cáceres

No information available

Results and Publications

Intention to publish date	30/09/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	1. Additional documents not available, planned publication of protocol 2. Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Gemma Sáez (gemmasaez@unex.es).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	06/05/2021	09/08/2021	Yes	No
Results article		02/05/2023	11/09/2023	Yes	No

Editorial Notes

12/09/2023: Internal review.
11/09/2023: Publication reference added.
04/03/2022: The study hypothesis was updated.
09/08/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added.
29/04/2021: The secondary outcome measures were updated.
06/04/2021: The interventions were updated.
23/03/2021: The trial participating centre was changed from 'The researchers will request the participation of associations belonging to FADEMUR: Federación de Asociación de Mujeres Rurales, which will help with participant recruitment' to 'The study is distributed through public resources that have contact with IPV victims (dependent of the IMEX, Womens institute of Extremadura), as well as associations belonging to FADEMUR (Federación de Asociación de Mujeres Rurales), which helps with participant recruitment'.
23/02/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 22/02/2021 to 08/03/2021.
2. The recruitment end date was changed from 05/03/2021 to 20/03/2021.
3. The overall trial end date was changed from 30/08/2021 to 16/08/2021.
4. The trial participating centre was changed from 'The researchers will request the participation of the public resources dependent of the IMEX (Womens institute of Extremadura)' to 'The researchers will request the participation of associations belonging to FADEMUR: Federación de Asociación de Mujeres Rurales, which will help with participant recruitment'.
19/01/2021: Trial's existence confirmed by bioethics and biosafety committee of the University of Extremadura.