SAFE: a self-support eHealth intervention to support women exposed to intimate partner violence.

Intimate Partner Violence (IPV) is defined as any physical, sexual,
psychological, or economic violence that occurs between former or current
spouses or partners [5]. It is a common social problem worldwide, and one that
is distinctly gendered [5-7]. The prevalence of IPV is particularly alarming in
light of its association with a range of negative health outcomes for women and
children [5]. Research consistently shows that abused women are at increased
risk of depression, anxiety, posttraumatic stress disorder, and suicide [8], as
well as physical problems [6]. About one out of three women have experienced
either physical and/or intimate partner violence or non-partner sexual violence
in their lifetime [9-12]. In the Netherlands at least 20% of women have been
ever physically abused by a former or current partner, 11% is victim of sexual
violence by a former or current partner and one out of eight of all Dutch women
have been raped ever during their lifetime [12-19]. Children growing up in a
violent home are more often direct victims of child abuse and are exposed to
violence acts as well. Being a witness of intimate partner violence has similar
consequences as to being a direct victim of child abuse [20-24]. One in three
will become a perpetrator or victim themselves in their future partner
relationships: the intergenerational transmission of violence [25]. Despite the
negative outcomes of being a victim of IPV, there is limited evidence of
effectiveness for interventions in health care settings, with inconclusive
results in terms of the effects on women*s physical and psychosocial well-being
[26-30].
Many women feel uncomfortable revealing their experience with IPV, even if the
issue is raised in a sensitive manner by the health professional [31]. They may
feel that the abuse is not serious enough to mention or worry about disclosure
if their abusive partner sees the same health care professional [32]. The
pathway to disclosure can be long and challenging for women, and by the time
the health professional becomes aware of the abuse, if at all, they may have
missed a valuable opportunity to intervene earlier and more effectively [33].
EHealth is a rapidly developing and upcoming mode of therapy. Although eHealth
is still in its infancy, more attention has been paid to the theory and
different categories of eHealth interventions in recent years. In a recent
systematic review of online health interventions, Webb, Joseph, Yardley, and
Michie (2010) examined the role of theoretical background, behaviour change
techniques, and mode of delivery on the intervention*s effectiveness [34]. They
found that increased use of theory to inform the intervention led to a greater
effect size. In terms of behaviour change techniques, the most valuable were
found to be information provision, self-monitoring, and problem solving, with
action planning and the provision of feedback also having significant positive
effects. Interventions that provided an *enriched information environment* and
offered automated tailored feedback were found to have significant effects on
behaviour change. From the literature, we know that peer and social support are
effective methods to change behaviour, both offline and online [35-41]. Social
support, furthermore, has proven to be effective in adults exposed to violence
and is associated with good mental and physical health outcomes [42, 43].
Offering an IPV intervention in an online format may assist in overcoming some
of the barriers encountered in health care settings. Online interventions are
being increasingly used as a way of self-managing health conditions, with
promising results [44-51]. Overall, evidence suggests that eHealth cognitive
therapy interventions for depression and anxiety are effective, especially if
healthcare providers are involved [52]. Lintvedt et al. (2013) point out that
an internet- based intervention is constantly available and accessible from any
location [53]. This flexibility allows women to access the intervention at
unexpected times when an abusive partner is not present, as opposed to the
health care setting where they must schedule an appointment. Delivering an
intervention online also allows women to self-identify and
self-manage without disclosure to a third party. This may be particularly
beneficial for women who are unable to disclose the abuse to a health care
professional and are not ready to attend a specialized support service [54].
The internet provides an anonymous environment where women can safely search
for information and explore possibilities for help. Women who do not have safe
Internet access at home often have access in other locations such as family or
friends* homes, public libraries, or community agencies or access the Internet
wirelessly using a Smartphone [55-57].

Relevance
Intimate Partner Violence (IPV) has been defined within the ZONmw program
Gender and Health (4b) as one of the gender based themes that are threatening
the (mental) health of women showing knowledge gaps on insights into the
healthcare needs of victims. In the Netherlands 200.000 women yearly are victim
of IPV and one in three women have encountered partner violence at some time in
their lives. Abused women are at risk of psychiatric conditions as well as
medical unexplained physical symptoms [6]. IPV is therefore strongly
interconnected with two other themes defined within the ZONmw program Gender
and Health as important: Unexplained physical symptoms (4e) and Psychological
and psychiatric conditions (4f). As violence against women has several health
consequences, studies have shown that the burden of diseases related to
intimate partner violence is high. Victims are more likely to consult their GP,
have more chronic complaints and use more painkillers and antidepressants
[58,59].
It is estimated that the costs of healthcare for the physical and psychological
treatment of female victims of violence against women (visits to health care,
pharmaceuticals, emergency room, hospital stay, mental healthcare) are 1200-
3200 euro per victim per year, which does not include absence in work or social
life [3, 4]. The total costs estimated of IPV are ¤280 million annually for
official services (police, emergency, shelters) and ¤74-129 million yearly for
employers due to absence of work [2]. IPV has thus a major impact on society
with a tremendous loss of wellbeing and health and increasing costs. The
limited evidence of effectiveness of interventions to diminish violence and
negative consequences in a population that is difficult to reach, asks for easy
accessible low-costs interventions [26, 27, 30]. Within usual health care
settings many victims worry about privacy and safety [32] and find provided
care not attune to personal needs. Without any doubt also an important barrier
for victims to disclose is not being ready to accept help [60]. The relevance
of an eHealth intervention certainly is that an eHealth intervention might
improve the awareness and readiness of victims to disclose their violent
experiences, as a first step without any health care contact to get ready to
change and to increase the willingness to tailored treatment. Disclosure by
victims of IPV makes it also possible to deal with violence in an early stage.
By offering an internet-based intervention online we might overcome the earlier
mentioned barriers, which will lead to an increased awareness of being in an
unhealthy situation with possibilities to change and to decrease (mental)
health symptoms. Internet has the advantages of a constant availability and
easy accessibility. The added value of an internet based intervention lies in
facilitating equity of access for most victims as they are afraid of losing
safety and privacy, being blamed as victim, especially for the women who might
otherwise be disadvantaged such as women in remote locations, ethnic
minorities, or women closely monitored by an abusive partner. Above all it
guarantees anonymity and safety, which is highly important for minority groups
in our society [61]. Besides, we chose women only as our target group, as
involvement of male participants
could be a threat for female victims of IPV, and should ask a very different
design of the internet intervention.
Our project will strive to include adult persons with a variety on
socio-economic status, ethnicity and sexual orientation, in all ages except
children and adolescents as these youngsters need special legal prerequisites.
The strategy followed in Feel the ViBe for dissemination online resulted in a
diverse group of participants [1]. Patient participation is
organized by the patient representatives in our project group. They will
construct a patient advisory board consisting of 8 victims with a diverse
background and who will be involved in all phases of this project, from start
to implementation. This innovative project combines the experiences of multiple
experts from different fields (victims, primary care, medical psychology,
gender medicine, gender based violence and eHealth interventions), which will
support the development of a valuable internet-based intervention named SAFE.
As women compared to men are more vulnerable and susceptible to suffer from
violence an intervention focussing on female victims will greatly diminish the
gender gap in health. The unique approach of qualitative and quantitative
methods including a RCT is also considered to be a very successful basis to
ameliorate health inequalities.

Victims of IPV, living in an unsafe and unhealthy situation, are faced with a
broad range of physical and emotional symptoms. Standard and easy-accessible
care to facilitate change into a safer situation is lacking. The project aims
to launch an internet-based self-support intervention to enhance awareness and
decision making, for women exposed to IPV named SAFE. As low threshold access
is important, we aim to make SAFE freely available and as accessible as
possible for functionally illiterates, migrants and other non-native
Dutch-speaking participants (by collaboration with the national institute
Pharos). Our hypotheses is that using SAFE will lead in victims to an increased
awareness of being in an unhealthy situation with possibilities to change, an
increase of self-efficacy and perceived support, a decrease of (mental) health
symptoms such as depression and anxiety and lastly to person-tailored changes
in their violent living situation.

The project consists of several parts:
1. The development of SAFE, based on victim*s experiences, expert opinions,
comparable eHealth interventions and literature. (Which is already approved of
by the committee.)
2. A randomized controlled parallel-group trial to evaluate the effectiveness
and efficacy of the SAFE intervention (RCT),
3. A process evaluation of SAFE to gain insight into meaningful usage
parameters to evaluate the use of a fully automatic web-based intervention,
including feasibility measures, and using mixed-methods.

The Research Questions for the RCT and process evaluation following are:
- Is SAFE an effective intervention to increase self-efficacy in women exposed
to IPV? (primary outcome)
- Is SAFE an effective intervention to increase awareness and perceived
support, and to lower (mental) health symptoms in women exposed to IPV?
(secondary outcomes)
- Is use of the SAFE intervention associated with a significant change in the
primary and secondary outcomes?
- Is SAFE a feasible tool in providing information and support to women exposed
to IPV?

RCT: A randomized controlled parallel-group trial (SAFE vs. Minimal
Intervention).
Women will be recruited by either entering the public website of SAFE, which
they found on Google or trough related pages; or directed by healthcare
professionals. The public website of SAFE will contain a specific research page
on which women can find information on the research. Women can choose to
participate by entering SAFE trough a large button, after which they enter the
registration process. Participants that are registered and have given consent
will answer the baseline questionnaire (T0). After completion participants will
be randomly allocated by computer by a statistician who is blinded to the
baseline data (with an allocation ratio of 1:1) to either SAFE or a minimal
intervention providing only general background information on IPV and e-mail
support In Case of Emergency (ICE). Data will be collected at baseline (T0), at
3 months (T1), at 6 months (T2) and at 12 months (T3). Furthermore,
participants are asked to complete 2 short questionnaires after completing a
module (VAS). All data will be self-reported online.

Process evaluation: Participants in the RCT study who completed all follow-up
questionnaires are asked to participate in semi-structured online interviews.
Furthermore, we analyze the online data from the website.

SAFE is a pure self-support intervention without therapist contact, consisting
of four modules: 1. providing information about IPV and relationships, thereby
raising awareness; 2. identifying the social environment thereby increasing
support; 3. increasing self-efficacy by learning about physical and mental
health and problem solving techniques; and 4. providing information on
professional help. Within the modules we use psycho-education, assignments,
assessments and life stories of fellow sufferers in video or stories. The use
of a general forum, chat, online library and an e-mail support line supports
the four modules. SAFE is designed as a website which is also suitable for use
on a mobile phone. An escape-button, deleting search history and instructions
on how to use private web navigation are included.
The participants complete questionnaires at four moments: at registration (T0),
at 3 months (T1), at 6 months (T2) and at 12 months (T3). Furthermore,
participants are asked to complete 2 short questionnaires after completing a
module (VAS).
The control group receives a minimal intervention consisting of general
background information on intimate partner violence and help, and e-mail
support in case of emergency.

We will ask the Committee on Research Involving Human Subjects of the
Radboudumc (Dutch initials: CMO) to assess this study. There is a small chance
there are negative effects from participation in SAFE (hypothetical risk that
the violence will escalate) therefore we think that this study does fall within
the remit of the Medical Research Involving Human Subjects Act (WMO).