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

Background
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.
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 following are:
1. What are key elements of SAFE, an eHealth intervention for women exposed to
IPV, according to victims and experts?
2. Is SAFE an effective intervention to increase awareness, self-efficacy and
perceived support?
3. Is SAFE an effective intervention to lower (mental) health symptoms in women
exposed to IPV?
4. Does SAFE lead to change concerning their violent living situation?
5. Is SAFE a feasible tool to deliver care to women exposed to IPV?

Interview study: To start the development of SAFE we will perform
semi-structured interviews with female victims of IPV to identify wishes and
needs for eHealth, as well as key elements for SAFE. Additionally we will
address safety as an important factor and ask them to
their needs concerning their safety when participating in SAFE. Finally we will
ask female victims of IPV how disseminate the existence of SAFE. The interview
study will have a qualitative design using semi-structured face-to-face
interviews. This method allows one to gather rich data about a difficult
subject in a vulnerable group. The participants engage in semi-structured
interviews, using an interview guide that will be based on literature and
expert opinions. Interviews are audio taped with the interviewees* consent.
Interviews will last 45-60 minutes. The recorded interviews will be transcribed
verbatim and emailed to the participants (when they allow) for member check.

RCT: A randomized controlled parallel-group trial (SAFE vs. Minimal
Intervention).
For the development of SAFE we will address female victims of IPV with help of
an organisation that supports female victims of IPV and ask these women to
engage in a series of two meetings. In the first meeting we will present the
pilot version of SAFE and ask for feed-back on facilitating and hindering
factors for participation in SAFE. Additionally, we will provide them with a
login and ask them to evaluate the intervention with help of a structured list.
This structured list will consist of 1) a Web Evaluation Questionnaire and 2)
the *checklist toegankelijke informatie* from Pharos. The web evaluation
questionnaire (WEQ) will contain questions about content, layout, the perceived
effectiveness and usefulness of the website, as well as the question to give
the website a motivated overall score from 0 to 10, based on their experiences
and taking into account their own wishes and needs. A final question is a
so-called free text field, to catch suggestions and new ideas. The WEQ will be
derived from an earlier version used for Feel the ViBe [84] and has as goal to
identify issues for further improvement, to collect possible facilitators and
barriers for using, and to evaluate if the website will meet the expectations
of the target group. We will ask all women if they prefer to complete the
structured list on their own or with help, and if they need a device to access
SAFE. All women who completed the structured list will be asked to join a
second meeting. In the second meeting we will
discuss their findings and possible changes to the intervention based upon
these findings until we reach consensus on the final content of SAFE. To be
able to perform an RCT (see hereunder; Q2), we will consequently lock the
intervention for further changes for the duration of the RCT. Women who took
part in the development are free to use their login during the RCT, but will be
excluded from any analysis.

RCT: 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 or posters and flyers in waiting rooms. 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 interviews. The
audio of the interviews will be recorded and transcribed verbatim.

At this stage we expect SAFE to be a pure self-support intervention without
therapist contact, consisting of four modules: 1. providing information about
IPV thereby raising awareness; 2. identifying the social environment thereby
increasing support; 3. increasing self-efficacy by learning problem solving
techniques; and 4. providing information on professional help. Within the
modules we will possibly use psycho-education, assignments, assessments and
life stories of fellow sufferers in Video or Diaries. The use of a general
forum, chat, online library and an e-mail support line could support the four
modules. At this stage, SAFE could be designed as a website or as an
application. While both have advantages, we expect a website optimized for
mobile devices to fit the target group the best, as applications are, in
nature, installed on a device, which could lead to dangerous situations when
the perpetrator of the violence would control these devices. Besides, websites
are available from all
devices, while apps are not. An escape-button, deleting search history and
instructions on how to use private web navigation will be 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 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. We expect no negative
effects of participation in SAFE and therefore we think that this study does
not fall within the remit of the Medical Research Involving Human Subjects Act
(WMO).