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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45906
Enrollment
88
Registered
2019-03-07
Start date
2019-04-02
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depressieve stemmingsstoornissen en -afwijkingen Intimate partner violence

Interventions

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 genera

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: RCT: Women, aged 18 years and older, self-identifying themselves as being a victim of IPV through a series of questions and consequently registering online for SAFE. Additionally, eligible women need to have access to a safe computer and/or mobile phone and Internet connection.

Exclusion criteria

Exclusion criteria: RCT: The upper age limit has been set at 50 for the trial because women of childbearing age bear the greatest health burden associated with DV, and are the most likely to be in relationships where IPV is present. Women are excluded if in a follow up contact they identify that they have not been in an unhealthy or abusive relationship or experienced fear of partner in the past 12 months. Participants not reading the Dutch language are excluded in the RCT, because content of the website (at start) and all outcome measures are in Dutch.;Women of 18 years and older are given access to the minimal intervention part of the website if they cannot participate in the study. We will not collect T1, T2, and T3 data from them.

Design outcomes

Primary

MeasureTime frame
We chose Self-efficacy, measured by The General Self-Efficacy Scale (GSE) as primary outcome measure. This scale assesses a general sense of perceived self-efficacy, aiming to predict coping ability and adaptation to stressful life events. The Scale has 10 questions with response choices on a 4-point scale: Not at all true/Hardly true/ Moderately true /Exactly true. The GSE has been validated in both the Dutch and international community (a0.78-0.94) [94-96]. We hypothesize that the intervention group scores a higher mean self-efficacy score than the comparison group, immediately after intervention completion and at 6 months post-baseline. The GSE will take about 5 minutes to complete.

Secondary

MeasureTime frame
1. Anxiety and Depression, measured by the Hospital Anxiety and Depression Scale (HADS). Existing mental health research supports the mediating effects of self-efficacy on mental health, specifically depression. EHealth has been shown effective to reduce depressive symptoms [53, 97-101]. The HADS is commonly used to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety (HADS-A) and seven relate to depression (HADS-D). Cronbach's alpha for HADS-A varied from.68 to.93 (mean.83) and for HADS-D from.67 to.90 (mean.82) [102-104]. We hypothesize that participants in the intervention group show a lower mean depression score than the comparison group, as measured by the HADS at 6 months post-baseline. The HADS takes about 5 minutes to complete. 2. Awareness, measured by a modified version of the Contemplation Ladder, as used in the I-decide study [87]. Women will indicate their position on a modified version of the Contemplation Ladder [105], a tool originally developed to measure readiness to cease smoking. The ladder is designed to measure awareness of abuse from 0*10 based on how ready the woman is to make positive changes to her situation. The Contemplation Ladder, modified version will take about 5 minutes to complete. 3. Perceived support (social), measured by the Medical Outcomes Survey - Social Support, 5-item version (MOS-SS5). This is a 5-item version of the MOS social support survey. The questions ask the woman how often she has access to support from someone in her life, with response options on a 5-point Likert scale (a 0.88) [106, 107]. The MOS-SS5 will take about 5 minutes to complete. 4. Fear of Partner, measured by a visual analogue scale (VAS) (0-100). The participant will be asked to rate their current level of fear of their partner or ex-partner, on a sliding scale from 0 (not at all afraid) to 10 (very a

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)