The first objective is to investigate whether biofeedback on HRV and voice volume will lead to a larger decrease of IPV compared to treatment as usual (CBT only). Second, to test the premise that IPV perpetrators have trouble self-observing bodily…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Het gaat niet om een aandoening, maar om het gebruik van geweld, waarbij wel sprake kan zijn van comorbide stoornissen, die echter geen focus zijn van het onderzoek.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the combined amount of reduction in the occurence
of physical and psychological violence as measured with the equally named
subscales of the Conflict Tactics Scale-2 (CTS-2).
Secondary outcome
Secondary measures are the Anger Bodily Sensations Questionnaire (ASBQ) and
HRV-values pre- and posttreatment. We will also analyze the effect of
motivation on treatment outcome.
Background summary
Meta-analyses of current treatments of intimate partner violence (IPV)
perpetrators show little to no effect in reducing violent behavior in intimate
relationships. Current practice in Europe is to treat risk factors with
cognitive behavioral therapy (CBT). An important therapy goal is to learn
self-control, which requires an early recognition of increasing arousal in
order to prevent escalation. However, the scientific literature on IPV shows
that perpetrators have difficulties in self-observing bodily signals that
accompany the build-up of arousal preceding IPV. A high level of emotional
arousal further hampers the ability to self-observe and subsequently to
self-control behavior. Because of this, we presume that IPV perpetrators can
not fully profit from *top down* CBT interventions aimed at developing
self-control.
With our newly developed smartphone application, GRIP-app, we aim to contribute
to the awareness of bodily signals that are associated with increased arousal
and subsequently contribute to the facilitation of reaching treatment goals of
IPV perpetrators. GRIP-app works in concordance with a wearable heart rate
sensor. It offers biofeedback on stress level (derived from heart rate
variability, a general marker of physiological arousal) and voice volume to
help perpetrators recognize increasing arousal. The smartphone will signal a
notification when a preset threshold is surpassed. We presume that by providing
biofeedback and supporting self-observation, perpetrators can practise
self-control before arousal becomes too high, thus preventing violence. This
presumption is built on prior research in other fields that shows that using
wearable technology contributes to achieving health-related goals by increasing
self-regulative abilities as well as increasing commitment to achieving these
goals.
Study objective
The first objective is to investigate whether biofeedback on HRV and voice
volume will lead to a larger decrease of IPV compared to treatment as usual
(CBT only). Second, to test the premise that IPV perpetrators have trouble
self-observing bodily signals related to arousal, and whether adding
biofeedback to treatment increases awareness of bodily arousal signals. Third,
to explore whether HRV-values improve from pretest to posttest after using
biofeedback. Fourth, to gain an impression of the feasibility and practical
implications of using biofeedback with the newly developed GRIP-app and to
establish future research directions.
Study design
Randomized Controlled Trial (RCT) comparing treatment as usual (TAU) with CBT
to an experimental condition where biofeedback is added to CBT (EXP). After
obtaining informed consent, subjects will be randomly assigned to one of the
two treatment conditions, both with a 9-week duration. The primary outcome
measure will be administrated at T0 (before intervention period) and T1 (after
intervention period).
Intervention
TAU consists of the CBT-based safety for partners treatment module, developed
by De Waag, which focuses on motivation, psycho-education and self-control.
Five out of eight weeks are aimed at self-control interventions. During this
time, subjects in the experimental condition (EXP) will be instructed to wear a
chest strap and use GRIP-app as often as possible and comfortable.
Study burden and risks
Regarding the burden, participants in the treatment as usual condition (TAU)
will receive regular treatment, and in addition fill out the outcome
questionnaires, and undergo a 5-minute baseline and posttreatment measurement
of HRV by wearing a heart rate sensor (see below).
Participants in the experimental biofeedback condition (EXP) will undergo these
same procedures and additionally wear a Polar H7 heart rate sensor during weeks
4-8, used in conjunction with GRIP-app on their smartphone. As for comfort,
participants might experience some physical discomfort by wearing the Polar H7,
because the device is worn on a soft chest strap which has to be made wet
before use. The chest strap also might feel tight or slightly painful to the
skin after prolonged wear. However, the strap is adjustable in size, addressing
tightness, and participants are free to limit their wearing time to the minimum
requirement or to leave the study and continue with regular treatment. We have
not found any risks or serious negative effects associated with wearing the
chest strap in literature. We will provide wearing instructions and therapists
will continually inquire into reasons that preclude wearing the strap, being
medical or otherwise.
As for data privacy, because Bluetooth is required, participants are exposed to
possible malevolent hacking attempts. However, we believe that the hardware and
software will primarily be used in the (relatively) safe home environment, and
that the Bluetooth requirement does not deviate from most people*s standard
usage of their smartphone. All data on physiological measures is handled
exclusively through secure network connections, accessing a server through a
cryptographic network protocol, where a therapist dashboard protected by hashed
passwords is coupled to GRIP-app with a unique code. No safety credentials are
hard-coded into the source code. Users have control over the data they share
with their therapist.
Participants referred by a probation officer might feel watched or controlled.
Data collection is limited to surpassings of the thresholds, only viewed before
the start of a therapy session and then discussed in-session with their
therapist. Participants are free to quit the study if they do feel watched,
without naming a reason. When quitting, we will ask whether their data might
still be used for data analysis or if they want to have it permanently removed.
Weighed against each other, we believe that the possible benefits of the
experimental condition * reduction of IPV - outweigh the possible burdens and
risks.
Wisselweg 151
Almere 1314CC
NL
Wisselweg 151
Almere 1314CC
NL
Listed location countries
Age
Inclusion criteria
- Recent perpetration of IPV (in the year prior to referral);
- Age: 18 or above.
- Subject is in possession of a smartphone running iOS 11.2.5 or higher, or
Android 6.0 or higher;
- Sex: Male;
- The relationship in which violence occurred is still on-going. Partners do
not necessarily need to be living together, but will need to be visiting each
other at least three times a week to be included. Because of the short duration
of the study, we want to be sure that there is enough time for the intervention
to be practised. Therapist will monitor whether the relationship goes on during
the study;
- Lack of self-control, as assessed during the intake procedure, is a risk
factor that is targeted in treatment.
Exclusion criteria
- Treatment is mandatory / referral by a probation officer;
Sensitivity to crisis, liability to act out dangerously towards oneself or
others, requiring immediate intervention, e.g. suicidality, serious self-harm,
psychosis;
- Substance abuse of a severity that requires clinical treatment or which
therapists deem to need treatment before any other interventions take place;
- Referral is part of conditions imposed by a judge or a probation officer.
- Aggressive behavior occurring only outside of an intimate relationship;,
Additional exclusion criteria for participation in this study:
- Stalking behaviour as primary reason as referral for treatment;
- A restraining order issued by the mayor during the intervention period (this
prevents contact between partners);
- Any reason that leads to a subject not willing or not being able to wear a
chest strap, i.e. medical reasons, psychological conditions such as panic
disorder, or any reason of relevance to the subject;
- Having or entering a new relationship where IPV does not occur.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL69507.018.19 |
OMON | NL-OMON25289 |