Reducing vulnerability for victimization in depressed patients through emotion-regulation training: a randomized controlled trial.

Depressed patients are 3.8 times more likely to be a victim of a violent crime
in comparison to people in the general population. In a sample of 104 depressed
outpatients, 34% were victim of at least one violent crime in the previous 12
months (Meijwaard et al., 2015). Depressed patients seem to be particularly
vulnerable to violent crimes such as assault, threat and sexual crimes. The
high victimisation rates found in depressed patients, combined with the notable
prevalence rates of depression, underline the relevance of an intervention
aimed at reducing victimisation in depressed patients, which does not yet exist.

Apart from previous victimisation, symptom severity and depression (Cougle,
2009; Teasdale, 2009; van Weeghel, 2009; Iverson, 2011), emotion regulation
(ER) is assumed to be an underlying mechanism in victimisation (i.e., Marx et
al., 2005). Emotion dysregulation (ED) is considered to be a consequence of and
a risk factor for both victimisation and depression. The influence of ED on
victimisation seems highly relevant for patients with depression. Many studies
have shown that symptom severity of (past) depression is likely to coincide
with ED (Campbell-Sills, 2006; Garnefski & Kraaij, 2006; Ehring, 2008).
Depressed patients report increased ER problems such as experiencing,
differentiating, attenuating and modulating emotions as compared to healthy
controls (Brockmeyer, 2012). Therefore, the addition of an emotion regulation
training to regular treatment is expected to reduce victimisation risk in
previously victimized depressed patients.

Since previous findings underline the hypothesis that ER may play a key role as
an underlying mechanism leading to (re)victimisation, we suggest that a
clinical intervention aimed at enhancing ER skills may decrease
(re)victimisation risk. Therefore, in this study we want to examine the
effectiveness of the addition of online Emotion-Regulation Training (ERT) to
Treatment As Usual (TAU) in reducing future victimisation in high risk
outpatients suffering from a depression, who have been violently victimized at
least once in the past three years. Patients will be randomly allocated to TAU
or to TAU complemented with ERT. We expect patients in the experimental
condition, who receive additional ERT training, to be more resistant to future
victimisation as compared to patients in the control condition.

A 2-arm randomized controlled trial examining the (cost-)effectiveness of ERT
added to standard treatment (TAU), as compared to standard treatment alone in
outpatients with a depression. Patients in both the control and experimental
condition receive TAU. Patients in the experimental condition also receive ERT.
Assessments will take place at baseline, 8 and 14 weeks after start of
treatment, and 6, 12, 24 and 36 months after baseline. An additional
questionnaire will be assessed in August 2020 regarding the Covid-19 measures.
The primary endpoint is the total number of violent crime occurrences during
the three years follow up, as measured with the Integrale Veiligheidsmonitor
(IVM). An economic evaluation will be conducted alongside the RCT.

The experimental intervention will consist of an abbreviated and adapted
version of the ER skills training (ERT, a short version of the Affect
Regulation Training [ART]) as developed by Berking (2007). ERT will be provided
as an online training and will be added to Treatment As Usual. ERT is a highly
structured intervention that enhances ER skills and contains techniques from
CBT, dialectical behavioural therapy, emotion-focused therapy,
mindfulness-based interventions, self-compassion trainings and problem-solving
therapies. ERT starts with a thorough psycho-education of emotional reactions
and seven neuroaffective vicious cycles that are considered important for
long-term maintenance of negative emotions. Then, seven skills that are
designed to interrupt these cycles are taught to the participants.In our
abbreviated version, we will focus on four ER skills Non-judgmental awareness,
Acceptance and tolerance, Identification of emotions and Modification of
emotions. The selection of skills that we will focus on, is completely based on
existing literature regarding emotion dysregulation in depression and
victimization.

Burden:
Subjects will have to invest time when participating in this study. Subjects in
the experimental condition will need to invest more time than subjects in the
control condition. On the other hand, they will participate in an extra
intervention of which we assume that it improves emotion regulation skills and
reduced vulnerability for victimisation. A more specific overview of time
investment for this study can be found in section E2.
Participants in both conditions will complete questionnaires at baseline (2
assessments), 8 weeks, 14 weeks and 6 months after start of treatment and 12,
24 and 36 months after randomisation. An overview of these questionnaires can
be found in section K1.

Risks:
There are no anticipated risks involved in participating in this research.