To develop and test an innovative evidence-based therapeutic tool (EMDT add-on intervention) that reduces the frequency and intensity of intrusive suicidal images and thoughts, in order to prevent the transition from suicidal ideation to suicidal…
ID
Source
Brief title
Condition
- Suicidal and self-injurious behaviours NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the level of compellingness, vividness, and
frequency of suicidal intrusions (images and thoughts) as measured by the
Intrusion interview (see attachment 1).
Secondary outcome
Additional parameters are:
- Depressive symptoms (BDI-II)
- Suicidal behaviour
- Suicidal Ideation
Furthermore, we will be looking at:
- Quality of Life
- Societal costs
- Rumination
- Hopelessness
- Executive functioning (as a potential process measure to unravel the
underlying mechanism of the intervention)
Background summary
Suicide prevention interventions have been developed, however little remains
known about which processes link suicidal plans to the act of suicide (O'Connor
& Nock, 2014). Recent studies revealed that the majority of patients diagnosed
with major depression or bipolar disorder report repetitive intrusive
suicide-related images and thoughts (Crane et al., 2014; Hales, Deeprose,
Goodwin, & Holmes, 2011; Holmes et al., 2005). These images may be both
distressing and comforting to an individual (Crane et al., 2014). Furthermore,
suicide-related images and thoughts are conceptually linked to the process of
rumination (replaying one's problems and their causes over and over in one's
head), and as such may play a pivotal causal role in the development of
suicidality (Morrison & O'Connor, 2008). In fact, an important mechanism that
increases suicidal intrusions is their attempt to avoid them. Especially the
cognitive effort of stopping intrusions appears to have a counterproductive
effect, as it inflates their frequency and intensity instead (Abramowitz,
Tolin, & Street, 2001), rendering feelings off uncontrollability related to
suicidal ideation and images. Our central assumption is that the frequency and
intrusiveness of suicidal imagery determines the actual risk of suicide.
Experimental and clinical studies show that vividness of both negative and
positive intrusive images may be reduced by dual task interventions taxing the
working memory such as eye movements (van den Hout et al., 2011). It is assumed
that recalling an emotional image and performing eye movements require working
memory resources. Since the eye movements reduce resources for recall, the
image is rendered less intense, even upon recall (Engelhard, van den Hout,
Janssen, & van der Beek, 2010). We hypothesize that eye movements during
suicidal imagery retrieval, will reduce the intensity and frequency of such
imagery, and may be crucial in preventing suicide amongst depressed patients.
Study objective
To develop and test an innovative evidence-based therapeutic tool (EMDT add-on
intervention) that reduces the frequency and intensity of intrusive suicidal
images and thoughts, in order to prevent the transition from suicidal ideation
to suicidal behavior.
Research Questions:
1. What is the prevalence (presence, frequency) and nature (qualitative content
and intensity) of intrusive suicidal mental images and thoughts in depressed
patients with suicidal ideation?
2. Is the degree of suicidal ideation associated with the presence, frequency,
qualitative content and intensity of intrusive suicidal mental images and
thoughts?
3. Is EMDT effective as an additive intervention in reducing intrusive suicidal
mental images and thoughts in depressed patients?
4. Is EMDT effective as an additive intervention in reducing suicidal ideation,
depressive symptoms, and functional disability in depressed patients?
5. Is the reduction of intrusive suicidal imagery as a result of EMDT the
underlying mechanism of change of a reduction in suicidal ideation, and/or
depressive symptoms?
6. Is the reduction of suicidal imagery as a result of EMDT the underlying
mechanism of change of the transition from suicidal ideation and thoughts to
suicidal behavior?
Study design
First, a Pilot study (Phase 1) is conducted to inform us about the feasibility,
potential adverse events, and the usability of the intervention. This
monocenter study will take place at GGZ InGeest Amsterdam where 6 patients are
included. They are initially screened with the BDI-II and SIDAS. Eligible
patients will be interviewed about their suicidal intrusions (using the
Intrusion Interview). Next, participants receive (a maximum of) 6 EMDT sessions.
Once results of the pilot study are analyzed, the multicenter research will
take place and is split up into two phases. Phase 2 (qualification phase)
includes an observational study examining the compellingness, content,
frequency, and intensity of vivid intrusive suicidal imagery and ideation in
350 patients. After providing oral and written informed consent, patients will
perform a small Breathing Focus Task and will be interviewed by trained staff
members of the mental health care institution they are currently being treated.
In addition, they are asked to complete a set of (online) self-report
instruments.
Phase 3 (intervention phase) will consist of an open, multicenter randomized
controlled trial that will evaluate the effects of an EMDT add-on intervention
in reducing the intensity and frequency of suicidal imagery and ideation in 90
suicidal patients. Participants from the qualification phase (phase 2) who are
burdened by suicidal imagery are eligible and invited to participate in this
next phase. They are initially screened with a diagnostic interview if
necessary (MINI) and the BDI-II and SIDAS. After given written and oral
informed consent, participants are asked to complete a set of (online)
self-report measures (baseline assessments). Recruitment and interventions will
take place at the mental health care institution where they are currently
receiving treatment, including Altrecht, Dimence, Parnassia Groep, ProPersona,
and GGZ Eindhoven.
Participants will be randomized on a 1:1 basis (stratified for mental health
care institution) into the intervention group (Care-as-usual + EMDT add-on
treatment [n=45]) or the control group (Care-as-usual treatment only [n=45]).
Participants in the experimental group will receive six EMDT add-on sessions
over a period of six weeks. Multiple assessments will be carried out at:
pre-treatment (baseline), during treatment, post-EMDT (3 or 6 weeks after
baseline), and at 3, 6, 9, and 12 months follow-up periods. Self-report
assessments will be administered online, while the Intrusion Interview and a
brief cognitive task will be administered face-to-face at the mental health
care institution by trained staff members of the institution.
Intervention
The EMDT Protocol has been developed in co-creation with patients and mental
health professionals involved in mental health care for depressed patients with
suicidal ideation (through focus groups). Seven (formerly) depressed patients
with suicidal ideation have been approached to participate in a focus group
interview. Another focus group of six mental health care professionals will be
composed. In the focus group interviews, the needs and requirements for the
newly developed EMDT intervention to target suicidal intrusions and the safety
requirements of the new add-on module will be identified. This will be noted in
a 'List of practice recommendations for evidence-based EMDT aimed at intrusive
suicidal imagery'. This way, we will ensure that EMDT meets the needs of
patients and their mental health care providers. Moreover, the pilot study
(phase 1) includes a structured evaluation interview in which we receive
feedback from the participants about their experiences with the treatment.
EMDT add-on treatment
The treatment will be an add-on module that addresses intrusive suicidal images
and can be added to regular treatment. It will consist of six sessions each
approximately 1 hour, in the course of three to six weeks, delivered at the
participants* mental health care center. Trained and supervised intervention
psychologists from each participating center will carry out the EMDT sessions.
Each session will consist of the following steps:
1. Selection of intrusive suicidal flash-forward target images with related
ideation, informed by the baseline intrusion interview (Qualification phase).
2. Consecutive set of eye movements of 24 seconds by 10 second breaks (I.
Engelhard et al., 2012; van Veen et al., 2015). Between the sets, subjective
units of distress scale (SUDS, scale 0-10) are administered to assess level of
distress during imagery.
3. If the image still produces stress, the dual task procedure will be repeated
for the target.
4. This procedure is repeated for all target images until all SUDS are at
approximately 0.
All EMDT sessions will be videotaped (after informed consent from the patient),
and a random sample of 30% will be rated for treatment integrity.
Study burden and risks
Initially it is understood that many people exercise great caution with regard
to inclusion of a high-risk vulnerable group, and want to avoid an increased
risk of being suicidal. However, to date, extensive research shows that
participating in research has not resulted in increased risks and that
experimental treatments at reducing suicidality often also show this effect
(Huisman, 2017). Looking at the prevalence in a clinical suicidal population
regarding suicide attempts, there is an increased possibility that at least one
suicide attempt will occur throughout the study. Again, this is not due to any
risks associated to the EMDT-add on intervention or participation in the study,
but rather because of the high prevalence of suicide attempts in this
particular clinical sample. If the patient is showing increased high suicidal
risk, the therapist may motion toward the hospitalization of patients for their
own safety. (More information can be found in the risk-classification form B2.4
and section 9.3 ).
A potential unforeseen risk that could occur is in accordance with the working
mechanisms of EMDR in that the fear associated to the images could be
diminished. This, in turn, might take away the inhibiting effect of fear with
suicidality (thus making it less scary to perform a suicidal act). A second
potential unforeseen risk is that a small portion of the patients may
experience an increase or worsening of symptoms when actively recalling and
engaging with the suicidal intrusions.
Physical discomfort: there is a possibility that the patient will feel worn out
or tired after an EMDT session, as taxing working memory and retrieving vivid
intrusions may be experienced as exhausting.
Psychological discomfort: retrieving vivid, emotional suicidal intrusions may
cause an increase in feelings scared and stressed. (This is an important aspect
of the treatment: during the EMDT session, the patient is asked to place
themselves in the most emotional status of the intrusion)
Prior to treatment, the patient is invited to complete a screening. Multiple
questionnaires will be administered online. the intrusion interview and the
additional 6 EMDT sessions require the patient to visit their mental health
institution.
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
*Participants in Phase 1 will not be included in Phase 2 and 3.
Participants of Phase 2 however, may be eligible to participate in Phase 3 as
well., In order to be eligible to participate in the Pilot study (Phase 1), a
subject must meet all of the following criteria:
a. Have a minimum age of 18 years
b. Score ><= 20 on the Beck Depression Inventory
c. Have suicidal ideation: score ><=1 on Suicidal Ideation Attributes Scale
(SIDAS)
d. Currently receiving treatment (Care-as-usual) at GGZ InGeest Amsterdam
e. Adequate proficiency in the Dutch language
f. Have suicidal intrusions (as measured through the Intrusion Interview) that
are experienced as a burden, In order to be eligible to participate in Phase 2,
a subject must meet all of the following criteria:
a. Have a minimum age of 18 years
b. Have suicidal ideation: score ><=1 on Suicidal Ideation Attributes Scale
(SIDAS)
c. Currently receiving treatment (Care-as-usual) at a mental health institution
d. Adequate proficiency in the Dutch language, In Phase 3, a subject must meet
the following additional criteria:
e. Have suicidal intrusions (as measured through the Intrusion Interview) that
are experienced as a burden.
f. Score ><=20 on the Beck Depression Inventory
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in phases 1 or 3 of this study:
a. DSM-IV Psychotic disorder diagnosis
b. DSM-IV Depression with psychotic features diagnosis
c. DSM-IV Bipolar disorder diagnosis
d. High dropout risk (i.e. poor response rate when trying to get in contact
with potential participant), Exclusion criteria for phase 2 are slightly
different:
a. Current DSM-IV Psychotic disorder diagnosis
b. High dropout risk (i.e. poor response rate when trying to get in contact
with potential participant)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL60318.029.17 |