The main purpose of this study is to find out whether EMDR is a safe and effective treatment to reduce the symptoms of PTSD in people with mild intellectual disability and borderline intellectual functioning. In addition, it is expected to reduceā¦
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PTSD symptoms
The Adapted Anxiety Disorder Interview Schedule-Adults, PTSD section
(ADIS-C-PTSD, LVB-Adult version, unpublished) (Mevissen et al., 2014), is used
to measure type and severity of PTSD symptoms in adults with mild ID and
borderline IF. Mevissen et al. (2014) developed the Adapted ADIS-C -PTSD for
the assessment of PTSD in children and adolescents with mild to borderline IF.
A recent study showed good interrater reliability, content and convergent
validity (Mevissen et al., in press). Next to the child version, the ADIS-PTSD-
LVB-Adult version Interview was developed. At this moment a study on its
psychometric characteristics is in progress.
The first part of the ADIS-PTSD-LVB-Adult version consists of 29 questions
addressing different types of traumatic events. The response format for each
question is *yes*, *no* or *otherwise*. When participant responds to the
question about one of the traumatic events in the affirmative, the participant
is asked three more questions: (1) *what happened?*; (2) *how did you react to
that*; (3) *how old were you when it happened?*. To help the participant to
keep in mind the events when symptoms are asked, all events the participants
are exposed to, are visualized on a time line. Next, the participant is asked
which event actually is the worst to think about. The second part of the
interview consists of 40 questions about PTSD symptoms and several questions
addressing atypical symptoms. For these questions, the response format is
*yes*, *no* or *otherwise. The participant is then asked to rate his or her
subjective level of daily life impairment. To this end a thermometer card is
used.
During the selection process the entire interview will be conducted by an EMDR
therapist, trained in administering the interview. To monitor the weekly
changes in PTSD symptoms only the second part of the interview will be used.
The monitoring of the weekly changes will be carried out by a research
assistant.
Secondary outcome
Psychotic symptoms
Psychotic symptoms will be weekly monitored by means of the Psychotic Symptom
Rating Scale Interview (PSYRATS) (Haddock, 1994), in Dutch translation
(Valmaggia, 1998). The interview uses the Auditory Hallucination Rating Scale
(AHRS; 11 questions, total score ranges from 0-55). The AHRS assesses the
frequency, duration, location, loudness, causal attribution of daily life
caused by hearing voices. The Delusion Rating Scale (DRS; 6 questions, total
score ranges from 0-30) and assesses the extent and duration of preoccupation
with the delusion, the credibility of the delusion, the extent and severity of
discomfort and suffering, and the disruption of daily life caused by the
delusions. All PSYRATS items are scored from 0 (not) to 5 (continuously).
Results of a study by Haddock and his colleagues (1999) showed an adequate
internal reliability, largely good test-retest reliability and logical
inter-correlations between subscales of the PSYRATS interrater reliability
(AHRS alphas .78-100; DRS .88-.99) and validity were found to be good to
excellent.
Although the PSYRATS (sub-scale AHRS and sub-scale DRS) are used in studies for
non-disabled patients, there are indications that it is also useful in people
with mild ID and borderline IF. Hatton and his colleagues (2005) found that the
PSYRATS, especially the scale for auditory hallucinations, are well-suited to
people with ID and psychotic symptoms. In addition, in comparable studies,
where participants are included with an IQ of 70, also used the PSYRATS (De
Bont, et al., 2013; De Bont et al., 2016, Van den Berg & Van der Gaag; 2012;
Van den Berg et al., 2015). This suggests that the PSYRATS can be used reliably
in persons with mild ID to borderline IF.
The PSYRATS will be administrated by a research assistant at pre-and
post-treatment and follow-up.
General psychopathology and distress
The Brief symptom Inventory (BSI) is a short version of the SCL-90-R to quickly
measure psychological symptoms (Derogatis, 1983; 1993) in Dutch translation (De
Beurs, 2004). (The BSI has 53 items and contains 9 subscales: requires 8-10
minutes to complete, making it well-suited for repeated administrations over
time to evaluate patients* progress. The results of a study by Wieland,
Kapitein, Otter, & Baas (2012) suggest that the BSI is useful in patients with
either a mild ID or borderline IF. Internal consistencies ranged from 0.70 to
0.96 and are considered good to adequate. Subscale intercorrelations showed a
degree of differentiation between the subscales. Discriminant validity was
shown for the subscales depression, anxiety and phobic anxiety. Confirmatory
factor analysis showed that the underlying structure of the BSI could be
described by the same nine-factor model as reported in previous studies. As a
result of the psychometric properties, the study mentioned above supports the
use of the BSI as a screener for psychopathology and a general outcome measure
in people with a mild ID and borderline IF.
The BSI will be administered by a research assistant at pre- and post-treatment
and follow-up.
General psychopathology
The Health of the Nation Outcome Scales (HoNOS) (Wing, Beevor, Curtis, Park,
Hadden & Burns, 1998) in Dutch translation (Mulder et al., 2004a) will be used
to assess overall mental health and social functioning. The clinician assesses
the patient*s situation. The HoNOS has 12 items and contains four subscales;
behavioral (problems), (physical & cognitive) impairment, (psychiatric)
symptoms, and social (functioning). These items can be scored between zero (*no
problem present*) to four (*severe to very severe problem*) (Mulder et al.,
2004a). Research results on the HoNOS vary for both test-retest (Orrel, Yard,
Handysides, Schapira, 1999) and interrater-reliability (Amin, Singh, Croudace,
Jones, Medley & Harrison, 1999; Bebbington, Brugha, Hill, Marsden, Window,
1999; Brook, 2000).. Good training before using the HoNOS is advisable (Amin et
al., 1999) and increases interrater-reliability (Brooks, 2000). HoNOS
reasonably measures social functioning and general psychopathology and is
sensitive to change (Wing, et al., 1998), especially in chronic and more severe
psychiatric problems (Amin et al., 1999).
In Dutch research in patients with a mild ID and borderline IF who have severe
behavioral and mental health problems the internal consistency of the HoNOS
completed by (psychiatric) nurses was 0.74 and 0.48 when completed by
psychiatrists/psychologists (Tenneij, Didden, Veltkamp & Koot; 2009).
The HoNOS is part of Routine Outcome Monitoring in GGZ-Oost Brabant and will be
administrated by a research assistant at pre- and post-treatment and follow-up.
Background summary
Persons with mild intellectual disabilities (ID) and borderline intellectual
functioning (IF) have 2 to 4 times more chances of developing psychiatric
disorders (Dekker, Koot, Van der Ende, & Verhulst, 2002; Neijmeijer, et al.,
2013) as ptss (Mevissen & De Jongh , 2010; Didden et al., 2016; Wielland et
al., 2014) a psychosis (see eg, Cooper et al., 2007; Welch et al., 2011; Morgan
et al., 2008; Zammit et al. 2004). Although PTSD is common in psychosis, few
studies have been conducted on effective treatment methods in non-disabled with
comorbid PTSD and psychosis. Past or present comorbid psychotic disorder is the
highest criterion for exclusion in random clinical PTSD outcomes studies
(Bradley, Green, Russ, Dutra, & Westen, 2005; Powers, Halpern, Ferenschak,
Gillihan, & Foa, 2010; Ronconi, Shiner, & Watts, 2014; Spinazzola, Blaustein &
Van der Kolk, 2005). Research shows that 87% of clinicians see comorbid
psychosis as a contraindication for psychotherapeutic intervention, such as
long-term exposure (PE) (Becker, Zayfert, & Anderson, 2004). They feared
failure or symptom aggravation or the induction of false memories in this
vulnerable group (Becker et al., 2004; Van Minnen, Hendriks, & Ollf, 2010,
2010; Read, Hammersley & & Rudegeair, 2007). It is very important to
investigate effective treatments for individuals with a mild ID to borderline
IF and comorbid PTSD and psychosis. Since cognitive behavioral therapy mainly
includes verbal interventions, homework assignments and exercises outside the
sessions, this treatment seems less suitable for this target group. Treatment
studies in persons with mild ID and borderline IF are limited (Gilderthorp,
2014; Mevissen & De Jongh, 2010; Mevissen, Lievegoed & De Jongh, 2011; Mevissen
et al., 2016; Mevissen, 2016). Jowett and colleagues (2016) conclude from a
literature review of 6 case studies that there are sufficient indications that
EMDR is a safe intervention for this group of patients in the intellectual and
adaptive skills of persons with a mild ID and borderline IF.
Researchers of this current research are not aware of (published) studies on
the effectiveness of EMDR on PTSD in persons with mild ID and borderline IF and
psychosis. In studies in the general population it appears that EMDR is a safe
and effective method and even positively affects psychotic symptoms (see, for
example, De Fur, Van Minnen, De Jongh, 2013, De Bont, Van den Berg, Van der
Vleugel, & De Roos, 2016; Van den Berg & Van der Gaag, 2012).
Study objective
The main purpose of this study is to find out whether EMDR is a safe and
effective treatment to reduce the symptoms of PTSD in people with mild
intellectual disability and borderline intellectual functioning.
In addition, it is expected to reduce the severity of symptoms of PTSD in
people who have a slight identifier to the F-boundary and psychosis after edder
treatment. In addition, it is expected that Amdere will also improve overall
performance and reduce mental complaints: hallucinations and hallucinations.
(Psi) and General
Study design
The present study uses a multiple baseline across subjects design. When
patients are eligible, they will be randomly allocated to different baseline
(B) lengths (a-e). The start of the therapy will be randomized over 3-7 weeks
of the baseline phase. Studies comparable to the proposed research (See de
Bont, et al., 2013, de Bont et al., 2016; Verhagen et al., in preparation) have
similar baseline lengths. For each baseline phase, two participants will be
randomly assigned. Participants will be weekly assessed with primary measures
during baseline (B), treatment (T) and post-treatment (P). Secondary measures
in order to measure auditory hallucinations, delusions and general
psychopathology will be applied at three time points (t1-t3). That is, before
and after treatment and at follow-up (FU), three months after the end of
treatment (Table 1).
Table 1 Planning of measurements
Baseline a : t1 BBB TTTTTTTTTTTTt2 PPPPPPP t3 FU
Baseline b : t1 BBBB TTTTTTTTTTTTt2 PPPPPP t3 FU
Baseline c : t1 BBBBB TTTTTTTTTTTTt2 PPPPP t3 FU
Baseline d : t1 BBBBBB TTTTTTTTTTTTt2 PPPP t3 FU
Baseline e : t1 BBBBBBB TTTTTTTTTTTTt2 PPP t3 FU
t1= baseline B= baseline 3-7 weeks T=treatment 12 weeks, P=post treatment 2-6
weeks, t2= post treatment measurement, t3 FU= follow up after 3 months.
During baseline, each participant will be assessed weekly for a period between
3-7 weeks on the ADIS-C-PTSD-LVB-Adult version (only the second part) and
potential/possible adverse events, and once on the AHRS, DRS, BSI and HoNOS
(t1). During the treatment phase (12 weeks) participants will be measured
weekly on the second part of the ADIS-C-PTSD-LVB-Adult version interview and
potential/possible adverse events. Participants will be assessed weekly for 3-7
weeks after the end of treatment on the ADIS-C-PTSD-LVB-Adult version (second
part) and potential/ possible adverse events. During this phase (t2) they will
also be assessed once on the AHRS, DRS, BSI and HoNOS. Three months after the
end of treatment (t3), participants will be assessed on all measures (i.e.,
ADIS-C-PTSD-LVB-Adult version (second part), AHRS, DRS, BSI and HoNOS.
Intervention
EMDR is an eight-phase protocolized approach intended to resolve the symptoms
that can result from disturbing and unprocessed life experiences (Shapiro,
2001). The patient is asked to focus on an image that provides negative
emotional reaction. Then the patient is asked to call this disturbing event in
mind and focus on the most intrusive still image (called *target*), and the
negative thought about oneself (negative cognition), the negative emotion and
physical stress that is caused by the target. At the same time the patient is
asked to concentrate on a distracting task, preferably following the fingers of
the therapist moving from left to right. This is called desensitization and is
repeated until the negative charge on the target has become neutral and the
(physical) tension has decreased (Shapiro, 2001). Finally, the patient is asked
to replace his or here negative cognition with a positive cognition.
At the core of the EMDR method, the working memory taxation plays an
important role as an explanation for the treatment effects (Van den Hout &
Engelhard, 2011; Ten Broeke, De Jongh, & Oppenheim, 2012). The working memory
has a limited capacity and is therefore unable to retain the aversive memory
(target) in all its intensity while simultaneously paying attention to another
task. As a result, the memory is stored less vividly and emotionally
(Engelhard, Van den Hout, & Smeets, 2011; Gunter & Bodner, 2008; Kavanagh,
Freese, Andrade, & May, Van den Hout & Engelhard, 2011). Negative cognitions
associated with the memory of the traumatic event lose credibility and positive
cognitions become more believable (Van den Hout & Engelhard, 2011; De Jongh,
Ernst, Marques, Hornsveld, 2013; Ten Broeke et al., 2012). This leads to
changes in meaningfulness and consolidation of functional representations
(Baddeley, 2012).
The treatment as applied in this study
All participants will receive a maximum of twelve EMDR sessions of ninety
minutes. Early completion is allowed. For each participant, a case
conceptualization based upon the Two Method Approach (Ten Broeke, et al., 2012)
will be made, approved by an accredited supervisor of the Dutch EMDR
Association. After target selection, the standard EMDR-protocol in Dutch (De
Jongh & Ten Broeke, 2011) adapted from Shapiro*s (1995) work will be used.
Meanwhile all participants will continue to receive comparable treatment as
usual for psychosis delivered by multidisciplinary teams, with care usually
consisting of antipsychotic medication and treatment and/or supportive
counseling by psychiatrists, psychologists, nurses and case management.
Study burden and risks
Participants will be interviewed and tested before treatment, after treatment,
and at three months follow-up. That is a maximum of 24 times in 24 weeks. The
measurements will take approximately 360 minutes, no more than 15 minutes each
time. Participants will receive a maximum of twelve therapy sessions of
maximally 90 minutes each. A session of 90 minutes is according to the
guidelines of the general population. Early completion is allowed.
After the EMDR-sessions some participants might experience a short
increase in symptoms, which is a common response to this type of therapy. Major
adverse events are not to be expected nor have these been documented in
previous similar research with persons with or without mild ID and borderline
IF (Gilderthorp, 2014; De Bont, Minnen & De Jongh, 2013; Mevissen, Lievegoed &
De Jongh, 2011a; Mevissen, Didden, Korzilius, & De Jongh, Van den Berg et al.,
2015). Therapists are experienced in working with persons with mild ID to
borderline IF and psychosis and performing EMDR in persons with mild ID and
borderline IF and PTSD.
Kluisstraat 2
Boekel 5427 EM
NL
Kluisstraat 2
Boekel 5427 EM
NL
Listed location countries
Age
Inclusion criteria
Ten participants between 18 and 65 years of age will be recruited for this study. They are mental care patients (i.e. at GGZ Oost Brabant). They receive health care from the specialist department for persons with mild Intellectual disorders to borderline Intellectual functioning and mental disorders (LVB-P circuit).
All participants are diagnosed with a mild ID or borderline IF on the basis of results of an intelligence test (e.g. WAIS II; WAIS IV). Participants have a current psychotic disorder, as assessed by the Mini PAS-ADD (M.i.n.i International Neuropsychiatric interview-Psychiatric Assessment Schedules for Adults with Developmental Disabilities (Prosser, Moss, Costello, Simpson, & Patel, 1997), in Dutch translation (Moss & Van Gennep, 2008), and a current PTSD as assessed by the by the Anxiety Disorder Interview Schedule-Children section PTSD which has been adapted for Adults with mild ID and borderline IF (ADIS-C-PTSD-LVB-Adult version) (Mevissen, Barnhoorn, Didden, & De Jongh, 2014).
Exclusion criteria
Exclusion
-poor language skills (dutch)
-IQ <60
-no full mental competence
-high suicide risk
-severe substance abuse
-change in medication <2months
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 | NL63533.091.17 |