Objective: The primary objective is to examine whether EMDR therapy has mood-stabilizing effects in traumatized patients with mild depressive and/or manic symptoms. The secondary objective is to examine the hypothesis that EMDR is an effective and…
ID
Source
Brief title
Condition
- Manic and bipolar mood disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is a significant decrease in affective symptoms
measured by daily mood reports with the National Institute of Mental Health
Life Chart Methodology (NIMH LCM), Altman Selfrating Mania Scale-NL (ASRM-NL)
and/or the Inventory of Depressive Symptoms-Self Report (IDS-SR).
Secondary outcome
The secondary study parameter is a significant reduction of trauma symptoms
measured by the Clinician Administered PTSD Scale (CAPS) and the PTSD Checklist
for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5).
Another study parameter is that EMDR does not lead to mood episodes or an
increase of mood symptoms.
Background summary
Traumatic events are frequently experienced by patients with bipolar disorder
(BD) and can lead to symptoms of post-traumatic stress disorder (PTSD). There
is a high prevalence rate of lifetime PTSD in patients with bipolar disorder,
much higher than lifetime prevalence in the general population. A history of
traumatic events is associated with a poorer outcome of the bipolar disorder,
and this comorbidity may also have a negative impact on response to treatment
for the mood symptoms. Still, psychotherapeutic interventions directed to this
comorbidity are seldom studied so far. Eye Movement Desensitization and
Reprocessing therapy (EMDR) has found to be very effective to treat PTSD, but
bipolar disorder is an exclusion criterion in most PTSD trials. Recently there
are studies that prove EMDR to be a safe and effective intervention to treat
PTSD, also in patients with a severe mental illness, such as psychotic
disorder. There is only one randomized controlled pilot-study that studied the
effect of EMDR in patients with bipolar disorder and mild depressive and/or
manic symptoms (subsyndromal mood symptoms) and a history of traumatic events
which suggests EMDR may be an effective and safe intervention to treat not only
trauma symptoms but also subsyndromal mood symptoms. This research aims to
study the mood-stabilizing effect of augmenting EMDR to treatment as usual in
patients with bipolar disorder and trauma symptoms, by using daily monitoring
of mood symptoms. We hypothesize that the EMDR intervention leads to a decrease
in lability and intensity of (subsyndromal) depressive and/or manic
symptoms.
Study objective
Objective: The primary objective is to examine whether EMDR therapy has
mood-stabilizing effects in traumatized patients with mild depressive and/or
manic symptoms. The secondary objective is to examine the hypothesis that EMDR
is an effective and safe intervention in patients with a bipolar disorder, thus
whether trauma symptoms reduce and EMDR does not lead to an increase of
affective symptoms or full blown episodes.
Study design
A single-centre randomized clinical trial with 2 arms: a treatment as usual
condition (TAU) and a condition in which EMDR is augmented to treatment is
usual. The two groups will be compared at baseline (T0), posttreatment (T1) and
at 8-weeks follow-up (T2).
In addition to this a case series design will be used, involving a baseline, a
treatment and a follow-up phase.
Intervention
Participants are randomized to receive 8 90-minute sessions of EMDR next to
treatment as usual or to receive only treatment as usual. Standard protocols
are used, and treatment is not preceded by stabilizing psychotherapeutic
interventions.
Study burden and risks
All participants that agree to participate in this study are submitted to a
baseline measurement which consists of several selfreport questionnaires and a
clinical interview to assess the frequency and intensity of the clinician*s
rated PTSD symptoms. This is above the standard measurements that patients are
submitted to that are referred for treatment of the bipolar disorder, and takes
time for each participant. In both groups, participants are submitted to extra
questionnaires to assess the level of PTSD and affective symptoms on two
occasions more. They are also asked to register their mood daily but that*s
also standard in treatment as usual for bipolar patients. In the intervention
group participants will have 8 sessions of EMDR. EMDR is found to be a safe
intervention for patients in the treatment of PTSD symptoms, but in the first
three days after an EMDR session patients can experience an increase of images
and feelings associated with the experienced trauma. Patients will be well
informed of this possibility.
We hypothesize that the EMDR intervention leads to a decrease in lability and
intensity of (subsyndromal) depressive and/or manic symptoms.
Nieuwe Houtenseweg 12
Utrecht 3524 SH
NL
Nieuwe Houtenseweg 12
Utrecht 3524 SH
NL
Listed location countries
Age
Inclusion criteria
- * 18 years of age
- A primary diagnosis of DSM-5 bipolar I or II disorder
- A history of (a) traumatic event(s) that is still causing clinically relevant distress
Exclusion criteria
- Organic brain disorder
- Mental retardation
- Dependency of drugs and/or alcohol
- Severe suicidality or psychosis in the last month
- Moderate to severe depressive or hypomanic symptoms at the start of the intervention (CGI-BP mania > 4, CGI-BP depression > 5).
- Patients are currently in some other form of psychological treatment for trauma
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 | NL66729.041.18 |