The primary objective is to test whether the augmentation of imagery processing, using EMDR, to CBT, results in greater reductions of clinician rated depression symptoms in participants with a depressive disorder with intrusive imagery associated…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is depression severity measured with the Hamilton
Depression Rating Scale (HDRS; Hamilton, 1960)
The 17-item HDRS is a clinician rating that consists of depressive symptoms
that are recorded using 5- or 3-point scales reflecting presence and severity
over the past week.
To enhance the interrater reliability the HDRS will be queried with the
structured interview guide for the HDRS (SIGH-D; Williams, 1988). This
structured interview has proven to produce uniformly higher item- and
summary-scale reliabilities than the unstructured HDRS (Moberg et al., 2002;
Allen et al., 2010).
Secondary outcome
Remission from depression, which will be defined as a score of * 6 as
administered with the Hamilton Depression Rating Scale (HDRS; Riedel et al.,
2010).
To test self-reported depression severity the Inventory of Depressive
Symptomatology-Self Report (IDS-SR) will be used. The IDS-SR is a self-report
questionnaire (Rush, Gullion, Basco, Jarrett, & Trivedi, 1996) and consists of
30 items (rated zero to three), each describing a depressive symptom in four
levels of severity. The IDS-SR asks for all DSM cores symptom domains including
mood, cognitive and psychomotor symptoms, but also covers commonly associated
symptoms including anxiety. The IDS-SR has high internal consistency (*=0.92,
Rush et al., 2003). Remission is defined as an IDS-SR-30 score of 14 or less.
The Depressive Symptomatology-Self Report (IDS-SR) will also be used as
a weekly before sessions measurement of self-reported depressive symptoms to
assess speed of recovery. Two visual analogue scales will be used to measure
decrease of emotionality and vividness of the most distressing (memory) image
(Leer, Engelhard, & Van Den Hout, 2014).
Background summary
Depression is a common mental disorder. Globally, an estimated 350 million
people of all ages suffer from depression. Depression is the leading cause of
disability worldwide, and is a major contributor to the overall global burden
of disease (World Health Organization [WHO], 2016). Over the past three
decades, numerous studies have demonstrated that cognitive behavior therapy
(CBT), interpersonal psychotherapy (IPT), and antidepressant medication (ADM)
are equally efficacious in the treatment of major depressive disorder (De Maat,
Dekker, Schoevers & De Jonghe, 2006; Cuijpers, Andersson, Donker, & van
Straten, 2011). However, a substantial proportion of depressed patients fail to
receive any benefit from therapy. Psychological treatments were found to be
equally effective with a mean effect size of 0.67, which was reduced after
adjustment for publication bias to 0.42 (Cuijpers, van Straten, Bohlmeijer,
Hollon, & Andersson, 2010). Thus, there remains room for improvement of the
existing psychotherapies. Most existing treatments are generic, in that they
are applied without regard to the specific pattern of depressive symptoms
reported by individual patients. Major depressive disorder (MDD) is a clinical
syndrome notable for heterogeneity of its clinical presentation, genetics,
neurobiology, clinical course, and treatment responsiveness (Rush, 2006). A
possible approach to enhance treatment efficacy, is to target specific symptoms
with focused, theoretically-driven interventions, with the aim of achieving
more rapid change in defined subgroups of depressed patients (Brewin et al.,
2009). This protocol describes a Randomized Controlled Trial (RCT) of cognitive
behavior therapy augmented with imagery reprocessing using eye movement
desensitization and reprocessing (EMDR) for a subset of depressed patients with
intrusive memories.
Imagery plays a role across a wide range of mental disorders (Pearson,
Deeprose, Wallace-Hadrill, Heyes, & Holmes, 2013). We use the term imagery to
refer to mental images and the accompanying experience of sensory information
without a direct external stimulus. Traditionally, depression has been
associated with verbal, rather than imagery based processes, such as negative
rumination (Fresco, Frankel, Mennin, Turk, & Heimberg, 2002). However, a role
for imagery has more recently become of concern, with up to 90% of depressed
patients reporting distressing intrusive memories of past experiences (Birrer,
Michael, & Munsch, 2007). Several studies have shown that patients with
depression frequently experience high levels of intrusive visual memories
(Birrer et al., 2007; Brewin, Hunter, Carroll, & Tata, 1996; Patel et al.,
2007; Reynolds, & Brewin, 1999). Patients with depression, like patients with
posttraumatic stress disorder, typically have memories of specific
autobiographical events that intrude into consciousness at high frequency.
Brewin, Reynolds, & Tata (1999) found that the presence of intrusions in
clinically depressed patients negatively influences the course of the disorder
even when initial symptoms are controlled for, suggesting that they are an
important maintaining factor. Experimental research indicates that imagery may
elicit stronger emotional responses than corresponding verbal cognitions
(Holmes, & Mathews, 2010).
Whereas memories of personal illness, injury, or assault are more
common in PTSD, the content of intrusive memories in depression consists mainly
of memories of death, illness, injury to family members, and interpersonal
problems (Brewin et al., 1996). These memories can be vivid, full of sensory
details, distressing, absorbing, and associated with intense negative emotions.
The intrusive imagery can also be accompanied by a re-experiencing of emotions
and physical sensations associated with the original event, but to a lesser
extent by a sense of *nowness* as seen in PTSD. Also, the intrusive imagery was
found to be experienced as highly uncontrollable and interfering significantly
with patients* everyday lives (Patel et al., 2007). Furthermore, negative,
maladaptive appraisals of intrusive memories, (e.g., *having this memory means
that I am weak*) have been proposed to maintain the occurrence of intrusive
memories, and in turn, depressive symptoms (Starr, & Moulds, 2006;Williams, &
Moulds, 2008). As a result, interventions targeting these intrusions in this
subgroup of depressed patients could potentially improve treatment outcomes.
The primary aim is to study the effect of augmenting CBT with
reprocessing intrusive imagery, by using EMDR. EMDR is a guideline
evidence-based treatment for PTSD (Bisson, & Andrew, 2007), but there*s limited
evidence for it*s efficacy in other mental health problems such as depression.
EMDR is a therapeutic approach oriented to reprocess dysfunctionally stored
traumatic memories by reducing the vividness and emotional intensity of mental
images (Hornsveld et al., 2010; Leer, Engelhard, & Van Den Hout, 2014; Van den
Hout, 2001; Van den Hout, & Engelhard, 2012; Van den Hout, Bartelski, &
Engelhard, 2013). The goal of EMDR is to address past, present and future
issues related to traumatic events and reprocess them. We hypothesize that by
reprocessing imagery, in a way of reducing the vividness and emotional
intensity of the intrusive imagery with EMDR, patients will become more
susceptible to CBT.
Although the activation and confrontation of these intrusive imagery
may be intense and temporarily distressing, the effect of the reprocessing can
be extremely positive and lead to significant cognitive shifts that promotes
openness to CBT. Indeed EMDR was found to enhance effects of CBT in a
case-control study in which EMDR therapy was added to CBT compared to CBT. The
addition of a mean of 7 sessions of EMDR therapy to a mean of 45 sessions of
CBT resulted in a significant difference in symptom decline compared to 47
sessions of CBT alone (Hofmann et al., 2014).
This study aims to target a specific group of patients with intrusive imagery
associated with negative (traumatic) life event in the onset and/or course of
the depressive disorder. To our knowledge, no (pilot) RCT has been published
that tested the effects of augmentation of CBT with EMDR in a specific subgroup
of patients with intrusive imagery associated with negative (traumatic) life
event in the onset and/or course of the depressive disorder.
Study objective
The primary objective is to test whether the augmentation of imagery
processing, using EMDR, to CBT, results in greater reductions of clinician
rated depression symptoms in participants with a depressive disorder with
intrusive imagery associated with negative (traumatic) life event in the onset
and/or course of the depressive disorder.
Study design
A single-blind single-centre pilot randomized controlled trial with two arms
CBT: EMDR/CBT (ImaginD protocol) versus CBT. The two groups will be compared at
baseline (T0), midtreatment (T1), posttreatment (T2) and at 3-month follow-up
(T3). Assessment will contain a baseline imagery interview, structured
interview of depressive symptoms, a self-report depressive symptom
questionnaire, and two visual analogue scales concerning emotionality and
vividness of the most distressing image. Similarly, before every treatment
session depression symptoms will be assessed via self-report to track course of
self-reported depression symptoms during treatment.
Intervention
The patients in the intervention group receive a treatment of 16 sessions EMDR
& CBT (maximum of 6 sessions EMDR followed by CBT). Patients in the control
group will follow 16 sessions CBT. Randomization will be performed by an
external researcher using a computerized random number generator.
Study burden and risks
There are no potential risks for the participants when participating in the
study. EMDR is a safe procedure, evidence-based in PTSS. Both treatment options
will be offered by skilled and experienced therapists. The measurements take a
total of 3 hours and 45 minutes.
The subjects may benefit from the intervention (therapeutic effect). They get a
supplement to their evidence-based treatment.
Lijnbaan 4
Den Haag 2512VA
NL
Lijnbaan 4
Den Haag 2512VA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* a primary diagnosis of major depressive disorder (MINI)
* presence of disturbing intrusive imagery associated with negative (traumatic) life event in the onset and/or course of the depressive disorder
* able to undergo psychotherapy
* willingness to receive EMDR on stressful memories
* the patient is currently not using antidepressants or the use of antidepressants has been unchanged for at least six weeks and no change in the use of antidepressants is planned
Exclusion criteria
* a primary diagnosis other than major depressive disorder
* estimated IQ below 70
* substance dependence
Design
Recruitment
metc-ldd@lumc.nl
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 | NL61354.058.17 |