The purpose of this study is to expand the so far limited research on the effectiveness of ImRs in the treatment of OCS. The primary objective is to investigate whether the application of ImRs, after previous outpatient ERP treatment, leads to…
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Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to investigate whether ImRs lead to symptom reduction
in patients with OCS who have not sufficiently benefited from previous
outpatient ERP treatment.
Secondary outcome
Secondary Objectives:
To investigate whether Mastery and believability of core cognitions (related to
the memories processed in ImRs) change in a positive way to indicate the
possible mechanism of action of ImRs in OCD. In addition, to investigate
whether using ImRs leads to change in the areas of dysfunctional schemas,
depressive symptoms, quality of life and the emotions guilt, shame, anger,
sadness, fear and disgust.
It is hypothesized that an increase in Mastery leads to a decrease in OCS
symptoms.
It is hypothesized that a decrease in the believability of the Core Cognitions
leads to a decrease in OCS symptoms.
The hypothesis is that the practice of ImRs will lead to a decrease in
dysfunctional schemas.
The hypothesis is that practicing ImRs will lead to a decrease in depressive
symptoms.
The hypothesis is that practicing ImRs will lead to an increase in quality of
life.
It is hypothesized that the practice of ImRs will lead to a decrease in the
emotions guilt, shame, anger, sadness, fear, and disgust.
Background summary
Obsessive-compulsive disorder (OCD) is a severe disorder that causes
limitations for patients in multiple areas of life. When not treated, this
disorder takes on a chronic nature. Effective forms of treatment for OCS
include Exposure and Response Prevention (ERP) and Cognitive Therapy (CT).
However, research shows that 40% of patients do not benefit sufficiently from
these first choice treatments. Scaling up therapy to clinical treatment is
drastic for the patient and his/her environment and is socially costly. There
is a need to explore alternative forms of treatment for OCS that act on other
working mechanisms than exposure in vivo (which includes ERP) to increase the
response to psychological treatments. One of these alternative treatments is
Imaginary Rescripting (ImRs). ImRs is a technique by which past memories are
edited through mental imagination, creating different meaning. Research shows
that past events may be related to the onset and severity of OCS symptoms. It
also appears that 80% of patients with OCS have mental images of a direct or
associated memory of aversive past events. When these negative events are
worked on, a decrease in compulsive symptoms may be possible. Meanwhile, some
small studies have been done in patients with OCS and a (partial) treatment
with ImRs and the results are encouraging.
Study objective
The purpose of this study is to expand the so far limited research on the
effectiveness of ImRs in the treatment of OCS. The primary objective is to
investigate whether the application of ImRs, after previous outpatient ERP
treatment, leads to symptom reduction in patients who have not benefited, or
have benefited too little, from ERP treatment (Y-bocs score of 16 or higher).
If positive results are obtained, another study may be conducted in the form of
an RCT, which will provide more insight into the effectiveness of this
treatment intervention in OCS. Also, two process measures will be included in
the study (Mastery and Core Cognitions) to gain more insight into the working
mechanisms of ImRs in OCD.
Study design
This is an efficacy study in the form of a randomized single case design with
repeated measurements (within-subject time-series design). This study is an
experimental study that is suitable for research into the effects of treatment
in which the chance of spontaneous recovery is small. This is the case with
non-responders to previous outpatient CBT for OCS.
Patients all receive the same intervention, but are randomly assigned to
different time periods before and after treatment, during which symptoms are
monitored 2-weekly. By measuring the change in symptoms over time weekly, the
causal relationship between intervention and treatment outcome can be
established. The 11-week study period will be divided into four phases:
T0: Screening
T1: Baseline 2.5-5.5 weeks
T2: Active intervention (3 weeks, pretreatment session + 2x ImRs per week)
T3: Post-treatment phase 2.5-5.5
T4: Follow-up (after 3 months)
Intervention
The intervention used is ImRs. ImRs is a technique from schema therapy that
rewrites images and changes events in a more desirable direction. The aversive
memories from childhood are rewritten, therefore changing the meaning of the
original memory or forming an alternative, more competitive memory. ImRs is an
effective therapeutic technique that is becoming more widely used and
increasingly researched. A recent meta-analysis shows that ImRs is effective
for treating negative memories in various mental disorders such as depressive
disorder, post-traumatic stress disorder, social phobia and also OCS.
Patients in this study will receive a preteratment session and six sessions of
ImRs (two sessions per week). The affect bridge will be used to select the
memory that will be worked on with ImRs. A recent situation related to the
obsessive-compulsive disorder will serve as a gateway to original meaningful
experiences.
In the first two ImRs sessions, the therapist will rescript the situation. In
the following sessions, the patient will step into the picture as an adult and
rescript the situation. If necessary, the therapist can assist or possibly
rescript himself again (if the patient's capabilities do not allow it).
In this study, the ImRs is described as a stand-alone intervention, without the
addition of other treatment methods such as cognitive restructuring.
The therapists conducting the ImRs sessions have already been trained in the
application of ImRs and will also receive supervision. Also, the ImRs sessions
will be recorded (audio) and scored using a compliance checklist.
Study burden and risks
The burden will consist of the completion of questionnaires and the
administration of interviews. Interviews will be conducted twice a week with an
average duration of 15-30 minutes. Also, four measurement moments will take
place throughout the study and a measurement will last approximately 60-90
minutes.
Nijmeegsebaan 61
Nijmegen 6525DX
NL
Nijmeegsebaan 61
Nijmegen 6525DX
NL
Listed location countries
Age
Inclusion criteria
- Patients have a current DSM-5 diagnosis of obsessive-compulsive disorder as
classified with the MINI--S.
- The main compulsive symptoms come from the domains of "worry about/anxiety
about bacteria and contamination" and "fear of being responsible for
calamity/misfortune, injury or misfortune" as measured with the DOCS.
- Patients possess imaginary ability.
- Patients have a Y-BOCS score of 16 or higher.
- Patients have an age between 18 and 64 years.
- Patients had previously an adequate CBT for the OCD with insufficiently
treatment effect (Y-BOCS 16 or higher).
Exclusion criteria
-Patients are diagnosed with a severe depressive disorder for which they need
immediate treatment.
-Acute suicidality or high risk of suicide
-Patients are diagnosed with a psychosis for which they need immediate
treatment.
-Intellectual disability (IQ below 70) or severe cognitive function disorders.
-Substance abuse or dependance or alcohol abuse or dependence which requires
treatment.
-Psychofarmacology is changed in the last 8 weeks
-Having an additional treatment for the OCD
-Inability to fill in questionary due to lack of the Dutch language
-Other comorbid psychiatric disorders are not an exclusion criteria
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 | NL78486.091.22 |