The primary objectives of the current study is to investigate if the three treatments, EMDR, EMDR 2.0 or the Flash technique, are effective in decreasing PTSD symptoms and which treatment is most effective in decreasing PTSD symptoms. Another…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
Traumagerelateerde stoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary dependent variables for measuring the effectiveness of the
treatment are the presence of the diagnosis PTSD (CAPS-5) and complex PTSD
(ITQ) and the severity of PTSD symptoms (PCL-5, CAPS-5, ITQ). The CAPS-5 and
ITQ are administered before treatment and four and twelve weeks after
termination of treatment.
Secondary outcome
De secondary dependent variables for measuring the effectiveness of treatment
are depressive, dissociative and general psychiatric symptoms (BDI, DES and BSI
respectively) and experiential avoidance (AAQ-II). The dependent variables for
measuring treatment efficiency are amount of treated targets per session and
duration of each session. The dependent variables for measuring treatment
acceptability are four open questions about treatment acceptability with answer
options rated on a 7-point scale. Safety of the intervention will be measured
with the amount of serious aversive events (SAEs). The PCL-5, BDI, BSI and
AAQ-II will be adminstered weekly during the treatment period and biweekly
until 12 weeks after termination of treatment. The treatment acceptability
questionnaire will be adminstered after the first and final treatment session.
Background summary
Eye Movement Desensitization and Reprocessing (EMDR) therapy is an evidence
based treatment for patients suffering from a post-traumatic stress disorder
(PTSD). To investigate if EMDR therapy can be applied more effective and
efficient, an adapted version of EMDR therapy has been developed, which will be
referred to as EMDR 2.0. A recent experimental study with healthy participants
suggests that EMDR 2.0 is not more effective than EMDR in decreasing the
emotionality and vividness of aversive memories. EMDR 2.0 however seems to be
more efficient than EMDR with respect to amount of sets of working memory
taxation per session. Another type of treatment that can be applied to prepare
for EMDR treatment or as a stand alone PTSD treatment is the Flash technique. A
recent experimental study with healthy participants shows that a digital
version of Flash is as effective as EMDR in decreasing the emotional load and
vividness of aversive memories. Although EMDR 2.0 and the Flash technique show
positive results in healthy participants, both treatment have not yet been
investigated in a clinical population diagnosed with PTSD. In the current study
it will therefore be investigated which of these treatments, EMDR, EMDR 2.0 or
the Flash technique, is most effective and efficient in decreasing PTSD
symptoms in patients diagnosed with PTSD.
Study objective
The primary objectives of the current study is to investigate if the three
treatments, EMDR, EMDR 2.0 or the Flash technique, are effective in decreasing
PTSD symptoms and which treatment is most effective in decreasing PTSD
symptoms. Another primary objective is to investigate which treatment is most
efficient. A secondary objective is to investigate which treatment is most
effective in decreasing comorbid depressive, dissociative and general
psychiatric symptoms and experiential avoidance. A third objective is to
investigate how EMDR, EMDR 2.0 and the Flash technique are experienced in terms
of acceptability. A fourth objective is to investigate what moderators of
treatment are.
Study design
The design of the current study is an Open Randomized Controlled Trial (RCT)
with one between-subjects factor (treatment condition: EMDR vs EMDR 2.0 vs de
Flash technique) and one within subjects factor (time).
Intervention
There are three treatment conditions: EMDR, EMDR 2.0 and the Flash technique.
Patients are divided at random to one of the three treatment conditions. The
treatments consist of six weekly sessions of 60 minutes. After the treatment
follows a period of 12 weeks in which self-report questionnaires (PCL-5, BDI,
BSI and AAQ-II) will be administered biweekly. After 4 (FU1) and 12 (FU2) weeks
the CAPS-5, ITQ and DES will be administered. After the first and the last
treatment session, a treatment acceptability questionnaire will be
administered.
Study burden and risks
It is possible that a patient finds the recall of a traumatic memory difficult,
or overwhelming, because this refers to the traumatic events. This is something
that could happen in any treatment for PTSD. The therapists that participate in
the current study are used to these kinds of situations. One should realize
that PTSD patients are used to the fact that the emotionally loaded memories
can be activated in daily life due to triggers of any kind. PTSD patients tend
to recover quickly. There are little contraindications known for traumafocused
treatment such as EMDR, EMDR 2.0 or the Flash technique. The additional burden
that is caused by participation in the study consists of completing additional
measurements. These measurements take about 30 minutes, for 18 weeks, what
comes down to around 360 minutes or 6 hours. Therefore, we find the burden of
patients justified. Patients participating in the current study receive
treatment several months sooner than patients that are applied for regular
treatment. Moreover, patients in all conditions receive traumafocused treatment
after the study if they still experience symptoms.
Heidelberglaan 1
Utrecht 3584CS
NL
Heidelberglaan 1
Utrecht 3584CS
NL
Listed location countries
Age
Inclusion criteria
Estimated IQ > 80
PTSD diagnosis according to the DSM-5
18 years or older
Sufficient understanding of the Dutch language
Exclusion criteria
Acute suicidality
PTSD diagnosis not the primary diagnosis
Changes in medication during, or 6 weeks prior to participation in the research
Use of strongly sedating medication
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 | NL79163.041.22 |