Determine if VSDT is effective in reducing PTSD symptoms, both directly and at 1- and 3-month follow-up. This will be investigated in a Randomized Controlled Trial (RCT).
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The dependent variables are the presence of PTSD and the severity of the PTSD
symptoms, respectively measured with the CAPS-5 and the PCL-5. Secondary
outcome measures are depressive symptoms and general psychiatric symptoms,
measured with the Beck Depression Inventory (BDI-II) and the Brief Symptom
Inventory (BSI) respectively. The CAPS-5 will be conducted at the screening and
at follow-up after one and three months. The PCL-5, BDI-II and the BSI will be
measured weekly throughout the study.
Secondary outcome
Secondary outcome measures are depressive symptoms and general psychiatric
symptoms, measured with the Beck Depression Inventory (BDI-II) and the Brief
Symptom Inventory (BSI) respectively. These will be weekly conducted throughout
the study.
Background summary
Eye Movement Desensitization and Reprocessing (EMDR) is an evidence based
therapy often indicated for patients suffering from post traumatic stress
disorder (PTSD). A new therapy that shows resemblence with EMDR therapy is
Visual Schema Displacement Therapy. Results from two recent studies among
healthy participants comparing the two treatments showed that VSDT was more
effective in reducing the emotional intensity of emotional memories. The
question remains if and to what extent VSDT is effective in reducing PTSD
symptoms in patients who are diagnosed with PTSD.
Study objective
Determine if VSDT is effective in reducing PTSD symptoms, both directly and at
1- and 3-month follow-up. This will be investigated in a Randomized Controlled
Trial (RCT).
Study design
The study employs a mixed design with both within and between subjects factors.
57 PTSD patients will be randomly assigned to one of three conditions (EMDR,
VSDT, waiting list). Both the VSDT and the EMDR condition include 6 sessions of
90 minutes each. PTSD symptoms will be monitored weekly using the Psychotrauma
Checklist for DSM-5 (PCL-5), during and following the intervention until the
last follow-up measurement after 3 months. A clinical interview for PTSD
(Clinician-administered PTSD Scale for DSM-5; CAPS-5) will be conducted upon
inclusion, after one month, and after three months after the treatment
sessions.
Intervention
The study has three conditions: EMDR, VSDT and a Waitlist control condition
(WL). All patients will be randomly assigned to one of the three conditions.
Both active interventions conist of six weekly sessions of 90 minutes. The
waiting list conditions consists of 6 weeks of no intervention. All conditions
are followed by a 12-week period, during which self-report measures are
conducted. Follow-up measurements using the CAPS-5 will be conducted four and
twelve weeks after the treament period.
Study burden and risks
Patiens might find it difficult to recollect an emotionally loaded memory of a
traumatic event, or might be overwhelmed by it; the memory refers to the
traumatic event. This might happen in every form of trauma treatment. The
participating therapists are used to deal with these situations. It should be
realised that patients suffering from PTSD are used to the activation of the
emotional memory by all kinds of triggers in daily life. Usually, PTSD patients
recover quickly. There are few contro-indications known for traumafocused
treatment with EMDR therapy. On grounds of niether theoretical considerations
and practical experience should it be expected to be different for VSDT. That
is why we deem the burden and risks placed upon participants justified.
Nevertheless, we will first complete Study I with the aim of testing the safety
of the therapy and its effect on PTSD symptoms, before we start Study II.
Because of this study, patients will receive treatment a few months earlier
than patients who are on the regular waiting list. Moreover, patients in the
study are offered traumafocused therapy upon completion of the study when they
still experience residual complaints.
Heidelberglaan 1
Utrecht 3584 CS
NL
Heidelberglaan 1
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
- IQ > 80 (estimation)
- PTSD diagnosis according tot he DSM-5 with one or more traumatic events.
- Age: from 18 years
- Sufficient command of the Dutch language
Exclusion criteria
- Acutely suicidal patients
- PTSD diagnosis not the primary diagnosis
- Changes in medication prescription during, or 3 months 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
In other registers
Register | ID |
---|---|
CCMO | NL68921.041.19 |
OMON | NL-OMON25957 |