The purpose of the present study is to determine superiority in efficacy of a phase-based treatment (i.e., EMDR therapy preceded by Skills Training in Affective and Interpersonal Regulation, STAIR) versus trauma-focused treatment alone (i.e., EMDR…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters include the presence of a PTSD diagnosis, the
severity of (Complex) PTSD symptoms, before and after completion of treatment,
and at follow-up after 3 and 6 months.
Secondary outcome
Secondary parameters include severity of comorbid symptoms (i.e., anxiety,
depression, general psychopathology), dissociation, health-related quality of
life and drop out during treatment in both conditions.
Background summary
Complex Post Traumatic Stress Disorder (Complex PTSD) is a term used to denote
a severe form of PTSD following repeated interpersonal traumatization in
childhood. This construct comprises symptom clusters reflecting difficulties
regulating emotions, disturbances in relational capacities, alterations in
attention and consciousness, adversely affected belief systems and
somatization. According to the guidelines of the International Society of
Traumatic Stress Studies (ISTSS), treatment should be *phase-based*, indicating
that patients with Complex PTSD symptoms will profit more from trauma-focused
treatment if this phase in treatment is preceded by a stabilization phase aimed
at achieving patient safety and improving emotion regulation, clients* positive
self-concept, and interpersonal skills. However, superiority of a phase-based
approach starting with a stabilization phase is yet to be established.
Study objective
The purpose of the present study is to determine superiority in efficacy of a
phase-based treatment (i.e., EMDR therapy preceded by Skills Training in
Affective and Interpersonal Regulation, STAIR) versus trauma-focused treatment
alone (i.e., EMDR therapy) to treat individuals suffering from (Complex) PTSD
due to a history of repeated sexual and/or physical abuse in childhood (by a
caretaker or person in authority, and before the age of 18). Our first aim is
to test the hypothesis that a phase-based treatment (EMDR preceded by STAIR) is
significantly more effective with regard to PTSD (proportion of lost diagnoses
and decrease of PTSD symptoms), would lead to a significantly better outcome in
terms of comorbid symptom decrease, lower drop-out rate, and increased quality
of life, than when the direct trauma-focused treatment (EMDR alone) is applied.
Our second aim is to identify possible predictors of worse outcome and drop-out
(e.g. pre-treatment anxiety, depression, and personality disorders).
Study design
A randomized controlled trial, with two conditions (STAIR-EMDR therapy versus
EMDR therapy alone). Intervention: Patients in one study arm will receive 8
sessions of 90 minutes STAIR (stabilization component), followed by 16 sessions
of 90 minutes EMDR therapy (trauma-focused component). In the second study arm,
patients will receive 16 sessions of 90 minutes of EMDR therapy.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Patients will be subjected to a series of
measures before, during and after treatment and at 3 and 6 months follow-up.
Major adverse effects, different than occurring during treatment as usual, are
not expected, because these have not been documented in previous studies.
Nico Bolkesteinlaan 1
Deventer 7416 SB
NL
Nico Bolkesteinlaan 1
Deventer 7416 SB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a patient must meet all of the following criteria: a) meeting the criteria for PTSD, according to the Clinical-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013), b) having symptoms of Complex PTSD, c) reporting a history of repeated physical and/or sexual abuse by a caretaker or person in authority during childhood (before the age of 18), d) being in the age between 18 and 65 years, e) giving an informed consent for study participation.
Exclusion criteria
A patient who meets any of the following criteria will be excluded from participation in this study: a) insufficient competence in speaking the Dutch language, b) high risk of suicidality assessed by the BDI-II (Beck, Steer, and Brown, 1996), c) currently in treatment for PTSD, d) severe alcohol or drug dependence or abuse, e) IQ under 80, and f) victim of ongoing physical and/or sexual abuse.
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 | NL56641.044.16 |
| OMON | NL-OMON22074 |