(1) The study aims to investigate whether the effects of stabilization + TF-CBT on PTSD symptoms in survivors of early-onset chronic interpersonal trauma can be replicated in a routine clinical setting. (2) The study secondly aims to investigate…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main dependent variables are
(1) the percentage of participants meeting DSM-IV criteria for PTSD according
to the Structured Clinical Interview for the DSM-IV (SCID; First, Spitzer,
Gibbon, & Williams, 1996)
(2) the PTSD symptom severity, assessed with the Clinian-administered PTSD
Scale (CAPS; Blake et al., 1995) and the Posttraumatic Diagnostic Scale (PDS;
Foa, Cashman, Jaycox, & Perry, 1997).
Secondary outcome
Secondary study parameters are:
(1) Symptom levels/clinical problems typically associated with PTSD following
early-onset chronic interpersonal trauma, namely
(a) Symptom levels of depression assessed with the Beck Depression Inventory
(BDI; Beck, Rush, Shaw, & Emery, 1979)
(b) Levels of anger, assessed with the State Trait Anger Inventory (STAXI;
Spielberger, 1991)
(c) Emotion regulation difficulties, assessed with the Difficulties in Emotion
Regulation Scale (DERS; Gratz & Roemer, 2004)
(d) Interpersonal problems, assessed with the Inventory of Interpersonal
Problems (IIP; Horowitz, Rosenberg, Baer, Ureno, & Villasenor, 1988)
(e) Dissociation, assessed with the Dissociative Experiences Scale (DES;
Bernstein & Putnam, 1986)
(f) Quality of Life, assessed with the WHO Quality of Life Questionnaire
(WHO-QoL; Trompenaars, Masthoff, Van Heck, Hodiamont, & De Vries, 2005)
(2) Variables shown to be involved in the maintenance of PTSD that can be
expected to be reduced as a consequence of successful treatment, namely
(a) negative trauma-related appraisals, assessed with the Posttraumatic
Cognitions Inventory (PTCI; van Emmerik, Schoorl, Emmelkamp, & Kamphuis, 2006)
(b) dysfunctional coping strategies (e.g., avoidance, safety behaviours,
rumination, thought suppression) assess with the Responses to Intrusions
Questionnaire (RIQ; Ehring, Ehlers, & Glucksman, 2006) and the Avoidance and
Safety Behaviours Questionnaire (ASBQ; Ehring et al., 2006)
(c) characteristics of the trauma memory, assessed with the Trauma Memory
Questionnaire (TMQ; Halligan, Michael, Clark, & Ehlers, 2003) and a narrative
task
(d) social support, assessed with the Crisis Support Scale (CSS; Joseph, 1999)
Background summary
Eye movement desensitization and reprocessing (EMDR) and trauma-focused
cognitive-behavioural therapy (TF-CBT) have both been found to be effective in
treating post-traumatic stress disorder (PTSD) following single-event traumas
and to be more effective than pure anxiety management or stabilization
treatments. However, much less is known about the efficacy of the different
treatment approaches in survivors of early-onset repeated or chronic
interpersonal trauma. Recent evidence suggests that a combination of
stabilization + TF-CBT is efficacious in this population. Although EMDR is also
often used in survivors of chronic interpersonal trauma, evidence on its
efficacy are still poor. The aim of the current study is to compare the
efficacy of (1) stabilization + TF-CBT and (2) stabilization + EMDR using a
randomized controlled trial in a routine clinical setting.
Study objective
(1) The study aims to investigate whether the effects of stabilization + TF-CBT
on PTSD symptoms in survivors of early-onset chronic interpersonal trauma can
be replicated in a routine clinical setting. (2) The study secondly aims to
investigate whether the effects of stabilization + EMDR differ from those of
stabilization + TF-CBT.
Study design
The study design is a randomized clinical trial, in which patients are randomly
assigned to two treatments: (1) stabilization + TF-CBT and (2) stabilization +
EMDR. Dependent variables will be assessed at pre-treatment, mid-treatment
(following stabilization), post-treatment, 3 months post-treatment and 12
months post-treatment.
Intervention
In both conditions, participants will first receive 8 sessions of stabilization
treatment according to the STAIR protocol (Cloitre, Cohen, & Koenen, 2006). In
the second phase, participants will either receive 16 sessions of TF-CBT
consisting of imaginal exposure to their traumatic event (modified prolonged
exposure; see Cloitre et al., 2006) or 16 sessions of EMDR (Shapiro, 1995).
Study burden and risks
In both conditions, participants will receive bona fide treatments for PTSD.
Content, intensity and duration of the treatment are comparable to usual
clinical care for this group within PsyQ Zaandam. In order to study the effects
of the treatment participants will be asked to fill in a number of
questionnaires and complete interview before treatment, at mid-treatment, at
post-treatment and at 3- and 12-months follow-up. The benefit for individual
participants concerns the fact that they receive a bona fide treatment for
their condition and that this treatment will be provided by experienced
therapists who will receive additional supervision for the cases treated within
the project. On a more general level, the study addresses a highly relevant
topic, which has to date been under-researched. The study has the potential to
greatly improve knowledge about the efficacy of treatments for PTSD following
type-II trauma.
Roetersstraat 15
1094 JP
NL
Roetersstraat 15
1094 JP
NL
Listed location countries
Age
Inclusion criteria
1) Meeting DSM-IV criteria for PTSD
2) having experienced repeated or chronic interpersonal trauma before the age of 14 (e.g., sexual or physical abuse)
3) at least 18 years of age
4) having sufficient fluency in Dutch to complete treatment and research protocol
5) Participants using prescribed anti-depressant medication are required to be on a stable dose for at least 2 weeks before the beginning of treatment and remain on this dose throughout the treatment.
Exclusion criteria
1) Psychiatric problems that may interfere with the study participation or that require more intensive care than can be offered in the present study, including dementia, psychotic symptoms, depression with suicidal ideation, full-blown borderline personality disorder, substance dependence
2) current use of tranquilizers
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 | NL31098.018.10 |