The research aims to review and compare imaginairy exposure to new forms of treatment for patients with comorbid PTSD due to multiple and repeated abuse in childhood within the primary support group. It is expected that these new forms of treatment…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
PTSS
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Self report questionnaires:
The non-fear emotions guilt, shame, anger and sorrow will be constructed to 4
composite measures that will serve as the primary outcome measures.
* Anger Expression Scale (AEQ)
* Self-expression and control questionnaire (ZECV)
* State-Trait Anger Inventory (ZAV)
* Guilt scale Kubany (translated version see annex)
* Shame scale Smucker (translated version see annex)
* Grief (Poms, Lobbestael)
Secondary outcome
Secondary outcomes
* PDS: Severity and frequency of PTSD is measured with the Dutch version of the
PSS-SR (Foa, Riggs, Dancu, & Rothbaum, 1993; Arntz, 1993). This contains 17
items that correspond to the DSM IV PTSD symptoms, each rated on a 0-3 point
scale.
* Dutch translation of the Clinician-Administered PTSD Scale (CAPS-DX)
* PTCI: Dysfunctional trauma-related cognitions measured by the Posttraumatic
Cognitions Inventory (Foa, Ehlers, Clark, Tolin & Orsillo, 1999, Van Emmerik,
Schoorl, Kamphuis & Emmelkamp, 2006)
* Symptom BSI (The Fair)
* Difficulties in Emotion Regulation Scale (MANAGERS) translated version (Gratz
and Roemer, 2004).
* SMI mode List (web version)
* Self-image (Self-Ideal Discrepancy) (MSGO-revised, W. Van Beek, 2009)
Assessment of emotion activation, dissociation and habituation per session:
* SUD scores: are determined every 10 minutes during the session
* Dissociation rating scale at the beginning and end of the session
* PDS
* Emotion Scale: per emotion a 10 point scale
*
Predictors:
* Dissociation trait (DIS-Q): Vanderlinden, van Dyck, Vandereycken, Vertommen
* Tonic immobility scale: Original version of Forsyth, Marx, Fuse, Heidt &
Gallup, 2000, Dutch translation, Van Minnen & Hagenaars, 2009. 12 items on a 6
point scale with possible responses during an experience in which patients were
persuaded or forced into unwanted sexual activity without consent.
* HVR (heart rate variability)
* Personality disorders SCID-2
* Questionnaire for the therapeutic relationship: Working Alliance Inventory,
patient version (WAI-P), therapists version (WAI-T)
Background summary
Meta-analyses show that Trauma Focused Cognitive behavioral therapy, imaginal
exposure and eye movement desensitization-reprocessing are the most effective
psychological treatments for posttraumatic stress disorder (PTSD) (Bisson et
al, 2007, Bradley, Greene, Russ, Dutra & West, 2005; Cloitre, 2009, Seidler &
Wagner, 2006). 40-70% of patients show that relatively short treatments (9-12
sessions of 90 minutes) lead to significant reductions in PTSD symptoms. There
is as yet little research on the use of these protocols in PTSD cases as a
result of prolonged interpersonal abuse in childhood within the primary support
group. The question arises whether new forms of treatment, with a more active
intervention in key processes that play a role in the development of PTSD *
like dysfunctional basic schemas and tonic immobility (TI), are more effective
than a proven effective form of treatment like Imaginal Exposure (IE).
Study objective
The research aims to review and compare imaginairy exposure to new forms of
treatment for patients with comorbid PTSD due to multiple and repeated abuse in
childhood within the primary support group. It is expected that these new forms
of treatment will lead to a better end-state functioning, less dropout and a
greater appreciation for practicality of therapists.
Study design
This study is a multicenter randomized 3-group trial.
3 conditions: IE, ImRes, DramaRes. The normal waiting list is the control
group, randomization will be applied at clinics where there is no waiting list.
Two sessions of 90 minutes per week for 6 weeks, last 4 weeks once a week.
Total 16 sessions plus daily homework.
Duration of treatment 10 weeks.
Homework:
* IE: listen to recording of the session 2 times a week
* ImRes: listen to recording of the session 2 times a week.
* DramaRes: Exercise at home and recording 2 times.i
Exposure in vivo falls outside the trial in all conditions.
55 patients in each condition.
Measurement 6 after 2 weeks measurement 3 after 10 weeks (therapy end) and
follow-up after 3 months (measurement 4), 12 months (measurement 5). Preferably
the waiting list condition no treatment to offer, if not possible, a supportive
contact. After the 3d measurement (after 10 weeks) this condition will be
offered one of the three treatments. After the trial the remaining conditions
will be assessed to see if the treatment can be paused or if it should be
continued as TAU.
Per session, several measurements (see outcomes).
Measurement 1 IE Measurement 2 follow up IE
Measurement 3, 4, 5
Measurement 1 ImRes Measurement 2 follow up ImRes
Measurement 3, 4, 5
Measurement 1 DramaRes Measurement 2 follow up DramaRes Measurement 3, 4,
5
Intervention
Regular interventions from protocol operations that are in use in Mental Health
Care institutions but have as yet not been researched in RCT.
Study burden and risks
Not applicable
Sarphatistraat 27 A
1018EV Amsterdam
Nederland
Sarphatistraat 27 A
1018EV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1. Principal Diagnosis PTSD according to DSM-IV criteria.
2. Comorbid disorder on axis I and axis II
3. Interpersonal abuse (sexual, physical or mental abuse) within the primary support group in childhood before age 16. Age difference with the perpetrator is at least 5 years.
Exclusion criteria
1. Psychosis, severe depression with suicidal behavior, dissociative identity disorder, mental retardation.
2. On axis IV: no fixed residence, major financial problems, no aid figure, problems with police and law, current abuse, continuous abuse.
3. Medication (SSRIs) should be set before joining the trial. Preferably no use of benzodiazepines. No interim medication change.
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 | NL33167.097.10 |