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Treatment of PTSD due to chronic interpersonal violence in early childhood: which treatment works best?


- candidate number19550
- NTR NumberNTR4817
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-sep-2014
- Secondary IDs 
- Public TitleTreatment of PTSD due to chronic interpersonal violence in early childhood: which treatment works best?
- Scientific TitleTreatment of PTSD due to chronic interpersonal violence in early childhood: Waitinglist versus Imagery Exposure versus Imagery Rescripting
- ACRONYMPTSD in early childhood
- hypothesisThis study focuses on PTSD due to repeated and prolonged interpersonal abuse in childhood (eg sexual and / or physical abuse) within the immediate environment. By using a Randomized controlled design, we examine whether Imaginary Exposure is more effective as compared to a waitinglist with regard to severity of PTSD symptoms, and whether Imaginaire Rescripting is more effective as compared to Imaginary Exposure.

Primary hypotheses:
We expect that in this patient group with repeated and prolonged interpersonal abuse in childhood within the immediate environment, Imaginary Exposure will be more effective as compared to a waiting list condition. Moreover, we expect that Imaginary Rescripting is more effective as compared to Imaginary exposure, based on the hypothesis that Imaginary Rescripting more actively intervenes in key pathological processes in PTSD.

Secondary hypotheses:
- We expect that ImRes is less heavy for patients as compared to IE, thus expecting drop-outs to be lower in the ImRes group as compared to the IE group
- We expect that for those with a higher ‘Tonic Immobility Score’, ImRes is more effective as compared to IE, because ImRes directly focuses on TI.
- We expect that for those with higer dissociation scores, ImRes is more effective.
- We expect that emotion-regulation will improve more in the ImRes group as compared to the IE group, as ImRes not only focuses on fear but also explicitly on other emotions.
- We expect self-image to improve more in the ImRes condition as compared to the IE condition, as this intervention focuses more explicitly on the UCS/UCR representation.
- Healt Condition(s) or Problem(s) studiedPost-Traumatic Stress Disorder (PTSD)
- Inclusion criteria1. Meeting DSM-IV criteria for PTSD
2. Comorbidity with depression, anxiety disorder, ADHD, dissociative disorder, reactive psychotic disorder, alcohol/drugs consumption, borderline personality disorder and cluster C personality disorder are included.
3. Having experienced repeated or chronic interpersonal trauma before age of 16 (e.g. sexual, fysical or emotional abuse) by one or more perpetrators for example (foster-/step-) parents, elder brother, sister, uncle, aunt, nephew, niece, friend of parents, someone from the neigbourhood, school, sport, institution, church and give minimal two examples. Age difference is 5 years with the perpetrator.
4. At least 18 years of age till 85 years old.
5. Having sufficient fluency in Dutch to complete treatment and research protocol
6. Participants using prescribed anti-depressed medication are required to be a stable dose for at least 3 months before the beginning of the treatment and remain on this dose throughout the treatment. The same applies for benzodiazepinens with a maximum of 30 mg equivalents.
7.Signed informed consent
- Exclusion criteria1. Other treatments for one or more psychiatric disorders
2. Schizofrenia, active suicidality, dissociative identity disorder, mentally retarded
3. No fixed residence, major financial problems, , no aid figure, problems with justitice and law, current sexual and fysical abuse
4. Use of other psychofarmaca than SSRI's or start with medication within the study
5. Don't speak Dutch well enough.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-jun-2015
- planned closingdate1-okt-2018
- Target number of participants173
- InterventionsThis study is a randomized controlled trial with three conditions.
Three conditions: Waiting list, Imaginaire Exposure (IE), Imaginaire Rescripting (ImRes).
Duration of intervention: 2 sessions per week of 90 minutes for 5 weeks, 6 weeks 1 time per week for 90 minutes. Total 16 seats plus two times weekly homework (max. 1 hour).
Treatment duration: 11 weeks.
Exposure in vivo is in all conditions beyond the research otherwise not clear what the active elements of the two conditions.
By Condition 64 patients enrolled and the waiting list group 45.
• Measurement 1: After inclusion, so at the start of treatment
• Measurement 2: After 11 weeks (ending therapy)
• Measurement 3: At follow-up after 6 months
- Primary outcomePrimary outcome measure:
PTSD symptoms:
• PDS (self-report): Severity of PTSD is measured by the Dutch version of the PDS (Foa, Riggs, Dancu, & Rothbaum, 1993; Arntz, 1993) contains 17 items that correspond to the DSM-IV PTSD symptoms, each rated on a 0-3 - point scale.
- Secondary outcome• Clinical Interview PTSD: Dutch translation of the Clinician - Administered PTSD Scale (CAPS-DX, KIP) in an interview (conducted by a research assistant who is blind to the condition) measuring severity of PTSD symptoms, contains 30 items, each rated at a 0-4 scale.
Self-report questionnaires:
• Anger Expression Scale (AEQ): it measures how one behaves in general, when one is angry, 40 items, range 1-4
• State-Trait Anger Inventory (ZAV): Measuring severity of anger: state and trait; 20 items, range 1-4
• Guilt scale Kubany (translated version), degree of guil, 40 items, range 1-5 (where non - extreme value)
• Shame scale Smucker (translated version): degree of shame, 32 items, range 1-5 ( completely true - completely false)
Other symptoms that occur in PTSD occur in childhood:
• Complaints List (Brief Symptom Inventory (BSI), the Stock Exchange) is a multi-dimensional list of complaints that represents the extent to which surveyed suffered from mental and/or physical symptoms during the past period, a score also the total number of complaints, symptoms total available and the severity of the symptoms present, nine subscales (SOM, COG, INT, DEP, ANG, HOS, FOB, PAR, PSY), 53 items, range 0-4 (not at all to very much).
• Depression (BDI - II) (Beck): severity of depression , 21 items , range 0-3.
• Difficulties in Emotion Regulation Scale (DERS) , translated version (Gratz and Roemer, 2004) , measurement problems with emotion regulation, 21 items, range 1-5.
• PTCI: Dysfunctional trauma-related cognitions are measured by the Posttraumatic Cognitions Inventory (Foa, Ehlers, Clark, Tolin & Orsillo 1999, from Emmerich, Schoorl, Emmelkamp & Kamphuis, 2006) 36 items, range 1-7
• Self-image Rosenberg, measuring self-esteem, 20 items, range 1-4
- TimepointsThis study is a randomized controlled trial with three conditions.
Three conditions: Waiting list, Imaginaire Exposure (IE), Imaginaire Rescripting (ImRes).
Duration of intervention: 2 sessions per week of 90 minutes for 5 weeks, 6 weeks 1 time per week for 90 minutes. Total 16 seats plus two times weekly homework (max. 1 hour) .
Treatment duration 11 weeks.
Exposure in vivo is in all conditions beyond the research otherwise not clear what the active elements of the two conditions.
By Condition 64 patients enrolled and the waiting list group 45.
• Measurement 1: After inclusion, so at the start of treatment
• Measurement 2: after 11 weeks (ending therapy)
• Measurement 3: at follow -up after 6 months
- Trial web sitewww.pm-psychotherapieamsterdam.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. P.M. Jong, de
- CONTACT for SCIENTIFIC QUERIESDrs. P.M. Jong, de
- Sponsor/Initiator Psychotherapy & Movement
- Funding
(Source(s) of Monetary or Material Support)
Psychotherapy & Movement Amsterdam
- PublicationsNot yet.
- Brief summaryMeta-analyses show that Trauma-Focused Cognitive Behavioral, Imaginary 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). These relatively short treatments (9-12 sessions of 90 minutes) results in a considerable reduction of PTSD symptoms in 40-70% of patients. However, the vast majority of research has been conducted on PTSD following a single traumatic event. Research examining the application of these two protocols to PTSD as a result of repeated and prolonged interpersonal abuse in childhood (eg sexual and / or physical abuse) within the immediate environment is scant. Whether Imaginary Exposure should be regarded a ‘golden standard treatment’ in this patient group is unknown, en thus, research examining the effectiveness of Imaginary Exposure in this patient group is needed. Moreover, a novel treatment called ‘Imaginary Rescripting’ may more actively intervene in key processes that play a role in the development of PTSD such as dysfunctional based schedules and tonic immobility (TI). Hence, it may be more effective as compared to Imaginary Exposure.

This study focuses on PTSD due to repeated and prolonged interpersonal abuse in childhood (eg sexual and / or physical abuse) within the immediate environment. By using a Randomized controlled design, we examine whether Imaginary Exposure is more effective as compared to a waitinglist with regard to severity of PTSD symptoms, and whether Imaginaire Rescripting is more effective as compared to Imaginary Exposure.
- Main changes (audit trail)CHANGES 17-okt-2015

Inclusion criteria NEW:
1. Meeting DSM-IV criteria for PTSD
2. Comorbidity with depression, anxiety disorder, ADHD, dissociative disorder, reactive psychotic disorder, alcohol/drugs consumption, borderline personality disorder and cluster C personality disorder are included.
3. Having experienced repeated or chronic interpersonal trauma before age of 16 (e.g. sexual, physical or emotional abuse) by one or more perpetrators for example (foster-/step-) parents, elder brother, sister, uncle, aunt, nephew, niece, friend of parents, someone from the neighbourhood, school, sport, institution, church and give minimal two examples. Age difference is 5 years with the perpetrator.
4. At least 18 years of age till 85 years old.
5. Sufficient fluency in Dutch to complete treatment and research protocol
6. Participants using antidepressant medication are required to be a stable dose for at least 3 months before the beginning of the treatment and remain on this dose throughout the treatment. The same applies for benzodiazepinens with a maximum of 30 mg oxazepam equivalents.
7.Signed informed consent

Exclusion criteria NEW:
1. Other psychiatric treatments
2. Schizophrenia, active suicidality, dissociative identity disorder, mentally retarded
3. No fixed residence, major financial problems, , no aid figure, problems with justice and law, current sexual and physical abuse
4. Use of other psychotropic drugs than antidepressants and benzodiazepines.
5. Insufficient fluency in Dutch

Intervention NEW:
This study is a randomized controlled trial with three conditions, i.e. Waiting list (WL), Imaginary Exposure (IE), Imaginary Rescripting (ImRes).
Treatment duration is 11 weeks, during the first 5 weeks 2 sessions of 90 minutes each will be provided, followed by 6 weeks of one 90 minute session.
In the treatment conditions, homework of maximum 1 hr per week is given.
No sessions for the waitinglist will be provided.

Primary outcome NEW:
Primary outcome measure is severity of PTSD symptoms, as assessed with the Post-Traumatic Stress Diagnostic Scale PDS (self-report) (Foa, Riggs, Dancu, & Rothbaum, 1993; Arntz, 1993), Dutch version

Secondary outcome NEW:
• Drop out during study
• Severity of PTSD symptoms as assessed with the Clinician - Administered PTSD Scale (CAPS-DX, KIP) Self-report questionnaires:
• Anger Expression Scale (AEQ)
• State-Trait Anger Inventory (ZAV)
• Guilt scale Kubany
• Shame scale Smucker
• Brief Symptom Inventory (BSI)
• Beck Depression Inventory (BDI - II)
• Difficulties in Emotion Regulation Scale (DERS) (Gratz and Roemer, 2004)
• PTCI: Posttraumatic Cognitions Inventory (Foa, Ehlers, Clark, Tolin & Orsillo 1999, from Emmerich, Schoorl, Emmelkamp & Kamphuis, 2006)
• Self-image Rosenberg

Timepoints NEW:
• Measurement 1: After inclusion, so at the start of treatment
• Measurement 2: After 11 weeks (ending therapy)
• Measurement 3: At follow-up, 6 months after measurement 2
- RECORD26-sep-2014 - 17-okt-2015


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