Condition category
Mental and Behavioural Disorders
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
28/04/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof A.J.L.M. Balkom, van

ORCID ID

Contact details

VU University Medical Center
Department of Psychiatry/GGZ Buitenamstel
Ernststraat 887
Amsterdam
1081 HL
Netherlands
+31 (0)20 7884502 or +31 (0)20 7885630
vanbalkom@ggzba.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The effectiveness of a 20-week stabilising group therapy in patients with complex PTSD is superior to treatment as usual (TAU).

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Post Traumatic Stress Disorder (PTSD)

Intervention

20-week group stabilising treatment for complex PTSD plus TAU versus TAU alone.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. CAPS and Davidson Trauma Scale (severity of PTSD symptoms)
2. SCID-DESNOS (overall severity of complex PTSD symptoms)
3. Borderline Personality Disorder Severity Index (BPDSI) (severity of affect-dysregulation and self-destructiveness)
4. Dissociative Experiences Scale (DES)

Secondary outcome measures

1. Self Esteem (SE measure)
2. SDQ (somatic dissociation)
3. WHO Quality of Life (QoL)
4. SCL-90 (comorbid psychopathology)
5. BDI (depression)
6. STAI (anxiety)

Overall trial start date

20/03/2006

Overall trial end date

20/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Females diagnosed with Complex PTSD according to SCID-DESNOS with or without comorbid axis I or axis II disorders (see also exclusion criteria).

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

72

Participant exclusion criteria

Comorbid psychotic disorders, substance dependence; antisocial personality disorder or dissociative identity disorder, all diagnosed with SCID-I, SCID-D or SCID-II.

Recruitment start date

20/03/2006

Recruitment end date

20/03/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1081 HL
Netherlands

Sponsor information

Organisation

VU University Medical Center, Department of Psychiatry and GGZ Buitenamstel (The Netherlands)

Sponsor details

A.J. Ernststraat 887
Amsterdam
1081 HL
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes