What is the effect of a stabilising group treatment in complex PTSD patients? A Multicenter Randomised Clinical Trial for women with Child Abuse related Post Traumatic Stress Disorder with Associated Features.

ISRCTN	ISRCTN00874587
DOI	https://doi.org/10.1186/ISRCTN00874587
Protocol serial number	NL575, NTR631
Sponsor	VU University Medical Center, Department of Psychiatry and GGZ Buitenamstel (The Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw)

Submission date: 28/04/2006
Registration date: 28/04/2006
Last edited: 11/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

VU University Medical Center
Department of Psychiatry/GGZ Buitenamstel
Ernststraat 887
Amsterdam
1081 HL
Netherlands

Phone	+31 (0)20 7884502 or +31 (0)20 7885630
Email	vanbalkom@ggzba.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	What is the effect of a stabilising group treatment in complex PTSD patients? A Multicenter Randomised Clinical Trial for women with Child Abuse related Post Traumatic Stress Disorder with Associated Features.
Study objectives	The effectiveness of a 20-week stabilising group therapy in patients with complex PTSD is superior to treatment as usual (TAU).
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Post Traumatic Stress Disorder (PTSD)
Intervention	20-week group stabilising treatment for complex PTSD plus TAU versus TAU alone.
Intervention type	Other
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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)
Completion date	20/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	72
Total final enrolment	71
Key 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).
Key exclusion criteria	Comorbid psychotic disorders, substance dependence; antisocial personality disorder or dissociative identity disorder, all diagnosed with SCID-I, SCID-D or SCID-II.
Date of first enrolment	20/03/2006
Date of final enrolment	20/03/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Center

Amsterdam
1081 HL
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2012	11/01/2021	Yes	No

Editorial Notes

11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.