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 |
| Secondary identifying numbers | NL575, NTR631 |
- 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
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 |
|---|---|
| vanbalkom@ggzba.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 20/03/2006 |
| Completion date | 20/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
1081 HL
Netherlands
Sponsor information
VU University Medical Center, Department of Psychiatry and GGZ Buitenamstel (The Netherlands)
University/education
University/education
A.J. Ernststraat 887
Amsterdam
1081 HL
Netherlands
"ROR" |
https://ror.org/00q6h8f30 |
|---|
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development (ZonMw)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
