Cognitive behavioural therapy (CBT) for the treatment of post-traumatic stress disorder (PTSD) in intensive care unit (ICU) survivors
| ISRCTN | ISRCTN97280643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97280643 |
| Secondary identifying numbers | 7987 |
- Submission date
- 21/05/2010
- Registration date
- 21/05/2010
- Last edited
- 11/04/2017
- 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
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Jacobus Preller
Scientific
Scientific
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| jacobus.preller@addenbrookes.nhs.uk |
Study information
| Study design | Single-centre observational treatment case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact jacobus.preller@addenbrookes.nhs.uk to request a patient information sheet |
| Scientific title | A randomised controlled pilot study of the effectiveness of recreating a coherent narrative of events using novel developments in cognitive and behaviour therapy for the treatment of post-traumatic stress disorder in survivors of intensive care treatment |
| Study hypothesis | A single-centre randomised single-blind controlled pilot study evaluating the efficacy of a brief psychological intervention for the treatment of intensive care unit (ICU) survivors with post-traumatic stress disorder (PTSD), based on novel developments in cognitive behavioural therapy (CBT) and narrative exposure therapy (NET). The study will create and implement a psychotherapeutic intervention to address the problem of fragmented and delusional memories, by creating a coherent narrative of events, which would allow the ICU survivor to process their ICU experience. The different components of the intervention proposed have been validated as an effective intervention in studies on PTSD (CBT). |
| Ethics approval(s) | Essex 2 Research Ethics Committee, 05/07/2007, ref: 07/Q0302/20 |
| Condition | Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care |
| Intervention | We plan to screen all patients discharged from ICU for symptoms of PTSD using questionnaires and to follow them up four weeks after discharge. After screening, patients with symptoms of PTSD would be randomly allocated to receive a brief specialised CBT-based intervention or normal aftercare. The non-intervention arm ceases at the 4-week follow-up stage. The intervention arm using cognitive behavioural therapy has the treatment occurring at between 3 and 6 months and final follow-up to measure outcome of treatment occurring at 12 months. |
| Intervention type | Other |
| Primary outcome measure | PTSD measurement questionnaires, measured at 3, 6, and 12 months after discharge |
| Secondary outcome measures | Assessed and analysed at the conclusion of the study: 1. Determine the incidence of PTSD 2. Develop a prediction score that can be used to identify the patients at risk of PTSD |
| Overall study start date | 01/01/2010 |
| Overall study end date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned sample size: 200 |
| Participant inclusion criteria | 1. Patients must be admitted to ICU for more than 24 hours 2. Patients must be older than 16 years 3. Patient must have physical and mental capacity to comprehend questions 4. The patient must be able to understand and communicate adequately in English |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/01/2010 |
| Recruitment end date | 01/01/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Addenbrooke's Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Website | http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html |
|---|---|
"ROR" |
https://ror.org/055vbxf86 |
Funders
Funder type
Research council
Addenbrooke's Charitable Trust, Cambridge University Hospitals
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Addenbrooke's Charitable Trust, Cambridge University Hospitals NHS Foundation Trust, ACT
- Location
- United Kingdom
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Arthritis Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
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 |
Editorial Notes
11/04/2017: No publications found, verifying study status with principal investigator.
