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 |
| Protocol serial number | 7987 |
| Sponsor | Addenbrooke's Hospital (UK) |
| Funders | Addenbrooke's Charitable Trust, Cambridge University Hospitals, Medical Research Council (MRC) (UK), Arthritis Research UK |
- 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 of protocol
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
| Primary study design | Observational |
|---|---|
| Study design | Single-centre observational treatment case-control study |
| Secondary study design | Case-control study |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
PTSD measurement questionnaires, measured at 3, 6, and 12 months after discharge |
| Key secondary outcome measure(s) |
Assessed and analysed at the conclusion of the study: |
| Completion date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 01/01/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/04/2017: No publications found, verifying study status with principal investigator.
