The effects of reducing worry in patients with persecutory delusions: finding out if worries can be reduced by brief cognitive therapy
| ISRCTN | ISRCTN23197625 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23197625 |
| Secondary identifying numbers | 09/160/06 |
- Submission date
- 07/03/2011
- Registration date
- 20/04/2011
- Last edited
- 18/12/2017
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Daniel Freeman
Scientific
Scientific
Department of Psychiatry
Oxford University
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
Study information
| Study design | Single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effects of reducing worry in patients with persecutory delusions: An explanatory randomised controlled trial |
| Study acronym | Worry Intervention Trial (WIT) |
| Study objectives | 1. A worry intervention will reduce levels of worry in individuals with persecutory delusions 2. A worry intervention will reduce persecutory delusions, especially levels of distress 3. The improvements will be maintained at follow-up |
| Ethics approval(s) | NHS Research Ethics Service Oxford REC B, application ref 11/SC/0001 - approval pending as of 09/03/2011 |
| Health condition(s) or problem(s) studied | Persecutory delusions in the context of schizophrenia or related diagnosis |
| Intervention | 1. Six sessions of CBT for worry over 2 months for patients randomised to intervention arm 2. This is in addition to their standard psychiatric care 3. The control condition is standard psychiatric care |
| Intervention type | Other |
| Primary outcome measure | 1. Penn State Worry Questionnaire (PSWQ; Meyer et al, 1990) 2. Psychotic Symptoms Rating Scale - Delusions (PSYRATS; Haddock et al, 1999) |
| Secondary outcome measures | 1. Paranoid Thoughts Scale (Green et al, 2008) 2. Positive and Negative Symptom Scale (PANSS; Kay, 1991). 3. EQ-5D (Brooks et al, 2003) |
| Overall study start date | 01/09/2011 |
| Completion date | 01/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 1. A current persecutory delusion as defined by Freeman and Garety (2000); scoring at least 3 on the conviction scale of the PSYRATS (Haddock et al, 1999) 2. That the delusion has persisted for at least one month 3. A clinical diagnosis of schizophrenia, schizoaffective disorder or delusional disorder (i.e. diagnosis of non-affective psychosis (F2) in the International Classification of Diseases and Diagnostic and Statistical Manual IV) 4. A clinically significant level of worry, as indicated by scores above 44 on the Penn State Worry Questionnaire (see Startup and Erickson, 2006) 5. Aged between 18 and 65 6. Where major changes in medication are being made, entry to the study would not occur until at least a month after stabilisation of dosage |
| Key exclusion criteria | 1. A primary diagnosis of alcohol or substance dependency 2. Organic syndrome or learning disability 3. A command of spoken English inadequate for engaging in therapy 4. Currently having individual cognitive behavioural therapy (CBT) (though previous CBT experience is not an exclusion) |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 01/03/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oxford University
Oxford
OX3 7JX
United Kingdom
OX3 7JX
United Kingdom
Sponsor information
The Efficacy and Mechanism Evaluation Programme (MRC/NIHR) (UK)
Government
Government
NETSCC - Efficacy and Mechanism Evaluation
Alpha House
University of Southampton Science Park
Southampton
SO16 7NS
United Kingdom
| Website | http://www.eme.ac.uk |
|---|---|
"ROR" |
https://ror.org/0187kwz08 |
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | pilot study results | 01/03/2010 | Yes | No | |
| Protocol article | protocol | 21/11/2012 | Yes | No | |
| Results article | results | 01/04/2015 | Yes | No |
Editorial Notes
18/12/2017: internal review.
