Evaluation of CBT in older persons with anxiety: a pilot study
ISRCTN | ISRCTN55236453 |
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DOI | https://doi.org/10.1186/ISRCTN55236453 |
Secondary identifying numbers | N0081165259 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 12/08/2016
- 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
Mr Norman Finlayson
Scientific
Scientific
c/o Barnsdale Ward
Brandon Mental Health Unit
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Phone | +44 116 229 4083 |
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Norman.Finlayson@leicspart.nhs.uk |
Study information
Study design | Randomised controlled pilot study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
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 | Evaluation of CBT in older persons with anxiety: a pilot study |
Study objectives | The aim of this study is to 1. Test the research methodology of a CRT designed to evaluate the short term and medium term benefits of manualised cognitive behaviour therapy (MCBT) over treatment as usual (TAU), in older adults experiencing anxiety with or without mild depression in inpatient and day care settings 2. Obtain an estimate of any treatment effects in order to carry out a power calculation for a larger study |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Anxiety disorders |
Intervention | Participants in the study will be recruited from an inpatient setting and a day hospital setting; information regarding the purpose and nature of the study will be given. Informed consent to enter the study will be obtained and participants will be randomly allocated to either the intervention group or the treatment as usual group in each setting. Randomisation will be achieved by using a sealed envelope technique, for each setting (inpatient/day hospital) an equal number of envelopes marked intervention group or control group, an envelope will be picked for each individual entering the trial. The intervention group will receive a fifteen-week course of group CBT using a treatment manual. Measures will be applied pre and post treatment and at one month and six month intervals. As this is a pilot study it is anticipated that 6-10 participants will be recruited for each group (treatment as usual and CBT) in both settings (inpatient care and day hospital). Six being the lowest number required to run the group, ten allows for some drop out during treatment. |
Intervention type | Other |
Primary outcome measure | The following measures will be used: Penn State Worry Questionnaire (Meyer et al 1990) Beck Anxiety Inventory (BAI) Beck et al (1988) Beck Depression Inventory 1 (BDI) Beck et al (1986) Outcome measures will be completed pre and post treatment, and at one month and six month intervals after completion of treatment. All groups (intervention and control in both settings) will complete measures at the same times. The member of research staff responsible for collection and completion of the measures will be blind to the participants status within the trial. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/03/2005 |
Completion date | 31/05/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Not Specified |
Target number of participants | 20 |
Key inclusion criteria | 1. Diagnosis of generalised anxiety disorder, panic with or without moderate depression 2. Have the capacity to give informed consent 3. Have a sufficient level of literacy in order to use the materials provided during the course 4. Have a maximum score of no more than 29 (a score of 30 plus indicates severe depression) on the Beck Depression Inventory 1 (Beck et al 1986) 5. Any current physical health problems are stable and expected to be stable for the duration of the trial |
Key exclusion criteria | 1. Clinical diagnosis of an organic brain syndrome including dementia as assessed by their consultant 2. Severe sensory impairment that could prevent use of the material provided during the course 3. Non-English speaking 4. Should participants experience a significant change in their physical health during the trial they may continue with the trial if they wish, but their data will be excluded from the analysis. |
Date of first enrolment | 01/03/2005 |
Date of final enrolment | 31/05/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
c/o Barnsdale Ward
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
https://ror.org/03sbpja79 |
Funders
Funder type
Hospital/treatment centre
Leicestershire Partnership NHS Trust
No information available
Results and Publications
Intention to publish date | |
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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
12/08/2016: No publications found in PubMed, verifying study status with principal investigator.