Evaluation of CBT in older persons with anxiety: a pilot study

ISRCTN	ISRCTN55236453
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

c/o Barnsdale Ward
Brandon Mental Health Unit
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Phone	+44 116 229 4083
Email	Norman.Finlayson@leicspart.nhs.uk

Study information

Study design	Randomised controlled pilot study
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
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

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Hospital/treatment centre

Leicestershire Partnership NHS Trust

No information available

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

12/08/2016: No publications found in PubMed, verifying study status with principal investigator.