Contact information
Type
Scientific
Primary contact
Mr Norman Finlayson
ORCID ID
Contact details
c/o Barnsdale Ward
Brandon Mental Health Unit
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 116 229 4083
Norman.Finlayson@leicspart.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0081165259
Study information
Scientific title
Evaluation of CBT in older persons with anxiety: a pilot study
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/03/2005
Overall trial end date
31/05/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
20
Participant 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.
Recruitment start date
01/03/2005
Recruitment end date
31/05/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
c/o Barnsdale Ward
Leicester
LE5 4PW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leicestershire Partnership NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary