Condition category
Mental and Behavioural Disorders
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
12/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 participant’s 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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

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