Condition category
Mental and Behavioural Disorders
Date applied
19/03/2008
Date assigned
04/04/2008
Last edited
22/10/2012
Prospective/Retrospective
Prospectively 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

Dr Sonja Kruger

ORCID ID

Contact details

Towngate House Hospital
1 Towngate Close
OFF Queensway
Guiseley
Leeds
LS20 9LA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Cognitive behavioural therapy (CBT) for carers of patients with Alzheimer's disease: a randomised controlled trial

Acronym

The CBTAC Study

Study hypothesis

Many individuals with Alzheimer's disease live in their own homes, cared for by a member of their family. Providing such care can be a source of significant stress. Carers can present with depression, anxiety, loneliness and other psychological strain. The present study seeks to evaluate the efficacy of CBT in treating psychological distress in a group of Alzheimer's carers.

Hypothesis:
12 sessions of cognitive behavioural therapy (CBT) will significantly reduce the Geriatric Depression Scale scores in carers of patients with Alzheimer's disease, in comparison with a group receiving treatment as usual.

Ethics approval

Ethics approval pending from Leeds East Research Ethics Committee as of 19/03/2008. To be submitted April 2008.

Study design

Prospective, single-centre, unblinded, randomised controlled 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

Psychological distress in Alzheimer's carers

Intervention

The treatment group will receive between 10 - 12 sessions of weekly CBT over a three-month period. The sessions will last for 50 minutes each, they will see the same therapist every week. Participants will be asked to complete self report questionnaires before treatment starts, after three months of treatment and again after six months of the start of the study. These questionnaires aim to indicate their distress and will be compared to similar measures in the treatment as usual group.

The treatment as usual group (control group), will receive support already offered to Alzheimer's carers in the area. This consist of a carer appointment with nurses, a monthly support group with other carers, and a monthly Forget Me Not Cafe, a support meeting with the person they care for. The participants in the control group will complete the same questionnaires as those in the treatment group, at similar time intervals.

The questionnaires used are:
1. Geriatric Depression Scale
2. Carer Strain Index
3. Carer Burden Inventory score

All participants will also complete a Mini-Mental State Examination to assess their cognition as to be included in the study, as well as a socio-demographic questionnaire at the beginning.

Total duration of follow-up for both treatment and control arm will be six months from start of treatment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

12 sessions of CBT will significantly reduce the Geriatric Depression Scale scores in carers of patients with Alzheimer's disease, in comparison with a group receiving treatment as usual. For the Geriatric Depression Rating Scale (GDS) an improvement of a score out of 15 will be measured, where a score greater than 5 indicates probable depression.

These measures will be taken in all participants (treatment and control groups), prior to start of treatment, after 3/12 and again after 6/12 of start of treatment, thus T0, T3 and T6. These scores will then be compared to detect within participant and between group differences at three different time points.

Secondary outcome measures

1. 12 sessions of CBT will significantly reduce the Carer Strain Index scores in carers of patients with Alzheimer's disease, in comparison with a group receiving treatment as usual. For the Carer Strain Index score (CSI) an improvement of a score out of 12 will be measured, where a score greater than 7 indicates a high level of strain.
2. 12 sessions of CBT will significantly reduce the Carer Burden Inventory scores in carers of patients with Alzheimer's disease, in comparison with a group receiving treatment as usual. For the Carer Burden Inventory score (CBI) an improvement of a score out of 88 will be measured, where a score between 61 - 88 indicates severe burden, 41 - 60 moderate to severe burden, 21 - 40 mild to moderate burden and 0 - 20 indicates little or no burden.

These measures will be taken in all participants (treatment and control groups), prior to start of treatment, after 3/12 and again after 6/12 of start of treatment, thus T0, T3 and T6. These scores will then be compared to detect within participant and between group differences at three different time points.

Overall trial start date

01/07/2008

Overall trial end date

01/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary carer of an individual with Alzheimer's disease
2. Willing to engage actively in 10 - 12 weekly therapy sessions, over a three month period
3. Willing to complete self report questionnaires before treatment starts, at three months and six months after entering the study
4. Aged 18 - 90 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 participants will be recruited

Participant exclusion criteria

1. Carers not fluent in English (due to nature of the treatment)
2. Evidence of cognitive impairment, assessed as a Mini-Mental State Examination score of less than 26/30
3. Currently prescribed certain psychotropic medication, i.e., antipsychotics, mood stabilisers, hypnotics and sedatives. Those receiving antidepressants will not be excluded
4. The person they care for with Alzheimer's disease is under 65 (pre-senile dementia)

Recruitment start date

01/07/2008

Recruitment end date

01/02/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Towngate House Hospital
Leeds
LS20 9LA
United Kingdom

Sponsor information

Organisation

Leeds Partnerships NHS Foundation Trust (UK)

Sponsor details

Twenty One Fifty
Thorpe Park
Leeds
LS15 8ZB
United Kingdom

Sponsor type

Government

Website

http://www.leedsmentalhealth.nhs.uk/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (UK)

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