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
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