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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN77610095 |
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Date of registration:
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04/04/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cognitive Behavioural Therapy (talking therapy) for Alzheimer's Carers
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Scientific title:
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Cognitive behavioural therapy (CBT) for carers of patients with Alzheimer's disease: a randomised controlled trial |
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Date of first enrolment:
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01/07/2008 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN77610095 |
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Study type:
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Interventional |
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Study design:
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Prospective, single-centre, unblinded, randomised controlled study (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Sonja
Kruger |
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Address:
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Towngate House Hospital
1 Towngate Close
OFF Queensway
Guiseley
LS20 9LA
Leeds
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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)
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psychological distress in Alzheimer's carers
Mental and Behavioural Disorders
Psychological distress
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Investigator initiated and funded (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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