Contact information
Type
Scientific
Primary contact
Dr Richard Cheston
ORCID ID
Contact details
Charter House
Seymour Road
Trowbridge
BA14 8LS
United Kingdom
+44 01225 356414
richard.cheston@awp.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0038161728
Study information
Scientific title
Acronym
Study hypothesis
Can a 10 week programme of group psychotherapy reduce levels of depression for people with dementia compared to 10 weeks of group relaxation?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Mental and Behavioural Disorders: Dementia
Intervention
Pilot RCT. Random allocation to [A] 10 week group psychotherapy; [B] 10 week group relaxation.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Cornell Scale
Secondary outcome measures
RAID, the BASDEC depression scale, the Beck Anxiety Inventory, BASQUID scale and the ZARIT carer burden scale. Pilot will test feasibility of blinding, determine effect size, determine attrition rate.
Overall trial start date
23/03/2005
Overall trial end date
31/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
28 participants in each of the two arms. Participants with a diagnosis of Alzheimer's disease or other dementia and MMSE score of at least 18, recruited from patients who have attended either the memory monitoring service in Bradford and Warminster or who have been assessed by a Consultant Psychiatrist.
Modified 18 July 2008: the trial recruited 9 (and not 28) participants to each arm.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
28 anticipated. Modified 18 July 2008: 9 to each arm, total 18
Participant exclusion criteria
1. Significant premorbid history of functional mental health problems
2. Spouse not giving assent
3. Not living with a carer and/or if the social support is not sufficiently well-developed.
Recruitment start date
23/03/2005
Recruitment end date
31/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Charter House
Trowbridge
BA14 8LS
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Avon and Wiltshire Mental Health Partnership NHS Trust (UK), NHS R&D Support Funding
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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19484606
Publication citations
-
Results
Cheston R, Jones R, A small-scale study comparing the impact of psycho-education and exploratory psychotherapy groups on newcomers to a group for people with dementia., Aging Ment Health, 2009, 13, 3, 420-425, doi: 10.1080/13607860902879409.