Condition category
Mental and Behavioural Disorders
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/09/2011
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

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

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

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

  1. 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.

Additional files

Editorial Notes