A feasibility study to determine the potential for developing a pilot RCT to evaluate the effectiveness of a 10 week psychotherapy group for people with dementia in reducing levels of depression compared to a relaxation group
| ISRCTN | ISRCTN92122115 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92122115 |
| Secondary identifying numbers | N0038161728 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 28/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Richard Cheston
Scientific
Scientific
Charter House
Seymour Road
Trowbridge
BA14 8LS
United Kingdom
| Phone | +44 01225 356414 |
|---|---|
| richard.cheston@awp.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Dementia |
| Intervention | Pilot RCT. Random allocation to [A] 10 week group psychotherapy; [B] 10 week group relaxation. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 23/03/2005 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 28 anticipated. Modified 18 July 2008: 9 to each arm, total 18 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 23/03/2005 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Charter House
Trowbridge
BA14 8LS
United Kingdom
BA14 8LS
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Avon and Wiltshire Mental Health Partnership NHS Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2009 | Yes | No |
