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 |
| Protocol serial number | N0038161728 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Avon and Wiltshire Mental Health Partnership NHS Trust (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Cornell Scale |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Charter House
Trowbridge
BA14 8LS
United Kingdom
BA14 8LS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
