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Trial registered on ANZCTR


Registration number
ACTRN12615000798561
Ethics application status
Not yet submitted
Date submitted
15/07/2015
Date registered
31/07/2015
Date last updated
1/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Drama Therapy for Older People with Dementia: A Pilot Study
Scientific title
The effect of drama therapy on depression, anxiety, socialisation and wellbeing in older people with dementia
Secondary ID [1] 287091 0
None
Universal Trial Number (UTN)
U1111-1172-2074
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 295603 0
Depression 295604 0
Anxiety 295605 0
Condition category
Condition code
Neurological 295881 295881 0 0
Dementias
Mental Health 295884 295884 0 0
Depression
Mental Health 295885 295885 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 weeks of group drama therapy sessions, which will last for 1 hour per week. These sessions will be led by a qualified and experienced drama therapist. The drama therapy sessions will include a warm-up (such as vocal exercises, physical warm-ups like balloon games, or memory games), a main activity (such as telling an improvised story as a group or creating characters and narratives with props) and a warm-down. A register of attendance will be kept to monitor adherence.
Intervention code [1] 292333 0
Treatment: Other
Intervention code [2] 292413 0
Lifestyle
Comparator / control treatment
There are two control groups in this study:
1) An active control group: This group will participate in 10 weeks of conversation sessions led by the drama therapist. These sessions will involve group discussions on topics such as wellbeing, interests, memories and current events. This group is included to control for the likelihood that simply paying extra care to the residents and engaging them in a group activity will cause psychological and social improvements.
2) A waiting-list control group: This group will receive no intervention above the standard level of care. However, they will receive 10 weeks of drama therapy or conversation sessions (depending on which activity is found to be more enjoyable/beneficial for people with dementia) after the main study is complete. These sessions will begin 15-20 weeks after the start of the study (the schedule is still to be finalised).
Control group
Active

Outcomes
Primary outcome [1] 295559 0
Depression Score (as measured by the Geriatric Depression Scale-15)
Timepoint [1] 295559 0
This measure will be administered in Weeks 0 (Pre-test), 2, 4, 6, 8 (Mid-tests), 10 (Post-test) and 14 (Follow-up) of the study.
Primary outcome [2] 295560 0
Anxiety Score (as measured by the Geriatric Anxiety Inventory-Short Form)
Timepoint [2] 295560 0
This measure will be administered in Weeks 0 (Pre-test), 2, 4, 6, 8 (Mid-tests), 10 (Post-test) and 14 (Follow-up) of the study.
Primary outcome [3] 295561 0
Wellbeing (as measured by the Affectometer-2)
Timepoint [3] 295561 0
This measure will be administered in Weeks 0 (Pre-test), 2, 4, 6, 8 (Mid-tests), 10 (Post-test) and 14 (Follow-up) of the study.
Secondary outcome [1] 315849 0
Socialisation (as measured by the Withdrawal Scale of the MOSES)
Timepoint [1] 315849 0
This measure will be administered in Weeks 0 (Pre-test), 2, 4, 6, 8 (Mid-tests), 10 (Post-test) and 14 (Follow-up) of the study.
Secondary outcome [2] 315850 0
Engagement with and enjoyment of the drama therapy/conversation sessions. This will be measured using the Music in Dementia Assessment Scales (MiDAS), which were originally designed to assess music therapy but have been adapted for drama therapy in this study.
Timepoint [2] 315850 0
This will be measured in Weeks 1-10 of the study.

Eligibility
Key inclusion criteria
Documented diagnosis of dementia, with mild-moderate cognitive impairment.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe cognitive impairment or other disabilities which may reduce the individual's ability to engage with the therapy (e.g. uncorrected hearing impairment).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/12/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 7033 0
New Zealand
State/province [1] 7033 0

Funding & Sponsors
Funding source category [1] 291649 0
University
Name [1] 291649 0
Massey University
Country [1] 291649 0
New Zealand
Funding source category [2] 291715 0
Charities/Societies/Foundations
Name [2] 291715 0
New Zealand Federation of Graduate Women, North Shore Branch
Country [2] 291715 0
New Zealand
Primary sponsor type
Individual
Name
Sophie Buchanan
Address
School of Psychology, Massey University
North Shore Library Building
229 Dairy Flat Highway
Albany Village
North Shore
Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 290317 0
University
Name [1] 290317 0
Massey University
Address [1] 290317 0
Massey University
Private Bag 11 222
Palmerston North 4442
Country [1] 290317 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293176 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 293176 0
Ethics committee country [1] 293176 0
New Zealand
Date submitted for ethics approval [1] 293176 0
01/09/2015
Approval date [1] 293176 0
Ethics approval number [1] 293176 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58794 0
Miss Sophie Buchanan
Address 58794 0
School of Psychology, Massey University
North Shore Library Building
229 Dairy Flat Highway
Albany Village
North Shore
Auckland 0632
Country 58794 0
New Zealand
Phone 58794 0
+64 27 3346200
Fax 58794 0
Email 58794 0
soph.buchanan@gmail.com
Contact person for public queries
Name 58795 0
Sophie Buchanan
Address 58795 0
School of Psychology, Massey University
North Shore Library Building
229 Dairy Flat Highway
Albany Village
North Shore
Auckland 0632
Country 58795 0
New Zealand
Phone 58795 0
+64 27 3346200
Fax 58795 0
Email 58795 0
soph.buchanan@gmail.com
Contact person for scientific queries
Name 58796 0
Sophie Buchanan
Address 58796 0
School of Psychology, Massey University
North Shore Library Building
229 Dairy Flat Highway
Albany Village
North Shore
Auckland 0632
Country 58796 0
New Zealand
Phone 58796 0
+64 27 3346200
Fax 58796 0
Email 58796 0
soph.buchanan@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.