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Trial registered on ANZCTR


Registration number
ACTRN12619000924156p
Ethics application status
Not yet submitted
Date submitted
19/06/2019
Date registered
3/07/2019
Date last updated
3/07/2019
Date data sharing statement initially provided
3/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A community group to improve loneliness in older adults
Scientific title
A community based psychosocial group treatment for older adults with loneliness
Secondary ID [1] 298528 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Loneliness 313340 0
Condition category
Condition code
Mental Health 311782 311782 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psychosocial group intervention
Two trained facilitators (an Age Concern staff and a volunteer) facilitate each group which has 6-8 participants. The group meets for 3 hours once a week for 12 weeks (a total of 12 group meetings).

The participants are transported to group meetings and back by van or other transport options. The group meetings included coffee, breaks and lunches; meetings are free of charge.

The psychosocial group intervention has three components:

a. Mindfulness and relaxation practice (20 minutes)

a. In the art/inspiring activities (60 minutes), various artists (musicians, actors, artists) attend the meetings, participants visit cultural events and sights, and participants actively produce their own art. We will introduce a bicultural approach by including Maori art (e.g. bone carvings, weaving) to both Maori and non-Maori group participants.

c. Group interpersonal psychotherapy (IPT) (60 minutes). IPT was developed for the treatment of adult depression in the 1970s and has been modified for numerous mental health conditions including older adult depression. It is a manual based, time-limited (12-16 sessions) and evidence based talking therapy. It is designed to improve communication skills and to modify expectations in relationships. IPT identifies and works on problem areas in a person’s relationship with others. The problem area of interpersonal sensitivity relates to people with loneliness/social isolation. Our treatment protocol will follow the group IPT guide published by the WHO. (REF) The aim is to help people to be less lonely and take steps to form ties with members of their community. Strategies used to help with loneliness include finding out if the participant wants to have more people around them; assisting the participant in finding opportunities to change their habits and end their social isolation by increasing activities with other people and joining in the community, workplace or places of religious worship; guiding the group to support each other and using extensive role-play and feedback in preparing and reviewing their interactions and activities with others.

The remaining 40 minutes is allowed for coffee/tea at arrival and lunch at the end.
Attendance list will be used to monitor adherence to the intervention.

REF:
World Health Organization and Columbia University. Group Interpersonal Therapy (IPT) for Depression (WHO generic field-trial version 1.0). World Health Organisation. 2016. Available from: http://apps.who.int/iris/bitstream/handle/10665/250219/WHO-MSD-MER-16.4-eng.pdf;jsessionid=AA494AA829B02735BEECAC06326EE85E?sequence=1
Intervention code [1] 314777 0
Treatment: Other
Comparator / control treatment
Treatment as usual: Age Concern’s accredited visitor service (AVS)
- An accredited visitor will visit the participants at their home for about an hour per week for 12 weeks.
- The AVS is a befriending service that provides regular visits to older people who would like more company. Accredited visitors are volunteers who are keen to spend time with an older adult to enjoy conversation and shared interests and activities.
Control group
Active

Outcomes
Primary outcome [1] 320463 0
de Jong Gierveld Loneliness Scale
Timepoint [1] 320463 0
12 weeks (i.e. immediately post-intervention)
Primary outcome [2] 320549 0
Number of potential participants approached through Age Concern willing to take part in the trial.

Measured by using a record kept by Age Concern and the research team.
Timepoint [2] 320549 0
At the completion of all 4 groups.
Primary outcome [3] 320562 0
Number of potential participants approached through District Health Board's interRAI assessment team willing to take part in the trial

Measured by using a record kept by District Health Board and the research team.
Timepoint [3] 320562 0
At the completion of all 4 groups.
Secondary outcome [1] 371693 0
WHO Quality of Life-BREF
Timepoint [1] 371693 0
12 weeks (i.e. immediately post-intervention)
Secondary outcome [2] 371694 0
Satisfaction with Life Scale
Timepoint [2] 371694 0
12 weeks (i.e. immediately post-intervention)
Secondary outcome [3] 371695 0
General Health Questionnaire
Timepoint [3] 371695 0
12 weeks (i.e. immediately post-intervention)
Secondary outcome [4] 371696 0
Geriatric Depression Scale (15 items)
Timepoint [4] 371696 0
12 weeks (i.e. immediately post-intervention)
Secondary outcome [5] 371697 0
Cumulative Illness Rating Scale
Timepoint [5] 371697 0
12 weeks (i.e. immediately post-intervention)
Secondary outcome [6] 371698 0
Montreal Cognitive Assessment
Timepoint [6] 371698 0
12 weeks (i.e. immediately post-intervention)
Secondary outcome [7] 371699 0
Blood pressure (BP) measured by an automated BP machine
Timepoint [7] 371699 0
12-weeks (i.e. immediately post-intervention)
Secondary outcome [8] 371700 0
Body Mass Index: Height measured with a tape and weight measured with a scale.
Timepoint [8] 371700 0
12-weeks (i.e. immediately post-intervention)
Secondary outcome [9] 371984 0
Participants’ adherence and drop-out rates: measured by using an attendance sheet..
Timepoint [9] 371984 0
At the completion of all 4 groups.
Secondary outcome [10] 371985 0
Expenses of conducting the 4 groups and training group facilitators. A budget will be kept to monitor expenses. We are just measuring expenses for the 4 groups, not other resource uses in this feasibility study.
Timepoint [10] 371985 0
At the completion of the 4 groups.
Secondary outcome [11] 371986 0
Attendance records of group facilitators attending the interpersonal training and ongoing supervision.
Timepoint [11] 371986 0
At the completion of the 4 groups.

Eligibility
Key inclusion criteria
The study will recruit participants from Age Concern in Auckland and Dunedin, New Zealand. Potential participants are people with subjective loneliness who are referred to their AVS. Staff at Age Concern will approach potential participants about this study, and the research team will provide further information and obtain informed consent.

Inclusion criteria:
(i) Age 65+
(ii) living in the community, including retirement village
(iii) adequate hearing and vision to allow participation in group work
(iv) ability to move independently without another person’s aid
(v) a score of 3 or above on the de Jong Gierveld Loneliness Scale
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
(i) significant cognitive impairment (Montreal Cognitive Assessment score <25/30)
(ii) participants are required to be intervention naïve, e.g. they have not received AVS or any other loneliness service before
(iii) significant medical co-morbidities likely to impact on survival over 2-year period (e.g. terminal cancer).

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)
Participants will be randomised to receive either the psychosocial group intervention or treatment as usual using a computer generated list. Random allocation will incorporate randomised blocks (of between 4 and 8 participants) to ensure a balanced design at any time during the trial.

When a participant is eligible to take part in the trial, the researcher who recruited the participant will contact our off-site statistician who is the holder of the allocation schedule.

Each new participant will be given their allocation after consent to take part has been given and baseline assessments have been made.

The following groups of people will be blinded for the assignment to interventions: outcome measure assessors and statistician completing the analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be performed centrally by an independent biostatistician who is not involved in the day to day running of the trial. The allocation sequence will be concealed from the researcher enrolling participants by each allocation being contained in an opaque, sealed, sequentially numbered envelope.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe the baseline demographic characteristics and baseline and post-intervention outcome measures. As part of this feasibility study, we will obtain information on drop-out rates and the de Jong Loneliness Scale in terms of its scores range, improvement in scores and variability in the score. This information will enable us to do a power calculation for a future full study.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2020
Actual
Date of last participant enrolment
Anticipated
31/07/2020
Actual
Date of last data collection
Anticipated
30/11/2020
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment outside Australia
Country [1] 21617 0
New Zealand
State/province [1] 21617 0
Auckland, Dunedin

Funding & Sponsors
Funding source category [1] 303074 0
Government body
Name [1] 303074 0
Health Research Council of New Zealand
Country [1] 303074 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Level 12, Auckland Hospital Support Building, 2 Park Road, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 303058 0
None
Name [1] 303058 0
Address [1] 303058 0
Country [1] 303058 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303622 0
New Zealand Health and Disability Ethics Committees
Ethics committee address [1] 303622 0
Ethics committee country [1] 303622 0
New Zealand
Date submitted for ethics approval [1] 303622 0
01/08/2019
Approval date [1] 303622 0
Ethics approval number [1] 303622 0

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

Contacts
Principal investigator
Name 94294 0
Dr Gary Cheung
Address 94294 0
Level 12, Auckland Hospital Support Building, 2 Park Road, Grafton, Auckland 1023
Country 94294 0
New Zealand
Phone 94294 0
+6421332823
Fax 94294 0
Email 94294 0
[email protected]
Contact person for public queries
Name 94295 0
Gary Cheung
Address 94295 0
Level 12, Auckland Hospital Support Building, 2 Park Road, Grafton, Auckland 1023
Country 94295 0
New Zealand
Phone 94295 0
+6421332823
Fax 94295 0
Email 94295 0
[email protected]
Contact person for scientific queries
Name 94296 0
Gary Cheung
Address 94296 0
Level 12, Auckland Hospital Support Building, 2 Park Road, Grafton, Auckland 1023
Country 94296 0
New Zealand
Phone 94296 0
+6421332823
Fax 94296 0
Email 94296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a feasibility study for our research team to plan a more definitive trial. Aggregated data can be made available, but not individual participant data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2379Study protocol    377809-(Uploaded-19-06-2019-04-46-37)-Study-related document.docx



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.