Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000998741
Ethics application status
Approved
Date submitted
27/06/2022
Date registered
15/07/2022
Date last updated
15/07/2022
Date data sharing statement initially provided
15/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Developing Evidence-Based Interventions for Older Adults with Depression and Anxiety in Inpatient Services: A Feasibility Study
Scientific title
Developing Evidence-Based Interventions for Older Adults with Depression and Anxiety in Inpatient Services: A Feasibility Study
Secondary ID [1] 307443 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 326809 0
Depression 326811 0
Condition category
Condition code
Mental Health 324028 324028 0 0
Anxiety
Mental Health 324029 324029 0 0
Depression
Public Health 324030 324030 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will engage in an inpatient group psychological program designed to reduce depression and anxiety in older adults who are currently staying in hospital. The program consists of eight one-hour modules designed to be delivered weekly.

Treatment modules include psychoeducation, mood monitoring, pleasant event scheduling, physical exercise scheduling, problem solving, thought restructuring, communication strategies, and sleep hygiene.

Modules are presented in face-to-face group sessions facilitated by a therapist. Activities such as identifying symptoms of anxiety and low mood are completed during a session. Participants are encouraged to practise skills covered in the treatment modules outside of group sessions.

The approximate size of the groups will be groups of 3-4.

Adherence to the intervention will be monitored using session attendance checklists.
Intervention code [1] 323886 0
Behaviour
Intervention code [2] 323887 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331814 0
Patient-reported acceptability of the Ageing Wisely Inpatient Program collected at the end of each session via self-report measure designed specifically for this study.
Timepoint [1] 331814 0
Immediately after each session.
Primary outcome [2] 331815 0
Feasibility, as indicated by 1) recruitment of 80% of the target sample size (40 participants) in a six-month recruitment period, as indicated by audit of attendance records and 2) intention to continue the program post the research trial by inpatient staff as assessed by study-specific questionnaire.
Timepoint [2] 331815 0
At the end of the trial.
Secondary outcome [1] 411261 0
Change in psychological distress symptom severity on the Kessler Psychological Distress Scale – Severity (self-report).
Timepoint [1] 411261 0
At discharge and 3-month follow-up.
Secondary outcome [2] 411262 0
Change in depression symptom severity on the Geriatric Depression Scale – Severity (self-report).
Timepoint [2] 411262 0
At discharge and 3-month follow-up.
Secondary outcome [3] 411263 0
Change in anxiety symptom severity on the Geriatric Anxiety Scale – Severity (self-report).
Timepoint [3] 411263 0
At discharge and 3-month follow-up.
Secondary outcome [4] 411264 0
Acceptability of the Inpatient Ageing Wisely Program, as indicated by completion rates of the modules. Data on module completion rates will be collected using session attendance checklists.
Timepoint [4] 411264 0
Immediately after last participant completed treatment.

Eligibility
Key inclusion criteria
Aged 65 years or older; anxiety and/or depression is the main interfering problem according to the inpatient service intake assessment; has capacity to provide informed consent for participation. Participants must be an inpatient in one of the participating hospitals (Greenwich or Braeside Hospitals). The participant will also have sufficient English literacy.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
English language illiteracy, current psychotic or manic episode, drug/alcohol dependence, significant uncorrected hearing loss and likely moderate to severe dementia based as assessed by clinical staff. Co-morbidity with other psychiatric diagnose (with the exception of psychotic or bipolar disorder) is allowed in order to establish a clinically relevant, broadly representative sample. Patients who are currently receiving care under the Mental Health Act may be eligible to participate when their status change to voluntary patients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analyses will be conducted using a linear mixed model with repeated measures to analyse changes in participant measure scores. Mean ratings for Questions 2-6 of the therapist survey will be calculated for each session delivered and averaged across clinicians. Multiple imputation will be used to manage missing data. Descriptive statistics will be used to describe the demographic and clinical characteristics of the participants and the outcome variables at each measurements points (baseline, discharge, and 3-month follow-up).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/06/2022
Date of last participant enrolment
Anticipated
1/09/2022
Actual
Date of last data collection
Anticipated
1/01/2023
Actual
Sample size
Target
40
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22632 0
Greenwich Hospital - Greenwich
Recruitment hospital [2] 22633 0
Braeside Hospital - Prairiewood
Recruitment postcode(s) [1] 37906 0
2065 - Greenwich
Recruitment postcode(s) [2] 37907 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 311713 0
University
Name [1] 311713 0
Macquarie University 2021 Research Acceleration Scheme
Country [1] 311713 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road, Macquarie Park, NSW 2109
Country
Australia
Secondary sponsor category [1] 313171 0
None
Name [1] 313171 0
Address [1] 313171 0
Country [1] 313171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311164 0
Saint Vincent’s Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 311164 0
Translational Research Centre, 97-105 Boundary Street, Darlinghurst NSW 2010
Ethics committee country [1] 311164 0
Australia
Date submitted for ethics approval [1] 311164 0
11/03/2022
Approval date [1] 311164 0
18/05/2022
Ethics approval number [1] 311164 0
2022/ETH00440

Summary
Brief summary
Anxiety and depressive disorders, which frequently co-occur, are the most common mental disorders in older adults (Beekman et al., 2000; Sunderland et al., 2015). The co-occurrence of anxiety and depression in older adults is associated with worse outcomes than either disorder alone, including increased risk of cognitive decline and dementia (de Beurs et al., 2009; Paterniti et al., 2002; Wetherell et al., 2004). Anxiety and depression can be successfully treated in community-dwelling older adults using psychological interventions, with the strongest evidence for cognitive behavioural therapy (CBT) (Wuthrich et al., 2021). When symptoms cannot be managed in the community or when individuals are at risk of self- harm, older adults are managed in inpatient wards. With the population rate of overnight mental health-related hospital stays for older Australians increased by a striking 82.4%, from 2006–07 to 2018–19 (Australian Institute of Health and Welfare, 2020), more needs to be done to assist older adults in inpatient wards. However, there are no evidence-based psychological interventions in inpatient settings that target anxiety and depression in older adults. Instead, psychotropics are used, including benzodiazepines which increases risk of falls and cognitive decline. Therefore, interventions developed using evidence- based practice that are feasible in this challenging setting are needed. Challenges to psychological management include disorientation of patients in these settings, variable attendance, and admission durations. Therefore, this project brings together experts in older adult mental health across multiple disciplines (clinical psychology, biostatistics, primary care) with clinical practitioners in inpatient services to co-design a group therapy intervention and evaluation procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120174 0
Dr Jessamine Chen
Address 120174 0
School of Psychological Sciences, Room 706, 4 First Walk, Macquarie University, Macquarie Park, NSW 2109
Country 120174 0
Australia
Phone 120174 0
+61 02 9850 9882
Fax 120174 0
Email 120174 0
Jessamine.Chen@mq.edu.au
Contact person for public queries
Name 120175 0
Dr Jessamine Chen
Address 120175 0
School of Psychological Sciences, Room 706, 4 First Walk, Macquarie University, Macquarie Park, NSW 2109
Country 120175 0
Australia
Phone 120175 0
+61 02 9850 9882
Fax 120175 0
Email 120175 0
Jessamine.Chen@mq.edu.au
Contact person for scientific queries
Name 120176 0
Dr Jessamine Chen
Address 120176 0
School of Psychological Sciences, Room 706, 4 First Walk, Macquarie University, Macquarie Park. NSW 2109
Country 120176 0
Australia
Phone 120176 0
+61 02 9850 9882
Fax 120176 0
Email 120176 0
Jessamine.Chen@mq.edu.au

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 public health data that cannot be shared.


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.