Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001460796
Ethics application status
Approved
Date submitted
2/11/2022
Date registered
17/11/2022
Date last updated
17/11/2022
Date data sharing statement initially provided
17/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Effect of Metacognitive Training (MCT-Silver) as a Community-Based Program on Outcomes of Depressive Symptoms in Older Adults
Scientific title
Outcomes for Older Adults with Depressive Symptoms: A Case Series Evaluating Metacognitive Training (MCT-Silver) in an Australian Community Sample
Secondary ID [1] 308313 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 328097 0
Condition category
Condition code
Mental Health 325153 325153 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MCT-Silver is a psychotherapeutic approach aimed to reduce depressive symptoms and improving thinking styles commonly associated with depression in older adults. MCT-Silver takes an educational approach, helping participants gain (metacognitive) distance from the cognitive biases and thinking styles thought to underlie the maintenance of depression, with particular focus on later-life experiences and symptomatology (i.e., geriatric depression).

MCT-Silver is run via videoconferencing with 8 x 1 hour sessions, bi-weekly (i.e., 2 sessions per week). Participants complete each session from home with a facilitator videoconferencing remotely. Attendance to sessions is recorded for each participant. Facilitators have at least an honours degree in psychology and undergo a six hour online training certification at least 2 weeks prior to their first session, to facilitate MCT-Silver via a manualised structure.

MCT-Silver consists of 8 modules, each explaining either a cognitive bias associated with depression (mental filters, black and white thinking, magnification/ minimisation, rumination/ withdrawal, jumping to conclusions) or a common ageing experience (memory, values, self-esteem).

The fundamental components of all modules are 1) an educational summary, 2) a demonstration of the negative consequences of the cognitive bias via examples and exercises, and 3) participants are offered an alternative thinking strategy which they practice in-session, using their own example. Each module follows this stepped approach that is guided by a facilitator and ends with a summary of learning points. Examples of exercises undertaken by participants include being asked to describe a situation they'd used an unhelpful cognitive bias, what was it in their behaviour/ situation that hints towards that cognitive bias, and what an alternative thought/ action may be. Other examples include brainstorming daily activities enjoyed by the participants and what values reflect that activity, and drawing a picture of how they view themselves vs drawing a picture of their ideal self.

Each session has a presentation that is screen-shared for the participant to follow and provides a summary of the information presented by the facilitator, instructions for activities and reference points to the workbook. A workbook is provided to participants that further explains and accompanies the information provided by the facilitator in-session. The workbook is used in-session where participants follow the demonstrations mirroring the on-screen content and complete the exercises. The workbook used in this study is an adaptation of the workbook used in the parent study by Schneider et al. (2018) (see public notes). The original workbook can be sourced at https://clinical-neuropsychology.de/metacognitive-training-for-depression-mct-silver/ . The workbook has been adapted and re-designed specifically for this study.

MCT-Silver is adapted to be run individually (participant + facilitator), or in small groups (3-4 participants + facilitator). Participants are given the choice of delivery preference and discuss this option with a facilitator prior to undertaking the program. MCT-Silver is also adapted such that sessions do not need to be run on the same day/ time each week, as long as 2 sessions per week is adhered to.
Intervention code [1] 324764 0
Behaviour
Intervention code [2] 324772 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332985 0
Depressive Symptoms as assessed by the Center for Epidemiological Studies- Depression scale (CES-D), total score
Timepoint [1] 332985 0
Baseline T1, 1-week follow-up (post conclusion of program: T2), 3-month follow up (post conclusion of program: T3)
Secondary outcome [1] 415436 0
Dysfunctional attitudes toward self, outside world, and future as assessed by the Dysfunctional Attitudes Scale DAS-18B
Timepoint [1] 415436 0
Baseline T1, 1-week follow-up (post conclusion of program: T2), 3-month follow up (post conclusion of program: T3)
Secondary outcome [2] 415464 0
Metacognitions as assessed by the Metacognitions Questionnaire (MCQ-30)
Timepoint [2] 415464 0
Baseline T1, 1-week follow-up (post conclusion of program T2), 3-month follow-up (post conclusion of program T3)
Secondary outcome [3] 415467 0
Positive and negative affect as assessed by the Positive and Negative Affect Scale (PANAS)
Timepoint [3] 415467 0
Basline T1, 1-week follow-up (post conclusion of program T2), 3-month follow-up (post conclusion of the program T3)
Secondary outcome [4] 415468 0
Psychosocial quality of life as assessed by the Assessment of Quality of Life (AQoL-8D) psychosocial sub-scales (mental health, relationships, coping, self-worth, happiness). These sub-scales will be assessed as a composite secondary outcome.
Timepoint [4] 415468 0
Baseline T1, 1-week follow-up (post conclusion of program T2), 3-month follow-up (post conclusion of program T3)
Secondary outcome [5] 415469 0
Feasibility of MCT-Silver; as assessed by a 23-item 5-point likert scale evaluation questionnaire (e.g., MCT-Silver was useful and appropriate for my needs, I felt the program took my age into consideration), and 2 open-ended questions (what were the best aspects of the program? What could be improved?)
Timepoint [5] 415469 0
1-week follow-up (post conclusion of program T2)
Secondary outcome [6] 415790 0
State-based mood as assessed by the Positive and Negative Affect Scale (PANAS)
Timepoint [6] 415790 0
Start of week 2 (module 3 of the program), start of week 3 (module 5 of the program), start of week 4 (module 7 of the program).
Secondary outcome [7] 415791 0
Adherence and attrition rates will also be used to indirectly assess feasibility. Adherence will be assessed by number of sessions attended by each participant, and attrition will be assessed by the ratio of completion to non-completion of the program (i.e., withdrawal rate). A spreadsheet will track dates of enrolment, dates of sessions attended, dates of withdrawal. An audit of this spreadsheet will provide a composite overview of adherence and attrition.
Timepoint [7] 415791 0
1-week follow-up (post conclusion of program T2)

Eligibility
Key inclusion criteria
1) Must score greater than (or equal to) 7 on the Depression Anxiety and Stress Scale (DASS), depression subscale
2) Must live in Australia
3) Must speak, read and understand english and have the ability to understand and follow instructions
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of Mild Cognitive Decline (MCI) or dementia, confirmed by self-report

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)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/12/2022
Actual
Date of last participant enrolment
Anticipated
30/05/2023
Actual
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 312559 0
University
Name [1] 312559 0
Flinders University
Country [1] 312559 0
Australia
Funding source category [2] 312568 0
Charities/Societies/Foundations
Name [2] 312568 0
Breakthrough Mental Health Research Foundation
Country [2] 312568 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 314179 0
None
Name [1] 314179 0
Address [1] 314179 0
Country [1] 314179 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311888 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 311888 0
GPO Box 2100, Adelaide SA 5001
Ethics committee country [1] 311888 0
Australia
Date submitted for ethics approval [1] 311888 0
19/04/2022
Approval date [1] 311888 0
20/05/2022
Ethics approval number [1] 311888 0
5215

Summary
Brief summary
Depression in older adulthood is a risk factor for social isolation, poor health behaviours, and cognitive decline. Despite recognition as a debilitating risk factor for poor wellbeing outcomes, there remains a significant treatment gap for older adults seeking treatment for depressive symptoms. Hence, there is an opportunity to bridge this gap by addressing barriers of cost, effectiveness and accessibility. MCT-Silver is a novel, low-threshold, educational intervention that combines components of Cognitive Behavioural Therapy for depression with Metacognitive Training, targeting the problematic thinking styles that underlie depression. Content of MCT-Silver has been redesigned to specifically suit older adults. For example, modules emphasise the importance of constructive lifestyle changes, (re)defining values later in life, and at the same time, recognising the value of acceptance in response to age-related loss.

MCT-Silver will be piloted amongst older adults in the Australian community who self-identify with depressive symptoms. The primary aim of this project is to determine the effectiveness of MCT-Silver for reducing depressive symptoms and improving unhelpful thinking styles. The secondary aim of this project is to assess feasibility of the MCT-Silver program in an online, videoconference format. Feasibility will also be assessed by offering both group-based and one-on-one settings, as well as measuring adherence and attrition. It is also expected MCT-Silver will be positively evaluated by older adults as a measure of effectiveness.

Primary hypothesis: It is expected that older adults who complete MCT-Silver will show reduction in self-reported depression, depression-associated dysfunctional thinking styles, as well as improvements in quality of life and mood improvement.
Trial website
Trial related presentations / publications
Public notes
This study is a replication and extension of the below study:

Schneider, B.C., Bücker, L., Riker, S., & Jelinek, L. (2018). A pilot study of Metacognitive Training for Depression in older adults. Zeitschrift für Neuropsychologie, 29, 7-19.

Contacts
Principal investigator
Name 122726 0
Dr Ryan Balzan
Address 122726 0
School of Psychology Social Sciences North GPO Box 2100 Adelaide, 5001, South Australia
Country 122726 0
Australia
Phone 122726 0
+61 8 82013082
Fax 122726 0
Email 122726 0
ryan.balzan@flinders.edu.au
Contact person for public queries
Name 122727 0
Dr Ryan Balzan
Address 122727 0
School of Psychology Social Sciences North GPO Box 2100 Adelaide, 5001, South Australia
Country 122727 0
Australia
Phone 122727 0
+61 8 82013082
Fax 122727 0
Email 122727 0
ryan.balzan@flinders.edu.au
Contact person for scientific queries
Name 122728 0
Dr Ryan Balzan
Address 122728 0
School of Psychology Social Sciences North GPO Box 2100 Adelaide, 5001, South Australia
Country 122728 0
Australia
Phone 122728 0
+61 8 82013082
Fax 122728 0
Email 122728 0
ryan.balzan@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified line-by-line data
When will data be available (start and end dates)?
immediately following publication, ending 10 years following main results publication
Available to whom?
Case-by-case basis at the discretion of the principle investigator
Available for what types of analyses?
only to achieve the aims in the approved proposal(s)
How or where can data be obtained?
Access subject to approval by principle investigator (ryan.balzan@flinders.edu.au)


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.