Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000869673
Ethics application status
Approved
Date submitted
31/05/2023
Date registered
14/08/2023
Date last updated
14/08/2023
Date data sharing statement initially provided
14/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
COGtrain (cognitive training program) for women's mental health
Scientific title
COGtrain: The feasibility of a cognitive training program addressing women's cognitive function and mental health
Secondary ID [1] 309373 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
Mental health difficulties 329591 0
Mild cognitive impairment 330297 0
Condition category
Condition code
Mental Health 326518 326518 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 327156 327156 0 0
Other mental health disorders
Neurological 327157 327157 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive training may offer some promise in improving cognitive functioning. The type of cognitive training suggested to have the most generalisable benefits is an approach that employs ‘‘top-down’’ strategy training, with the aim of supporting memory skills, concentration, decision-making, and goal-directed behaviour.

The training program will incorporate i)individualised goal setting; ii) psychoeducation to explain how mood and trauma exposure can change the way we think (i.e. cognition) and iii) strategies for training different cognitive skills, including memory, attention, problem-solving and decision making, inhibitory control and emotion regulation. The topics covered during the 8 sessions will be the following: Introduction, Organisation, Problem Solving and Decision Making, Attention, Memory Skills, Emotional Regulation, Cognitive Flexibility, and Pulling Everything Together/Reflections/Feedback.

Mode of training will include psychoeducational content/lessons, interactive activities (group activities including acting out scenarios/case studies, memory and active listening challenges; individual activities including completing personalised wellness wheels, personality inventories), reflection and group discussion, mindfulness practice, short videos, homework activities (such as journaling, creative expression challenges, keeping attention logs). The frequency/duration of the intervention will be 1 x 2.5 hours session per week for eight weeks. The mode of administration will be face-to-face group sessions. Sessions will be co-facilitated by a neuropsychologist (principal investigator) and Cabrini mental health clinical staff. Session attendance checklists will be used to monitor adherence. Allocation will be determined by participants' choice to participate in COGTrain, or to participate in the control group while maintaining treatment as usual.
Intervention code [1] 325808 0
Treatment: Other
Comparator / control treatment
Treatment as usual: participants receive existing treatments in the course of standard care (information will be recorded as to any outpatient therapy programs the TAU group are receiving).
Control group
Active

Outcomes
Primary outcome [1] 334363 0
Primary outcome: Change in perceived or subjective cognitive functioning (Perceived Deficits Questionnaire - Depression (PDQ-D))
Timepoint [1] 334363 0
The outcomes will be measured at baseline and at week 8 (following 8 COGtrain sessions).
Primary outcome [2] 335034 0
Feasibility: To evaluate participants' overall satisfaction with COGtrain as well as gauge the perceived effectiveness of the treatment, a Likert scale survey will be used. Additional Likert scale questions will be used to assess more specific aspects of feasibility such as session duration and frequency as well as explore any challenges or barriers encountered during the study. To obtain suggestions for improvements or modifications to enhance the feasibility and acceptability of the training for future larger-scale studies, open-ended interview questions will be asked in an online feedback form at the completion of COGtrain, and results will be analysed using content analysis. These will be used to assess feasibility as a composite outcome.
Timepoint [2] 335034 0
The outcome will be measured at week 8 (following 8 COGtrain sessions).
Secondary outcome [1] 420396 0
• Change in Neurocognition - Neuropsychological tasks including Digit Span, Rey Auditory
Verbal Learning Test, Verbal fluency; Trails A and B and Tower of London. These will be assessed as a composite outcome.
Timepoint [1] 420396 0
The outcomes will be measured at baseline and at week 8 (following 8 COGtrain sessions).
Secondary outcome [2] 422780 0
• Change in Mood Symptom Severity - Depression, Anxiety, Stress (DASS) scale. These will be assessed as a composite outcome.
Timepoint [2] 422780 0
The outcomes will be measured at baseline and at week 8 (following 8 COGtrain sessions).
Secondary outcome [3] 422781 0
• Change in emotion regulation - Difficulties in Emotion Regulation Scale (DERS)
Timepoint [3] 422781 0
The outcomes will be measured at baseline and at week 8 (following 8 COGtrain sessions).
Secondary outcome [4] 422782 0
• Change in experience of complex post-traumatic stress disorder symptoms International Trauma Questionnaire
Timepoint [4] 422782 0
The outcomes will be measured at baseline and at week 8 (following 8 COGtrain sessions).
Secondary outcome [5] 422783 0
• Functional achievement in relation to individual goal setting as measured by Goal Attainment Scaling scores
Timepoint [5] 422783 0
The outcome will be measured at week 8 (following 8 COGtrain sessions).

Eligibility
Key inclusion criteria
Mental health difficulties; self-reported difficulties with cognition
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Change of primary outcome (PDS) at final timepoint compared to baseline, between COGTrain treatment and TAU groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24462 0
Cabrini Health Elsternwick Rehabilition Service - Elsternwick
Recruitment postcode(s) [1] 40045 0
3185 - Elsternwick

Funding & Sponsors
Funding source category [1] 313569 0
Charities/Societies/Foundations
Name [1] 313569 0
The Perpetual Trustees
Country [1] 313569 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 315353 0
None
Name [1] 315353 0
n/a
Address [1] 315353 0
n/a
Country [1] 315353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312750 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 312750 0
Wellington Rd, Clayton VIC 3800
Ethics committee country [1] 312750 0
Australia
Date submitted for ethics approval [1] 312750 0
04/04/2023
Approval date [1] 312750 0
15/05/2023
Ethics approval number [1] 312750 0
37504

Summary
Brief summary
Perceived cognitive difficulties are prevalent in people with mood and complex trauma. This includes difficulties in concentration, attention, planning and organisation, capacity to multitask, processing speed, and recall. The consequences of cognitive impairment include reduction in self-esteem, capacity to absorb information, and procrastination, as well as increases in the time necessary to complete tasks and avoidance of decision making. Such
impairments can consequently impact individuals' performance at work, in relationships and in hobbies, and diminish the benefits of therapy. These circumstances necessitate the development of affordable and accessible interventions that can be offered to individuals experiencing cognitive function deficits associated with mood and trauma disorders.
Cognitive training has been shown to be efficacious in aging populations, and populations with mild cognitive impairment, psychosis, and mood disorders. There is clear scope to develop and implement cognitive training for mood and complex trauma disorders in women's mental health. The research activities outlined in this application will specifically address the mental health needs of women with mood and complex trauma disorders.
Gender differences in mental ill health are well documented. The proposed project seeks to improve symptoms of mood and complex trauma disorders in women by improving underlying problems in cognitive abilities. The outcomes of this cognitive training research will directly benefit women. The broader benefits of this research activity will help retain females in work and study, including perimenopausal women who often reduce their
engagement in the workforce. Hence, this research activity will aid age and gender diversification and expertise in the modern workforce.

The aim of this research is to design and implement a cognitive training program (COGtrain) tailored toward women’s mental health. That is, incorporating education about the influence of sex hormones and reproductive life events on mood and cognition. This research activity will employ an open-label feasibility trial design with the aims of (a) examining the feasibility of utilizing COGtrain among women with mood and complex trauma disorders and (b) determining whether COGtrain leads to significant improvements on measures of perceived cognitive impairment; neuropsychological and psychological functioning, and individual goal setting.
Trial website
n/a
Trial related presentations / publications
Public notes
n/a

Contacts
Principal investigator
Name 125770 0
A/Prof Caroline Gurvich
Address 125770 0
HER Center, Level 4, 607 St Kilda Road, St Kilda, VIC, 3182
Country 125770 0
Australia
Phone 125770 0
+61 417015489
Fax 125770 0
Email 125770 0
caroline.gurvich@monash.edu
Contact person for public queries
Name 125771 0
A/Prof Caroline Gurvich
Address 125771 0
HER Center, Level 4, 607 St Kilda Road, St Kilda, VIC, 3182
Country 125771 0
Australia
Phone 125771 0
+61 417015489
Fax 125771 0
Email 125771 0
caroline.gurvich@monash.edu
Contact person for scientific queries
Name 125772 0
A/Prof Caroline Gurvich
Address 125772 0
HER Center, Level 4, 607 St Kilda Road, St Kilda, VIC, 3182
Country 125772 0
Australia
Phone 125772 0
+61 417015489
Fax 125772 0
Email 125772 0
caroline.gurvich@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be deidentified and available in a group format.


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.