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Trial registered on ANZCTR


Registration number
ACTRN12620000209998p
Ethics application status
Submitted, not yet approved
Date submitted
15/01/2020
Date registered
20/02/2020
Date last updated
20/02/2020
Date data sharing statement initially provided
20/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising mental health and wellbeing after post-stroke aphasia
Scientific title
Optimising mood and wellbeing with aphasia after stroke: a feasibility study of PRevention Intervention and Support in Mental health (PRISM).
Secondary ID [1] 300270 0
Nil
Universal Trial Number (UTN)
Trial acronym
Aphasia PRISM
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Post-stroke aphasia 315848 0
Condition category
Condition code
Stroke 314130 314130 0 0
Ischaemic
Stroke 314131 314131 0 0
Haemorrhagic
Neurological 314236 314236 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aphasia and communication support with self-selection of 1 of 3 psychological therapies: behavioural activiation; problem-solving therapy; or relaxation therapy.
The therapy will include the following: Participants will be provided with therapy worksheets for use in therapy session and home practice. Intervention providers will be provided with a therapy manual which includes instructions and therapy content for each therapy session.
Procedures include:
Behavioural activation: 7 x individual therapy sessions (preferably face to face with clinician or via phone/telehealth with clinician if unable to attend in person for up to 2 sessions) covering following themes:
-Identifying meaningful activities
-Structuring and scheduling activities
-Consistent daily activation
-Overcoming barriers
Problem-solving therapy: 7 x individual therapy sessions (preferably face to face with clinician or via phone/telehealth with clinician if unable to attend in person for up to two sessions) covering following themes:
-Identifying problems
-Listing solutions
-Potential consequences
-Best strategies
-Plan actions, implement plan and review results
Relaxation therapy: 7 x individual therapy sessions (preferably face to face with clinician or via phone/telehealth with clinician if unable to attend in person for up to two sessions) covering following themes:
-Explaining the relaxation response
-How & when to use relaxation exercises
-Practice of strategies (e.g., breathing & how to tense and relax muscles throughout the body)
-Planning to do relaxation exercises regularly and independently
- each of the procedures, activities, and/or processes used, including any enabling or support activities;
Intervention provider will be a qualified stroke health professional (Grade 1,2 or 3 clinician and experience with managing at least one person with aphasia in past 12 months). They will be trained by the research team in supported conversation for adults with aphasia (SCA) and all therapy types (behavioural activation; problem solving; relaxation therapy). Supervision will be available from senior allied health team members/managers and/or medical staff in the clinical setting as required. The research team will offer regular supervision and support to the intervention providers as required (composed of psychologists and speech pathologists).
Mode of delivery: individual sessions and face to face. Up to 2 sessions may be via telehealth/phone if participant unable to attend in person (dependent on communication skills).
Intervention will be delivered 1 x session per week (30-60 mins) for 7-8 week duration.
The intervention will occur at community centre or participant's home.
Intervention providers will keep a therapy log sheet and video-record up to 2 therapy sessions per participant to monitor intervention fidelity.
Intervention code [1] 316546 0
Rehabilitation
Intervention code [2] 316629 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322518 0
Acceptability of intervention to participants with aphasia - rating out of 10 of individual sessions/overall program; topic guide questions in qualitative interview
Timepoint [1] 322518 0
Rating out of 10: weekly sessions; immediately post-intervention (8 weeks) and follow-up (3 months)
Qualitative interview: 1 to 6 weeks post-intervention
Secondary outcome [1] 379644 0
Composite secondary outcome - Recruitment and sampling through:
Recruitment rate per week (frequency of participants recruited per week)
barriers to recruitment (study specific survey and qualitative interviews with health professionals)
number of eligible participants (including proportion of eligible participants recruited) (percentage of proportion of those eligible and those who consent to participate).
Timepoint [1] 379644 0
Baseline
Secondary outcome [2] 379645 0
Composite secondary outcome - Data collection procedures and outcome measures through:
completion rates of outcome measures at time points (percentage of proportion of participants who complete outcome measures)
assessment duration (mean duration in minutes of assessment at pre, immediately post and follow-up)
experiences and preferences of assessments by participants (qualitative interview)
Timepoint [2] 379645 0
Baseline, immediately post-intervention and 3 months follow-up
Secondary outcome [3] 379646 0
Composite secondary outcome - Resource and ability to manage and implement through:
Acceptability of intervention to stroke health professionals using rating out of 10 and questionnaire items of usefulness (study specific rating tool and qualitative interview)
Experiences, barriers and facilitators of the recruitment, training, content and delivery of intervention reported by stroke health professionals (in semi-structured interviews)
Scores on a study specific survey Likert scale (knowledge and skills) reported by stroke health professionals
Fidelity monitoring of log sheets; sample of video-recorded therapy sessions.
Timepoint [3] 379646 0
Pre-post training (knowledge and skills of health professionals); during intervention and post-intervention (fidelity monitoring) and 1 to 6 weeks post intervention (qualitative interviews).
Secondary outcome [4] 379659 0
Stroke Aphasic Depression Questionnaire-10 (SADQ-10) (completed by family member);








Timepoint [4] 379659 0
Baseline, immediately post-intervention (8 weeks) and follow-up (3 months)
Secondary outcome [5] 380184 0
Depression Intensity Scale Circles (DISCs);
Timepoint [5] 380184 0
Baseline, prior to weekly therapy sessions, post-intervention (8 weeks) and follow up (3 months)
Secondary outcome [6] 380185 0
Behavioural Outcomes of Anxiety (BOA) (completed by family member);
Timepoint [6] 380185 0
Baseline, immediately post-intervention (8 weeks) and follow-up (3 months)
Secondary outcome [7] 380186 0
Stroke and Aphasia Quality of Life scale-39;
Timepoint [7] 380186 0
Baseline, immediately post-intervention (8 weeks) and follow up ( 3 months)
Secondary outcome [8] 380187 0
Communication Confidence Rating Scale;
Timepoint [8] 380187 0
Baseline, immediately post-intervention (8 weeks) and follow up ( 3 months)
Secondary outcome [9] 380188 0
Community Integration Questionnaire;
Timepoint [9] 380188 0
Baseline, immediately post-intervention (8 weeks) and follow-up (3 months)
Secondary outcome [10] 380189 0
Western Aphasia Battery-Revised Aphasia Quotient.
Timepoint [10] 380189 0
Baseline, immediately post-intervention (8 weeks) and follow-up (3 months)
Secondary outcome [11] 380190 0
General Health Questionnaire-12 (for family members only)
Timepoint [11] 380190 0
Baseline, immediately post-intervention (8 weeks) and follow-up (3 months)

Eligibility
Key inclusion criteria
1) Adults aged 18 years or over and diagnosed with aphasia due to stroke
Subclinical/low symptoms of depression/anxiety: i.e. Stroke Aphasic Depression Questionnaire-10 (SADQ) score of equal to or less than 8 (community version) or equal to or less than 12 (hospital version) and Behavioural Outcomes of Anxiety score of equal to or less than 17 and Depression Intensity Scale Circles equal to or less than 3
2) Adequate hearing, vision skills and English skills to participate in intervention as judged by stroke health professional
3) Up to 5 years post-stroke and aphasia onset
4) Capacity to consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Concomitant progressive neurological disorder (e.g. dementia)
2) Mental health illness or above threshold symptoms of depression/anxiety: i.e. Stroke Aphasic Depression Questionnaire-10 (SADQ) score of > 8 (community version) or > 12 (hospital version) and Behavioural Outcomes of Anxiety score of > 17 and Depression Intensity Scale Circles > 3
3) Participant in other aphasia or psychological care/mental health study

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Up to participants can complete the feasibility study with resources allocated. Sampling for maximum variation of participants across 3 community centres as per characteristics of aphasia severity (mild, mod and severe) and gender (male and female).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15622 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 29024 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 304693 0
Charities/Societies/Foundations
Name [1] 304693 0
Speech Pathology Australia
Address [1] 304693 0
1/114 William St Melbourne VIC 3000
Country [1] 304693 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive
Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 305005 0
Hospital
Name [1] 305005 0
Monash Health
Address [1] 305005 0
Clayton Rd
Clayton VIC 3168
Country [1] 305005 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305113 0
Monash Health
Ethics committee address [1] 305113 0
Clayton Rd
Clayton VIC 3168
Ethics committee country [1] 305113 0
Australia
Date submitted for ethics approval [1] 305113 0
22/01/2020
Approval date [1] 305113 0
Ethics approval number [1] 305113 0

Summary
Brief summary
Aphasia, an acquired communication disorder occurs in a third of the stroke population. It affects the ability to talk, understand, read and write. Aphasia also negatively impacts on the person's self-identity, relationships, work and daily activities. People with aphasia commonly experience depression and/or anxiety. However, there is a treatment gap in provision of modified psychological care for the communication disability associated with aphasia. This study will feasibility test a new program 'Aphasia PRevention and Support in Mental health' (PRISM) - a level 1, evidence-based communication support and psychological therapy to optimise mood and wellbeing. A mixed methods approach will be used to investigate the acceptability of the therapy program to participants in a community setting. Participants will participate in qualitative interviews and complete clinically valid and feasible outcome measures (e.g., acceptability ratings, mood, quality of life, communication confidence and community integration measures). Data will be collected and analysed. Findings will be disseminated via publications and conference presentations.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99310 0
Dr Caroline Baker
Address 99310 0
La Trobe University
Centre of Research Excellence in Aphasia Recovery and Rehabilitation
Kingsbury Drive
Bundoora VIC 3086
Country 99310 0
Australia
Phone 99310 0
+61 3 94791802
Fax 99310 0
Email 99310 0
C.Baker@latrobe.edu.au
Contact person for public queries
Name 99311 0
Dr Caroline Baker
Address 99311 0
La Trobe University
Centre of Research Excellence in Aphasia Recovery and Rehabilitation
Kingsbury Drive
Bundoora VIC 3086
Country 99311 0
Australia
Phone 99311 0
+61 3 94791802
Fax 99311 0
Email 99311 0
C.Baker@latrobe.edu.au
Contact person for scientific queries
Name 99312 0
Dr Caroline Baker
Address 99312 0
La Trobe University
Centre of Research Excellence in Aphasia Recovery and Rehabilitation
Kingsbury Drive
Bundoora VIC 3086
Country 99312 0
Australia
Phone 99312 0
+61 94791802
Fax 99312 0
Email 99312 0
C.Baker@latrobe.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
Not intended for wider use beyond current study as per ethics application.
What supporting documents are/will be available?
No other documents available
Summary results
No Results