Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001174976
Ethics application status
Approved
Date submitted
5/10/2020
Date registered
9/11/2020
Date last updated
19/04/2023
Date data sharing statement initially provided
9/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Modified and tailored cognitive behavioural therapy to treat depression for stroke survivors with aphasia
Scientific title
Modified and tailored cognitive behavioural therapy to treat depression for stroke survivors with aphasia
Secondary ID [1] 302251 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ADaPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-stroke depression 318969 0
Aphasia 318970 0
Condition category
Condition code
Mental Health 316936 316936 0 0
Depression
Stroke 317088 317088 0 0
Ischaemic
Stroke 317089 317089 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baseline (Phase A)
Following consent procedures, baseline data collection will be completed using the measures below, twice weekly for a number of weeks (randomised to either 2.5, 4.5, or 6.5 weeks – following a randomised multiple baseline design). Initially data will be collected in person to ensure data integrity. However, telephone, mail out and computer-based prompting to complete measures will be considered, dependent on participant ability. The measures collected are listed below.
• Demographic and Medical Information – Data and Contact Sheet (patient, close other or hospital with consent) – initial contact only
• Depression Intensity Scale Circles (DISCs) – twice weekly
• Stroke Aphasic Depression Questionnaire-Community 10 (SADQ-C10; close other) – twice weekly
• Subjective Units of Distress Measure – Depressive Symptoms Adapted for Aphasia (SUDS-DA; patient) – twice weekly
• Subjective Units of Distress Measure – Anxiety Symptoms Adapted for Aphasia (SUDS-AA; patient) – twice weekly
• Western Aphasia Battery (WAB-R; patient) – initial contact only
• Behavioural Outcomes of Anxiety (BOA; close other) – twice weekly
• Assessment for Living with Aphasia (ALA; patient) – initial contact only
• Aphasia-friendly EQ5D (CPI-3L, UKPI-3L, or UKPI-5L; patient) – initial contact and at the end of follow up

Intervention (Phase B: 10 sessions over 4 months)
Participants will begin their intervention of cognitive behavioural therapy tailored to the cognitive consequences of stroke and using supported communication techniques, in line with the Tailored Cognitive Behavioural Therapy for Aphasia (TCBTA) protocol. All therapy sessions will be delivered by a clinical neuropsychologist with more than eighteen years’ experience and with extensive experience in conducting tailored psychological interventions with stroke survivors. They will be conducted at the Thinking Matters’ clinic in Elwood, or via video-conferencing platform. It is anticipated that most participants will complete therapy in approximately 10 sessions; however, some variability is expected. Sessions will begin weekly, progressing to fortnightly (e.g., 6 weekly sessions followed by 4 fortnightly sessions), with homework undertaken between sessions. During this intervention phase, data collection will continue as per the baseline phase. That is, twice-weekly completion of the following measures: DISCs (patient), SADQ-10C (close other), SUDS-DA (patient), SUDS-AA (patient), BOA (close other).

Following completion of the therapy, the participant will be invited to complete a semi-structured interview which will explore their qualitative experience of the therapy.

Following completion of therapy, a 4-week follow up (Phase A) will commence. At the end of the follow-up phase, the patient will again complete the aphasia-friendly EQ5D. Subsequently, two booster sessions will be provided over four weeks (Phase C). Following completion of the booster sessions, a second 4-week follow up (Phase A) will commence. As per all previous phases, the DISCs, SADQ-10C, SUDS-DA, SUDS-AA and BOA will be completed twice weekly.

Therapy sessions will be audio recorded for the purpose of ensuring quality of the treatment. In order to ensure fidelity to the protocol, some participants may need to be video-recorded, as the nature of aphasia communication may involve a lot of non-verbals. The CBT programme follows a manualised treatment regimen. To measure the quality of this intervention, and standardise its delivery, sessions will be recorded and reviewed at a later date. This is to ensure that the delivery of the clinical intervention is consistent with the regimen prescribed in the manual. Specifically, this analysis is called: Therapist Treatment Adherence Analysis. A second researcher on this study (i.e., not the clinical neuropsychologist delivering the intervention) will review 20% of the recorded sessions and compare the content to the treatment manual. Adherence of 80% or more will be considered adequate.
Intervention code [1] 318537 0
Treatment: Other
Intervention code [2] 318763 0
Behaviour
Comparator / control treatment
Randomised multiple baseline design (participants begin the intervention following a baseline period of 2.5, 4.5, or 6.5 weeks). During the baseline period, participants will not undergo any intervention, but data collection will be conducted twice weekly using all outcome measures.
Control group
Active

Outcomes
Primary outcome [1] 325041 0
The primary outcome measure is the Depression Intensity Scale Circles (DISCs), a 6-point ordinal graphic rating scale depicting six circles with an increasing proportion of dark shading which represents severity of depression.
Timepoint [1] 325041 0
Administered twice-weekly throughout the baseline, intervention, and follow-up phases.
Secondary outcome [1] 386649 0
Subjective Units of Distress Measure - Depressive Symptoms Adapted for Aphasia (SUDS-DA), a 10-point scale completed by stroke participants.
Timepoint [1] 386649 0
Administered twice-weekly over the baseline, intervention, and follow-up phases.
Secondary outcome [2] 386650 0
Stroke Aphasic Depression Questionnaire - Community 10 (SADQ-C10) will be used as the generalisation dependent variable.
Timepoint [2] 386650 0
The close other will complete this questionnaire twice-weekly over the baseline, intervention, and follow-up phases.
Secondary outcome [3] 386651 0
Behavioural Outcomes of Anxiety (BOA), a 10-item questionnaire to assess anxiety after stroke.
Timepoint [3] 386651 0
A close other will complete this questionnaire twice-weekly over the baseline, intervention, and follow-up phases.
Secondary outcome [4] 397443 0
Subjective Units of Distress Measure - Depressive Symptoms Adapted for Aphasia (SUDS-DA), a 10-point scale completed by stroke participants.
Timepoint [4] 397443 0
Administered twice-weekly over the baseline, intervention, and follow-up phases.

Eligibility
Key inclusion criteria
Recent ischaemic or haemorrhagic stroke; clinical diagnosis of aphasia (either receptive, expressive or both) from a speech pathologist using the Western Aphasia Battery (WAB-R); self-reported (score of 2 or more on the Depression Intensity Scale Circles (DISCs)) low mood; capacity to consent (with assistance) to research participation; and capacity and availability to engage in a multi-session therapeutic program with a private clinical neuropsychologist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Individuals under the age of 18 years are not eligible to participate in the project as we are
interested in the efficacy of this intervention in the adult population.
2. Individuals with a previous or concurrent major neurological (e.g. head injury, dementia) or
psychiatric (e.g. schizophrenia, bipolar disorder) history will be excluded as these variables will likely confound the results and limit the conclusions that can be drawn from the study. Individuals with a long psychiatric history or progressive neurological conditions will likely experience a different treatment effect; therefore, it will be difficult to draw conclusions about the intervention if these individuals are included.
3. Individuals who are not able to engage and do not have access to transport to attend a multi-session (approximately 10 sessions) therapeutic program with a private clinical neuropsychologist. The clinic is centre-based and there is no funding for home based interventions; therefore, the individual would need to be able to arrange their own transport to the clinic.

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
Other
Other design features
Randomised multiple baseline design (participants begin the intervention following a baseline period of 2.5, 4.5, or 6.5 weeks). Participants are allocated at random, with three participants for each baseline length.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will include both visual and statistical inspection of the outcomes. The raw data record of the outcome measures will be graphed using Graphpad Prism 7 to allow for visual inspection, separately for all nine participants, and separately for the four dependant variables (DVs): DISCs (primary DV), SUDS-DA, SADQ-10C (generalisation DV), SUDS-AA, and BOA. Structured visual analysis will be conducted within and between phases, in accordance with established guidelines (Gast & Spriggs, 2010), and focus on level (magnitude), trend/slope (progress over time), variability (stability), immediacy of phase effect, phase overlap, and consistency of similar phase data patterns. Quantitative statistical analysis across phases will be conducted using Tau-U, a non-overlap method which is robust in managing small data sets and outliers in data, and can control for effects of trend in the baseline (Parker, Vannest, & Davis, 2014; Parker, Vannest, Davis, & Sauber, 2011). Planned comparisons between adjacent conditions will investigate the efficacy of adapted CBT to treat depression in stroke survivors with aphasia. Results will be presented at the individual level as well as pooled across participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/01/2021
Actual
18/02/2021
Date of last participant enrolment
Anticipated
Actual
24/06/2022
Date of last data collection
Anticipated
Actual
16/01/2023
Sample size
Target
9
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306672 0
Government body
Name [1] 306672 0
National Health and Medical Research Council
Country [1] 306672 0
Australia
Funding source category [2] 306896 0
University
Name [2] 306896 0
Monash University
Country [2] 306896 0
Australia
Primary sponsor type
Individual
Name
A/Prof Rene Stolwyk
Address
Turner Institute for Brain and Mental Health
School of Psychological Sciences
18 Innovation Walk, Clayton Campus
Monash University
Clayton, Victoria 3800
Country
Australia
Secondary sponsor category [1] 307223 0
Individual
Name [1] 307223 0
Prof Ian Kneebone
Address [1] 307223 0
Graduate School of Health
University of Technology Sydney
Level 9, Building 20, 100 Broadway
Chippendale NSW 2008
Country [1] 307223 0
Australia
Secondary sponsor category [2] 307453 0
Individual
Name [2] 307453 0
Sonia Thomas
Address [2] 307453 0
Thinking Matters, Neuropsychological Rehabilitation Services
7 McCrae St
Elwood, Victoria 3184
Country [2] 307453 0
Australia
Secondary sponsor category [3] 307454 0
Individual
Name [3] 307454 0
Priscilla Tjokrowijoto
Address [3] 307454 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton, VIC 3800
Country [3] 307454 0
Australia
Secondary sponsor category [4] 307455 0
Individual
Name [4] 307455 0
Dr Brooke Ryan
Address [4] 307455 0
Graduate School of Health,
University of Technology Sydney
100 Broadway, Chippendale NSW 2008
Country [4] 307455 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306852 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 306852 0
Ethics committee country [1] 306852 0
Australia
Date submitted for ethics approval [1] 306852 0
09/10/2017
Approval date [1] 306852 0
26/03/2020
Ethics approval number [1] 306852 0
2020-7888-42464
Ethics committee name [2] 306855 0
University of Technology Sydney Human Research Ethics Expedited Review Committee
Ethics committee address [2] 306855 0
Ethics committee country [2] 306855 0
Australia
Date submitted for ethics approval [2] 306855 0
24/07/2020
Approval date [2] 306855 0
18/08/2020
Ethics approval number [2] 306855 0
UTS HREC REF NO. ETH20-5000

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

Contacts
Principal investigator
Name 105234 0
A/Prof Renerus John Stolwyk
Address 105234 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
18 Innovation Walk, Clayton Campus
Monash University
Clayton, Victoria 3800
Country 105234 0
Australia
Phone 105234 0
+61 3 990 20099
Fax 105234 0
Email 105234 0
[email protected]
Contact person for public queries
Name 105235 0
Priscilla Tjokrowijoto
Address 105235 0
Stolwyk Research Group
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton, Victoria 3800
Country 105235 0
Australia
Phone 105235 0
+61 411894941
Fax 105235 0
Email 105235 0
[email protected]
Contact person for scientific queries
Name 105236 0
Renerus John Stolwyk
Address 105236 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
18 Innovation Walk, Clayton Campus
Monash University
Clayton, Victoria 3800
Country 105236 0
Australia
Phone 105236 0
+61 3 990 20099
Fax 105236 0
Email 105236 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


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.