Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001051831
Ethics application status
Approved
Date submitted
28/06/2021
Date registered
10/08/2021
Date last updated
10/05/2023
Date data sharing statement initially provided
10/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of the "Kalmer" relaxation intervention on emotional distress after stroke
Scientific title
A pilot study investigating the effect of the "Kalmer" relaxation intervention on emotional distress in people with Aphasia after stroke
Secondary ID [1] 304128 0
none
Universal Trial Number (UTN)
NA
Trial acronym
REDS
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
anxiety 321816 0
depression 321817 0
stroke 321818 0
aphasia 321819 0
Condition category
Condition code
Stroke 319547 319547 0 0
Haemorrhagic
Stroke 319548 319548 0 0
Ischaemic
Mental Health 319549 319549 0 0
Anxiety
Mental Health 319550 319550 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All ten participants will have access to the online and self-managed "kalmer" relaxation video intervention via a log in. Participants will have a choice between progressive muscle relaxation, yogic breathing, or imaginal relaxation tasks to complete for five days a week for five weeks for as many minutes/hours as they like. Progressive muscle relaxation involves tensing and releasing of the major muscles in the body (e.g. legs, chest, shoulders etc.) while engaging in deep breathing to remove tension in the body. Yogic breathing involves deep diaphragmatic breathing to slow down the heart rate and increase blood flow to the brain. Imaginal relaxation involves listening to a guided meditation and imagining a calming scene such as a beach or forest, while breathing slowly and deeply. Participants can choose ANY of the relaxation strategies to complete each day for the duration of the five week trial. Participants will also be given some psycho-education on anxiety and depression after stroke. This psycho-education will come in the form of a printable PDF document (designed specifically for the study by the research team) that provides basic information on what anxiety and depression is, how common it is after stroke, information on what relaxation it is and why it can be helpful, and information outlining that the "Kalmer" relaxation intervention was co-designed alongside 12 people with aphasia. Participants will also have the option of a weekly phone call (without a maximum duration) to the registered psychologist researcher for support with using the intervention. No additional counselling will be given. The mode of delivery will be online and be provided individually for participants and they can do the intervention in their homes or anywhere they choose. Treatment adherence will measured online to determine how often videos were completed throughout the trial.
Intervention code [1] 320463 0
Treatment: Other
Intervention code [2] 320464 0
Rehabilitation
Intervention code [3] 320465 0
Behaviour
Comparator / control treatment
Not applicable, all participants will receive this treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327406 0
Change in score on the Behavioural Outcomes of Anxiety
Timepoint [1] 327406 0
Pre-intervention, immediately post-intervention completion and 3 months follow up post-intervention completion..
Primary outcome [2] 327407 0
Change in score on the Stroke Aphasic Depression Questionnaire (10 items)
Timepoint [2] 327407 0
pre-intervention, immediately post-intervention completion and 3 months follow up post-intervention completion.
Primary outcome [3] 327408 0
Qualitative data will be collected in a semi-structured focus group (no maximum duration) and for participants who are unable to attend a focus group, a semi-structured one-on-one interview of no more than 1 hour will be used.
Timepoint [3] 327408 0
One week after completion of the intervention AND 3 months after completion of the intervention,
Secondary outcome [1] 394998 0
nil
Timepoint [1] 394998 0
nil

Eligibility
Key inclusion criteria
1. Score 80% or below on the Carer COAST scale (Long et al., 2009) a measure of communication ability completed by a carer.
2. A score of 17 or more on the Behavioural Outcomes of Anxiety scale completed by a carer and/or
3. A score of 6 or more in the Stroke Aphasia Depression Questionnaire (SADQ 10)
4. Support of a carer with regular (daily) contact with the person with aphasia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants presenting with active suicidal ideation.
Participants with psychosis.

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
No power calculations requires given this is a preliminary study. Improvement scores on anxiety and depression outcome measures will be reported on. For the qualitative data, a thematic analysis using an inductive approach will be used to analyse the data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/08/2021
Actual
22/02/2022
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
25/10/2023
Actual
Sample size
Target
12
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 25493 0
United Kingdom
State/province [1] 25493 0
United Kingdom

Funding & Sponsors
Funding source category [1] 308508 0
University
Name [1] 308508 0
University Of Technology Sydney
Country [1] 308508 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
100 Broadway, Sydney NSW 2008
Country
Australia
Secondary sponsor category [1] 309360 0
None
Name [1] 309360 0
NA
Address [1] 309360 0
NA
Country [1] 309360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308467 0
University of Technology Sydney Human Research Ethics Comittee
Ethics committee address [1] 308467 0
100 Broadway, Chippendale NSW 2008
Ethics committee country [1] 308467 0
Australia
Date submitted for ethics approval [1] 308467 0
23/09/2020
Approval date [1] 308467 0
28/10/2020
Ethics approval number [1] 308467 0
ETH20-5387

Summary
Brief summary
Anxiety and depression after stroke are associated with poor rehabilitation outcomes. High quality evidence on psychological treatments for these conditions in this population is lacking. Relaxation training is a proven treatment for anxiety in the non-stroke population and has shown promise in those with stroke. The aim of the proposed investigation is to investigate the effectiveness of this treatment for those with communication problems via a case series study. In this study 10 stroke survivors will complete relaxation training five times a week for five weeks and their depression and anxiety symptoms will be measured before and after treatment. Following this participants will be given the opportunity to provide feedback on the intervention. It is hypothesised that this relaxation video will reduce both anxiety and depressive symptoms in stroke survivors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110790 0
Prof Ian Kneebone
Address 110790 0
Graduate School of Health, School of Clinical Psychology, University of Technology Sydney, 100 Broadway, Chippendale NSW 2008
Country 110790 0
Australia
Phone 110790 0
+61 2 9514 4280
Fax 110790 0
NA
Email 110790 0
[email protected]
Contact person for public queries
Name 110791 0
Miss Rebecca El-Helou
Address 110791 0
Graduate School of Health, School of Clinical Psychology, University of Technology Sydney, 100 Broadway, Chippendale NSW 2008
Country 110791 0
Australia
Phone 110791 0
+61 424687505
Fax 110791 0
Email 110791 0
[email protected]
Contact person for scientific queries
Name 110792 0
Prof Ian Kneebone
Address 110792 0
Graduate School of Health, School of Clinical Psychology, University of Technology Sydney, 100 Broadway, Chippendale NSW 2008
Country 110792 0
Australia
Phone 110792 0
+61 2 9514 4280
Fax 110792 0
NA
Email 110792 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.