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Investigating the effect of the "Kalmer" relaxation intervention on emotional distress after stroke

A pilot study investigating the effect of the "Kalmer" relaxation intervention on emotional distress in people with Aphasia after stroke

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001051831
Acronym
REDS
Enrollment
11
Registered
2021-08-10
Start date
2022-02-22
Completion date
2023-05-31
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 t

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.

Sponsors

University of Technology Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Participants presenting with active suicidal ideation. Participants with psychosis.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026