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A randomised controlled trial of combined Cognitive Rehabilitation and Psychological Intervention following stroke.

A randomised controlled trial of combined Cognitive Rehabilitation and Psychological Intervention for memory dysfunction following stroke.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001445864
Enrollment
1
Registered
2021-10-25
Start date
2022-05-17
Completion date
2022-05-17
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

This study aims to evaluate the effectiveness of a combined 6 week Cognitive Rehabilitation and Psychological intervention delivered via Telehealth in improving patient outcomes post-stroke in a pragmatic randomised wait-list controlled trial. It is expected that the proposed intervention will improve patients’ cognition, psychological wellbeing, functional abilities and QoL. Eighty participants with a diagnosis of stroke within the previous 6-months and self-reported cognitive or psychological difficulties referred to the ISLHD Rehabilitation and Medical Psychology Department by multidisciplinary teams on Rehabilitation and Neurology wards within ISLHD, will be randomised to a 6-week combined Cognitive Rehabilitation and Psychological Telehealth Intervention or Waitlist Control Group. Participants will attend an assessment session prior to the Group, immediately following the Group, and at 3 months follow up after completing group, and will be assessed with a varied of neuropsychological tests (primary outcome measure being RAVLT) and psychological wellbeing measures (DASS-21) and quality of life(SF-36) .

Interventions

The manualised Making the Most of your Memory: An everyday Memory Skills Program (Radford, et al., 2012) adapted for Telehealth delivery (Lawson, et al., 2020), will be modified to include psychological intervention for managing distress, mood and anxiety commonly exacerbated following stroke. Weekly sessions will be 2.5 hours for 6 weeks in length and follow a consistent structure each week: (i) Psychoeducation on cognitive functioning, (ii) Introduction and practice of internal and external c

The manualised Making the Most of your Memory: An everyday Memory Skills Program (Radford, et al., 2012) adapted for Telehealth delivery (Lawson, et al., 2020), will be modified to include psychological intervention for managing distress, mood and anxiety commonly exacerbated following stroke. Weekly sessions will be 2.5 hours for 6 weeks in length and follow a consistent structure each week: (i) Psychoeducation on cognitive functioning, (ii) Introduction and practice of internal and external cognitive compensatory strategies, (iii) Education on Lifestyle factors (diet, sleep and exercise on cognitive function and wellbeing), and (iv) Psychoeducation and Practice of Psychological Strategies for mood and anxiety (eg. psychoeducation on emotional changes following stroke, including stress, depression and anxiety, cognitive and behavioural interventions including cognitive challenging of unhelpful thinking, behavioural interventions for low mood, stress management strategies including relaxation and mindfulness, and Value-based action). The mode of delivery will be telehealth sessions of 8 participants. They will be conducted by Clinical Psychologists and/or Clinical Neuropsychologists via PEXIP, a NSW Health approved platform with the capability to provide secure group-based intervention with presentation capabilities to display content and for interactive participant engagement. We will monitor attendance, engagement in skills practice during Group, and completion of homework tasks. Reference: Radford, K., Lah, S., Thayer, Z., Say, M. J., & Miller, L. A. (2012). Improving memory in outpatients with neurological disorders using a group-based training program. Journal of the International Neuropsychological Society: JINS, 18(4), 738. Lawson, D. W., Stolwyk, R. J., Ponsford, J. L., McKenzie, D. P., Downing, M. G., & Wong, D. (2020). Telehealth delivery of memory rehabilitation following stroke. Journal of the International Neuropsychological Society, 26(1), 58-71.

Sponsors

Illawarra Shoalhaven Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Participants (i) must be at least 18 years of age, (ii) have a confirmed diagnosis of stroke within the previous 6 months and no longer in hospital, (iii) self-reported cognitive difficulties and/or adjustment concerns, which are confirmed by neuropsychological and clinical assessment on pre-testing, (iv) English as preferred language of use, (v) estimated premorbid full scale IQ greater than or equal to 80, (vi) access to a technology suitable for Telehealth, and (vii) ability to attend weekly sessions over a 6 week period, and an assessment session before and immediately after the intervention, as well as at 3 month follow up.

Exclusion criteria

(i) non-English speaking background, diagnosis (ii) diagnosis of a neurodegenerative disorder, (ii) diagnosis of traumatic brain injury or other serious neurological condition eg. epilepsy or brain tumour, (iii) diagnosis of premorbid psychiatric illness (other than mood or anxiety) or (iv) severe physical, language or cognitive deficits that are not able to be otherwise supported and prevent engagement with the Telehealth intervention.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026