Digital Intervention + Cognitive Strategies for Post-Stroke Depression
Recruiting in Palo Alto (17 mi)
Overseen byAbhishek Jaywant, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Weill Medical College of Cornell University
Must be taking: Antidepressants
Disqualifiers: Receptive aphasia, Dementia, Psychosis, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial tests a new treatment for stroke patients with depression and thinking problems. The treatment uses an iPad app to train the brain and online coaching to teach new thinking strategies. It aims to improve mood, thinking skills, and daily functioning.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but if you are on an antidepressant, you must be on a stable dose for at least 8 weeks before joining the study.
What data supports the effectiveness of the treatment AKL-T01, an iPad-based cognitive training program, Metacognitive Strategy Training, and Enhanced Metacognitive Strategy Training for post-stroke depression?
Research shows that metacognitive strategy training can improve rehabilitation engagement and daily functioning in stroke patients, and cognitive training has been well received, leading to improvements in everyday functioning. These findings suggest that combining these approaches may help address cognitive and functional challenges in post-stroke depression.
12345Is the digital intervention with cognitive strategies safe for humans?
The digital intervention combining cognitive training and metacognitive strategy training has been found to be feasible and acceptable in individuals with chronic stroke, with high satisfaction and completion rates, indicating it is generally safe for humans.
36789How is the treatment for post-stroke depression using AKL-T01 and Metacognitive Strategy Training different from other treatments?
This treatment is unique because it combines a digital cognitive training program with metacognitive strategies, which are techniques to help patients think about their own thinking. This approach is different from traditional treatments that may focus solely on medication or talk therapy, as it specifically targets cognitive processes and uses technology to enhance recovery.
110111213Eligibility Criteria
This trial is for individuals who had their first stroke at least 6 months ago and are now experiencing moderate depression and executive dysfunction. They must be able to use an iPad, not have severe language or speech impairments, no major neurological conditions other than stroke, and if on antidepressants, they should be on a stable dose for at least 8 weeks.Inclusion Criteria
Able to adhere to all testing and study requirements and willingness to participate in the full study duration
I have been on the same dose of antidepressant for at least 8 weeks.
You have significant symptoms of depression, as measured by a specific scale, called the Montgomery Asberg Depression Rating Scale, with a score of 18 or higher.
+6 more
Exclusion Criteria
You have a history of severe mental illness like psychosis or mania.
You have severe problems with seeing or paying attention to half of your visual field.
I have a significant neurological condition, but not a stroke.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the digital intervention (AKL-T01) and metacognitive strategy coaching for post-stroke depression and executive dysfunction
6 weeks
Weekly virtual coaching sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests a digital therapeutic (iPad-based cognitive training) combined with metacognitive strategy training. It aims to improve cognitive skills, alleviate symptoms of depression, enhance daily functioning, and potentially affect brain connectivity in post-stroke patients.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AKL-T01Experimental Treatment2 Interventions
Participants in the intervention group will complete 25 minutes of AKL-T01 per day, 5 days/week, for 6 weeks. AKL-T01 trains rapid multitasking on an iPad in an immersive videogame-like environment. Participants complete go/no-go + navigation exercises by moving the iPad to navigate a character on a path while tapping when a certain stimulus is presented and ignoring other stimuli. Participants will also receive weekly 45-minute metacognitive strategy coaching sessions delivered by a clinician. Sessions use guided questions and worksheets (shared virtually) to help participants reflect on their experience with AKL-T01 and link it to daily functioning, generate strategies for daily activities, and explore any emotional responses that arise during gameplay.
Group II: Enhanced Metacognitive Strategy TrainingPlacebo Group1 Intervention
In the control group, participants will complete-at the same frequency and duration as the intervention group-iPad-based games designed to provide general cognitive stimulation (word searches, checkers, and "spot the differences" between two pictures). Concurrently with these cognitive stimulation games, participants will receive weekly metacognitive strategy coaching sessions akin to that described above.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Weill Cornell Medical CenterNew York, NY
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Who Is Running the Clinical Trial?
Weill Medical College of Cornell UniversityLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Psychometric properties of the post-stroke depression scale in the sequelae stage. [2023]To evaluate the psychometric properties of the Post-Stroke Depression Scale in the Sequelae Stage (PSDS-SS).
The feasibility of meta-cognitive strategy training in acute inpatient stroke rehabilitation: case report. [2021]Meta-cognitive strategy training may be used to augment inpatient rehabilitation to promote active engagement and subsequent benefit for individuals with cognitive impairments after stroke. We examined the feasibility of administering a form of meta-cognitive strategy training, Cognitive Orientation to daily Occupational Performance (CO-OP), during inpatient rehabilitation. We trained an individual with cognitive impairments after right hemisphere stroke to identify performance problems, set self-selected goals, develop plans to address goals, and evaluate performance improvements. To assess feasibility, we examined the number of meta-cognitive training sessions attended, the number of self-selected goals, and changes in goal-related performance. We also examined changes in rehabilitation engagement and disability. The participant used the meta-cognitive strategy to set eight goals addressing physically oriented, instrumental, and work-related activities. Mean improvement in Canadian Occupational Performance Measure Performance Scale scores was 6.1. Pittsburgh Rehabilitation Participation Scale scores (measuring rehabilitation engagement) improved from 3.2 at admission to 4.9 at discharge. Functional Independence Measure scores (measuring disability) improved from 68 at admission, to 97 at discharge. Performance Assessment of Self-Care Skills scores improved from 1.1 at admission to 2.9 at discharge. The results indicate that meta-cognitive strategy training was feasible during inpatient rehabilitation and warrants further evaluation to determine its effectiveness.
Feasibility of Augmenting Cognitive Strategy Training With Non-Invasive Brain Stimulation. [2023]Many individuals post-stroke have difficulty identifying if or how they can continue performing meaningful daily life tasks. The objective of this study was to evaluate the feasibility of metacognitive strategy training (MCST) and transcranial direct current stimulation (tDCS) in chronic stroke. A case series design was used. Participants completed 12 intervention sessions over 4 weeks consisting of 20 min of tDCS and 45 min of MCST to address occupational performance goals. Feasibility outcomes of acceptability and safety/tolerability were evaluated and measures of occupational performance were administered pre- and post-intervention. Participants perceived the intervention to be highly acceptable and relevant to their needs. Large improvements were observed for performance and satisfaction with goals trained (Hedge's g = 2.07 and 2.11, respectively) and untrained (Hedge's g = 1.25 and 1.43, respectively) within the intervention. An intervention combining MCST with tDCS was feasible to administer and positively received by stakeholders; further research is warranted.
The influence of self-efficacy, pre-stroke depression and perceived social support on self-reported depressive symptoms during stroke rehabilitation. [2022]Post-stroke depression (PSD) is the most common mental disorder following stroke; however, little is known about its pathogenesis. We investigated the predictive value and mutual relationship of psychological factors such as self-efficacy and social support and known risk factors such as pre-stroke depression, activities of daily living (ADL), cognitive functioning, and age for the emergence of depressive symptoms in the acute phase after stroke. Ninety-six ischaemic stroke inpatients residing at a rehabilitation centre completed an interview about 6.5 weeks post-stroke. The interview included demographic data, psychiatric anamnesis, the Barthel Index, Mini-Mental State Examination, Social Support Questionnaire, Generalized Self-Efficacy Scale, Stroke Self-Efficacy Questionnaire, and the Geriatric Depression Scale. A multiple regression analysis was performed to ascertain the predictive value of the factors on depressive symptoms. High self-efficacy, no history of pre-stroke depression, and high levels of perceived social support were the strongest protective factors for depressive symptoms. The influence of cognitive functioning on depressive symptoms was fully mediated by general self-efficacy, and general self-efficacy was a stronger predictor than stroke-specific self-efficacy. Neither ADL nor age significantly predicted depressive symptoms. Our findings suggest that consideration of self-efficacy and perceived social support in the inpatient rehabilitation setting may help prevent PSD.
A randomized control trial of the effects of home-based online attention training and working memory training on cognition and everyday function in a community stroke sample. [2023]Cognitive difficulties are common following stroke and can have widespread impacts on everyday functioning. Technological advances offer the possibility of individualized cognitive training for patients at home, potentially providing a low-cost, low-intensity adjunct to rehabilitation services. Using this approach, we have previously demonstrated post-training improvements in attention and everyday functioning in fronto-parietal stroke patients. Here we examine whether these benefits are observed more broadly in a community stroke sample. Eighty patients were randomized to either 4 weeks of online adaptive attention training (SAT), working memory training (WMT) or waitlist (WL). Cognitive and everyday function measures were collected before and after the intervention, and after 3 months. During training, weekly measures of patients' subjective functioning were collected. The training was well received and compliance good. No differences in our primary end-point, spatial bias, or other cognitive functions were observed. However, on patient-reported outcomes, SAT participants showed greater levels of improvement in everyday functioning than WMT or WL participants. In line with our previous work, everyday functioning improvements were greatest for patients with spatial impairments and those who received SAT training. Whether attention training can be recommended for stroke survivors depends on whether cognitive test performance or everyday functioning is considered more relevant.
Neurofeedback as a form of cognitive rehabilitation therapy following stroke: A systematic review. [2022]Neurofeedback therapy (NFT) has been used within a number of populations however it has not been applied or thoroughly examined as a form of cognitive rehabilitation within a stroke population. Objectives for this systematic review included: i) identifying how NFT is utilized to treat cognitive deficits following stroke, ii) examining the strength and quality of evidence to support the use of NFT as a form of cognitive rehabilitation therapy (CRT) and iii) providing recommendations for future investigations. Searches were conducted using OVID (Medline, Health Star, Embase + Embase Classic) and PubMed databases. Additional searches were completed using the Cochrane Reviews library database, Google Scholar, the University of Toronto online library catalogue, ClinicalTrials.gov website and select journals. Searches were completed Feb/March 2015 and updated in June/July/Aug 2015. Eight studies were eligible for inclusion in this review. Studies were eligible for inclusion if they: i) were specific to a stroke population, ii) delivered CRT via a NFT protocol, iii) included participants who were affected by a cognitive deficit(s) following stroke (i.e. memory loss, loss of executive function, speech impairment etc.). NFT protocols were highly specific and varied within each study. The majority of studies identified improvements in participant cognitive deficits following the initiation of therapy. Reviewers assessed study quality using the Downs and Black Checklist for Measuring Study Quality tool; limited study quality and strength of evidence restricted generalizability of conclusions regarding the use of this therapy to the greater stroke population. Progression in this field requires further inquiry to strengthen methodology quality and study design. Future investigations should aim to standardize NFT protocols in an effort to understand the dose-response relationship between NFT and improvements in functional outcome. Future investigations should also place a large emphasis on long-term participant follow-up.
Feasibility and Acceptability of a Remotely Delivered Executive Function Intervention That Combines Computerized Cognitive Training and Metacognitive Strategy Training in Chronic Stroke. [2023]Executive dysfunction after stroke is associated with limitations in daily activities and disability. Existing interventions for executive dysfunction show inconsistent transfer to everyday activities and require frequent clinic visits that can be difficult for patients with chronic mobility challenges to access. To address this barrier, we developed a telehealth-based executive function intervention that combines computerized cognitive training and metacognitive strategy. The goal of this study was to describe intervention development and to provide preliminary evidence of feasibility and acceptability in three individuals who completed the treatment protocol. The three study participants were living in the community and had experienced a stroke >6 months prior. We assessed satisfaction (Client Satisfaction Questionnaire-8 [CSQ-8]), credibility (Credibility and Expectancy Questionnaire), and feasibility (percent of sessions completed). All three subjects rated the treatment in the highest satisfaction category on the CSQ-8, found the treatment to be credible, and expected improvement. Participants completed a median of 96% of computerized cognitive training sessions and 100% of telehealth-delivered metacognitive strategy training sessions. Individuals with chronic stroke may find a remotely delivered intervention that combines computerized cognitive training and metacognitive strategy training to be feasible and acceptable. Further evaluation with larger samples in controlled trials is warranted.
The Effects of Computer Based Cognitive Rehabilitation in Stroke Patients with Working Memory Impairment: A Systematic Review. [2020]To evaluate benefits and harms for computer based cognitive rehabilitation (CBCR) on working memory impairment after stroke.
Online awareness of performance on a functional cognitive assessment in individuals with stroke: A case-control study. [2022]Unawareness is a significant barrier to cognitive rehabilitation following acquired brain injury. Little is known about online awareness of cognitively-based instrumental activities of daily living (C-IADL) after stroke, particularly C-IADLs that emphasize executive functions. Our goal was to evaluate in stroke patients (1) online awareness during and immediately after a C-IADL task that emphasizes executive functions and (2) the association between awareness and performance on the C-IADL task. Seventy-seven stroke patients on an acute inpatient rehabilitation unit and 77 control participants completed the 10-item Weekly Calendar Planning Activity (WCPA-10), a standardized C-IADL task that requires working memory, planning, shifting, and inhibition. Trained examiners observed the use of a self-checking strategy and self-recognition of errors during the task. Immediately after the task, participants estimated their accuracy, and rated their own performance, which was compared with objective accuracy. Relative to the control group, stroke patients overestimated their accuracy, less often recognized errors, and less frequently used a self-checking strategy. Overestimation was associated with worse overall performance on the WCPA-10. Findings suggest that poor online awareness of C-IADL performance is common in stroke patients undergoing acute inpatient rehabilitation. Increasing awareness through metacognitive interventions should be a core focus of early post-stroke cognitive rehabilitation.
Clinical studies on event-related potentials (ERPs) N400 and the related factors in patients with poststroke depression (PSD). [2017]To evaluate event-related potentials (ERPs), N400, and the related factors in patients with poststroke depression (PSD).
Lower cognitive control network connectivity in stroke participants with depressive features. [2020]Around one-third of people develop depression following ischaemic stroke, yet the underlying mechanisms are poorly understood. Post-stroke depression has been linked to frontal infarcts, mainly lesions in the left dorsolateral prefrontal cortex (DLPFC). But depression is a network disorder that cannot be fully characterised through lesion-symptom mapping. Researchers of depression in non-stroke populations have successfully tapped into the cognitive control network (CCN) using the bilateral DLPFC as a seed, and found that CCN resting-state connectivity is reduced in even mildly depressed subjects, compared to healthy controls. Hence, we aimed to investigate the association between post-stroke depressive features and the CCN resting-state connectivity in a stroke population. We analysed DLPFC resting-state connectivity in 64 stroke participants, 20 of whom showed depressive features assessed with the Patient Health Questionnaire (PHQ-9) at 3 months after stroke. We directly compared groups showing symptoms of depression with those who did not, and performed a regression with PHQ-9 scores in all participants, controlling for age, gender, lesion volume and stroke severity. Post-stroke depression was associated with lower connectivity between the left DLPFC and the right supramarginal gyrus (SMG) in both group and regression analyses. Neither the seed nor the results overlapped with stroke lesions. These findings confirm an important role of the left DLPFC in post-stroke depression, but now show that large-scale network disruptions following stroke associated with depressive features occur without lesions in the DLPFC.
Proposing a new stroke-specific screening tool for depression: Examination of construct validity and reliability. [2022]The optimal tool for identifying depression after stroke is yet to be identified. In the present study, we propose a new context-specific screening tool for PSD and examined its construct validity and reliability within existing data on recent stroke survivors.
Subthreshold depression and cognitive impairment but not demented in stroke patients during their rehabilitation. [2016]Subthreshold depression (sD) and cognitive impairment but not demented (CIND) in stroke patients are associated with poorer rehabilitative outcomes. Their diagnosis can easily be operationalized using validated scales.