Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT05162781
Collaborator
National Institute on Aging (NIA) (NIH), Posit Science (Other)
120
Enrollment
1
Location
4
Arms
39
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will compare two approaches to cognitive rehabilitation in adults with stroke with persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based computer "game" that trains cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. This training is termed Speed of Processing Training (SOPT). One approach will add (A) in-lab training on everyday activities with important cognitive components and (B) procedures designed to transfer improvements in cognition from the treatment setting to everyday life. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will add (A) in-lab training on relaxation, healthy nutrition, and healthy sleep and (B) procedures designed to promote integration of these lifestyle changes into everyday life. This approach is termed Brain Fitness-Heath Education Lifestyle Program (BF-HELP).

Both CICT and BF-HELP will involve 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life; The set of the latter procedures is termed the Transfer Package. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. Family caregivers in both groups will also receive training on how to best support participants in their therapeutic program.

The study will also test if there is an advantage to placing follow-up phone calls after treatment ends. The purpose of the calls will be to support transition of any behavioral changes achieved during treatment into everyday life on a long-term basis.

Participants will be randomly assigned to the interventions.

Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Speed of Processing Training
  • Behavioral: Instrumental Activities of Daily Living In-lab Training
  • Behavioral: Cognitive Transfer Packagke
  • Behavioral: Family Caregiver Coaching
  • Behavioral: Follow-up Phone Calls
  • Behavioral: Healthy Lifestyle In-lab Training
  • Behavioral: Healthy Lifestyle Transfer Package
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Half of the participants will receive CICT, which consists of SOPT, IADL training in the lab, and a Transfer Package targeting IADL performance outside it. The other half will receive BF-HELP, which consists of SOPT, in-lab training on relaxation, nutrition, and sleep hygiene, and a Transfer Package targeting implementation of these lifestyle changes outside it. Half of the CICT group will receive 15 follow-up phone calls over the course of one year. The other CICT participants will receive none. The same will apply to the BF-HELP group. The phone calls will support integration of the behavioral changes targeted during treatment to everyday life afterwards. For all participants, outcome testing will take place one month before treatment (Baseline 1), one day before treatment (Baseline 2 aka Pre-treatment), one day afterwards (Post-treatment), 6-months afterwards (6-month Follow-up), and 12-months afterwards (12-month follow-up). Randomization will take place after Baseline 2.Half of the participants will receive CICT, which consists of SOPT, IADL training in the lab, and a Transfer Package targeting IADL performance outside it. The other half will receive BF-HELP, which consists of SOPT, in-lab training on relaxation, nutrition, and sleep hygiene, and a Transfer Package targeting implementation of these lifestyle changes outside it. Half of the CICT group will receive 15 follow-up phone calls over the course of one year. The other CICT participants will receive none. The same will apply to the BF-HELP group. The phone calls will support integration of the behavioral changes targeted during treatment to everyday life afterwards. For all participants, outcome testing will take place one month before treatment (Baseline 1), one day before treatment (Baseline 2 aka Pre-treatment), one day afterwards (Post-treatment), 6-months afterwards (6-month Follow-up), and 12-months afterwards (12-month follow-up). Randomization will take place after Baseline 2.
Masking:
Single (Outcomes Assessor)
Masking Description:
Tester will be blinded to group assignment of participants.
Primary Purpose:
Treatment
Official Title:
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: CICT with Follow-up Phone Calls

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) shaping on IADL and (B) the Cognitive Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.

Behavioral: Speed of Processing Training
This training component targets cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. Cognitive processing speed is thought to be a basic capacity of the brain that underlies several other cognitive functions. Training is implemented using a web-based computer "game", in which participants are required to fixate on a target at the center of the screen and identify targets in the periphery. The game is made progressively more difficult, in small increments, as participants gain mastery by increasing the speed at which targets are presented and increasing the number of distractors.
Other Names:
  • SOPT
  • Behavioral: Instrumental Activities of Daily Living In-lab Training
    The training component is thought to bridge SOPT training, which targets a basic cognitive capacity, and IADL performance in daily life. This training component will involve repeated trials in which participants will practice carrying out simulated IADL tasks in the lab under the supervision of the trainer. The training will follow shaping principles, i.e., task requirements will be made progressively more challenging, in small increments, as participants gain mastery. Frequent, positive feedback will be provided.
    Other Names:
  • IADL In-lab Training
  • Behavioral: Cognitive Transfer Packagke
    This training component is designed to transfer improvements in cognition from the treatment setting to everyday life. Elements of this package include negotiating a behavioral contract about the roles of the participant and family caregiver in the treatment, monitoring behavior outside the lab, and assigning performance of IADL as homework.

    Behavioral: Family Caregiver Coaching
    One or more family members of the participant will receive coaching on how to best support the participant in carrying out the in-home components of the intervention.

    Behavioral: Follow-up Phone Calls
    After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis after.

    Experimental: CICT without Follow-up Phone Calls

    Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) shaping on IADL and (B) the Cognitive Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. No follow-up phone calls will be made after treatment ends.

    Behavioral: Speed of Processing Training
    This training component targets cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. Cognitive processing speed is thought to be a basic capacity of the brain that underlies several other cognitive functions. Training is implemented using a web-based computer "game", in which participants are required to fixate on a target at the center of the screen and identify targets in the periphery. The game is made progressively more difficult, in small increments, as participants gain mastery by increasing the speed at which targets are presented and increasing the number of distractors.
    Other Names:
  • SOPT
  • Behavioral: Instrumental Activities of Daily Living In-lab Training
    The training component is thought to bridge SOPT training, which targets a basic cognitive capacity, and IADL performance in daily life. This training component will involve repeated trials in which participants will practice carrying out simulated IADL tasks in the lab under the supervision of the trainer. The training will follow shaping principles, i.e., task requirements will be made progressively more challenging, in small increments, as participants gain mastery. Frequent, positive feedback will be provided.
    Other Names:
  • IADL In-lab Training
  • Behavioral: Cognitive Transfer Packagke
    This training component is designed to transfer improvements in cognition from the treatment setting to everyday life. Elements of this package include negotiating a behavioral contract about the roles of the participant and family caregiver in the treatment, monitoring behavior outside the lab, and assigning performance of IADL as homework.

    Behavioral: Family Caregiver Coaching
    One or more family members of the participant will receive coaching on how to best support the participant in carrying out the in-home components of the intervention.

    Active Comparator: BF-HELP with Follow-up Phone Calls

    Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) training on relaxation, healthy nutrition, and healthy sleep, and (B) the Healthy Lifestyle Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.

    Behavioral: Speed of Processing Training
    This training component targets cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. Cognitive processing speed is thought to be a basic capacity of the brain that underlies several other cognitive functions. Training is implemented using a web-based computer "game", in which participants are required to fixate on a target at the center of the screen and identify targets in the periphery. The game is made progressively more difficult, in small increments, as participants gain mastery by increasing the speed at which targets are presented and increasing the number of distractors.
    Other Names:
  • SOPT
  • Behavioral: Family Caregiver Coaching
    One or more family members of the participant will receive coaching on how to best support the participant in carrying out the in-home components of the intervention.

    Behavioral: Follow-up Phone Calls
    After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis after.

    Behavioral: Healthy Lifestyle In-lab Training
    This training component is designed to promote lifestyle changes that support brain fitness. Participants will receive education and coaching in the lab on relaxation, healthy nutrition, and healthy sleep.

    Behavioral: Healthy Lifestyle Transfer Package
    This training component is designed to support integration into everyday life of the lifestyle changes training in the lab. Elements of this package include negotiating a behavioral contract about the roles of the participant and family caregiver in the treatment, monitoring behavior outside the lab, and assigning relaxation exercises, for example, as homework.

    Active Comparator: BF-HELP without Follow-up Phone Calls

    Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) training on relaxation, healthy nutrition, and healthy sleep, and (B) the Healthy Lifestyle Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. No follow-up phone calls will be made after treatment ends.

    Behavioral: Speed of Processing Training
    This training component targets cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. Cognitive processing speed is thought to be a basic capacity of the brain that underlies several other cognitive functions. Training is implemented using a web-based computer "game", in which participants are required to fixate on a target at the center of the screen and identify targets in the periphery. The game is made progressively more difficult, in small increments, as participants gain mastery by increasing the speed at which targets are presented and increasing the number of distractors.
    Other Names:
  • SOPT
  • Behavioral: Family Caregiver Coaching
    One or more family members of the participant will receive coaching on how to best support the participant in carrying out the in-home components of the intervention.

    Behavioral: Follow-up Phone Calls
    After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis after.

    Behavioral: Healthy Lifestyle In-lab Training
    This training component is designed to promote lifestyle changes that support brain fitness. Participants will receive education and coaching in the lab on relaxation, healthy nutrition, and healthy sleep.

    Behavioral: Healthy Lifestyle Transfer Package
    This training component is designed to support integration into everyday life of the lifestyle changes training in the lab. Elements of this package include negotiating a behavioral contract about the roles of the participant and family caregiver in the treatment, monitoring behavior outside the lab, and assigning relaxation exercises, for example, as homework.

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life in Neurological Disorders Measures (Neuro-QOL), Cognitive Function Scale [Change from Day 30 to Day 60, i.e., from Pre- to Post-treatment]

      The Neuro-QOL assesses function in daily life in several domains; it is a widely used, validated, transdiagnostic, self-report measure. The development and use of the Neuro-QOL is supported by the National Institutes of Health. The component of the Neuro-QOL that assessed cognitive function will be used here. Items are rated by respondents using a five-point scale: 1 = not at all, 5 = very much. Higher scores indicate better function.

    2. Assessment of Motor and Process Skills (AMPS) [Change from Day 30 to Day 60, i.e., from Pre- to Post-treatment]

      This widely used, well-validated, test measures how well participants can complete tasks that simulate everyday IADL in the laboratory. Tasks with important cognitive components will be selected from a bank of 140 standardized tasks; samples are eating a snack and drinking a beverage, re-potting a small house plant, and making a tuna salad sandwich. Only the Process scale, which assess cognitive function, will be scored. To calculate this scale score, the performance of the participant is evaluated on multiple dimensions; the dimension ratings are entered into custom software that outputs scores that index the motor and cognitive function of the participant. Higher scores indicate better function. This test will be videotaped and scored from videotape by raters blinded to intervention assignment and testing occasion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Primary Inclusion Criteria:
    • stroke > 1 year previously

    • mild-to-moderate general cognitive impairment as determined by a Montreal Cognitive Assessment (MOCA) score between 10-26

    • impairment in cognitive processing speed; this will be determined by a time greater than 100 ms on Task 2 and greater than 300 ms on Task 3 of the Useful Field of View (UFOV) test

    • some impairment in performance of daily activities; this will be determined by a score of 3 or below on the Cognitive Task Activity Log (CTAL)

    Additional Inclusion Criteria:
    • 40 years or older; no upper limit if medically stable

    • sufficiently fit, from both a physical and mental health perspective, to take part in study

    • adequate sight and hearing to complete UFOV test

    • adequate thinking skills, e.g., ability to follow directions, retain information, to complete UFOV and CTAL, as marked by judgement of the screener that the candidate is able to adequately complete the UFOV and CTAL

    • reside in the community (as opposed to a hospital or skilled nursing facility)

    • able to travel to laboratory on multiple occasions

    • caregiver available

    Exclusion Criteria:
    • cognitive impairment due to a developmental disability, psychiatric disorder, or substance abuse or due to another type of brain injury, such a traumatic brain injury, or a progressive brain disease, such as Alzheimer's Dementia

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Alabama at BirminghamBirminghamAlabamaUnited States35294

    Sponsors and Collaborators

    • University of Alabama at Birmingham
    • National Institute on Aging (NIA)
    • Posit Science

    Investigators

    • Principal Investigator: Edward Taub, PhD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edward Taub, University Professor, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT05162781
    Other Study ID Numbers:
    • IRB-300008211
    • 1R01AG070049-01A1
    First Posted:
    Dec 17, 2021
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Edward Taub, University Professor, University of Alabama at Birmingham
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 8, 2022