Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Stroke; Cognitive Dysfunction

Treatments: Behavioral: Healthy Lifestyle In-lab Training; Behavioral: Speed of Processing Training; Behavioral: Follow-up Phone Calls; Behavioral: Cognitive Transfer Packagke; Behavioral: Healthy Lifestyle Transfer Package; Behavioral: Family Caregiver Coaching; Behavioral: Instrumental Activities of Daily Living In-lab Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05162781

IRB-300008211

1R01AG070049-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

CICT with Follow-up Phone Calls

Experimental group

Description:

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.

Treatment:

Behavioral: Instrumental Activities of Daily Living In-lab Training

Behavioral: Family Caregiver Coaching

Behavioral: Cognitive Transfer Packagke

Behavioral: Follow-up Phone Calls

Behavioral: Speed of Processing Training

CICT without Follow-up Phone Calls

Experimental group

Description:

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.

Treatment:

Behavioral: Instrumental Activities of Daily Living In-lab Training

Behavioral: Family Caregiver Coaching

Behavioral: Cognitive Transfer Packagke

Behavioral: Speed of Processing Training

BF-HELP with Follow-up Phone Calls

Active Comparator group

Description:

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.

Treatment:

Behavioral: Family Caregiver Coaching

Behavioral: Healthy Lifestyle Transfer Package

Behavioral: Follow-up Phone Calls

Behavioral: Speed of Processing Training

Behavioral: Healthy Lifestyle In-lab Training

BF-HELP without Follow-up Phone Calls

Active Comparator group

Description:

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.

Treatment:

Behavioral: Family Caregiver Coaching

Behavioral: Healthy Lifestyle Transfer Package

Behavioral: Follow-up Phone Calls

Behavioral: Speed of Processing Training

Behavioral: Healthy Lifestyle In-lab Training