Trial Outcomes & Findings for Memory and Attention Adaptation Training-Geriatrics (MAAT-G) Phase II (NCT NCT04669301)
NCT ID: NCT04669301
Last Updated: 2025-07-15
Results Overview
The Functional Assessment of Cancer Therapy-Cognition tool is a 50-question tool that evaluates memory and mental function in the past 7 days. The range of scores for the tool are 0 to 200 with higher scores generally indicating worse health outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Results posted on
2025-07-15
Participant Flow
Participant milestones
| Measure |
Supportive Therapy (Time and Attention Control)
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Supportive therapy (time and attention control): Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
|
MAAT-G Intervention
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
MAAT-G: Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
|
Caregivers
Patients in this study had the option to enroll a caregiver.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
2
|
|
Overall Study
COMPLETED
|
33
|
31
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
Supportive Therapy (Time and Attention Control)
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Supportive therapy (time and attention control): Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
|
MAAT-G Intervention
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
MAAT-G: Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
|
Caregivers
Patients in this study had the option to enroll a caregiver.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
0
|
Baseline Characteristics
Memory and Attention Adaptation Training-Geriatrics (MAAT-G) Phase II
Baseline characteristics by cohort
| Measure |
Supportive Therapy (Time and Attention Control)
n=36 Participants
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Supportive therapy (time and attention control): Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
|
MAAT-G Intervention
n=34 Participants
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
MAAT-G: Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
|
Caregivers
n=2 Participants
Patients in this study had the option to enroll a caregiver.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).Population: Two members of the ST population opted not to respond to the FACT-COG survey. Caregiver data was not collected for this measure.
The Functional Assessment of Cancer Therapy-Cognition tool is a 50-question tool that evaluates memory and mental function in the past 7 days. The range of scores for the tool are 0 to 200 with higher scores generally indicating worse health outcomes.
Outcome measures
| Measure |
Supportive Therapy (Time and Attention Control)
n=34 Participants
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Supportive therapy (time and attention control): Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
|
MAAT-G Intervention
n=34 Participants
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
MAAT-G: Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
|
Caregivers
Patients in this study had the option to enroll a caregiver.
|
|---|---|---|---|
|
Mean of the Functional Assessment of Cancer Therapy-Cognition (FACT-COG)
|
155.8 score on a scale
Standard Deviation 29
|
152.7 score on a scale
Standard Deviation 27.9
|
—
|
SECONDARY outcome
Timeframe: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).Population: The study population missing did not have access to the technology required to complete the CANTAB, resulting in only 59 patients total rather than the 64 enrolled. CANTAB data for caregivers was not collected.
The CANTAB Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. The subject is shown a complex visual pattern, followed by four similar patterns after a brief delay. The subject must select the pattern that exactly matches the sample. Better speed of response and a higher number of correct patterns indicate better health outcomes. (Patients only) The least squares mean for the variable Delay Match to Sample Total Correct at the 12-second delay (DMSTC-12) is analyzed.
Outcome measures
| Measure |
Supportive Therapy (Time and Attention Control)
n=28 Participants
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Supportive therapy (time and attention control): Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
|
MAAT-G Intervention
n=31 Participants
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
MAAT-G: Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
|
Caregivers
Patients in this study had the option to enroll a caregiver.
|
|---|---|---|---|
|
Least Squares Mean for Delay Match to Sample Total Correct at the 12-second Delay (DMSTC-12) From the Cambridge Neuropsychological Test Automated Battery (CANTAB)
|
4.04 correct patterns
Standard Error .17
|
4.10 correct patterns
Standard Error .16
|
—
|
SECONDARY outcome
Timeframe: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).Population: Two members of the ST population opted not to respond to the COWA survey. Caregiver data was not collected for this measure.
The Controlled Oral Word Association (COWA) tool is a measure of verbal fluency evaluating expressive language and executive function. Subjects are asked to freely generate as many words as they can that start with one of the prompted letters ("C", "F", and "L") in the span of one minute. Greater numbers of words indicate better health outcomes. (Patients only)
Outcome measures
| Measure |
Supportive Therapy (Time and Attention Control)
n=34 Participants
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Supportive therapy (time and attention control): Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
|
MAAT-G Intervention
n=34 Participants
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
MAAT-G: Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
|
Caregivers
Patients in this study had the option to enroll a caregiver.
|
|---|---|---|---|
|
Mean of the Controlled Oral Word Association (COWA) Tool
|
12.4 words generated
Standard Deviation 3.4
|
11.4 words generated
Standard Deviation 3.2
|
—
|
SECONDARY outcome
Timeframe: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).Population: Two members of the ST population opted not to respond to the HVLT-R survey. Caregiver data was not collected for this measure.
The Hopkins Verbal Learning Test-Revised (HVLT-R) tool is a test of verbal learning and memory. Researchers read a list of 12 words to subjects and ask them to report as many of the words as they can recall. The reporting period is timed. Higher numbers of correctly remembered words, along with lower reporting times, are indicative of better health outcomes. (Patients only)
Outcome measures
| Measure |
Supportive Therapy (Time and Attention Control)
n=34 Participants
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Supportive therapy (time and attention control): Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
|
MAAT-G Intervention
n=34 Participants
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
MAAT-G: Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
|
Caregivers
Patients in this study had the option to enroll a caregiver.
|
|---|---|---|---|
|
Mean of the Hopkins Verbal Learning Test-Revised (HVLT-R)
|
8 words recalled
Standard Deviation 1.8
|
7.7 words recalled
Standard Deviation 1.7
|
—
|
SECONDARY outcome
Timeframe: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).Population: Two members of the ST population opted not to respond to the GDS survey. Caregiver data was not collected for this measure.
The Geriatric Depression Screen (GDS) tool is a 15 question psychological assessment with "yes" or "no" answers (ranging from 0 to 15, with a higher score indicating more depression). The questions pertain to emotional state and vary between positive and negative presentation. (Patients only)
Outcome measures
| Measure |
Supportive Therapy (Time and Attention Control)
n=34 Participants
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Supportive therapy (time and attention control): Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
|
MAAT-G Intervention
n=34 Participants
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
MAAT-G: Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
|
Caregivers
Patients in this study had the option to enroll a caregiver.
|
|---|---|---|---|
|
Mean of the Geriatric Depression Screen (GDS)
|
2.3 score on a scale
Standard Deviation 2.2
|
3.3 score on a scale
Standard Deviation 2.4
|
—
|
SECONDARY outcome
Timeframe: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).Population: Two members of the ST population opted not to respond to the GAD-7 survey. Caregiver data was not collected for this measure.
The Generalized Anxiety and Depression 7-item scale (GAD-7) is a 7-item question tool that evaluates feelings of anxiety over the previous 2 weeks. Each question is ranked from 0 to 3, with higher scores indicating worse health outcomes (the range for the survey is 0-21). (Patients only)
Outcome measures
| Measure |
Supportive Therapy (Time and Attention Control)
n=34 Participants
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Supportive therapy (time and attention control): Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
|
MAAT-G Intervention
n=34 Participants
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
MAAT-G: Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
|
Caregivers
Patients in this study had the option to enroll a caregiver.
|
|---|---|---|---|
|
Mean of the Generalized Anxiety and Depression 7-item Scale (GAD-7)
|
3.4 score on a scale
Standard Deviation 4.9
|
4 score on a scale
Standard Deviation 4
|
—
|
SECONDARY outcome
Timeframe: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).Population: Two members of the ST population opted not to respond to the IADL survey. Caregiver data was not collected for this measure.
The Instrumental Activities of Daily Living (IADL) tool asks questions about functional independence. There are 7 questions on scale of most to least independence. The range of this scale is 3 to 21, with a higher score indicating less independence. (Patients only)
Outcome measures
| Measure |
Supportive Therapy (Time and Attention Control)
n=34 Participants
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Supportive therapy (time and attention control): Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
|
MAAT-G Intervention
n=34 Participants
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
MAAT-G: Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
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Caregivers
Patients in this study had the option to enroll a caregiver.
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|---|---|---|---|
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Mean of the Instrumental Activities of Daily Living (IADL)
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12.8 score on a scale
Standard Deviation 2
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12.9 score on a scale
Standard Deviation 1.7
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SECONDARY outcome
Timeframe: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).Population: Only 29 patients from each group (ST and MAAT-G) were selected; some patients did not allow the interview to be audiorecorded thus it was not included in the qualitative coding, thus the denominator for each group is less than in previous outcome measures. Caregiver data was not collected for this measure.
Semi-structured interview with patients about experience with workshop sessions - proportion of patients who expressed perceived benefit from workshops.
Outcome measures
| Measure |
Supportive Therapy (Time and Attention Control)
n=29 Participants
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Supportive therapy (time and attention control): Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
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MAAT-G Intervention
n=29 Participants
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
MAAT-G: Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
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Caregivers
Patients in this study had the option to enroll a caregiver.
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|---|---|---|---|
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Experience Interview - Proportion of Patients Who Expressed Perceived Benefit From Workshops.
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16 Participants
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28 Participants
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Adverse Events
Supportive Therapy (Time and Attention Control)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MAAT-G Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Supportive Therapy (Time and Attention Control)
n=36 participants at risk
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Supportive therapy (time and attention control): Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
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MAAT-G Intervention
n=34 participants at risk
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
MAAT-G: Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
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Caregivers
n=2 participants at risk
Patients in this study had the option to enroll a caregiver.
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|---|---|---|---|
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Nervous system disorders
Memory impairment (mild)
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2.8%
1/36 • Number of events 1 • Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
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2.9%
1/34 • Number of events 1 • Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
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0.00%
0/2 • Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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2.8%
1/36 • Number of events 1 • Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
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0.00%
0/34 • Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
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0.00%
0/2 • Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
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Nervous system disorders
Tremor
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2.8%
1/36 • Number of events 1 • Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
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0.00%
0/34 • Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
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0.00%
0/2 • Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place