Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Ruff 2 & 7 Selective Attention Task (RSAT) |
Psychometric validation/measurement of participant's subjective complaint of attention disturbance |
Eligibility screening (Pretreatment) |
|
Other |
Reliable Digit Span (RDS) |
The Reliable Digit Span (RDS) test, scored from the forward and backward digit span from the Wechsler Adult Intelligence Scale version 4 (WAIS-IV), will be used to determine the potential presence of suboptimal effort; cutoff for the RDS will be a score 7. |
Eligibility screening (Pretreatment) |
|
Other |
Mental Health Screening Form 3rd edition (MHSF-III) |
The MHSF-III is a structured interview that will be used to screen for the presence of exclusionary major psychopathology. |
Eligibility screening (Pretreatment) |
|
Other |
Wide Range Achievement Test, 4th edition (WRAT-4; word-reading subtest) |
The word-reading subtest of the WRAT-4 will administered to obtain a measure of estimated premorbid cognitive functioning, and groups will be matched, on average, for scores on this test. |
Group matching (Pretreatment) |
|
Primary |
Timed Instrumental Activities of Daily Living (TIADL) |
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded. |
Baseline TIADL Reaction Time assessed pretreatment |
|
Primary |
Timed Instrumental Activities of Daily Living (TIADL) |
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded. |
Change from Baseline in TIADL Reaction Time assessed at 8 weeks |
|
Primary |
Timed Instrumental Activities of Daily Living (TIADL) |
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded. |
Change from Baseline in TIADL Reaction Time assessed at 12 weeks (1-month post treatment) |
|
Primary |
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy |
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded. |
Change from Baseline in TIADL Accuracy assessed at 4 weeks |
|
Primary |
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy |
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded. |
Change from Baseline in TIADL Accuracy assessed at 8 weeks |
|
Primary |
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy |
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded. |
Change from Baseline in TIADL Accuracy assessed at 12 weeks (1 month post treatment) |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score |
Assesses global outcome, including ability, adjustment and community participation indices. |
Change from Baseline in MPAI-4 Ability Score assessed at 4 weeks |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score |
Assesses global outcome, including ability, adjustment and community participation indices. |
Change from Baseline in MPAI-4 Ability Score assessed at 8 weeks |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score |
Assesses global outcome, including ability, adjustment and community participation indices. |
Change from Baseline in MPAI-4 Ability Score assessed at 12 weeks (1 month post treatment) |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score |
Assesses global outcome, including ability, adjustment and community participation indices. |
Change from Baseline in MPAI-4 Adjustment Score assessed at 4 weeks |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score |
Assesses global outcome, including ability, adjustment and community participation indices. |
Change from Baseline in MPAI-4 Adjustment Score assessed at 8 weeks |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score |
Assesses global outcome, including ability, adjustment and community participation indices. |
Change from Baseline in MPAI-4 Adjustment Score assessed at 12 weeks (1 month post treatment) |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score |
Assesses global outcome, including ability, adjustment and community participation indices. |
Change from Baseline in MPAI-4 Participation Score assessed at 4 weeks |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score |
Assesses global outcome, including ability, adjustment and community participation indices. |
Change from Baseline in MPAI-4 Participation Score assessed at 8 weeks |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score |
Assesses global outcome, including ability, adjustment and community participation indices. |
Change from Baseline in MPAI-4 Participation Score assessed at 12 weeks (1 month post treatment) |
|
Primary |
Timed Instrumental Activities of Daily Living (TIADL) - Reaction Time score |
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded. |
Baseline (pretreatment) on TIADL - Reaction Time score |
|
Primary |
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy score |
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded. |
Baseline (pretreatment) on TIADL - Accuracy score |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) |
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration. |
Baseline (pretreatment) MPAI-4 Adjustment score |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) |
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration. |
Baseline (pretreatment) MPAI-4 Participation score |
|
Primary |
Attention Network Test (ANT) Alerting Reaction Time score |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in Altering Reaction Time Score assessed at 4 weeks |
|
Primary |
Attention Network Test (ANT) Alerting Reaction Time score |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in Altering Reaction Time Score assessed at 8 weeks |
|
Primary |
Attention Network Test (ANT) Alerting Reaction Time score |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in Altering Reaction Time Score assessed at 12 weeks (1 month post treatment) |
|
Primary |
Attention Network Test (ANT) Orient Reaction Time score |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Baseline (pretreatment) Orienting Reaction Time score |
|
Primary |
Attention Network Test (ANT) Orienting Reaction Time score |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in Orienting Reaction Time Score assessed at 4 weeks |
|
Primary |
Attention Network Test (ANT) Orienting Reaction Time score |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in Orienting Reaction Time Score assessed at 8 weeks |
|
Primary |
Attention Network Test (ANT) Orienting Reaction Time score |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in Orienting Reaction Time Score assessed at 12 weeks (1 month post treatment) |
|
Primary |
Attention Network Test (ANT) Executive-Control Reaction Time score |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Baseline (pretreatment) Executive-Control Reaction Time score |
|
Primary |
Attention Network Test (ANT) Executive-Control Reaction Time score |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in Executive-Control Reaction Time Score assessed at 4 weeks |
|
Primary |
Attention Network Test (ANT) Executive-Control Reaction Time score |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in Executive-Control Reaction Time Score assessed at 8 weeks |
|
Primary |
Attention Network Test (ANT) Executive-Control Reaction Time score |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in Executive-Control Reaction Time Score assessed at 12 weeks (1 month post treatment) |
|
Primary |
Attention Network Test (ANT) Alerting Reaction Time score |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Baseline (pretreatment) Alerting Reaction Time score |
|
Primary |
ANT ERP (N1) Alerting Amplitude |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Baseline ANT ERP (N1) Alerting Amplitude assessed pretreatment |
|
Primary |
ANT ERP (N1) Alerting Amplitude |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 4 weeks |
|
Primary |
ANT ERP (N1) Alerting Amplitude |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 8 weeks |
|
Primary |
ANT ERP (N1) Alerting Amplitude |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 12 weeks (1 month post treatment) |
|
Primary |
ANT ERP (N1) Orienting Amplitude |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Baseline ANT ERP (N1) Orienting Amplitude assessed pretreatment |
|
Primary |
ANT ERP (N1) Orienting Amplitude |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 4 weeks |
|
Primary |
ANT ERP (N1) Orienting Amplitude |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 8 weeks |
|
Primary |
ANT ERP (N1) Orienting Amplitude |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 12 weeks (1 month post treatment) |
|
Primary |
ANT ERP (P3) Executive Amplitude |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Baseline ANT ERP (P3) Executive Amplitude assessed pretreatment |
|
Primary |
ANT ERP (P3) Executive Amplitude |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Baseline ANT ERP (P3) Executive Amplitude assessed at 4 weeks |
|
Primary |
ANT ERP (P3) Executive Amplitude |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Baseline ANT ERP (P3) Executive Amplitude assessed at 8 weeks |
|
Primary |
ANT ERP (P3) Executive Amplitude |
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation. |
Baseline ANT ERP (P3) Executive Amplitude assessed at 12 weeks (1 month post treatment) |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score |
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration. |
Baseline MPAI-4 Ability Score assessed pretreatment |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score |
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration. |
Baseline MPAI-4 Adjustment Score assessed pretreatment |
|
Primary |
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score |
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration. |
Baseline MPAI-4 Participation Score assessed pretreatment |
|
Secondary |
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO) |
The MAAS-LO is a 12-item 6-point Likert-type scale designed to measure everyday attentional lapses (infrequent to very frequent). |
Change from Baseline in MAAS-LO Score assessed at 4 weeks |
|
Secondary |
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO) |
The MAAS-LO is a 12-item 6-point Likert-type scale designed to measure everyday attentional lapses (infrequent to very frequent). |
Change from Baseline in MAAS-LO Score assessed at 8 weeks |
|
Secondary |
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO) |
The MAAS-LO is a 12-item 6-point Likert-type scale designed to measure everyday attentional lapses (infrequent to very frequent). |
Change from Baseline in MAAS-LO Score assessed at 12 weeks (1 month post treatment) |
|
Secondary |
Satisfaction with Life Scale (SWLS) |
The SWLS assesses patient's perceived satisfaction with life. It is a 5-item 7-point Likert-type scale with a range from "strongly disagree" to "strongly agree." The total score is used as a measure of satisfaction with life. |
Baseline SWLS Score assessed pretreatment |
|
Secondary |
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO) |
The MAAS-LO is a 12-item 6-point Likert-type scale designed to measure everyday attentional lapses (infrequent to very frequent). |
Baseline (pretreatment) on MAAS-LO |
|
Secondary |
Satisfaction with Life Scale (SWLS) |
The SWLS assesses patient's perceived satisfaction with life. It is a 5-item 7-point Likert-type scale with a range from "strongly disagree" to "strongly agree." The total score is used as a measure of satisfaction with life. |
Change from Baseline in SWLS Score assessed at 4 weeks |
|
Secondary |
Satisfaction with Life Scale (SWLS) |
The SWLS assesses patient's perceived satisfaction with life. It is a 5-item 7-point Likert-type scale with a range from "strongly disagree" to "strongly agree." The total score is used as a measure of satisfaction with life. |
Change from Baseline in SWLS Score assessed at 8 weeks |
|
Secondary |
Satisfaction with Life Scale (SWLS) |
The SWLS assesses patient's perceived satisfaction with life. It is a 5-item 7-point Likert-type scale with a range from "strongly disagree" to "strongly agree." The total score is used as a measure of satisfaction with life. |
Change from Baseline in SWLS Score assessed at 12 weeks (1 month post treatment) |
|