Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG050514 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Montefiore Medical Center | OTHER |
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective, and functioning outcomes.
The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective and functioning outcomes. Psychotherapy, also known as talking therapy, is the use of psychological methods to help a person change and overcome problems in desired ways. PATH-MCI differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. Supportive Therapy incorporates standard of care approaches by using non-specific techniques to provide a supportive environment and help patients to express their feelings & focus on their strengths and abilities.
The investigators plan to randomize 80 treatment subjects, older adults (40 at Cornell and 40 at Johns Hopkins) with MCI-depression. 80 study partners may also be potentially recruited. Both sites have shown feasibility of recruitment, randomization, retention, and assessment procedures for patients with MCI. Cornell has shown evidence of administration of PATH in this population. Certified mental health clinicians in PATH-MCI and ST-CI will administer 15 in-office sessions in six months.
The investigators propose to compare the effects of 15 sessions (12 weekly in first 12 weeks and 3 monthly booster sessions afterwards) of PATH-MCI vs. ST-CI in 80 older adults (treatment subjects) with MCI-depression. Research assistants, unaware of study hypotheses and participant randomization status, will perform research assessments at baseline and at 6 (no cognitive measures), 12, 24, 36 (no cognitive measures) and 52 weeks after randomization.
There will also be optional blood draws at study entry, 12, and 52 weeks. The purpose of the blood draws is to better understand whether response to psychotherapy treatment is affected by genes, by inflammation, or by the possible memory factor called BDNF (brain-derived neurotrophic factor). Also, all therapy sessions will be audiotaped (if the patient consents) and Dr. Shermer (a clinician outside of the Weill Cornell Institute of Geriatric Psychiatry) will evaluate randomly selected sessions and rate the therapists' adherence and competence based on the PATH-MCI and ST Adherence Scales
The study partner will provide information about the treatment subject and participate in treatment if agreed by the treatment subject. To explore the effects of PATH-MCI on the study partner, the investigators will collect the following data from the study partner: demographic, burden (Short Zarit Burden interview), and treatment satisfaction (Client Satisfaction Questionnaire).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PATH-MCI | Experimental | Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. |
|
| Supportive Therapy | Active Comparator | Supportive Therapy focuses on: 1. Facilitating expression of affect; 2. Conveying to the patient that he or she is understood; 3. Offering empathy; and 4. Highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PATH-MCI | Behavioral | Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Cognition Assessed by RBANS | Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS). The total score represents the simple sum of the five cognitive domain index scores (Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory). Total raw scores are converted based on the subjects age and a RBANS scoring manual. Higher scores indicate better functionality. The total scores range from 200 to 800. | Baseline, 12, 24, and 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disability Function Assessed With WHODAS-II | The 12-item WHODAS-II (World Health Organization Disability Assessment Schedule) assesses functional impairment across six domains of daily living. Each item is scored on a 5-point Likert scale ranging from 0 (No difficulty), 1 (Mild Difficulty), 2 (Moderate Difficulty), 3 (Severe Difficulty) and 4 (Extreme difficulty or cannot do). Each individual item has a minimum score of 0 and a maximum of 4. The total raw score is computed by summing all 12 items, resulting in a possible score range of 0 to 48. Higher score reflect greater functional impairment. Lower scores indicate better functional status and less reported difficulty with daily activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stress Reduction Assessed by Perceived Stress Scale | Perceived Stress Scale s the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The 10-item measure has 4 choice options; (0=Never, 1=Almost Never, 2=Sometimes, 3=Fairly Often, 4=Often). 4 items are reversed scored and the total score is summed across all items ranging from 0 to 40. Lower scores are better and indicate less stress. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dimitris Kiosses, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21224 | United States | ||
| Weill Cornell Medicine |
Data will be available as per NIH's data sharing policy.
Not provided
Data will be available as per NIH's data sharing policy.
Access criteria is determined by NIH and can be requested by applying online.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PATH-MCI | Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. PATH-MCI: Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. |
| FG001 | Supportive Therapy | Supportive Therapy focuses on: 1. Facilitating expression of affect; 2. Conveying to the patient that he or she is understood; 3. Offering empathy; and 4. Highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. Supportive Therapy: ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PATH-MCI | Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. PATH-MCI: Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Global Cognition Assessed by RBANS | Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS). The total score represents the simple sum of the five cognitive domain index scores (Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory). Total raw scores are converted based on the subjects age and a RBANS scoring manual. Higher scores indicate better functionality. The total scores range from 200 to 800. | The study was affected by the pandemic and by the inability of certain participants to complete assessment measures during the study. Therefore, there is a discrepancy between the numbers of randomized and the numbers of analyzed participants at different time points. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 12, 24, and 52 Weeks |
|
52 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PATH-MCI | Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. PATH-MCI: Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Depressive Episode | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dimitris Kiosses | Weill Cornell Medicine | 914-997-4381 | dkiosses@med.cornell.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2020 | Jun 18, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 15, 2023 | Jun 17, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Supportive Therapy | Behavioral | ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. |
|
|
| Baseline, 6, 12, 24, 36, and 52 Weeks |
| Change in Depression Assessed by MADRS | Depression assessed by Montgomery Asberg Depression Rating Scale (MADRS) Total Score. The MADRS is a 10 item questionnaire assessing severity of depression by scoring participants on mood, anxiety, sleep, concentration, appetite, and suicidal thoughts. The lowest score is 0, no depression symptoms, and the highest possible score is 60, severe depression symptoms. | Baseline, 6, 12, 24, 36, and 52 Weeks |
| Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS | The Delayed Recall subscale of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) assesses memory function across multiple tasks. It includes the following components: List Recall Total Score (range: 0-10), List Recognition Total Score (range: 0-20), Story Recall Total Score (range: 0-12), and Figure Recall Total Score (range: 0-20). The raw scores from these four components are summed to yield a Delayed Memory Index raw total score ranging from 0 to 62, with higher scores indicating better memory performance. To facilitate standardized interpretation, raw total scores are converted to age-adjusted Index Scores using normative data provided in the RBANS manual. These Index Scores have a mean of 100 and a standard deviation of 15, and are normed by decade (e.g., 60-69, 70-79, 80-89). Higher Index Scores reflect better memory functioning relative to age-matched peers. | Baseline, 12, 24, and 52 Weeks |
| Change in Executive Function Assessed by Trail Making Test | Trail Making Test is a neuropsychological assessment where raw scores are converted into a scaled score range from 1 to 25. Participants with scores between 1 - 8 have impaired performance; Mid range scores typically fall between 10 - 16, and subjects who fair the best on this measure have scores ranging from 20 - 25. | Baseline, 12, 24, and 52 Weeks |
| Baseline, 6, 12, 24, 36, and 52 Weeks |
| New York |
| New York |
| 10065 |
| United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine | White Plains | New York | 10605 | United States |
| Withdrawal by Subject |
|
| BG001 | Supportive Therapy | Supportive Therapy focuses on: 1. Facilitating expression of affect; 2. Conveying to the patient that he or she is understood; 3. Offering empathy; and 4. Highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. Supportive Therapy: ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.
PATH-MCI: Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.
| OG001 | Supportive Therapy | Supportive Therapy focuses on: 1. Facilitating expression of affect; 2. Conveying to the patient that he or she is understood; 3. Offering empathy; and 4. Highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. Supportive Therapy: ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. |
|
|
|
| Secondary | Change in Disability Function Assessed With WHODAS-II | The 12-item WHODAS-II (World Health Organization Disability Assessment Schedule) assesses functional impairment across six domains of daily living. Each item is scored on a 5-point Likert scale ranging from 0 (No difficulty), 1 (Mild Difficulty), 2 (Moderate Difficulty), 3 (Severe Difficulty) and 4 (Extreme difficulty or cannot do). Each individual item has a minimum score of 0 and a maximum of 4. The total raw score is computed by summing all 12 items, resulting in a possible score range of 0 to 48. Higher score reflect greater functional impairment. Lower scores indicate better functional status and less reported difficulty with daily activities. | The study was affected by the pandemic and by the inability of certain participants to complete assessment measures during the study. Therefore, there is a discrepancy between the numbers of randomized and the numbers of analyzed participants at different time points. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6, 12, 24, 36, and 52 Weeks |
|
|
|
|
| Secondary | Change in Depression Assessed by MADRS | Depression assessed by Montgomery Asberg Depression Rating Scale (MADRS) Total Score. The MADRS is a 10 item questionnaire assessing severity of depression by scoring participants on mood, anxiety, sleep, concentration, appetite, and suicidal thoughts. The lowest score is 0, no depression symptoms, and the highest possible score is 60, severe depression symptoms. | The study was affected by the pandemic and by the inability of certain participants to complete assessment measures during the study. Therefore, there is a discrepancy between the numbers of randomized and the numbers of analyzed participants at different time points. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6, 12, 24, 36, and 52 Weeks |
|
|
|
|
| Secondary | Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS | The Delayed Recall subscale of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) assesses memory function across multiple tasks. It includes the following components: List Recall Total Score (range: 0-10), List Recognition Total Score (range: 0-20), Story Recall Total Score (range: 0-12), and Figure Recall Total Score (range: 0-20). The raw scores from these four components are summed to yield a Delayed Memory Index raw total score ranging from 0 to 62, with higher scores indicating better memory performance. To facilitate standardized interpretation, raw total scores are converted to age-adjusted Index Scores using normative data provided in the RBANS manual. These Index Scores have a mean of 100 and a standard deviation of 15, and are normed by decade (e.g., 60-69, 70-79, 80-89). Higher Index Scores reflect better memory functioning relative to age-matched peers. | The study was affected by the pandemic and by the inability of certain participants to complete assessment measures during the study. Therefore, there is a discrepancy between the numbers of randomized and the numbers of analyzed participants at different time points. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 12, 24, and 52 Weeks |
|
|
|
|
| Secondary | Change in Executive Function Assessed by Trail Making Test | Trail Making Test is a neuropsychological assessment where raw scores are converted into a scaled score range from 1 to 25. Participants with scores between 1 - 8 have impaired performance; Mid range scores typically fall between 10 - 16, and subjects who fair the best on this measure have scores ranging from 20 - 25. | The study was affected by the pandemic and by the inability of certain participants to complete assessment measures during the study. Therefore, there is a discrepancy between the numbers of randomized and the numbers of analyzed participants at different time points. Trails A consists of the numbers being connected in sequence. Trails B alternate between numbers and letters. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 12, 24, and 52 Weeks |
|
|
|
|
| Other Pre-specified | Change in Stress Reduction Assessed by Perceived Stress Scale | Perceived Stress Scale s the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The 10-item measure has 4 choice options; (0=Never, 1=Almost Never, 2=Sometimes, 3=Fairly Often, 4=Often). 4 items are reversed scored and the total score is summed across all items ranging from 0 to 40. Lower scores are better and indicate less stress. | The study was affected by the pandemic and by the inability of certain participants to complete assessment measures during the study. Therefore, there is a discrepancy between the numbers of randomized and the numbers of analyzed participants at different time points. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6, 12, 24, 36, and 52 Weeks |
|
|
|
|
| 0 |
| 39 |
| 5 |
| 39 |
| 4 |
| 39 |
| EG001 | Supportive Therapy | Supportive Therapy focuses on: 1. Facilitating expression of affect; 2. Conveying to the patient that he or she is understood; 3. Offering empathy; and 4. Highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. Supportive Therapy: ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. | 0 | 41 | 1 | 41 | 6 | 41 |
| Masectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Breast Reconstruction | Surgical and medical procedures | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Skin Biopsy | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Retinal Detachment | Endocrine disorders | Non-systematic Assessment |
|
| Laminectomy and discectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Cataract | Eye disorders | Non-systematic Assessment |
|
| Skin Lesion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
Not provided
Not provided
| D001519 |
| Behavior |
| Week 6 Totals |
|
|
| Week 12 Totals |
|
|
| Week 24 Totals |
|
|
| Week 36 Totals |
|
|
| Week 52 Totals |
|
|
| 0.1212 |
| Mean Difference (Final Values) |
| 2.9618 |
| 2-Sided |
| 95 |
| -0.8038 |
| 6.7275 |
| Superiority |
| Week 12 | t-test, 2 sided | 0.5710 | Mean Difference (Final Values) | 1.0950 | 2-Sided | 95 | -2.7476 | 4.9377 | Superiority |
| Week 24 | t-test, 2 sided | 0.4377 | Mean Difference (Final Values) | -1.5524 | 2-Sided | 95 | -5.5256 | 2.4209 | Superiority |
| Week 36 | t-test, 2 sided | 0.6813 | Mean Difference (Final Values) | 0.8937 | 2-Sided | 95 | -3.4439 | 5.2312 | Superiority |
| t-test, 2 sided | 0.1620 | Mean Difference (Final Values) | 2.9457 | 2-Sided | 95 | -1.2234 | 7.1148 | Superiority |
| Week 6 Totals |
|
|
| Week 12 Totals |
|
|
| Week 24 Totals |
|
|
| Week 36 Totals |
|
|
| Week 52 Totals |
|
|
| 0.9735 |
| Mean Difference (Final Values) |
| -0.0564 |
| 2-Sided |
| 95 |
| -3.4397 |
| 3.3268 |
| Superiority |
| t-test, 2 sided | 0.5164 | Mean Difference (Final Values) | 1.0611 | 2-Sided | 95 | -2.1885 | 4.3107 | Superiority | Week 12 |
| Week 24 | t-test, 2 sided | 0.1970 | Mean Difference (Final Values) | -2.0 | 2-Sided | 95 | -5.0651 | 1.0651 | Superiority |
| Week 36 | t-test, 2 sided | 0.8342 | Mean Difference (Net) | 0.3620 | 2-Sided | 95 | -3.0907 | 3.8146 | Superiority |
| Week 52 | t-test, 2 sided | 0.4717 | Mean Difference (Final Values) | 1.2667 | 2-Sided | 95 | -2.2424 | 4.7758 | Superiority |
| Week 12 Totals |
|
|
| Week 24 Totals |
|
|
| Week 52 Totals |
|
|
| 0.4835 |
| Mean Difference (Final Values) |
| 0.4835 |
| 2-Sided |
| 95 |
| -15.2306 |
| 7.2967 |
| Superiority |
| Week 24 | t-test, 2 sided | 0.3590 | Mean Difference (Final Values) | -5.1560 | 2-Sided | 95 | -16.3357 | 6.0238 | Superiority |
| Week 52 | t-test, 2 sided | 0.8760 | Mean Difference (Final Values) | 1.1083 | 2-Sided | 95 | -13.1598 | 15.3765 | Superiority |
| Week 12 Totals (Trails A) |
|
|
| Week 24 Totals (Trails A) |
|
|
| Week 52 Totals (Trails A) |
|
|
| Baseline Totals (Trails B) |
|
|
| Week 12 Totals (Trails B) |
|
|
| Week 24 Totals (Trails B) |
|
|
| Week 52 Totals (Trails B) |
|
|
| 0.3615 |
| Mean Difference (Final Values) |
| -0.6953 |
| 2-Sided |
| 95 |
| -2.2261 |
| 0.8354 |
| Superiority |
| Trails B - Baseline | t-test, 2 sided | 0.5046 | Mean Difference (Final Values) | 0.9917 | 2-Sided | 95 | -1.9664 | 3.9498 | Superiority |
| Trails B - Week 12 | t-test, 2 sided | 0.0679 | Mean Difference (Final Values) | -2.0607 | 2-Sided | 95 | -4.2821 | 0.1607 | Superiority |
| Trails B - Week 24 | t-test, 2 sided | 0.1669 | Mean Difference (Final Values) | -0.8929 | 2-Sided | 95 | -2.1825 | 0.3968 | Superiority |
| Trails B - Week 52 | t-test, 2 sided | 0.2178 | Mean Difference (Final Values) | -1.4286 | 2-Sided | 95 | -3.8115 | 0.9543 | Superiority |
| Week 6 Totals |
|
|
| Week 12 Totals |
|
|
| Week 24 Totals |
|
|
| Week 36 Totals |
|
|
| Week 52 Totals |
|
|
| 0.2871 |
| Mean Difference (Final Values) |
| 1.7043 |
| 2-Sided |
| 95 |
| -1.4659 |
| 4.8744 |
| Superiority |
| Week 12 | t-test, 2 sided | 0.5910 | Mean Difference (Final Values) | 0.9167 | 2-Sided | 95 | -2.4737 | 4.3070 | Superiority |
| t-test, 2 sided | 0.6128 | Mean Difference (Final Values) | -1.0238 | 2-Sided | 95 | -5.0469 | 2.9993 | Superiority |
| Week 36 | t-test, 2 sided | 0.3326 | Mean Difference (Final Values) | 1.9276 | 2-Sided | 95 | -2.0231 | 5.8783 | Superiority |
| Week 52 | t-test, 2 sided | 0.2935 | Mean Difference (Final Values) | 2.0741 | 2-Sided | 95 | -1.8522 | 6.0004 | Superiority |