Cognitive Impairment, Depression
Conditions
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALPATH-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.
BEHAVIORALSupportive 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.
Sponsors
Johns Hopkins University
Montefiore Medical Center
National Institute on Aging (NIA)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Amnestic MCI as defined by Albert et al * Montgomery Asberg Depression Rating Scale (MADRS) greater than 7 and MADRS total less than 30 * Participants will be off antidepressants, cholinesterase inhibitors or memantine, or on a stable dosage for at least 12 weeks without any medical recommendation to adjust dosage in next 3 months (during treatment) * Clinical Dementia Rating (CDR) = 0.5 at screening * Subjects will have capacity to consent
Exclusion criteria
* Deemed to have a significant suicide risk as assessed by site PI and clinical team * Deemed too unstable medically or neurologically to safely enroll in a research trial * Deemed too psychiatrically unstable to safely enroll in randomized trial of psychotherapy. Requiring psychiatric hospitalization at baseline for safety. * Current involvement in psychotherapy * Lack of English fluency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Global Cognition Assessed by RBANS | Baseline, 12, 24, and 52 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disability Function Assessed With WHODAS-II | Baseline, 6, 12, 24, 36, and 52 Weeks | 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. |
| Change in Depression Assessed by MADRS | Baseline, 6, 12, 24, 36, and 52 Weeks | 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. |
| Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS | Baseline, 12, 24, and 52 Weeks | 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. |
| Change in Executive Function Assessed by Trail Making Test | Baseline, 12, 24, and 52 Weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Stress Reduction Assessed by Perceived Stress Scale | Baseline, 6, 12, 24, 36, and 52 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| 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. | 41 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Physician Decision | 0 | 5 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Supportive Therapy | Total | PATH-MCI |
|---|---|---|---|
| Age, Continuous | 73.56 years STANDARD_DEVIATION 7.42 | 73.71 years STANDARD_DEVIATION 7.57 | 73.87 years STANDARD_DEVIATION 7.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 75 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 67 Participants | 34 Participants |
| Sex: Female, Male Female | 20 Participants | 42 Participants | 22 Participants |
| Sex: Female, Male Male | 21 Participants | 38 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 41 |
| other Total, other adverse events | 4 / 39 | 6 / 41 |
| serious Total, serious adverse events | 5 / 39 | 1 / 41 |
Outcome results
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.
Time frame: Baseline, 12, 24, and 52 Weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PATH-MCI | Change in Global Cognition Assessed by RBANS | Baseline Totals | 434.66 Score on a Scale | Standard Deviation 68.96 |
| PATH-MCI | Change in Global Cognition Assessed by RBANS | Week 12 Totals | 438.46 Score on a Scale | Standard Deviation 70.27 |
| PATH-MCI | Change in Global Cognition Assessed by RBANS | Week 24 Totals | 448.57 Score on a Scale | Standard Deviation 71.78 |
| PATH-MCI | Change in Global Cognition Assessed by RBANS | Week 52 Totals | 435 Score on a Scale | Standard Deviation 111.04 |
| Supportive Therapy | Change in Global Cognition Assessed by RBANS | Week 52 Totals | 419.33 Score on a Scale | Standard Deviation 101.93 |
| Supportive Therapy | Change in Global Cognition Assessed by RBANS | Baseline Totals | 435.36 Score on a Scale | Standard Deviation 68.27 |
| Supportive Therapy | Change in Global Cognition Assessed by RBANS | Week 24 Totals | 449.08 Score on a Scale | Standard Deviation 64.75 |
| Supportive Therapy | Change in Global Cognition Assessed by RBANS | Week 12 Totals | 436 Score on a Scale | Standard Deviation 67.51 |
Comparison: Baselinep-value: 0.964495% CI: [-31.8605, 30.4583]t-test, 2 sided
Comparison: Week 12p-value: 0.88895% CI: [-32.3472, 37.2661]t-test, 2 sided
Comparison: Week 24p-value: 0.977395% CI: [-36.5024, 35.4785]t-test, 2 sided
Comparison: Week 52p-value: 0.617395% CI: [-47.0598, 78.3931]t-test, 1 sided
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.
Time frame: Baseline, 6, 12, 24, 36, and 52 Weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PATH-MCI | Change in Depression Assessed by MADRS | Week 52 Totals | 12.67 Score on a Scale | Standard Deviation 6.17 |
| PATH-MCI | Change in Depression Assessed by MADRS | Week 6 Totals | 14.97 Score on a Scale | Standard Deviation 8.57 |
| PATH-MCI | Change in Depression Assessed by MADRS | Week 12 Totals | 13.53 Score on a Scale | Standard Deviation 6.81 |
| PATH-MCI | Change in Depression Assessed by MADRS | Week 24 Totals | 10.67 Score on a Scale | Standard Deviation 6.61 |
| PATH-MCI | Change in Depression Assessed by MADRS | Week 36 Totals | 12.32 Score on a Scale | Standard Deviation 6.4 |
| PATH-MCI | Change in Depression Assessed by MADRS | Baseline Totals | 16.62 Score on a Scale | Standard Deviation 5.8 |
| Supportive Therapy | Change in Depression Assessed by MADRS | Week 36 Totals | 11.96 Score on a Scale | Standard Deviation 6.76 |
| Supportive Therapy | Change in Depression Assessed by MADRS | Baseline Totals | 16.59 Score on a Scale | Standard Deviation 6.01 |
| Supportive Therapy | Change in Depression Assessed by MADRS | Week 24 Totals | 12.67 Score on a Scale | Standard Deviation 5.85 |
| Supportive Therapy | Change in Depression Assessed by MADRS | Week 6 Totals | 15.03 Score on a Scale | Standard Deviation 5.47 |
| Supportive Therapy | Change in Depression Assessed by MADRS | Week 52 Totals | 11.4 Score on a Scale | Standard Deviation 6.4 |
| Supportive Therapy | Change in Depression Assessed by MADRS | Week 12 Totals | 12.47 Score on a Scale | Standard Deviation 6.38 |
Comparison: Baselinep-value: 0.981395% CI: [-2.6668, 2.7305]t-test, 2 sided
Comparison: Week 6p-value: 0.973595% CI: [-3.4397, 3.3268]t-test, 2 sided
p-value: 0.516495% CI: [-2.1885, 4.3107]t-test, 2 sided
Comparison: Week 24p-value: 0.19795% CI: [-5.0651, 1.0651]t-test, 2 sided
Comparison: Week 36p-value: 0.834295% CI: [-3.0907, 3.8146]t-test, 2 sided
Comparison: Week 52p-value: 0.471795% CI: [-2.2424, 4.7758]t-test, 2 sided
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.
Time frame: Baseline, 6, 12, 24, 36, and 52 Weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PATH-MCI | Change in Disability Function Assessed With WHODAS-II | Baseline Totals | 12.08 Score on a Scale | Standard Deviation 7.74 |
| PATH-MCI | Change in Disability Function Assessed With WHODAS-II | Week 6 Totals | 12.43 Score on a Scale | Standard Deviation 8.72 |
| PATH-MCI | Change in Disability Function Assessed With WHODAS-II | Week 12 Totals | 10.68 Score on a Scale | Standard Deviation 7.55 |
| PATH-MCI | Change in Disability Function Assessed With WHODAS-II | Week 24 Totals | 8.51 Score on a Scale | Standard Deviation 8.01 |
| PATH-MCI | Change in Disability Function Assessed With WHODAS-II | Week 36 Totals | 9.97 Score on a Scale | Standard Deviation 8.45 |
| PATH-MCI | Change in Disability Function Assessed With WHODAS-II | Week 52 Totals | 11.79 Score on a Scale | Standard Deviation 8.67 |
| Supportive Therapy | Change in Disability Function Assessed With WHODAS-II | Week 36 Totals | 9.08 Score on a Scale | Standard Deviation 8.19 |
| Supportive Therapy | Change in Disability Function Assessed With WHODAS-II | Baseline Totals | 10.95 Score on a Scale | Standard Deviation 8.57 |
| Supportive Therapy | Change in Disability Function Assessed With WHODAS-II | Week 24 Totals | 10.07 Score on a Scale | Standard Deviation 7.97 |
| Supportive Therapy | Change in Disability Function Assessed With WHODAS-II | Week 6 Totals | 9.47 Score on a Scale | Standard Deviation 7.16 |
| Supportive Therapy | Change in Disability Function Assessed With WHODAS-II | Week 52 Totals | 8.84 Score on a Scale | Standard Deviation 6.36 |
| Supportive Therapy | Change in Disability Function Assessed With WHODAS-II | Week 12 Totals | 9.58 Score on a Scale | Standard Deviation 8.17 |
Comparison: Baselinep-value: 0.545495% CI: [-2.5767, 4.8371]t-test, 2 sided
Comparison: Week 6p-value: 0.121295% CI: [-0.8038, 6.7275]t-test, 2 sided
Comparison: Week 12p-value: 0.57195% CI: [-2.7476, 4.9377]t-test, 2 sided
Comparison: Week 24p-value: 0.437795% CI: [-5.5256, 2.4209]t-test, 2 sided
Comparison: Week 36p-value: 0.681395% CI: [-3.4439, 5.2312]t-test, 2 sided
p-value: 0.16295% CI: [-1.2234, 7.1148]t-test, 2 sided
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.
Time frame: Baseline, 12, 24, and 52 Weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PATH-MCI | Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS | Baseline Totals | 76.66 Score on a Scale | Standard Deviation 20.18 |
| PATH-MCI | Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS | Week 12 Totals | 77.81 Score on a Scale | Standard Deviation 22.36 |
| PATH-MCI | Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS | Week 24 Totals | 81.89 Score on a Scale | Standard Deviation 21.89 |
| PATH-MCI | Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS | Week 52 Totals | 84.71 Score on a Scale | Standard Deviation 22.91 |
| Supportive Therapy | Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS | Week 52 Totals | 83.60 Score on a Scale | Standard Deviation 23.66 |
| Supportive Therapy | Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS | Baseline Totals | 79.59 Score on a Scale | Standard Deviation 18.92 |
| Supportive Therapy | Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS | Week 24 Totals | 87.04 Score on a Scale | Standard Deviation 20.4 |
| Supportive Therapy | Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS | Week 12 Totals | 81.78 Score on a Scale | Standard Deviation 22.12 |
Comparison: Baselinep-value: 0.51395% CI: [-11.8176, 5.9539]t-test, 2 sided
Comparison: Week 12p-value: 0.483595% CI: [-15.2306, 7.2967]t-test, 2 sided
Comparison: Week 24p-value: 0.35995% CI: [-16.3357, 6.0238]t-test, 2 sided
Comparison: Week 52p-value: 0.87695% CI: [-13.1598, 15.3765]t-test, 2 sided
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.
Time frame: Baseline, 12, 24, and 52 Weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PATH-MCI | Change in Executive Function Assessed by Trail Making Test | Baseline Totals (Trails B) | 23.63 Score on a Scale | Standard Deviation 5.16 |
| PATH-MCI | Change in Executive Function Assessed by Trail Making Test | Week 12 Totals (Trails A) | 24.19 Score on a Scale | Standard Deviation 4.13 |
| PATH-MCI | Change in Executive Function Assessed by Trail Making Test | Week 24 Totals (Trails A) | 25 Score on a Scale | Standard Deviation 0 |
| PATH-MCI | Change in Executive Function Assessed by Trail Making Test | Week 52 Totals (Trails A) | 25 Score on a Scale | Standard Deviation 0 |
| PATH-MCI | Change in Executive Function Assessed by Trail Making Test | Week 12 Totals (Trails B) | 22.65 Score on a Scale | Standard Deviation 5.96 |
| PATH-MCI | Change in Executive Function Assessed by Trail Making Test | Week 24 Totals (Trails B) | 24.11 Score on a Scale | Standard Deviation 3.33 |
| PATH-MCI | Change in Executive Function Assessed by Trail Making Test | Week 52 Totals (Trails B) | 23.57 Score on a Scale | Standard Deviation 4.13 |
| PATH-MCI | Change in Executive Function Assessed by Trail Making Test | Baseline Totals (Trails A) | 24.94 Score on a Scale | Standard Deviation 0.35 |
| Supportive Therapy | Change in Executive Function Assessed by Trail Making Test | Week 52 Totals (Trails A) | 25 Score on a Scale | Standard Deviation 0 |
| Supportive Therapy | Change in Executive Function Assessed by Trail Making Test | Baseline Totals (Trails A) | 25 Score on a Scale | Standard Deviation 0 |
| Supportive Therapy | Change in Executive Function Assessed by Trail Making Test | Week 12 Totals (Trails B) | 24.71 Score on a Scale | Standard Deviation 0.85 |
| Supportive Therapy | Change in Executive Function Assessed by Trail Making Test | Week 12 Totals (Trails A) | 24.89 Score on a Scale | Standard Deviation 0.47 |
| Supportive Therapy | Change in Executive Function Assessed by Trail Making Test | Week 52 Totals (Trails B) | 25 Score on a Scale | Standard Deviation 0 |
| Supportive Therapy | Change in Executive Function Assessed by Trail Making Test | Week 24 Totals (Trails A) | 25 Score on a Scale | Standard Deviation 0 |
| Supportive Therapy | Change in Executive Function Assessed by Trail Making Test | Week 24 Totals (Trails B) | 25 Score on a Scale | Standard Deviation 0 |
| Supportive Therapy | Change in Executive Function Assessed by Trail Making Test | Baseline Totals (Trails B) | 22.63 Score on a Scale | Standard Deviation 6.36 |
Comparison: Trails A Baselinep-value: 0.324895% CI: [-0.1841, 0.0628]t-test, 2 sided
Comparison: Trails A - Week 12p-value: 0.361595% CI: [-2.2261, 0.8354]t-test, 2 sided
Comparison: Trails B - Baselinep-value: 0.504695% CI: [-1.9664, 3.9498]t-test, 2 sided
Comparison: Trails B - Week 12p-value: 0.067995% CI: [-4.2821, 0.1607]t-test, 2 sided
Comparison: Trails B - Week 24p-value: 0.166995% CI: [-2.1825, 0.3968]t-test, 2 sided
Comparison: Trails B - Week 52p-value: 0.217895% CI: [-3.8115, 0.9543]t-test, 2 sided
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.
Time frame: Baseline, 6, 12, 24, 36, and 52 Weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PATH-MCI | Change in Stress Reduction Assessed by Perceived Stress Scale | Baseline Totals | 19.76 Score on a Scale | Standard Deviation 6.81 |
| PATH-MCI | Change in Stress Reduction Assessed by Perceived Stress Scale | Week 6 Totals | 18.35 Score on a Scale | Standard Deviation 7.45 |
| PATH-MCI | Change in Stress Reduction Assessed by Perceived Stress Scale | Week 12 Totals | 17.25 Score on a Scale | Standard Deviation 7.48 |
| PATH-MCI | Change in Stress Reduction Assessed by Perceived Stress Scale | Week 24 Totals | 16.34 Score on a Scale | Standard Deviation 8.33 |
| PATH-MCI | Change in Stress Reduction Assessed by Perceived Stress Scale | Week 36 Totals | 16.24 Score on a Scale | Standard Deviation 7.96 |
| PATH-MCI | Change in Stress Reduction Assessed by Perceived Stress Scale | Week 52 Totals | 17.07 Score on a Scale | Standard Deviation 7.85 |
| Supportive Therapy | Change in Stress Reduction Assessed by Perceived Stress Scale | Week 36 Totals | 14.31 Score on a Scale | Standard Deviation 7.26 |
| Supportive Therapy | Change in Stress Reduction Assessed by Perceived Stress Scale | Baseline Totals | 18.21 Score on a Scale | Standard Deviation 6.07 |
| Supportive Therapy | Change in Stress Reduction Assessed by Perceived Stress Scale | Week 24 Totals | 17.37 Score on a Scale | Standard Deviation 7.88 |
| Supportive Therapy | Change in Stress Reduction Assessed by Perceived Stress Scale | Week 6 Totals | 16.65 Score on a Scale | Standard Deviation 5.9 |
| Supportive Therapy | Change in Stress Reduction Assessed by Perceived Stress Scale | Week 52 Totals | 15.00 Score on a Scale | Standard Deviation 6.06 |
| Supportive Therapy | Change in Stress Reduction Assessed by Perceived Stress Scale | Week 12 Totals | 16.33 Score on a Scale | Standard Deviation 6.31 |
Comparison: Baselinep-value: 0.293295% CI: [-1.3747, 4.4908]t-test, 2 sided
Comparison: Week 6p-value: 0.287195% CI: [-1.4659, 4.8744]t-test, 2 sided
Comparison: Week 12p-value: 0.59195% CI: [-2.4737, 4.307]t-test, 2 sided
p-value: 0.612895% CI: [-5.0469, 2.9993]t-test, 2 sided
Comparison: Week 36p-value: 0.332695% CI: [-2.0231, 5.8783]t-test, 2 sided
Comparison: Week 52p-value: 0.293595% CI: [-1.8522, 6.0004]t-test, 2 sided