Trial Outcomes & Findings for Problem Adaptation Therapy for Mild Cognitive Impairment and Depression (NCT NCT03043573)
NCT ID: NCT03043573
Last Updated: 2025-08-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline, 12, 24, and 52 Weeks
Results posted on
2025-08-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
41
|
|
Overall Study
COMPLETED
|
36
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
12
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Physician Decision
|
0
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
Baseline Characteristics
Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
Baseline characteristics by cohort
| Measure |
PATH-MCI
n=39 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.
|
Supportive Therapy
n=41 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.87 years
STANDARD_DEVIATION 7.82 • n=5 Participants
|
73.56 years
STANDARD_DEVIATION 7.42 • n=7 Participants
|
73.71 years
STANDARD_DEVIATION 7.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12, 24, and 52 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
PATH-MCI
n=38 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.
|
Supportive Therapy
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Cognition Assessed by RBANS
Baseline Totals
|
434.66 Score on a Scale
Standard Deviation 68.96
|
435.36 Score on a Scale
Standard Deviation 68.27
|
|
Change in Global Cognition Assessed by RBANS
Week 12 Totals
|
438.46 Score on a Scale
Standard Deviation 70.27
|
436 Score on a Scale
Standard Deviation 67.51
|
|
Change in Global Cognition Assessed by RBANS
Week 24 Totals
|
448.57 Score on a Scale
Standard Deviation 71.78
|
449.08 Score on a Scale
Standard Deviation 64.75
|
|
Change in Global Cognition Assessed by RBANS
Week 52 Totals
|
435 Score on a Scale
Standard Deviation 111.04
|
419.33 Score on a Scale
Standard Deviation 101.93
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, 24, 36, and 52 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
PATH-MCI
n=38 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.
|
Supportive Therapy
n=39 Participants
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.
|
|---|---|---|
|
Change in Disability Function Assessed With WHODAS-II
Baseline Totals
|
12.08 Score on a Scale
Standard Deviation 7.74
|
10.95 Score on a Scale
Standard Deviation 8.57
|
|
Change in Disability Function Assessed With WHODAS-II
Week 6 Totals
|
12.43 Score on a Scale
Standard Deviation 8.72
|
9.47 Score on a Scale
Standard Deviation 7.16
|
|
Change in Disability Function Assessed With WHODAS-II
Week 12 Totals
|
10.68 Score on a Scale
Standard Deviation 7.55
|
9.58 Score on a Scale
Standard Deviation 8.17
|
|
Change in Disability Function Assessed With WHODAS-II
Week 24 Totals
|
8.51 Score on a Scale
Standard Deviation 8.01
|
10.07 Score on a Scale
Standard Deviation 7.97
|
|
Change in Disability Function Assessed With WHODAS-II
Week 36 Totals
|
9.97 Score on a Scale
Standard Deviation 8.45
|
9.08 Score on a Scale
Standard Deviation 8.19
|
|
Change in Disability Function Assessed With WHODAS-II
Week 52 Totals
|
11.79 Score on a Scale
Standard Deviation 8.67
|
8.84 Score on a Scale
Standard Deviation 6.36
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, 24, 36, and 52 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
PATH-MCI
n=37 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.
|
Supportive Therapy
n=39 Participants
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.
|
|---|---|---|
|
Change in Depression Assessed by MADRS
Baseline Totals
|
16.62 Score on a Scale
Standard Deviation 5.8
|
16.59 Score on a Scale
Standard Deviation 6.01
|
|
Change in Depression Assessed by MADRS
Week 6 Totals
|
14.97 Score on a Scale
Standard Deviation 8.57
|
15.03 Score on a Scale
Standard Deviation 5.47
|
|
Change in Depression Assessed by MADRS
Week 12 Totals
|
13.53 Score on a Scale
Standard Deviation 6.81
|
12.47 Score on a Scale
Standard Deviation 6.38
|
|
Change in Depression Assessed by MADRS
Week 24 Totals
|
10.67 Score on a Scale
Standard Deviation 6.61
|
12.67 Score on a Scale
Standard Deviation 5.85
|
|
Change in Depression Assessed by MADRS
Week 36 Totals
|
12.32 Score on a Scale
Standard Deviation 6.4
|
11.96 Score on a Scale
Standard Deviation 6.76
|
|
Change in Depression Assessed by MADRS
Week 52 Totals
|
12.67 Score on a Scale
Standard Deviation 6.17
|
11.4 Score on a Scale
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: Baseline, 12, 24, and 52 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
PATH-MCI
n=38 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.
|
Supportive Therapy
n=39 Participants
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.
|
|---|---|---|
|
Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS
Baseline Totals
|
76.66 Score on a Scale
Standard Deviation 20.18
|
79.59 Score on a Scale
Standard Deviation 18.92
|
|
Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS
Week 12 Totals
|
77.81 Score on a Scale
Standard Deviation 22.36
|
81.78 Score on a Scale
Standard Deviation 22.12
|
|
Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS
Week 24 Totals
|
81.89 Score on a Scale
Standard Deviation 21.89
|
87.04 Score on a Scale
Standard Deviation 20.40
|
|
Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS
Week 52 Totals
|
84.71 Score on a Scale
Standard Deviation 22.91
|
83.60 Score on a Scale
Standard Deviation 23.66
|
SECONDARY outcome
Timeframe: Baseline, 12, 24, and 52 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
PATH-MCI
n=33 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.
|
Supportive Therapy
n=30 Participants
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.
|
|---|---|---|
|
Change in Executive Function Assessed by Trail Making Test
Week 24 Totals (Trails B)
|
24.11 Score on a Scale
Standard Deviation 3.33
|
25 Score on a Scale
Standard Deviation 0.00
|
|
Change in Executive Function Assessed by Trail Making Test
Baseline Totals (Trails A)
|
24.94 Score on a Scale
Standard Deviation 0.35
|
25 Score on a Scale
Standard Deviation 0.00
|
|
Change in Executive Function Assessed by Trail Making Test
Week 12 Totals (Trails A)
|
24.19 Score on a Scale
Standard Deviation 4.13
|
24.89 Score on a Scale
Standard Deviation 0.47
|
|
Change in Executive Function Assessed by Trail Making Test
Week 24 Totals (Trails A)
|
25 Score on a Scale
Standard Deviation 0.00
|
25 Score on a Scale
Standard Deviation 0.00
|
|
Change in Executive Function Assessed by Trail Making Test
Week 52 Totals (Trails A)
|
25 Score on a Scale
Standard Deviation 0.00
|
25 Score on a Scale
Standard Deviation 0.00
|
|
Change in Executive Function Assessed by Trail Making Test
Baseline Totals (Trails B)
|
23.63 Score on a Scale
Standard Deviation 5.16
|
22.63 Score on a Scale
Standard Deviation 6.36
|
|
Change in Executive Function Assessed by Trail Making Test
Week 12 Totals (Trails B)
|
22.65 Score on a Scale
Standard Deviation 5.96
|
24.71 Score on a Scale
Standard Deviation 0.85
|
|
Change in Executive Function Assessed by Trail Making Test
Week 52 Totals (Trails B)
|
23.57 Score on a Scale
Standard Deviation 4.13
|
25 Score on a Scale
Standard Deviation 0.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6, 12, 24, 36, and 52 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
PATH-MCI
n=38 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.
|
Supportive Therapy
n=39 Participants
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.
|
|---|---|---|
|
Change in Stress Reduction Assessed by Perceived Stress Scale
Baseline Totals
|
19.76 Score on a Scale
Standard Deviation 6.81
|
18.21 Score on a Scale
Standard Deviation 6.07
|
|
Change in Stress Reduction Assessed by Perceived Stress Scale
Week 6 Totals
|
18.35 Score on a Scale
Standard Deviation 7.45
|
16.65 Score on a Scale
Standard Deviation 5.90
|
|
Change in Stress Reduction Assessed by Perceived Stress Scale
Week 12 Totals
|
17.25 Score on a Scale
Standard Deviation 7.48
|
16.33 Score on a Scale
Standard Deviation 6.31
|
|
Change in Stress Reduction Assessed by Perceived Stress Scale
Week 24 Totals
|
16.34 Score on a Scale
Standard Deviation 8.33
|
17.37 Score on a Scale
Standard Deviation 7.88
|
|
Change in Stress Reduction Assessed by Perceived Stress Scale
Week 36 Totals
|
16.24 Score on a Scale
Standard Deviation 7.96
|
14.31 Score on a Scale
Standard Deviation 7.26
|
|
Change in Stress Reduction Assessed by Perceived Stress Scale
Week 52 Totals
|
17.07 Score on a Scale
Standard Deviation 7.85
|
15.00 Score on a Scale
Standard Deviation 6.06
|
Adverse Events
PATH-MCI
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
Supportive Therapy
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PATH-MCI
n=39 participants at risk
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.
|
Supportive Therapy
n=41 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Major Depressive Episode
|
2.6%
1/39 • Number of events 1 • 52 Weeks
|
0.00%
0/41 • 52 Weeks
|
|
Surgical and medical procedures
Masectomy
|
2.6%
1/39 • Number of events 1 • 52 Weeks
|
0.00%
0/41 • 52 Weeks
|
|
Surgical and medical procedures
Breast Reconstruction
|
2.6%
1/39 • Number of events 1 • 52 Weeks
|
0.00%
0/41 • 52 Weeks
|
|
Cardiac disorders
Tachycardia
|
2.6%
1/39 • Number of events 1 • 52 Weeks
|
0.00%
0/41 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.6%
1/39 • Number of events 1 • 52 Weeks
|
0.00%
0/41 • 52 Weeks
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/39 • 52 Weeks
|
2.4%
1/41 • Number of events 2 • 52 Weeks
|
Other adverse events
| Measure |
PATH-MCI
n=39 participants at risk
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.
|
Supportive Therapy
n=41 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Sinusitis
|
2.6%
1/39 • Number of events 1 • 52 Weeks
|
0.00%
0/41 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Skin Biopsy
|
2.6%
1/39 • Number of events 1 • 52 Weeks
|
0.00%
0/41 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Fall
|
5.1%
2/39 • Number of events 2 • 52 Weeks
|
4.9%
2/41 • Number of events 2 • 52 Weeks
|
|
Endocrine disorders
Retinal Detachment
|
0.00%
0/39 • 52 Weeks
|
2.4%
1/41 • Number of events 1 • 52 Weeks
|
|
Surgical and medical procedures
Laminectomy and discectomy
|
0.00%
0/39 • 52 Weeks
|
2.4%
1/41 • Number of events 1 • 52 Weeks
|
|
Eye disorders
Cataract
|
0.00%
0/39 • 52 Weeks
|
2.4%
1/41 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Skin Lesion
|
0.00%
0/39 • 52 Weeks
|
2.4%
1/41 • Number of events 1 • 52 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place