Trial results for a study comparing Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) with Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) were posted on ClinicalTrials.gov on 2025-08-12. The study enrolled 80 participants with depression and cognitive impairment, finding no significant differences in key outcomes between the two interventions.
Background
Depression and cognitive impairment often co-occur in older adults, presenting complex challenges for treatment. Interventions that address both aspects are crucial for improving patient outcomes. This study aimed to compare two therapeutic approaches, Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) and Supportive Therapy for Cognitively Impaired Older Adults (ST-CI), to see their impact on cognitive, affective, and functioning outcomes.
Trial design
This completed study, designated as Phase NA, enrolled 80 participants diagnosed with Cognitive Impairment and Depression. The trial compared Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) against Supportive Therapy for Cognitively Impaired Older Adults (ST-CI). The primary objective was to evaluate improvements in cognitive, affective, and functioning outcomes, with key measurements focusing on global cognition and disability function.
Key results
The trial evaluated changes in global cognition and disability function:
- Change in Global Cognition Assessed by RBANS:
- At Baseline:
- PATH-MCI group mean was 434.66 (Standard Deviation 68.96) units on a scale.
- Supportive Therapy group mean was 435.36 (Standard Deviation 68.27) units on a scale.
- Analysis (t-test, 2 sided): Mean Difference (Final Values) -0.7011 (95.0% CI: -31.8605 to 30.4583), p-value 0.9644.
- At Week 12:
- PATH-MCI group mean was 438.46 (Standard Deviation 70.27) units on a scale.
- Supportive Therapy group mean was 436 (Standard Deviation 67.51) units on a scale.
- Analysis (t-test, 2 sided): Mean Difference (Final Values) 2.4595 (95.0% CI: -32.3472 to 37.2661), p-value 0.888.
- At Week 24:
- PATH-MCI group mean was 448.57 (Standard Deviation 71.78) units on a scale.
- Supportive Therapy group mean was 449.08 (Standard Deviation 64.75) units on a scale.
- Analysis (t-test, 2 sided): Mean Difference (Final Values) -0.5119 (95.0% CI: -36.5024 to 35.4785), p-value 0.9773.
- At Week 52:
- PATH-MCI group mean was 435 (Standard Deviation 111.04) units on a scale.
- Supportive Therapy group mean was 419.33 (Standard Deviation 101.93) units on a scale.
- Analysis (t-test, 1 sided): Mean Difference (Final Values) 15.6667 (95.0% CI: -47.0598 to 78.3931), p-value 0.6173.
- At Baseline:
- Change in Disability Function Assessed With WHODAS-II:
- At Baseline:
- PATH-MCI group mean was 12.08 (Standard Deviation 7.74) units on a scale.
- Supportive Therapy group mean was 10.95 (Standard Deviation 8.57) units on a scale.
- Analysis (t-test, 2 sided): Mean Difference (Final Values) 1.1302 (95.0% CI: -2.5767 to 4.8371), p-value 0.5454.
- At Week 6:
- PATH-MCI group mean was 12.43 (Standard Deviation 8.72) units on a scale.
- Supportive Therapy group mean was 9.47 (Standard Deviation 7.16) units on a scale.
- Analysis (t-test, 2 sided): Mean Difference (Final Values) 2.9618 (95.0% CI: -0.8038 to 6.7275), p-value 0.1212.
- At Baseline:
What this means
The trial results indicate that both Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) and Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) yielded similar outcomes in terms of global cognition and disability function over the study periods. The statistical analyses consistently showed high p-values (e.g., 0.9644 for baseline cognition, 0.1212 for Week 6 disability function), suggesting no statistically significant difference between the two therapeutic approaches for the measured outcomes. This implies that for older adults experiencing both depression and mild cognitive impairment, both PATH-MCI and Supportive Therapy may offer comparable benefits in these areas, based on the current data.
Source
The results for this study were obtained from ClinicalTrials.gov, a public database of clinical studies. The trial results for study NCT03043573, titled "Problem Adaptation Therapy for Mild Cognitive Impairment and Depression," were posted on 2025-08-12 on clinicaltrials.gov.
