Trial Outcomes & Findings for Problem Adaptation Therapy (PATH) vs. Supportive Therapy in Treating Depressed, Cognitively Impaired Older Adults (NCT NCT00368940)
NCT ID: NCT00368940
Last Updated: 2017-07-24
Results Overview
Montgomery Asberg Depression Scale (MADRS) is a depression rating scale. Range of scores (1-35). Higher scores represent worse outcome (depression).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
12 week outcome
Results posted on
2017-07-24
Participant Flow
Participant milestones
| Measure |
PATH
Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
|
ST-CI
Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.
|
|---|---|---|
|
Intention-to-Treat
STARTED
|
37
|
37
|
|
Intention-to-Treat
COMPLETED
|
37
|
37
|
|
Intention-to-Treat
NOT COMPLETED
|
0
|
0
|
|
Completed 12-wk Treatment
STARTED
|
37
|
37
|
|
Completed 12-wk Treatment
COMPLETED
|
31
|
32
|
|
Completed 12-wk Treatment
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Problem Adaptation Therapy (PATH) vs. Supportive Therapy in Treating Depressed, Cognitively Impaired Older Adults
Baseline characteristics by cohort
| Measure |
PATH
n=37 Participants
Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
|
ST-CI
n=37 Participants
Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
71 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
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
37 participants
n=7 Participants
|
74 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 week outcomeMontgomery Asberg Depression Scale (MADRS) is a depression rating scale. Range of scores (1-35). Higher scores represent worse outcome (depression).
Outcome measures
| Measure |
PATH
n=37 Participants
Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
|
ST-CI
n=37 Participants
Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.
|
|---|---|---|
|
Montgomery Asberg Depression Scale (MADRS)
|
10.46 Units on MADRS scale
Standard Error 1.07
|
15.53 Units on MADRS scale
Standard Error 1.07
|
PRIMARY outcome
Timeframe: 12-week outcomeWHO Disability Assessment Schedule (WHODAS)-II is a disability scale. Range of scores: 12-43. Higher scores represent worse outcome (disability).
Outcome measures
| Measure |
PATH
n=37 Participants
Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
|
ST-CI
n=37 Participants
Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.
|
|---|---|---|
|
WHO Disability Assessment Schedule (WHODAS)-II
|
27.37 WHODAS-II units
Standard Error 1.16
|
32.14 WHODAS-II units
Standard Error 1.15
|
SECONDARY outcome
Timeframe: Outcome at 12 weeksHamilton Depression Rating Scale is a scale measuring depression severity. Range of scores: 1-33. Higher scores reflect worse outcome (depression).
Outcome measures
| Measure |
PATH
n=30 Participants
Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
|
ST-CI
n=30 Participants
Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.
|
|---|---|---|
|
Hamilton Depression Rating Scale
|
11.16 units on a scale
Standard Deviation 6.9
|
15.03 units on a scale
Standard Deviation 7.30
|
SECONDARY outcome
Timeframe: Outcome at 12 weeksSheehan Disability Scale is a measure of disability. Range of scores: 0-20. Higher scores reflect worse outcome (disability).
Outcome measures
| Measure |
PATH
n=30 Participants
Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
|
ST-CI
n=31 Participants
Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.
|
|---|---|---|
|
Sheehan Disability Scale.
|
5.40 units on a scale
Standard Deviation 4.91
|
12.16 units on a scale
Standard Deviation 3.87
|
Adverse Events
PATH
Serious events: 8 serious events
Other events: 0 other events
Deaths: 1 deaths
ST-CI
Serious events: 10 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PATH
n=37 participants at risk
Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
|
ST-CI
n=37 participants at risk
Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hospitalization due to a fall
|
10.8%
4/37 • Number of events 4 • From enty to 24 weeks
|
13.5%
5/37 • Number of events 5 • From enty to 24 weeks
|
|
Surgical and medical procedures
Tumor removal
|
2.7%
1/37 • Number of events 1 • From enty to 24 weeks
|
2.7%
1/37 • Number of events 1 • From enty to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for COPD or fluid in lungs
|
2.7%
1/37 • Number of events 1 • From enty to 24 weeks
|
2.7%
1/37 • Number of events 1 • From enty to 24 weeks
|
|
Vascular disorders
Hospitalization due to possible stroke
|
2.7%
1/37 • Number of events 1 • From enty to 24 weeks
|
2.7%
1/37 • Number of events 1 • From enty to 24 weeks
|
|
Gastrointestinal disorders
Hospitalization due to stomach virus or ulcer
|
5.4%
2/37 • Number of events 2 • From enty to 24 weeks
|
0.00%
0/37 • From enty to 24 weeks
|
|
Immune system disorders
Hospitalization following an exacerbation of scleroderma
|
0.00%
0/37 • From enty to 24 weeks
|
2.7%
1/37 • Number of events 1 • From enty to 24 weeks
|
|
Surgical and medical procedures
Cataract Surgery
|
0.00%
0/37 • From enty to 24 weeks
|
2.7%
1/37 • Number of events 1 • From enty to 24 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place