Trial Outcomes & Findings for Enhancing Mental Health Care by Scientifically Matching Patients to Providers' Strengths (NCT NCT02990000)
NCT ID: NCT02990000
Last Updated: 2020-07-30
Results Overview
The TOP-Clinical Scales consist of 58 items assessing 12 symptom and functional domains (risk-adjusted for case mix variables assessed via 37 items on the companion TOP-Case Mix form, such as divorce, job loss, comorbidity): work functioning, sexual functioning, social conflict, depression, panic/somatic anxiety, psychosis, suicidal ideation, violence, mania, sleep, substance abuse, and quality of life. Global symptom severity was assessed by averaging the z-scores (i.e., standard deviation units relative to the general population mean) across the 12 clinical scales. Higher scores indicate greater impairment. Given that we examined change over the entire treatment period for this outcome (in a longitudinal hierarchical linear model), we provide the average mean and standard deviation for the TOP-CS z-scores across all measurement occasions.
COMPLETED
NA
288 participants
Baseline and biweekly across 16 weeks
2020-07-30
Participant Flow
Participant milestones
| Measure |
Pragmatic Match
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
|
Scientific Match
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)
Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety).
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
133
|
|
Overall Study
Begin Treatment
|
119
|
99
|
|
Overall Study
COMPLETED
|
119
|
99
|
|
Overall Study
NOT COMPLETED
|
36
|
34
|
Reasons for withdrawal
| Measure |
Pragmatic Match
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
|
Scientific Match
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)
Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety).
|
|---|---|---|
|
Overall Study
Failed to provide data beyond baseline
|
36
|
34
|
Baseline Characteristics
Enhancing Mental Health Care by Scientifically Matching Patients to Providers' Strengths
Baseline characteristics by cohort
| Measure |
Pragmatic Match
n=119 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
|
Scientific Match
n=99 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)
Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety).
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
119 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
218 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
34.42 years
STANDARD_DEVIATION 11.55 • n=99 Participants
|
33.33 years
STANDARD_DEVIATION 10.72 • n=107 Participants
|
33.93 years
STANDARD_DEVIATION 11.17 • n=206 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
212 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
106 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
193 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
East Indian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=99 Participants
|
99 participants
n=107 Participants
|
218 participants
n=206 Participants
|
|
Treatment Outcome Package-Clinical Scales (TOP-CS): General Impairment
|
0.86 units on a scale
STANDARD_DEVIATION 0.78 • n=99 Participants
|
1.04 units on a scale
STANDARD_DEVIATION .96 • n=107 Participants
|
0.94 units on a scale
STANDARD_DEVIATION 0.87 • n=206 Participants
|
|
Symptom Checklist-10 (SCL-10): Global Psychological Distress
|
15.48 units on a scale
STANDARD_DEVIATION 7.93 • n=99 Participants
|
16.08 units on a scale
STANDARD_DEVIATION 7.74 • n=107 Participants
|
15.75 units on a scale
STANDARD_DEVIATION 7.83 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and biweekly across 16 weeksPopulation: All participants who were randomized to condition and completed at least one assessment after baseline (N = 218)
The TOP-Clinical Scales consist of 58 items assessing 12 symptom and functional domains (risk-adjusted for case mix variables assessed via 37 items on the companion TOP-Case Mix form, such as divorce, job loss, comorbidity): work functioning, sexual functioning, social conflict, depression, panic/somatic anxiety, psychosis, suicidal ideation, violence, mania, sleep, substance abuse, and quality of life. Global symptom severity was assessed by averaging the z-scores (i.e., standard deviation units relative to the general population mean) across the 12 clinical scales. Higher scores indicate greater impairment. Given that we examined change over the entire treatment period for this outcome (in a longitudinal hierarchical linear model), we provide the average mean and standard deviation for the TOP-CS z-scores across all measurement occasions.
Outcome measures
| Measure |
Pragmatic Match
n=119 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
|
Scientific Match
n=99 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)
Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety).
|
|---|---|---|
|
Average Z-Scores for the Treatment Outcome Package-Clinical Scales (TOP-CS; Kraus, Seligman, & Jordan, 2005)
|
0.57 units on a scale
Standard Deviation 0.80
|
0.56 units on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Baseline and biweekly across 16 weeksPopulation: All participants who were randomized to condition and completed at least one assessment after baseline (N = 218)
Global psychological distress was assessed with the Symptom Checklist-10 (SCL-10; Rosen, Drescher, Moos, \& Gusman, 1999), a 10-item, well validated and widely used self-report inventory that assesses psychological well-being. Total scores can range from 0 to 40, with higher scores indicating greater distress. Given that we examined change over the entire treatment period for this outcome (in a longitudinal hierarchical linear model), we provide the average mean and standard deviation for the SCL-10 total score across all measurement occasions.
Outcome measures
| Measure |
Pragmatic Match
n=119 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
|
Scientific Match
n=99 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)
Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety).
|
|---|---|---|
|
Symptom Checklist-10 (SCL-10; Rosen, Drescher, Moos, & Gusman, 1999) Total Score
|
12.52 units on a scale
Standard Deviation 8.01
|
12.06 units on a scale
Standard Deviation 7.70
|
SECONDARY outcome
Timeframe: Biweekly across 16 weeksPopulation: All participants who were randomized to condition and completed at least one assessment after baseline (N = 218)
The WAI is the most widely used alliance measure, assessing patient-therapist agreement on the goals and tasks of treatment, and the quality of their relational bond. This 12-item short form assesses these dimensions from the patient's perspective, with higher scores indicating a more positive relationship (theoretical range = 12 to 84). Given that we examined change over the entire treatment period for this outcome (in a longitudinal hierarchical linear model), we provide the average mean and standard deviation for the WAI total score across all measurement occasions.
Outcome measures
| Measure |
Pragmatic Match
n=119 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
|
Scientific Match
n=99 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)
Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety).
|
|---|---|---|
|
Working Alliance Inventory-Short Form, Patient Version (WAI-SF-P; Tracey, & Kokotovic, 1989) Total Score
|
66.75 units on a scale
Standard Deviation 13.35
|
68.44 units on a scale
Standard Deviation 12.00
|
SECONDARY outcome
Timeframe: Biweekly across 16 weeksPopulation: All participants who were randomized to condition and completed at least one assessment after baseline (N = 218)
The OE subscale of the CEQ is the most widely used and psychometrically sound measure of patients' expectations for the personal efficacy of treatment. The three OE items range from 1-9 or 0-100% (in 10 percentage point increments), with higher ratings indicating greater expectation for improvement. Given that the OE CEQ items are assessed on different scales, we re-scaled the items to the same metric before creating a total score (theoretical range = 3 to 27). Given that we examined change over the entire treatment period for this outcome (in a longitudinal hierarchical linear model), we provide the average mean and standard deviation for the OE subscale across all measurement occasions.
Outcome measures
| Measure |
Pragmatic Match
n=119 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
|
Scientific Match
n=99 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)
Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety).
|
|---|---|---|
|
Outcome Expectation (OE) Subscale of the Credibility/Expectancy Scale (CEQ; Devilly, & Borkovec, 2000)
|
18.12 units on a scale
Standard Deviation 5.45
|
19.15 units on a scale
Standard Deviation 5.30
|
SECONDARY outcome
Timeframe: Baseline and biweekly across 16 weeksPopulation: All participants who were randomized to condition and completed at least one assessment after baseline (N = 218)
The TOP-CS consists of 58 items assessing 12 symptom and functional domains (risk-adjusted for case mix variables assessed via 37 items on the companion TOP-Case Mix form, such as divorce, job loss, comorbidity): work functioning, sexual functioning, social conflict, depression, panic/somatic anxiety, psychosis, suicidal ideation, violence, mania, sleep, substance abuse, and quality of life. Domain-specific impairment reflects each patient's scores on their most elevated problem domain (i.e., the domain most elevated at baseline). These scores were standardized z-scores (i.e., standard deviation units relative to the general population mean), with higher scores indicating greater impairment. Given that we examined change over the treatment period for this outcome (hierarchical linear model), we provide the average mean and standard deviation for the most elevated TOP domain across all measurement occasions. Note that this measure was positively skewed so we log-transformed it.
Outcome measures
| Measure |
Pragmatic Match
n=119 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
|
Scientific Match
n=99 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)
Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety).
|
|---|---|---|
|
Domain-Specific Impairment on the Most Elevated Domain of the Treatment Outcome Package-Clinical Scales (TOP-CS)
|
0.27 units on a scale
Standard Deviation .24
|
0.28 units on a scale
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Early treatment discontinuation/continuation at session 2Population: All participants who were randomized to condition and completed at least one assessment after baseline (N = 218)
Early treatment discontinuation was operationalized as a patient discontinuing treatment after 2 or fewer sessions, whereas early continuation was operationalized as attending 3 or more treatment sessions. For analyses, early treatment discontinuation was coded 1 and early continuation was coded 0.
Outcome measures
| Measure |
Pragmatic Match
n=119 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
|
Scientific Match
n=99 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)
Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety).
|
|---|---|---|
|
Early Treatment Discontinuation (i.e., Attending 2 or Fewer Treatment Sessions)
|
22 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Assessed after 16 weeks of treatment or at the point of naturalistic treatment termination, whichever comes soonerPopulation: Due to a relatively large amount of missing data for this measure (compared to other study measures), this was considered a completer analysis that involved only the patients who completed this posttreatment measure (N = 97).
The Overall Provider Quality subscale of the TOP Satisfaction Scale assesses the extent to which patients are satisfied with their mental health care provider. This subscale reflects the average of 4 items, with higher scores indicating greater satisfaction (theoretical range = 1 to 6).
Outcome measures
| Measure |
Pragmatic Match
n=54 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
|
Scientific Match
n=43 Participants
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)
Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety).
|
|---|---|---|
|
Overall Provider Quality Subscale of the Treatment Outcome Package (TOP) Satisfaction Scale
|
5.01 units on a scale
Standard Deviation 1.35
|
5.17 units on a scale
Standard Deviation 1.11
|
Adverse Events
Pragmatic Match
Scientific Match
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michael J. Constantino
University of Massachusetts Amherst
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place