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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

288 participants

Primary outcome timeframe

Baseline and biweekly across 16 weeks

Results posted on

2020-07-30

Participant Flow

Participant milestones

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

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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 2

Population: 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

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 sooner

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Scientific Match

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 4135451388

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place