Mental IllnessNCT02990000
Enhancing Mental Health Care by Scientifically Matching Patients to Providers' Strengths
A study testing Scientific Match in people with Mental Illness, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
Research has shown that mental health care (MHC) providers differ significantly in their ability to help patients. In addition, providers demonstrate different patterns of effectiveness across symptom and functioning domains. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mental Illness
- What is being tested?
- Scientific Match
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18-70 years of age
- Being the primary, informed decision-maker for one's care
- Willingness to be randomized to condition and to complete a few study-specific measures
Who cannot join
- Being under 18 or over 70 years of age
- Not being responsible for one's own treatment decisions
- Unwillingness to be randomized to condition and/or to complete a few study-specific measures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Amherst
Amherst, Massachusetts, 01003
About this study
Research has shown that mental health care (MHC) providers differ significantly in their ability to help patients. In addition, providers demonstrate different patterns of effectiveness across symptom and functioning domains. For example, some providers are reliably effective in treating numerous patients and problem domains, others are reliably effective in some domains (e.g., depression, substance abuse) yet appear to struggle in others (e.g., anxiety, social functioning), and some are reliably ineffective, or even harmful, across patients and domains. Knowledge of these provider differences is based largely on patient-reported outcomes collected in routine MHC settings.
Unfortunately, provider performance information is not systematically used to refer or assign a particular patient to a scientifically based best-matched provider. MHC systems continue to rely on random or purely pragmatic case assignment and referral, which significantly "waters down" the odds of a patient being assigned/referred to a high performing provider in the patient's area(s) of need, and increases the risk of being assigned/referred to a provider who may have a track record of ineffectiveness. This research aims to solve the existing non-patient-centered provider-matching problem.
Specifically, the investigators aim to demonstrate the comparative effectiveness of a scientifically-based patient-provider match system compared to status quo pragmatic case assignment. The investigators expect in the scientific match group significantly better treatment outcomes (e.g., symptoms, quality of life) and higher patient satisfaction with treatment. The investigators also expect to demonstrate feasibility of implementing a scientific match process in a community MHC system and broad dissemination of the easily replicated scientific match technology in diverse health care settings. The importance of this work for patients cannot be understated. Far too many patients struggle to find the right provider, which unnecessarily prolongs suffering and promotes health care system inefficiency. A scientific match system based on routine outcome data uses patient-generated information to direct this patient to this provider in this setting. In addition, when based on multidimensional assessment, it allows a wide variety of patient-centered outcomes to be represented (e.g., symptom domains, functioning domains, quality of life).
Read the detailed description
Background and Significance:
Mental illness is an extraordinary and highly burdensome public health problem. Unfortunately, even for individuals who access mental health care (MHC), the care is too often substandard. Research has consistently demonstrated that approximately 10-15% of patients will deteriorate or experience harm during treatment. Further, when these rates are combined with no-change rates, only 40% or less of patients meaningfully recover. Importantly, treatment research has illuminated substantial variability in providers' outcomes. Simply put, the MHC provider impacts treatment outcomes, and stakeholders lack systematic access to valid and actionable information to optimize effective patient-provider matches. Without collecting and disseminating performance data, stakeholders lack vital information on which to base health care choices and personalize treatment. Conversely, there potentially is immense advantage to matching patients to providers based on scientific outcome data. Patients, stakeholders, researchers, and clinicians have all endorsed such applied knowledge transfer as a high priority. In response, the investigators have developed and piloted a technology to test this match concept and patient-centered health model.
Prominent health care agencies have placed outcome/performance measurement at the center of core initiatives. The Institute of Medicine specifically recommends integrating provider performance data in treatment decision-making. Despite this rhetoric, 2 Cochrane Reviews combined could only identify 4 studies that addressed this question with minimal methodology standards; the results were mixed. Importantly, none involved a targeted dissemination intervention, and none involved MHC. Previous research, including our own, has empirically demonstrated substantial differences in projected treatment effect sizes depending on to which therapist a patient is referred. The key evidence gap is the need for a rigorous test of the effectiveness of a targeted MHC provider-performance dissemination intervention compared to standard/pragmatic referral and case assignment. Relatedly, the Patient-Centered Outcomes Research Institute (PCORI) has called for increased "precision" or "personalized" treatment, with a focus on tailoring. The match algorithm responds directly to this high priority call to customize care in a personal and evidence-based way.
Specific Aims:
The aim of this comparative effectiveness research (CER) is to test an innovative, scientifically informed patient-therapist referral match algorithm based on MHC provider outcome data. The investigators will employ a randomized controlled trial (RCT) to compare the match algorithm with the commonplace pragmatic referral matching (based on provider availability, convenience, or self-reported specialty). Psychosocial treatment itself will remain naturalistically administered by varied providers (e.g., psychologists, social workers) to patients with complex mental health concerns within a partner clinic network, Psychological and Behavioral Consultants (PsychBC). The investigators hypothesize that the scientific match group will outperform the pragmatic match group in decreasing patient symptoms and treatment dropout, and in promoting patient functional outcomes, outcome expectations, and care satisfaction, as well as patient-therapist alliance quality. Doing so will establish the match algorithm as a mechanism of effective patient-centered MHC.
Methods:
The investigators will compare the effectiveness of naturalistic MHC either with or without the scientific matching aid with a double blind, individual level RCT. The investigators will first conduct a baseline assessment of PsychBC therapists' (target enrollment N=44) performance (across at least 15 cases) to determine their strengths in treating 12 behavioral health domains measured by the primary outcome tool on which our match algorithm is based -- the Treatment Outcome Package (TOP). The TOP is already administered routinely in our partner network. Based on years of predictive analytic research, this tool classifies therapists as "effective," "neutral," or "ineffective/harmful" for each TOP domain. The blinded therapists will be crossed over conditions.
Next, for the trial, new adult outpatients (target enrollment N=281) will be randomly assigned to the Match condition or case assignment as usual (typically based on pragmatic considerations, such as provider availability, convenience, or self-reported specialty). The only patient exclusion criterion will be people who are not the primary decision-maker for their care. Thus, patients will present with a multitude of problems across a spectrum of diagnoses. With therapist assignment as the only manipulation, participating therapists will treat patients fully naturalistically. Treatment outcomes will be assessed regularly through mutual termination or up to 16 weeks. Primary analyses will involve hierarchical linear modeling to examine comparative rates and patterns of change on the outcomes.
- Conditions
- Mental Illness
- Being tested
- Scientific Match
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scientific MatchBehavioural
Also called Match System
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).
| Study group | Role | What they receive |
|---|---|---|
| Pragmatic Match | No intervention | Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group) |
| Scientific Match | Experimental | Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group) Receives: Behavioral: Scientific Match |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Z-Scores for the Treatment Outcome Package-Clinical Scales (TOP-CS; Kraus, Seligman, & Jordan, 2005)
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.
Measured: Baseline and biweekly across 16 weeks
Secondary outcomes (6)
Symptom Checklist-10 (SCL-10; Rosen, Drescher, Moos, & Gusman, 1999) Total Score
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.
Measured: Baseline and biweekly across 16 weeks
Working Alliance Inventory-Short Form, Patient Version (WAI-SF-P; Tracey, & Kokotovic, 1989) Total Score
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.
Measured: Biweekly across 16 weeks
Outcome Expectation (OE) Subscale of the Credibility/Expectancy Scale (CEQ; Devilly, & Borkovec, 2000)
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.
Measured: Biweekly across 16 weeks
Domain-Specific Impairment on the Most Elevated Domain of the Treatment Outcome Package-Clinical Scales (TOP-CS)
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.
Measured: Baseline and biweekly across 16 weeks
Early Treatment Discontinuation (i.e., Attending 2 or Fewer Treatment Sessions)
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.
Measured: Early treatment discontinuation/continuation at session 2
Overall Provider Quality Subscale of the Treatment Outcome Package (TOP) Satisfaction Scale
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).
Measured: Assessed after 16 weeks of treatment or at the point of naturalistic treatment termination, whichever comes sooner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start6 Nov 2017
- Primary completion23 Sep 2019
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University at Albany, Psychological and Behavioral Consultants, Outcome Referrals, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael J Constantino, PhD, Principal investigator, University of Massachusetts, AmherstJames F Boswell, PhD, Principal investigator, University at Albany, SUNYDavid R Kraus, PhD, Principal investigator, Outcome Referrals, Inc.Thomas P Swales, PhD, Principal investigator, Psychological and Behavioral Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990000
- Sponsor's protocol ID
- IHS-1503-28573
- Status last verified
- May 2020
- First submitted
- 29 Nov 2016
- Last updated
- 30 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request on a case-by-case basis, we will share all IPD that underlie results in a publication (e.g., data extraction for meta-analyses). As appropriate, based on specific scientific journals' standards, we will provide analytic code used to generate published results.
Publications
Coyne AE, Gaines AN, DeFontes CG, Constantino MJ, Barcala-Delgado DI, Boswell JF, Kraus DR. Parsing the existential isolation-outcome association into its within- and between-patient components in naturalistic psychotherapy. Psychotherapy (Chic). 2025 Jun;62(2):235-242. doi: 10.1037/pst0000564. Epub 2025 Jan 20.
PubMed 39836135Coyne AE, Constantino MJ, Boswell JF, Gaines AN, Kraus DR. Therapist-Level Moderators of Patient-Therapist Match Effectiveness in Community Psychotherapy. Adm Policy Ment Health. 2024 Sep;51(5):738-752. doi: 10.1007/s10488-024-01360-8. Epub 2024 Apr 2.
PubMed 38565810Boswell JF, Constantino MJ, Coyne AE, Kraus DR. For whom does a match matter most? Patient-level moderators of evidence-based patient-therapist matching. J Consult Clin Psychol. 2022 Jan;90(1):61-74. doi: 10.1037/ccp0000644. Epub 2021 Jun 10.
PubMed 34110861Constantino MJ, Boswell JF, Coyne AE, Swales TP, Kraus DR. Effect of Matching Therapists to Patients vs Assignment as Usual on Adult Psychotherapy Outcomes: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):960-969. doi: 10.1001/jamapsychiatry.2021.1221.
PubMed 34106240
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Mental Health Care by Scientifically Matching Patients to Providers' Strengths
- ClinicalTrials.gov ID
- NCT02990000
- Acronym / sponsor ID
- IHS-1503-28573
- Conditions
- Mental Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University at Albany, Psychological and Behavioral Consultants, Outcome Referrals, Inc.
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Posted 14 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research has shown that mental health care (MHC) providers differ significantly in their ability to help patients. In addition, providers demonstrate different patterns of effectiveness across symptom and functioning domains. For example, some providers are reliably effective in treating numerous patients and problem domains, others are reliably effective in some domains (e.g., depression, substance abuse) yet appear to struggle in others (e.g., anxiety, social functioning), and some are reliably ineffective, or even harmful, across patients and domains. Knowledge of these provider differences is based largely on patient-reported outcomes collected in routine MHC settings.
Unfortunately, provider performance information is not systematically used to refer or assign a particular patient to a scientifically based best-matched provider. MHC systems continue to rely on random or purely pragmatic case assignment and referral, which significantly "waters down" the odds of a patient being assigned/referred to a high performing provider in the patient's area(s) of need, and increases the risk of being assigned/referred to a provider who may have a track record of ineffectiveness. This research aims to solve the existing non-patient-centered provider-matching problem.
Specifically, the investigators aim to demonstrate the comparative effectiveness of a scientifically-based patient-provider match system compared to status quo pragmatic case assignment. The investigators expect in the scientific match group significantly better treatment outcomes (e.g., symptoms, quality of life) and higher patient satisfaction with treatment. The investigators also expect to demonstrate feasibility of implementing a scientific match process in a community MHC system and broad dissemination of the easily replicated scientific match technology in diverse health care settings. The importance of this work for patients cannot be understated. Far too many patients struggle to find the right provider, which unnecessarily prolongs suffering and promotes health care system inefficiency. A scientific match system based on routine outcome data uses patient-generated information to direct this patient to this provider in this setting. In addition, when based on multidimensional assessment, it allows a wide variety of patient-centered outcomes to be represented (e.g., symptom domains, functioning domains, quality of life).
Detailed description
Background and Significance:
Mental illness is an extraordinary and highly burdensome public health problem. Unfortunately, even for individuals who access mental health care (MHC), the care is too often substandard. Research has consistently demonstrated that approximately 10-15% of patients will deteriorate or experience harm during treatment. Further, when these rates are combined with no-change rates, only 40% or less of patients meaningfully recover. Importantly, treatment research has illuminated substantial variability in providers' outcomes. Simply put, the MHC provider impacts treatment outcomes, and stakeholders lack systematic access to valid and actionable information to optimize effective patient-provider matches. Without collecting and disseminating performance data, stakeholders lack vital information on which to base health care choices and personalize treatment. Conversely, there potentially is immense advantage to matching patients to providers based on scientific outcome data. Patients, stakeholders, researchers, and clinicians have all endorsed such applied knowledge transfer as a high priority. In response, the investigators have developed and piloted a technology to test this match concept and patient-centered health model.
Prominent health care agencies have placed outcome/performance measurement at the center of core initiatives. The Institute of Medicine specifically recommends integrating provider performance data in treatment decision-making. Despite this rhetoric, 2 Cochrane Reviews combined could only identify 4 studies that addressed this question with minimal methodology standards; the results were mixed. Importantly, none involved a targeted dissemination intervention, and none involved MHC. Previous research, including our own, has empirically demonstrated substantial differences in projected treatment effect sizes depending on to which therapist a patient is referred. The key evidence gap is the need for a rigorous test of the effectiveness of a targeted MHC provider-performance dissemination intervention compared to standard/pragmatic referral and case assignment. Relatedly, the Patient-Centered Outcomes Research Institute (PCORI) has called for increased "precision" or "personalized" treatment, with a focus on tailoring. The match algorithm responds directly to this high priority call to customize care in a personal and evidence-based way.
Specific Aims:
The aim of this comparative effectiveness research (CER) is to test an innovative, scientifically informed patient-therapist referral match algorithm based on MHC provider outcome data. The investigators will employ a randomized controlled trial (RCT) to compare the match algorithm with the commonplace pragmatic referral matching (based on provider availability, convenience, or self-reported specialty). Psychosocial treatment itself will remain naturalistically administered by varied providers (e.g., psychologists, social workers) to patients with complex mental health concerns within a partner clinic network, Psychological and Behavioral Consultants (PsychBC). The investigators hypothesize that the scientific match group will outperform the pragmatic match group in decreasing patient symptoms and treatment dropout, and in promoting patient functional outcomes, outcome expectations, and care satisfaction, as well as patient-therapist alliance quality. Doing so will establish the match algorithm as a mechanism of effective patient-centered MHC.
Methods:
The investigators will compare the effectiveness of naturalistic MHC either with or without the scientific matching aid with a double blind, individual level RCT. The investigators will first conduct a baseline assessment of PsychBC therapists' (target enrollment N=44) performance (across at least 15 cases) to determine their strengths in treating 12 behavioral health domains measured by the primary outcome tool on which our match algorithm is based -- the Treatment Outcome Package (TOP). The TOP is already administered routinely in our partner network. Based on years of predictive analytic research, this tool classifies therapists as "effective," "neutral," or "ineffective/harmful" for each TOP domain. The blinded therapists will be crossed over conditions.
Next, for the trial, new adult outpatients (target enrollment N=281) will be randomly assigned to the Match condition or case assignment as usual (typically based on pragmatic considerations, such as provider availability, convenience, or self-reported specialty). The only patient exclusion criterion will be people who are not the primary decision-maker for their care. Thus, patients will present with a multitude of problems across a spectrum of diagnoses. With therapist assignment as the only manipulation, participating therapists will treat patients fully naturalistically. Treatment outcomes will be assessed regularly through mutual termination or up to 16 weeks. Primary analyses will involve hierarchical linear modeling to examine comparative rates and patterns of change on the outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pragmatic Match | No intervention | –Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group) |
| Scientific Match | Experimental | Behavioral: Scientific MatchRandomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18-70 years of age
- Being the primary, informed decision-maker for one's care
- Willingness to be randomized to condition and to complete a few study-specific measures
Key exclusion criteria (3 listed)
- Being under 18 or over 70 years of age
- Not being responsible for one's own treatment decisions
- Unwillingness to be randomized to condition and/or to complete a few study-specific measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scientific MatchAlso: Match SystemWe 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). | Behavioural | Scientific Match |
Primary outcome
Average Z-Scores for the Treatment Outcome Package-Clinical Scales (TOP-CS; Kraus, Seligman, & Jordan, 2005)
Time frame: Baseline and biweekly across 16 weeks
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.
6 secondary outcomes
Symptom Checklist-10 (SCL-10; Rosen, Drescher, Moos, & Gusman, 1999) Total Score
Time frame: Baseline and biweekly across 16 weeks
Working Alliance Inventory-Short Form, Patient Version (WAI-SF-P; Tracey, & Kokotovic, 1989) Total Score
Time frame: Biweekly across 16 weeks
Outcome Expectation (OE) Subscale of the Credibility/Expectancy Scale (CEQ; Devilly, & Borkovec, 2000)
Time frame: Biweekly across 16 weeks
Domain-Specific Impairment on the Most Elevated Domain of the Treatment Outcome Package-Clinical Scales (TOP-CS)
Time frame: Baseline and biweekly across 16 weeks
Early Treatment Discontinuation (i.e., Attending 2 or Fewer Treatment Sessions)
Time frame: Early treatment discontinuation/continuation at session 2
Overall Provider Quality Subscale of the Treatment Outcome Package (TOP) Satisfaction Scale
Time frame: Assessed after 16 weeks of treatment or at the point of naturalistic treatment termination, whichever comes sooner
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39836135Coyne AE, Gaines AN, DeFontes CG, Constantino MJ, Barcala-Delgado DI, Boswell JF, Kraus DR. Parsing the existential isolation-outcome association into its within- and between-patient components in naturalistic psychotherapy. Psychotherapy (Chic). 2025 Jun;62(2):235-242. doi: 10.1037/pst0000564. Epub 2025 Jan 20.
- Derived from this study: PubMed 38565810Coyne AE, Constantino MJ, Boswell JF, Gaines AN, Kraus DR. Therapist-Level Moderators of Patient-Therapist Match Effectiveness in Community Psychotherapy. Adm Policy Ment Health. 2024 Sep;51(5):738-752. doi: 10.1007/s10488-024-01360-8. Epub 2024 Apr 2.
- Derived from this study: PubMed 34110861Boswell JF, Constantino MJ, Coyne AE, Kraus DR. For whom does a match matter most? Patient-level moderators of evidence-based patient-therapist matching. J Consult Clin Psychol. 2022 Jan;90(1):61-74. doi: 10.1037/ccp0000644. Epub 2021 Jun 10.
- Derived from this study: PubMed 34106240Constantino MJ, Boswell JF, Coyne AE, Swales TP, Kraus DR. Effect of Matching Therapists to Patients vs Assignment as Usual on Adult Psychotherapy Outcomes: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):960-969. doi: 10.1001/jamapsychiatry.2021.1221.
- Study-specific websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon request on a case-by-case basis, we will share all IPD that underlie results in a publication (e.g., data extraction for meta-analyses). As appropriate, based on specific scientific journals' standards, we will provide analytic code used to generate published results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Constantino, PhD principal investigator
University of Massachusetts, Amherst
James F Boswell, PhD principal investigator
University at Albany, SUNY
David R Kraus, PhD principal investigator
Outcome Referrals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scientific Match in people with Mental Illness, run by University of Massachusetts, Amherst at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Z-Scores for the Treatment Outcome Package-Clinical Scales (TOP-CS; Kraus, Seligman, & Jordan, 2005) (time frame: Baseline and biweekly across 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02990000, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.