NCT02990000

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
4 months until next milestone

Results Posted

Study results publicly available

July 14, 2020

Completed
Last Updated

July 30, 2020

Status Verified

May 1, 2020

Enrollment Period

1.9 years

First QC Date

November 29, 2016

Results QC Date

May 15, 2020

Last Update Submit

July 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and biweekly across 16 weeks

Secondary Outcomes (6)

  • Symptom Checklist-10 (SCL-10; Rosen, Drescher, Moos, & Gusman, 1999) Total Score

    Baseline and biweekly across 16 weeks

  • Working Alliance Inventory-Short Form, Patient Version (WAI-SF-P; Tracey, & Kokotovic, 1989) Total Score

    Biweekly across 16 weeks

  • Outcome Expectation (OE) Subscale of the Credibility/Expectancy Scale (CEQ; Devilly, & Borkovec, 2000)

    Biweekly across 16 weeks

  • Domain-Specific Impairment on the Most Elevated Domain of the Treatment Outcome Package-Clinical Scales (TOP-CS)

    Baseline and biweekly across 16 weeks

  • Early Treatment Discontinuation (i.e., Attending 2 or Fewer Treatment Sessions)

    Early treatment discontinuation/continuation at session 2

  • +1 more secondary outcomes

Study Arms (2)

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)

Behavioral: Scientific Match

Interventions

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).

Also known as: Match System
Scientific Match

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Amherst

Amherst, Massachusetts, 01003, United States

Location

Related Publications (3)

  • 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.

  • Boswell 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.

  • Constantino 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.

Related Links

MeSH Terms

Conditions

Mental Disorders

Limitations and Caveats

The naturalistic design resulted in limited information on the treatments themselves, differing treatment lengths, and some missing data.

Results Point of Contact

Title
Dr. Michael J. Constantino
Organization
University of Massachusetts Amherst

Study Officials

  • Michael J Constantino, PhD

    University of Massachusetts, Amherst

    PRINCIPAL INVESTIGATOR
  • James F Boswell, PhD

    University at Albany, SUNY

    PRINCIPAL INVESTIGATOR
  • David R Kraus, PhD

    Outcome Referrals, Inc.

    PRINCIPAL INVESTIGATOR
  • Thomas P Swales, PhD

    Psychological and Behavioral Consultants

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 12, 2016

Study Start

November 6, 2017

Primary Completion

September 23, 2019

Study Completion

March 15, 2020

Last Updated

July 30, 2020

Results First Posted

July 14, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
We will begin sharing IPD upon request 6 months following the publication of our peer-reviewed final research report for PCORI, and we will maintain our de-identified data set indefinitely given possible future requests (e.g., to extract data for meta-analyses).
Access Criteria
We will share fully de-identified IPD, a corresponding data dictionary, and the above supporting information to professional scientific colleagues (with established reputations for publishing original psychotherapy research in accordance with ethical guidelines) for the purposes of replication efforts or meta-analyses. For other usages, such as requests to conduct novel secondary analyses, we will consider such collaborations on a case-by-case basis and clearly determine authorship arrangements in writing. Review requests, including a detailed plan for how the data will be used, should be directed via email to the PI, Dr. Michael Constantino (mconstantino@psych.umass.edu). Dr. Constantino reserves the right to deny individual share requests if the usage details are questionable or unclear.

Locations