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T.E.A.M. Feasibility and Efficacy Study 2.0 (TEAM)

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ClinicalTrials.gov Identifier: NCT03694106
Recruitment Status : Active, not recruiting
First Posted : October 3, 2018
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Alex Clarke, Feeling Good Institute

Tracking Information
First Submitted Date October 1, 2018
First Posted Date October 3, 2018
Last Update Posted Date March 3, 2020
Actual Study Start Date April 15, 2019
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 1, 2018)
NIH PROMIS 4 item depression questionnaire [ Time Frame: 9 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title T.E.A.M. Feasibility and Efficacy Study 2.0
Official Title Feasility Pilot of T.E.A.M. Psychotherapy Using Electronic Capture of Before and After Therapy Measures.
Brief Summary

T.E.A.M. psychotherapy was developed by one of the founders of cognitive therapy, David Burns and builds on traditional CBT with an emphasis on T = Testing, E = Empathy, A = Agenda Setting (assessing and building motivation) and M = Methods (including cognitive and behavioral methods). Because TEAM therapy is a data-driven therapy, its delivery hinges on the use of symptom measures and measures of the therapeutic alliance at every session with every patient. These measures are now available for collection thru computerized forms, making their collection and review considerably more accessible and efficient for the patient and therapist.

The following hypotheses will be tested:

  1. TEAM psychotherapy using computerized measurement collection is safe and feasible.
  2. TEAM psychotherapy using computerized measurement collection shows evidence of efficacy by exploratory non inferiority testing compared to benchmark studies with similar psychotherapeutic modalities
  3. Evidence for efficacy is strong enough to justify pursuit of an experimental randomized controlled clinical trial of TEAM therapy for major depressive disorder versus treatment as usual.
Detailed Description A gap currently exists between the technology available for collecting psychotherapy data and the application of this technology to psychotherapeutic settings to enhance treatment outcomes. A novel integration of Cognitive Behavior Therapy (CBT) informed psychotherapy and digitized data collection systems called T.E.A.M. therapy exists that bridges this gap and has yet to be tested. The purpose of this study is to explore whether TEAM CBT appears safe and feasible and has results similar to comparable and similar benchmark studies. This outcome will provide pilot data and a rationale for whether to pursue a separate randomized controlled trial in the future. We will compare the results of TEAM therapy using electronic data collection to similar psychotherapeutic treatments for common psychiatric problems such as depression, anxiety, relationship conflicts and maladaptive behaviors. We will also explore the data for its use in predictive modeling. This study is part of a wider goal of developing best practices in dissemination of standardized measurement based psychotherapies that are effective and use technology via computerized delivery systems guided by therapists. It is hoped that with computer based measurement systems for psychotherapy, more accurate and frequent information for therapists is available to modify earlier and more effectively their approaches. The measurement based systems will also allow performance by psychotherapists to be measured accurately and enable a type of machine based learning environment with feedback systems in place to improve providers' patient care in a more precise and personalized way.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Receiving TEAM therapy from Level 4 or above therapist.
Condition Depression, Anxiety
Intervention Behavioral: TEAM PSYCHOTHERAPY
Patients data will be collected from the first to the final psychotherapy session as performed normally by TEAM trained clinicians. The treatment-as-usual includes therapy sessions of 50 to 110minutes long, typically once or twice per week for an average of 8-12 sessions. Treatment as usual by these clinicians includes the use of psychological symptoms survey immediately before and after each psychotherapy session. Typically patients will fill out these surveys in the clinic's waiting area before and after each session.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 1, 2018)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 1, 2023
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 1. Cognitive functioning at a level and ability to use an electronic tool. 2. Demonstration of decisional capacity in order to participate in psychotherapy.

Exclusion Criteria:

1. Under age 18 3. Providers: not TEAM certified at a level 3 or above 2. Patients: Non-fluent English speakers. The tool for now is only available in English

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Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03694106
Other Study ID Numbers 41809
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Alex Clarke, Feeling Good Institute
Study Sponsor Feeling Good Institute
Collaborators Stanford University
Investigators
Principal Investigator: Maor Katz, MD Feeling Good Institute
Principal Investigator: Alex Clarke, MD Feeling Good Institute
PRS Account Feeling Good Institute
Verification Date February 2020