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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Depression, Anxiety Behavioral: TEAM PSYCHOTHERAPY

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasility Pilot of T.E.A.M. Psychotherapy Using Electronic Capture of Before and After Therapy Measures.
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. NIH PROMIS 4 item depression questionnaire [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Receiving TEAM therapy from Level 4 or above therapist.
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694106


Locations
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United States, California
Feeling Good Institute
Mountain View, California, United States, 94040
Sponsors and Collaborators
Feeling Good Institute
Stanford University
Investigators
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Principal Investigator: Maor Katz, MD Feeling Good Institute
Principal Investigator: Alex Clarke, MD Feeling Good Institute

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Responsible Party: Alex Clarke, Director of Research and Development, Feeling Good Institute
ClinicalTrials.gov Identifier: NCT03694106    
Other Study ID Numbers: 41809
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms