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Psychodynamic Psychotherapy for Psychosis

Primary Purpose

Psychotic Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychodynamic Psychotherapy
Usual Care
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders

Eligibility Criteria

16 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • completed the 2-3 year Coordinated Specialty Care (CSC) program
  • judged by present provider to be in an intermediate or advanced phase of recovery
  • had first episode of psychosis within the 3 years prior to enrollment

Exclusion Criteria:

  • established diagnosis of primary affective disorder, psychosis secondary to substance use or a medical illness
  • inability to communicate in English
  • eligibility for Department of Developmental Services
  • legally mandated to enter treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Psychodynamic Psychotheray

    Treatment as Usual

    Arm Description

    Following Coordinated Specialty Care, we will offer weekly psychodynamic psychotherapy and medication management sessions which will be conducted solely by the PI, Keith Gallagher, in the initial pilot period. Consent will be obtained to record audio and video of the sessions

    Following Coordinated Specialty Care, patients will be referred to general mental health providers in the community, which would typically include less intensive and frequent psychotherapy by a social worker or psychologist as well as medication management by a psychiatrist who may not be a specialist in psychotic disorders.

    Outcomes

    Primary Outcome Measures

    Overall Symptom Severity
    The Positive and Negative Symptom Scale (PANSS) will be used. This is a 30 item scale. Each item is measured on a 7-point scale from 1 (absent) to 7 (extreme). Items are summed to obtain an overall score.
    Overall Functioning - Social
    The Global Functioning: Social scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).
    Overall Functioning - Role
    The Global Functioning: Role scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).

    Secondary Outcome Measures

    Symptom Severity (Positive Symptoms)
    The positive symptoms subscale of the Positive and Negative Symptom Scale (PANSS) will be used. Each item is measured on a 7-point scale from 1 (absent) to 7 (extreme). Subscale items are summed to obtain a positive symptom score.
    Symptom Severity (Negative Symptoms)
    The negative symptoms subscale of the Positive and Negative Symptom Scale (PANSS) will be used. Each item is measured on a 7-point scale from 1 (absent) to 7 (extreme). Subscale items are summed to obtain an overall score.

    Full Information

    First Posted
    June 2, 2020
    Last Updated
    October 22, 2021
    Sponsor
    Yale University
    Collaborators
    University of Southern California, American Psychoanalytic Association
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04415541
    Brief Title
    Psychodynamic Psychotherapy for Psychosis
    Official Title
    Psychodynamic Psychotherapy for Psychosis: An Empirical Pilot Study of Efficacy, Therapeutic Action, and Machine Learning Analysis of Within-Session Speech and Behavior
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    COVID
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    August 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    University of Southern California, American Psychoanalytic Association

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The broad goals of our pilot study are to (1) determine whether psychodynamic psychotherapy for psychosis (PPfP), relative to treatment as usual (TaU), can maintain or augment clinical and functional benefits for patients who have achieved initial recovery in our coordinated specialty care (CSC) early psychosis treatment program; (2) to conduct novel empirical study of how various psychodynamic factors may inform candidate selection, mediate therapeutic effects, and influence relational aspects of the therapy; and (3) to conduct a detailed study of how features of therapist and patient speech and behavior influence therapeutic outcomes, therapeutic alliance alliance, and relational process. This registration focuses on the first goal.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychotic Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Psychodynamic Psychotheray
    Arm Type
    Experimental
    Arm Description
    Following Coordinated Specialty Care, we will offer weekly psychodynamic psychotherapy and medication management sessions which will be conducted solely by the PI, Keith Gallagher, in the initial pilot period. Consent will be obtained to record audio and video of the sessions
    Arm Title
    Treatment as Usual
    Arm Type
    Active Comparator
    Arm Description
    Following Coordinated Specialty Care, patients will be referred to general mental health providers in the community, which would typically include less intensive and frequent psychotherapy by a social worker or psychologist as well as medication management by a psychiatrist who may not be a specialist in psychotic disorders.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychodynamic Psychotherapy
    Intervention Description
    Intensive psychotherapy that is psychodynamically oriented.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual Care
    Intervention Description
    Conventional treatment offered in the community.
    Primary Outcome Measure Information:
    Title
    Overall Symptom Severity
    Description
    The Positive and Negative Symptom Scale (PANSS) will be used. This is a 30 item scale. Each item is measured on a 7-point scale from 1 (absent) to 7 (extreme). Items are summed to obtain an overall score.
    Time Frame
    From enrollment up to 5 years from enrollment.
    Title
    Overall Functioning - Social
    Description
    The Global Functioning: Social scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).
    Time Frame
    From enrollment up to 5 years from enrollment.
    Title
    Overall Functioning - Role
    Description
    The Global Functioning: Role scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).
    Time Frame
    From enrollment up to 5 years from enrollment.
    Secondary Outcome Measure Information:
    Title
    Symptom Severity (Positive Symptoms)
    Description
    The positive symptoms subscale of the Positive and Negative Symptom Scale (PANSS) will be used. Each item is measured on a 7-point scale from 1 (absent) to 7 (extreme). Subscale items are summed to obtain a positive symptom score.
    Time Frame
    From enrollment up to 5 years from enrollment.
    Title
    Symptom Severity (Negative Symptoms)
    Description
    The negative symptoms subscale of the Positive and Negative Symptom Scale (PANSS) will be used. Each item is measured on a 7-point scale from 1 (absent) to 7 (extreme). Subscale items are summed to obtain an overall score.
    Time Frame
    From enrollment up to 5 years from enrollment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: completed the 2-3 year Coordinated Specialty Care (CSC) program judged by present provider to be in an intermediate or advanced phase of recovery had first episode of psychosis within the 3 years prior to enrollment Exclusion Criteria: established diagnosis of primary affective disorder, psychosis secondary to substance use or a medical illness inability to communicate in English eligibility for Department of Developmental Services legally mandated to enter treatment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Keith Gallagher, MD
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Psychodynamic Psychotherapy for Psychosis

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