Psychodynamic Psychotherapy for Psychosis

Psychodynamic Psychotherapy for Psychosis: An Empirical Pilot Study of Efficacy, Therapeutic Action, and Machine Learning Analysis of Within-Session Speech and Behavior

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.

Study Overview

• Status: Withdrawn
• Conditions: Psychotic Disorders
• Intervention / Treatment: Behavioral: Psychodynamic Psychotherapy; Behavioral: Usual Care

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychodynamic Psychotheray; 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	Behavioral: Psychodynamic Psychotherapy; Intensive psychotherapy that is psychodynamically oriented.
Active Comparator: Treatment as Usual; 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.	Behavioral: Usual Care; Conventional treatment offered in the community.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment up to 5 years from enrollment.
Overall Functioning - Social	The Global Functioning: Social scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).	From enrollment up to 5 years from enrollment.
Overall Functioning - Role	The Global Functioning: Role scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).	From enrollment up to 5 years from enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment up to 5 years from enrollment.
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.	From enrollment up to 5 years from enrollment.

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: University of Southern California; American Psychoanalytic Association
• Investigators: Principal Investigator: Keith Gallagher, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 2000028087

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No