Psychodynamic Psychotherapy for Psychosis

Not Applicable

Withdrawn

• Conditions: Psychotic Disorders
• Interventions: Behavioral: Usual Care; Behavioral: Psychodynamic Psychotherapy

• Registration Number: NCT04415541
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Study Start: 2021-05
• Primary Completion: 2021-08
• Study Completion: 2021-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as Usual	Usual Care	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.
Psychodynamic Psychotheray	Psychodynamic Psychotherapy	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Symptom Severity (Positive Symptoms)	From enrollment up to 5 years from enrollment.	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)	From enrollment up to 5 years from enrollment.	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.