Psychodynamic Psychotherapy for Psychosis

Psychotic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04415541
• Other study ID #: 2000028087
• Status: Withdrawn
• Phase: N/A
• Start date: May 2021
• Est. completion date: August 2021

Study information

• Verified date: October 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Psychodynamic Psychotherapy
Intensive psychotherapy that is psychodynamically oriented.
• Usual Care
Conventional treatment offered in the community.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	American Psychoanalytic Association, University of Southern California

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.