Psychodynamic Psychotherapy for Psychosis

NCT04415541 | Withdrawn

• 1 other identifier: 2000028087
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychotic Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Symptom Severity (Positive Symptoms)

  From enrollment up to 5 years from enrollment.

• Symptom Severity (Negative Symptoms)

  From enrollment up to 5 years from enrollment.

Study Arms (2)

Psychodynamic Psychotheray

EXPERIMENTAL

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

Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

Psychodynamic Psychotherapy BEHAVIORAL

Intensive psychotherapy that is psychodynamically oriented.

Psychodynamic Psychotheray

Usual Care BEHAVIORAL

Conventional treatment offered in the community.

Treatment as Usual

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• University of Southern California: collaborator
• American Psychoanalytic Association: collaborator

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Psychotherapy, Psychodynamic

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Keith Gallagher, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: May 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10