Psychodynamic Psychotherapy for Psychosis: An Empirical Pilot Study of Efficacy, Therapeutic Action, and Machine Learning Analysis of Within-Session Speech and Behavior
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Yale University
- Primary Endpoint
- Overall Symptom Severity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 35 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Psychodynamic Psychotherapy (Behavioral)
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.
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
Overall Symptom Severity
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Symptom Severity (Positive Symptoms)(From enrollment up to 5 years from enrollment.)
- Symptom Severity (Negative Symptoms)(From enrollment up to 5 years from enrollment.)