Psychodynamic Psychotherapy for Psychosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Psychotic Disorders

Intervention / Treatment
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* Behavioral: Psychodynamic Psychotherapy
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychodynamic Psychotheray<br>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<br>* Intensive psychotherapy that is psychodynamically oriented.<br>|
| Active Comparator: Treatment as Usual<br>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<br>* Conventional treatment offered in the community.<br>|

What is the study measuring?
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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. |