- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04415541
Psychodynamic Psychotherapy for Psychosis
October 22, 2021 updated by: Yale University
Psychodynamic Psychotherapy for Psychosis: An Empirical Pilot Study of Efficacy, Therapeutic Action, and Machine Learning Analysis of Within-Session Speech and Behavior
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 Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Intensive psychotherapy that is psychodynamically oriented.
|
Active Comparator: 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.
|
Conventional treatment offered in the community.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From enrollment up to 5 years from enrollment.
|
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).
|
From enrollment up to 5 years from enrollment.
|
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).
|
From enrollment up to 5 years from enrollment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom Severity (Positive Symptoms)
Time Frame: 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.
|
From enrollment up to 5 years from enrollment.
|
Symptom Severity (Negative Symptoms)
Time Frame: 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.
|
From enrollment up to 5 years from enrollment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Keith Gallagher, MD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2021
Primary Completion (Anticipated)
August 1, 2021
Study Completion (Anticipated)
August 1, 2021
Study Registration Dates
First Submitted
June 2, 2020
First Submitted That Met QC Criteria
June 2, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
October 25, 2021
Last Update Submitted That Met QC Criteria
October 22, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000028087
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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