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WithdrawnNCT04415541Updated Oct 25, 2021

Psychodynamic Psychotherapy for Psychosis

An interventional study of Psychodynamic Psychotherapy and Usual Care in Psychotic Disorders, sponsored by Yale University. Withdrawn. Open to participants aged 16 Years to 35 Years. Per ClinicalTrials.gov, last updated 2021-10-25.

Sponsored by Yale University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
COVID
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
16 Years to 35 Years
Sex
All
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Study 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.

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Conditions studied

  • Psychotic Disorders

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03

In context

Psychotic Disorders

1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.

Browse Psychotic Disorders studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 35 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

    Behavioral: Psychodynamic Psychotherapy

  • 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.

    Behavioral: Usual Care

Interventions

  • BehavioralPsychodynamic Psychotherapy

    Intensive psychotherapy that is psychodynamically oriented.

  • BehavioralUsual Care

    Conventional treatment offered in the community.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment up to 5 years from enrollment.

  2. Overall Functioning - Social

    The Global Functioning: Social scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).

    Time frame: From enrollment up to 5 years from enrollment.

  3. Overall Functioning - Role

    The Global Functioning: Role scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).

    Time frame: From enrollment up to 5 years from enrollment.

Secondary outcomes

  1. 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.

    Time frame: From enrollment up to 5 years from enrollment.

  2. 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.

    Time frame: From enrollment up to 5 years from enrollment.

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04415541
Lead sponsor
Yale University
Collaborators
University of Southern California, American Psychoanalytic Association
Responsible party
Sponsor
First posted
Jun 4, 2020
Start date
May 2021 (estimated)
Primary completion
Aug 2021 (estimated)
Completion
Aug 2021 (estimated)
Last update
Oct 25, 2021

Study contacts

Keith Gallagher, MD
principal investigator · Yale University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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