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Completed

NCT Number: NCT01704833

Cognitive Behavioral Therapy for Paranoia in Schizophrenia

The main objective of this study is to determine the preliminary efficacy of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) relative to standard care in the treatment of persecutory delusions in patients diagnosed with schizophrenia or schizoaffective Disorder.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical College

New York, 10065, United States

About this study

Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) is a manualized intervention that combines group and individual modalities to reduce paranoia-biased information-processing and social avoidance, and to increase insight and reality testing capacity.

This is a randomized controlled clinical trial. Twenty four adults ages 18-65 with the primary DSM-IV Schizophrenia and Schizoaffective disorder and drug-refractory persecutory delusions will be recruited from outpatient clinics in New York City Metropolitan area. Participants will be randomly assigned to either experimental or control group. The experimental group will receive PFCBT in addition to standard care and the control group will receive standard care alone. PFCBT will include participation in one group session and one individual therapy session weekly over the 15 weeks. The preliminary efficacy of the intervention will be evaluated using standardized measures by blind evaluators conducted at baseline, post-treatment, and at 6-months post-termination follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 65 years
  • Met DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder, confirmed by the Clinical Structural Diagnostic Interview (SCID, First et al, 1997) -Reported persistent and distressing paranoid delusion(s);
  • A minimum severity score of 4 point Persecution subscale on The Positive and Negative Syndrome Scale (PANSS)
  • Had an adequate trial (6 months or more) and were stabilized on antipsychotic medications (no change in psychiatric medication prescribed in the last month

Exclusion criteria

-Substance misuse or medical disorder identified as the primary cause of delusions

Treatment and study plan

Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)

Behavioral

The PFCBT is a 15-week Program that includes weekly group and individual sessions.

Primary outcomes

  1. Change from Baseline in Persecution Severity at week 16 and at week 42.

    Time frame: Measured at baseline, at week 16, and at week 42.

    Measured by the Persecution sub-scale on Positive and Negative Syndrome Scale (PANSS).

Secondary outcomes

  1. Change from Baseline in Attributional Style at week 16.

    Time frame: Measured at baseline and at week 16.

    Internal Personal and Situational Attributions Questionnaire.Measures attributional style (a tendency to attribute cause for negative events to situational or personal causes).

  2. Change from Baseline in a Tendency to Jump to Conclusions at week 16.

    Time frame: Measured at baseline and at week 16.

    Measured by the BEADS Task. Measures a tendency to jump to conclusions when making a judgment.

  3. Change from Baseline in Cognitive Insight at week 16.

    Time frame: Measured at baseline and at week 16.

    Beck Cognitive Insight Scale. Measures cognitive insight.

  4. Change from Baseline in Dimensions of Paranoid Delusions

    Time frame: Measured at baseline, at week 16 and at week 42.

    Psychotic Symptom Rating Scales (PSYRATS), Delusions. Measure dimensions of delusions.

Other outcomes

  1. The Working Alliance Inventory (WAI)

    Time frame: Measured at week 16 (post CBT).

    Used to assess the participants' perceived alliance to the therapist.

  2. The Empathy Scale (ES)

    Time frame: Measured at week 16 (post CBT).

    Measures participants' perceptions of the therapist's warmth, genuineness, and empathy.

  3. Group Cohesiveness Scale (GCS)

    Time frame: Measured at week 16 (post CBT).

    Measures group cohesiveness.

  4. Changes from Baseline in Brain Circuitry at week 42.

    Time frame: Measured at baseline and at week 42.

    'Linguistic threat' fMRI paradigm is used to monitor brain circuitry changes associated with PFCBT.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression

Registry information

Acronym: CBTp

Important dates

Study start
2006
Primary completion
2009
Study completion
2017
First posted
Oct 11, 2012
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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