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Cognitive Behavioral Therapy for Paranoia in Schizophrenia (CBTp)

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ClinicalTrials.gov Identifier: NCT01704833
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Paranoid Delusions Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Paranoia in Schizophrenia
Study Start Date : September 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care.
Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)
The PFCBT is a 15-week Program that includes weekly group and individual sessions.

No Intervention: Treatment as Usual
This group receives standard care only.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704833


Locations
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United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
National Alliance for Research on Schizophrenia and Depression
Investigators
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Principal Investigator: Yulia Landa, Psy D. Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01704833    
Other Study ID Numbers: 0505007908
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Keywords provided by Weill Medical College of Cornell University:
Psychosis
Paranoia
Cognitive Behavioral Therapy
Delusions
Group Therapy
Additional relevant MeSH terms:
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Schizophrenia
Delusions
Paranoid Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Behavioral Symptoms