Paranoid DelusionsCBTpNCT01704833
Cognitive Behavioral Therapy for Paranoia in Schizophrenia
A study testing Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in people with Paranoid Delusions, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Paranoid Delusions
- What is being tested?
- Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -Substance misuse or medical disorder identified as the primary cause of delusions
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Paranoid Delusions
- Being tested
- Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)
- Keywords
- Psychosis, Paranoia, Cognitive Behavioral Therapy, Delusions, Group Therapy
- Medical subject headings
- Psychotic Disorders, Paranoid Disorders, Delusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)Behavioural
The PFCBT is a 15-week Program that includes weekly group and individual sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care. Receives: Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) |
| Treatment as Usual | No intervention | This group receives standard care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Persecution Severity at week 16 and at week 42.
Measured by the Persecution sub-scale on Positive and Negative Syndrome Scale (PANSS).
Measured: Measured at baseline, at week 16, and at week 42.
Secondary outcomes (4)
Change from Baseline in Attributional Style 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).
Measured: Measured at baseline and at week 16.
Change from Baseline in a Tendency to Jump to Conclusions at week 16.
Measured by the BEADS Task. Measures a tendency to jump to conclusions when making a judgment.
Measured: Measured at baseline and at week 16.
Change from Baseline in Cognitive Insight at week 16.
Beck Cognitive Insight Scale. Measures cognitive insight.
Measured: Measured at baseline and at week 16.
Change from Baseline in Dimensions of Paranoid Delusions
Psychotic Symptom Rating Scales (PSYRATS), Delusions. Measure dimensions of delusions.
Measured: Measured at baseline, at week 16 and at week 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startSep 2006
- Primary completionSep 2009
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paranoid DelusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Sponsor
- Investigators
- Yulia Landa, Psy D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704833
- Sponsor's protocol ID
- 0505007908
- Acronym
- CBTp
- Status last verified
- Dec 2018
- First submitted
- 27 Sep 2012
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Paranoia in Schizophrenia
- ClinicalTrials.gov ID
- NCT01704833
- Acronym / sponsor ID
- CBTp / 0505007908
- Conditions
- Paranoid Delusions
- Keywords
- Psychosis, Paranoia, Cognitive Behavioral Therapy, Delusions, Group Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Sep 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care. |
| Treatment as Usual | No intervention | –This group receives standard care only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -Substance misuse or medical disorder identified as the primary cause of delusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)The PFCBT is a 15-week Program that includes weekly group and individual sessions. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
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).
4 secondary outcomes
Change from Baseline in Attributional Style at week 16.
Time frame: Measured at baseline and at week 16.
Change from Baseline in a Tendency to Jump to Conclusions at week 16.
Time frame: Measured at baseline and at week 16.
Change from Baseline in Cognitive Insight at week 16.
Time frame: Measured at baseline and at week 16.
Change from Baseline in Dimensions of Paranoid Delusions
Time frame: Measured at baseline, at week 16 and at week 42.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yulia Landa, Psy D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in people with Paranoid Delusions, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.