Schizophrenia; PsychosisNCT04748679
Cognitive Behavioral Therapy (CBT) Study Evaluating the Updating of Persecutory Beliefs
A study testing Worry Intervention and Befriending in people with Schizophrenia; Psychosis and Persecutory Delusion, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine how Bayesian belief updating changes throughout psychotherapeutic treatment for persecutory delusions. Specifically, individuals with a psychotic disorder diagnosis who endorse both a current persecutory delusion with strong conviction and significant worry will be recruited and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia; Psychosis, Persecutory Delusion
- What is being tested?
- Worry Intervention and Befriending
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 29 May 2024
- 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
- Men and women age 18 - 65.
- Communicative in English.
- Premorbid Intelligence >79 (WTAR)
- Provide voluntary, written informed consent.
- Physically healthy by medical history.
- Weight <300 lbs
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- Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
- Diagnosis of a non-affective psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, brief psychotic disorder, psychosis NOS) confirmed by Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-5 (SCID) or diagnostic interview with a trained clinician.
- A persecutory delusion scoring at least a 3 on the conviction scale of the Psychotic Symptoms Rating Scale (PSYRATS) that had persisted for at least two weeks and that was not considered the direct result of substance use
- A clinically significant level of worry, as shown by a score of at least 44 on the Penn State Worry Questionnaire (PSWQ).
Who cannot join
- Age less than 18 or greater than 65.
- Not communicative in English.
- Premorbid IQ < 79 (WTAR)
- Unable to provide written informed consent.
- Current medical or neurological illness.
- History of severe head trauma.
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- Weight >300 lbs
- Primary diagnosis of alcohol or substance use disorder or personality disorder
- Conditions that preclude fMRI scanning (as defined in the fMRI Screening Form)
- Subjects who are actively involved with individual cognitive therapy (Past experience with individual therapy is not an exclusion)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
The purpose of this study is to examine how Bayesian belief updating changes throughout psychotherapeutic treatment for persecutory delusions. Specifically, individuals with a psychotic disorder diagnosis who endorse both a current persecutory delusion with strong conviction and significant worry will be recruited and randomized to receive either a CBT-based worry intervention for persecutory delusions or an active control condition (befriending therapy). The investigators will examine: 1) whether belief updating parameters change as delusion severity changes, 2) whether CBT contributes to greater change in belief updating parameters than befriending therapy, and 3) whether neural correlates of belief updating parameters, as measured using functional magnetic resonance imaging (fMRI), predict treatment response.
- Conditions
- Schizophrenia; Psychosis, Persecutory Delusion
- Being tested
- Worry Intervention, Befriending
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Worry InterventionBehavioural
The worry intervention is weekly individual therapy with a trained therapist
BefriendingBehavioural
The worry intervention is weekly individual therapy with a trained therapist
| Study group | Role | What they receive |
|---|---|---|
| Worry Intervention | Experimental | The Worry Intervention uses cognitive-behavioral therapy (CBT) techniques to support the patient in reducing the amount of time they worry throughout the week. It is an 8-week manualized treatment with 5 modules. Each session is 45-60 minutes. Receives: Behavioral: Worry Intervention |
| Befriending | Active comparator | Befriending therapy controls for the general factors of therapy (warmth, engagement) without any 'active' interventions. Individuals in the befriending arm will spend sessions talking with the therapist about things that interest them. It will also be conducted over 8-weeks with 45-60 minute sessions. Receives: Behavioral: Befriending |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computational Parameters of Belief Updating as Measured During a Probabilistic Reversal Learning Task
change in computational parameters after intervention
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks
Change in Delusion Severity Utilizing the Change in Psychotic Symptoms Rating Scale (PSYRATS)
The change in the Delusions subscale total of the Psychotic Symptoms Rating Scale (PSYRATS) from Baseline to Week 24. The Delusions subscale is a composite score of 6 items each rated from 0-4 with 4 indicating more severe symptomology. The Delusions subscale has a possible range of 0-24.
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks
Change in Neural Correlates of Belief Updating Parameters
Change in blood oxygen dependent level (BOLD) signal after intervention
Measured: Baseline, 8 weeks
Secondary outcomes (2)
Baseline Neural Predictors of Treatment Response
BOLD signal during belief updating task at baseline predicting treatment response
Measured: Baseline
Resting-State Predictors of Treatment Response
resting-state connectivity of functional networks predicting treatment response
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start30 Mar 2021
- Primary completion29 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Sheffield, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748679
- Sponsor's protocol ID
- 201882
- Status last verified
- Aug 2024
- First submitted
- 5 Feb 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sheffield JM, Sloan A, Liu J, Beals K, Hall LM, Gautier T, Moussa-Tooks A, Torregrossa LJ, Achee M, Armstrong K, Isham L, Diamond R, Heckers S, Freeman D, Brinen AP. Effects of Cognitive Behavioral Therapy for Worry Versus Befriending Therapy in Individuals with Persecutory Delusions: A Randomized Trial. Schizophr Bull Open. 2026 Jun 22;7(1):sgag026. doi: 10.1093/schizbullopen/sgag026. eCollection 2026.
PubMed 42453144Sheffield JM, Sloan AF, Corlett PR, Rogers BP, Vandekar S, Liu J, Beals KM, Hall LM, Gautier T, Moussa-Tooks AB, Torregrossa LJ, Achee M, Armstrong K, Woodward ND, Belt K, Freeman D, Isham L, Diamond R, Brinen AP, Heckers S. Prior Expectations of Volatility Following Psychotherapy for Delusions: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2517132. doi: 10.1001/jamanetworkopen.2025.17132.
PubMed 40553472
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy (CBT) Study Evaluating the Updating of Persecutory Beliefs
- ClinicalTrials.gov ID
- NCT04748679
- Acronym / sponsor ID
- 201882
- Conditions
- Schizophrenia; Psychosis, Persecutory Delusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 10 Feb 2021 (actual)
- 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 purpose of this study is to examine how Bayesian belief updating changes throughout psychotherapeutic treatment for persecutory delusions. Specifically, individuals with a psychotic disorder diagnosis who endorse both a current persecutory delusion with strong conviction and significant worry will be recruited and randomized to receive either a CBT-based worry intervention for persecutory delusions or an active control condition (befriending therapy). The investigators will examine: 1) whether belief updating parameters change as delusion severity changes, 2) whether CBT contributes to greater change in belief updating parameters than befriending therapy, and 3) whether neural correlates of belief updating parameters, as measured using functional magnetic resonance imaging (fMRI), predict treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Worry Intervention | Experimental | Behavioral: Worry InterventionThe Worry Intervention uses cognitive-behavioral therapy (CBT) techniques to support the patient in reducing the amount of time they worry throughout the week. It is an 8-week manualized treatment with 5 modules. Each session is 45-60 minutes. |
| Befriending | Active comparator | Behavioral: BefriendingBefriending therapy controls for the general factors of therapy (warmth, engagement) without any 'active' interventions. Individuals in the befriending arm will spend sessions talking with the therapist about things that interest them. It will also be conducted over 8-weeks with 45-60 minute sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women age 18 - 65.
- Communicative in English.
- Premorbid Intelligence >79 (WTAR)
- Provide voluntary, written informed consent.
- Physically healthy by medical history.
Key exclusion criteria (10 listed)
- Age less than 18 or greater than 65.
- Not communicative in English.
- Premorbid IQ < 79 (WTAR)
- Unable to provide written informed consent.
- Current medical or neurological illness.
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 |
|---|---|---|
| Worry InterventionThe worry intervention is weekly individual therapy with a trained therapist | Behavioural | Worry Intervention |
| BefriendingThe worry intervention is weekly individual therapy with a trained therapist | Behavioural | Befriending |
Primary outcome
Computational Parameters of Belief Updating as Measured During a Probabilistic Reversal Learning Task
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks
change in computational parameters after intervention
Change in Delusion Severity Utilizing the Change in Psychotic Symptoms Rating Scale (PSYRATS)
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks
The change in the Delusions subscale total of the Psychotic Symptoms Rating Scale (PSYRATS) from Baseline to Week 24. The Delusions subscale is a composite score of 6 items each rated from 0-4 with 4 indicating more severe symptomology. The Delusions subscale has a possible range of 0-24.
Change in Neural Correlates of Belief Updating Parameters
Time frame: Baseline, 8 weeks
Change in blood oxygen dependent level (BOLD) signal after intervention
2 secondary outcomes
Baseline Neural Predictors of Treatment Response
Time frame: Baseline
Resting-State Predictors of Treatment Response
Time frame: Baseline
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 15 Aug 2024.
- Derived from this study: PubMed 42453144Sheffield JM, Sloan A, Liu J, Beals K, Hall LM, Gautier T, Moussa-Tooks A, Torregrossa LJ, Achee M, Armstrong K, Isham L, Diamond R, Heckers S, Freeman D, Brinen AP. Effects of Cognitive Behavioral Therapy for Worry Versus Befriending Therapy in Individuals with Persecutory Delusions: A Randomized Trial. Schizophr Bull Open. 2026 Jun 22;7(1):sgag026. doi: 10.1093/schizbullopen/sgag026. eCollection 2026.
- Derived from this study: PubMed 40553472Sheffield JM, Sloan AF, Corlett PR, Rogers BP, Vandekar S, Liu J, Beals KM, Hall LM, Gautier T, Moussa-Tooks AB, Torregrossa LJ, Achee M, Armstrong K, Woodward ND, Belt K, Freeman D, Isham L, Diamond R, Brinen AP, Heckers S. Prior Expectations of Volatility Following Psychotherapy for Delusions: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2517132. doi: 10.1001/jamanetworkopen.2025.17132.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Worry Intervention and Befriending in people with Schizophrenia; Psychosis and Persecutory Delusion, run by Vanderbilt University Medical Center 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 10 inclusion and 10 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 15 Aug 2024. 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?
Computational Parameters of Belief Updating as Measured During a Probabilistic Reversal Learning Task (time frame: Baseline, 4 weeks, 8 weeks, 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04748679, which also lists 2 linked publications.
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 15 Aug 2024.