Cognitive Behavioral Therapy for Schizophrenia

(VIP Trial)

Overseen By Julia Sheffield, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must be taking: Antipsychotics

Disqualifiers: Uncontrolled diabetes, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the effects of cognitive behavioral therapy (CBT) on individuals with schizophrenia who experience persecutory delusions, which are false beliefs that others intend harm. The researchers seek to determine if CBT can alter how these individuals perceive and react to their surroundings. Participants will either receive CBT or continue their usual care (treatment as usual, TAU) with added phone check-ins. The trial suits individuals who have experienced strong delusional beliefs for at least two months, are stable on their medication, and have a schizophrenia-related disorder. As an unphased trial, it offers a unique opportunity to contribute to understanding how CBT can help manage delusions.

Do I have to stop taking my current medications for the trial?

The trial requires that participants have a stable medication regimen for at least two weeks before joining, so you will not need to stop taking your current medications.

What prior data suggests that Cognitive Behavioral Therapy and TAU are safe for treating schizophrenia?

Studies have shown that Cognitive Behavioral Therapy for psychosis (CBTp) is generally safe for people with schizophrenia. Research indicates that most patients handle CBTp well, with few reports of serious side effects. Participants often experience improvements in distress, daily functioning, and overall quality of life.

CBTp involves weekly one-on-one therapy sessions that address specific issues like worry and self-confidence, which can contribute to feelings of paranoia. The therapy is tailored to each person's unique experiences, enhancing its effectiveness and safety. Overall, evidence supports CBTp as a safe treatment option for managing symptoms in schizophrenia-related disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy for Psychosis (CBTp) because it focuses on the specific maintenance factors of paranoia, such as worry and self-confidence, which are not directly addressed by standard antipsychotic medications. Unlike traditional treatments that primarily rely on medication to manage symptoms of schizophrenia, CBTp offers a personalized therapeutic approach designed to empower patients by enhancing their coping strategies and self-confidence. Additionally, the TAU + Phone Check-In arm adds a unique supportive element by incorporating weekly therapist calls, potentially improving adherence and engagement in treatment.

What evidence suggests that Cognitive Behavioral Therapy might be an effective treatment for schizophrenia?

Studies have shown that Cognitive Behavioral Therapy for psychosis (CBTp), a treatment option in this trial, can alleviate symptoms of schizophrenia. Specifically, CBTp has small to medium effects in reducing delusions and hallucinations. A review of several studies found that improvements in symptoms like paranoia are considered low to medium. While CBTp does not cure schizophrenia, it can lessen symptom severity. Research also suggests that CBTp might outperform some other treatments in reducing overall symptoms of psychosis. Evidence indicates that CBTp can help those struggling with delusions feel better over time. Meanwhile, another group in this trial will receive treatment as usual (TAU) with additional phone check-ins, serving as the active comparator. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with schizophrenia-spectrum disorders who experience persecutory delusions. Participants will undergo Cognitive Behavioral Therapy (CBT) or Treatment As Usual (TAU) along with phone check-ins for 16 weeks and have assessments over 6 months, including an MRI if possible.

Inclusion Criteria

Communicative in English

Provide voluntary, written informed consent

I have been diagnosed with a type of non-affective psychotic disorder.

Exclusion Criteria

History of severe head trauma with loss of consciousness >30 minutes

Primary diagnosis of alcohol or substance use disorder or personality disorder

I do not have any serious illness that affects my thinking or memory.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in CBTp or TAU with phone check-ins for 16 weeks

16 weeks

Weekly phone check-ins

Assessment

Participants complete assessments at 4 timepoints over the course of 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy
• TAU

Trial Overview The study aims to see if CBT can change how patients with schizophrenia update their beliefs about the world's unpredictability after treatment of delusions. It also looks at whether brain activity linked to these beliefs changes after therapy.

How Is the Trial Designed?

Group I: CBTp Experimental Treatment 1 Intervention

Weekly individual psychotherapy targeting specific maintenance factors of paranoia (worry, anomalous experiences, self-confidence, and safety behaviors), tailored to the participant's experience

Group II: TAU + Phone Check-In Active Control 1 Intervention

Participants will continue with their regular care (treatment as usual (TAU)) without interference from the study team. In addition to TAU, a study therapist will call them weekly to review what treatment the participants have engaged in. Phone calls will last approximately 5-10 minutes

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Cognitive therapy (CT) has been shown to be an effective treatment for reducing psychotic symptoms in schizophrenia, with a mean effect size of 0.65 based on a meta-analysis of seven studies involving 340 subjects.

Patients receiving cognitive therapy continued to show improvements over time, with a follow-up effect size of 0.93, indicating that the benefits of CT may persist beyond the initial treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive therapy for psychosis in schizophrenia: an effect size analysis. Gould, RA., Mueser, KT., Bolton, E., et al.[2019]

Transcatheter aortic valve implantation (TAVI) is a less invasive and effective treatment for elderly, high-risk patients with severe aortic stenosis, showing improved survival and quality of life compared to medical treatment.

In a study of 101 patients with a median age of 81 years, the 12-month mortality rate was 17.8%, which is considered acceptable for this high-risk group, despite some minor complications during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early- and mid-term outcomes after transcatheter aortic valve implantation. Data from a single-center registry. Bagienski, M., Kleczynski, P., Dziewierz, A., et al.[2022]

In a randomized controlled trial with 41 patients suffering from schizophrenia, integrated psychological therapy (IPT) was found to significantly improve clinical and functional outcomes compared to standard treatment (TAU) over 36 weeks.

The IPT group also showed notable enhancements in cognitive and emotional functioning, suggesting that IPT may be an effective rehabilitation approach for addressing cognitive impairments in chronic schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of integrated psychological therapy on clinical, neuropsychological, emotional and functional outcome in schizophrenia: a RCT study. Aloi, M., de Filippis, R., Grosso Lavalle, F., et al.[2021]

Cognitive Behavioral Therapy (CBT) has demonstrated large clinical effects in reducing both positive and negative symptoms of schizophrenia, based on a review of seven randomized controlled trials.

Patients receiving routine care along with adjunctive CBT experienced additional benefits, suggesting that CBT can enhance treatment outcomes, although further research is needed to assess its long-term effectiveness and impact on relapse rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for schizophrenia: an empirical review. Rector, NA., Beck, AT.[2018]

In a study of 300 patients undergoing transfemoral TAVI, the procedure had a 100% success rate, with a low 30-day mortality rate of 2.3%, indicating it is a safe alternative for high-risk patients.

The rates of stroke (1.7%) and major vascular complications (3%) were also low, suggesting that TAVI is not only effective but also has a favorable safety profile in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation: a single-center experience of 300 cases. Finkelstein, A., Birati, EY., Abramowitz, Y., et al.[2013]

In a study involving nine patients with drug-resistant bipolar affective disorder, subcaudate stereotactic tractotomy led to a reduction in the frequency and severity of both depressive and manic episodes after surgery.

The procedure appeared to be more effective in reducing manic episodes compared to depressive ones, and some medications that were previously ineffective became useful post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome in bipolar affective disorder after stereotactic tractotomy. Lovett, LM., Shaw, DM.[2019]

Cognitive Behavioral Therapy (CBT) is effective in managing both positive and negative symptoms of schizophrenia, and it enhances treatment compliance and reduces aggression, making it a valuable complement to medication.

CBT is recommended by most clinical guidelines for schizophrenia due to its emerging benefits in early intervention, addressing comorbid substance misuse, and reducing relapse and hospitalization rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for schizophrenia. Rathod, S., Phiri, P., Kingdon, D.[2018]

Cognitive therapy has made significant progress in treating schizophrenia, particularly for patients who do not fully respond to medication, as shown in large-scale outcome studies.

Early intervention with cognitive therapy may help prevent the worsening of schizophrenia symptoms, highlighting its potential as a proactive treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive therapy of schizophrenia: a new therapy for the new millennium. Beck, AT., Rector, NA.[2018]

In a study of 142 patients with schizophrenia, only half were referred for cognitive-behavioral therapy (CBT), indicating that many who could benefit were not receiving this treatment.

Patients were less likely to be referred for CBT if they were perceived as doing well or unlikely to engage, suggesting that improving referral practices and outreach could help more patients access the benefits of CBT for relapse prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who does not get cognitive-behavioral therapy for schizophrenia when therapy is readily available? Kingdon, DG., Kirschen, H.[2018]

A study involving 205 patients with schizophrenia showed that brief cognitive-behavioral therapy (CBT) delivered by trained mental health nurses significantly reduced relapse rates at 24 months, with only 31.2% of CBT patients relapsing compared to 45.6% in the treatment as usual (TAU) group.

Patients receiving CBT also had shorter hospital stays, averaging 32.7 days compared to 48.9 days for those in the TAU group, indicating that CBT not only helps in preventing relapse but also reduces the need for hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of brief cognitive-behavioral therapy for schizophrenia delivered by mental health nurses: relapse and recovery at 24 months. Malik, N., Kingdon, D., Pelton, J., et al.[2019]

Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure that allows for the implantation of a biologic valve without removing the native valve, providing a safer alternative for patients at high surgical risk.

The PARTNER clinical trial demonstrated that TAVI leads to better outcomes compared to conservative medical treatment, highlighting its efficacy as a viable option for patients who are not suitable for traditional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidetector computed tomography evaluation of candidates for transcatheter aortic valve implantation. Guillén Subirán, ME., Ros Mendoza, LH., Angulo Herviás, E., et al.[2021]

A study involving 81 patients with severe psychotic and personality disorders showed that treatment in Therapeutic Communities (TC) led to significant improvements in global functioning, quality of life, and engagement in goal-oriented behaviors after 6 and 12 months.

Despite these positive outcomes, the study highlighted high dropout rates, particularly among patients with substance abuse issues and personality disorders, indicating a need for better pre-treatment strategies to enhance patient motivation and retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment outcomes of psychiatric rehabilitation: a follow-up study at an italian therapeutic community]. Salvi, V., Boccardo, F., Giannini, P., et al.[2017]

Cognitive behavioral therapy (CBT) has been shown to effectively reduce overall symptoms of schizophrenia, particularly the severity of delusions, based on clinical trials conducted since 1990.

The benefits of CBT are more pronounced when compared to routine care rather than other therapies that provide similar levels of therapist attention, indicating that CBT may offer unique advantages in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral psychotherapy for schizophrenia: a review of recent empirical studies. Dickerson, FB.[2019]

A multi-component psychological therapy combining integrated psychological therapy (IPT) and emotional management therapy (EMT) was tested on 77 outpatients with chronic schizophrenia, showing high treatment attendance (98%) and no hospital admissions in the experimental group during therapy.

Patients receiving IPT+EMT experienced significant reductions in clinical symptoms and improvements in cognitive functioning and quality of life compared to those receiving treatment as usual (TAU), indicating the therapy's effectiveness even in chronic stages of schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving clinical symptoms, functioning, and quality of life in chronic schizophrenia with an integrated psychological therapy (IPT) plus emotional management training (EMT): A controlled clinical trial. Ruiz-Iriondo, M., Salaberría, K., Polo-López, R., et al.[2021]

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