Cognitive Behavioral Therapy for Schizophrenia (VIP Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt University Medical Center
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to learn whether learning and belief updating change in response to the treatment of persecutory delusions, in individuals with schizophrenia-spectrum disorders.
The main questions are:
1. do prior expectations about environmental volatility reduce following effective psychotherapeutic treatment of delusions?
2. does corresponding brain activity related to volatility change with effective treatment of delusions?
Participants will:
1. engage in CBTp or TAU + phone check-ins for 16 weeks
2. complete assessments at 4 timepoints over the course of 6 months
3. complete an MRI when possible
How is Cognitive Behavioral Therapy for Schizophrenia different from other treatments?
Cognitive Behavioral Therapy (CBT) for schizophrenia is unique because it focuses on changing negative thought patterns and behaviors, rather than relying on medication. This therapy helps patients develop coping strategies and improve their daily functioning, offering a non-drug approach to managing symptoms.
19101112Is cognitive behavioral therapy safe for people with schizophrenia?
Cognitive behavioral therapy (CBT) for schizophrenia is generally considered safe, as studies show it can help reduce symptoms without causing harm. In one study, none of the patients receiving CBT required hospital admission during therapy, suggesting it is a safe treatment option.
245614What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Schizophrenia?
Research shows that Cognitive Behavioral Therapy (CBT) is effective in managing symptoms of schizophrenia, improving insight, and reducing relapse and hospitalization. It complements medication and is recommended by clinical guidelines for schizophrenia treatment.
3781314Do 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.
Eligibility Criteria
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
I have been diagnosed with a type of non-affective psychotic disorder.
Exclusion Criteria
I do not have any serious illness that affects my thinking or memory.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: CBTpExperimental Treatment1 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-InActive Control1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Outcome in bipolar affective disorder after stereotactic tractotomy. [2019]Nine patients have been treated by subcaudate stereotactic tractotomy for bipolar affective disorder resistant to drug treatments. In the majority, after the operation there was a reduction in frequency and severity of depressive and manic episodes. There was a trend for the operation to have more effect on the manic than on the depressive phases. Drugs which had been inert previously sometimes became therapeutically useful after surgery.
Cognitive behavioral psychotherapy for schizophrenia: a review of recent empirical studies. [2019]A set of cognitive behavioral psychotherapies (CBT) has been developed for schizophrenia. These interventions have been used for the treatment of both recent onset patients and those with treatment-refractory symptoms. This article reviews clinical trials of CBT for schizophrenia since 1990. The CBT interventions appear to be beneficial in reducing overall symptom levels, especially the severity of delusions. The relative efficacy of CBT is more evident when CBT is compared with routine care than when it is compared with other therapies matched for therapist attention. Further studies are needed to objectively determine the active ingredients of CBT and to better identify the interactions of CBT with concurrent psychosocial and medication treatments.
Cognitive therapy of schizophrenia: a new therapy for the new millennium. [2018]Over the past decade, major advances have been made in extending the principles and therapeutic strategies of cognitive therapy to the treatment of schizophrenia. In a number of large-scale outcome studies with cognitive therapy for schizophrenia, cognitive therapy has been shown to offer significant gains for those patients who have not been wholly helped with medications. It may even serve to prevent the consolidation of the illness if delivered with those in the early stage of the illness. We first outline the "state-of-the-art" conceptualization and strategies employed by cognitive therapists to treat positive and negative symptoms and then review the clinical trials.
Cognitive therapy for psychosis in schizophrenia: an effect size analysis. [2019]We conducted a meta-analysis using all available controlled treatment outcome studies of cognitive therapy (CT) for psychotic symptoms in schizophrenia. Effect sizes were calculated for seven studies involving 340 subjects. The mean effect size for reduction of psychotic symptoms was 0.65. The findings suggest that cognitive therapy is an effective treatment for patients with schizophrenia who have persistent psychotic symptoms. Follow-up analyses in four studies indicated that patients receiving CT continued to make gains over time (ES=0.93). Further research is needed to determine the replicability of standardized cognitive interventions, to evaluate the clinical significance of cognitive therapy for schizophrenia, and to determine which patients are most likely to benefit from this intervention.
Who does not get cognitive-behavioral therapy for schizophrenia when therapy is readily available? [2018]The evidence base for using cognitive-behavioral therapy in schizophrenia is well established; it is recommended in guidelines by the Schizophrenia Patient Outcomes Research Team.
Effectiveness of brief cognitive-behavioral therapy for schizophrenia delivered by mental health nurses: relapse and recovery at 24 months. [2019]Evidence of the efficacy of cognitive-behavioral therapy (CBT) for schizophrenia is increasing. There are very few studies of effectiveness, especially in the medium term.
Cognitive behavioral therapy for schizophrenia. [2018]Cognitive behavioral therapy (CBT) complements medication management and evidence has shown its effectiveness in managing positive and negative symptoms, promoting treatment resistance, and improving insight, compliance, and aggression in schizophrenia. There is emerging evidence in early intervention, comorbid substance misuse, and reducing relapse and hospitalization. CBT is now recommended by most clinical guidelines for schizophrenia. Treatment is based on engaging the patient in a therapeutic relationship, developing an agreed formulation, and then the use of a range of techniques for hallucinations, delusions, and negative symptoms. This article gives an overview of the current status of CBT for schizophrenia.
Cognitive behavioral therapy for schizophrenia: an empirical review. [2018]Early case studies and noncontrolled trial studies focusing on the treatment of delusions and hallucinations have laid the foundation for more recent developments in comprehensive cognitive behavioral therapy (CBT) interventions for schizophrenia. Seven randomized, controlled trial studies testing the efficacy of CBT for schizophrenia were identified by electronic search (MEDLINE and PsychInfo) and by personal correspondence. After a review of these studies, effect size (ES) estimates were computed to determine the statistical magnitude of clinical change in CBT and control treatment conditions. CBT has been shown to produce large clinical effects on measures of positive and negative symptoms of schizophrenia. Patients receiving routine care and adjunctive CBT have experienced additional benefits above and beyond the gains achieved with routine care and adjunctive supportive therapy. These results reveal promise for the role of CBT in the treatment of schizophrenia although additional research is required to test its efficacy, long-term durability, and impact on relapse rates and quality of life. Clinical refinements are needed also to help those who show only minimal benefit with the intervention.
Transcatheter aortic valve implantation: a single-center experience of 300 cases. [2013]Transcatheter aortic valve implantation (TAVI) has recently become an alternative to surgical aortic valve replacement in selected patients with high operative risk.
[Treatment outcomes of psychiatric rehabilitation: a follow-up study at an italian therapeutic community]. [2017]The treatment of severely ill patients with psychotic and personality disorders is often conducted in residential settings such as the Therapeutic Communities (TC). In these facilities a multidisciplinary model is employed to ensure integrative care of the complex psychiatric patient. Although the cost of such programs is very high, evidence of efficacy and effectiveness is scarce, especially in Italy.
Early- and mid-term outcomes after transcatheter aortic valve implantation. Data from a single-center registry. [2022]Transcatheter aortic valve implantation (TAVI) is a less invasive treatment option for elderly, high-risk patients with symptomatic severe aortic stenosis (AS) than aortic valve replacement. More importantly, TAVI improves survival and quality of life as compared to medical treatment in inoperable patients.
Multidetector computed tomography evaluation of candidates for transcatheter aortic valve implantation. [2021]In transcatheter aortic valve implantation (TAVI), a biologic valve mounted in a stent is implanted without removing the native valve. This procedure was first done in humans by Alain Cribier in 2002 and was included in clinical guidelines after the multicenter PARTNER (Placement of AoRtic TraNscathetER) randomized clinical trial, which showed that TAVI obtained better outcomes than conservative medical treatment and is an alternative to surgery in patients with high surgical risk. Candidates for TAVI must be assessed to determine whether the procedure is feasible, because TAVI is not ideal for all patients who are considered inoperable. Multidetector computed tomography plays an important role in the anatomic evaluation of candidates and in guiding the procedure in those who are finally selected.
Effectiveness of integrated psychological therapy on clinical, neuropsychological, emotional and functional outcome in schizophrenia: a RCT study. [2021]Background: Cognitive impairment is considered a central feature of schizophrenia (SZ) and several rehabilitation treatments have been developed to try to improve cognitive deficits.Aims: The aim of the present study was to analyze the effectiveness of integrated psychological therapy (IPT) compared with a standard treatment (TAU) in two groups of patients with SZ, using a comprehensive testing battery of clinical, cognitive, social cognition and functional outcome domains.Methods: Forty-one patients with SZ were assigned to IPT or TAU groups in a randomized controlled trial (RCT). Psychopathological, neuropsychological, emotional and functional outcome variables were assessed at baseline and after 36 weeks of treatment.Results: The IPT group showed significant improvements than the TAU group regarding clinical and functional outcome variables. Moreover, the IPT group improved significantly in the cognitive domains and emotional functioning. Finally, linear regression has highlighted that the improvement of cognitive variables depends on having done the IPT treatment.Conclusions: IPT seems to be effective in improving clinical, neuropsychological, emotional and functional outcome in chronic SZ inpatients. Further studies would be desirable to deepen the effectiveness of IPT in the field of the psychiatric rehabilitation pointing to the possibility of recovery from mental illness.
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. [2021]Objective: This paper describes the results of testing a multi-component psychological therapy that includes integrated psychological therapy (IPT), together with an adaptation of emotional management therapy (EMT), versus treatment as usual (TAU), delivered in a community mental health setting for individual with chronic schizophrenia. We investigated the effectiveness of a psychological intervention on clinical symptoms, cognitive and social functioning, as well as the feasibility of treatment and its acceptance. Method: 77 outpatients were recruited, 42 in the experimental group, who were treated with IPT + EMT, and 35 participants in control condition (TAU), both during 8 months. The subjects of both groups were assessed pre and postreatment. Results: Treatment attendance was 98% in experimental group and none of patients required hospital admission during therapy, meanwhile 11 patients from the TAU group withdrew and 3 were hospitalized during therapy. After therapy, patients in the experimental group compared to TAU, reduced clinical symptoms and improved cognitive functioning and quality of life. Conclusion: Psychological therapy seems to be a feasible intervention even in the chronic stages of the disease.