Behavioral Therapy for Early Psychosis

Overseen By Stephanie Rolin, MD, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Unable to consent, Not fluent English

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new behavioral therapy, called Adapted Behavioral Intervention, to help reduce violent behavior in individuals experiencing early psychosis. It targets those with conditions like schizophrenia or similar disorders who are already receiving treatment at specific clinics. Individuals diagnosed with early psychosis, experiencing symptoms like delusions or hallucinations for the first time, and seeking new coping strategies might be suitable candidates. Participants must be comfortable with interviews conducted in English throughout the study. As an unphased trial, this study provides a unique opportunity to explore innovative coping strategies for early psychosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this behavioral intervention is safe?

Research shows that starting treatment early for psychosis is generally safe and can improve health. Studies have found that these treatments can help with symptoms and daily functioning over time. This trial uses a special type of therapy designed to help people manage early signs of psychosis and reduce violent behavior.

Although this study is still in the early stages and lacks detailed safety data, therapies like this are usually well-tolerated. Without medication, the risk of side effects is typically lower than with drug treatments. Previous research on similar early psychosis programs indicates they can be effective without causing significant harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the adapted behavioral intervention for early psychosis because it offers a fresh approach to managing symptoms. Unlike traditional options like antipsychotic medications that often focus on chemical imbalances, this intervention targets emotional and cognitive responses, particularly anger, through psychological techniques. By tailoring the intervention to fit the OnTrackNY setting, there's hope that it will be more feasible and acceptable for both clinicians and participants, potentially leading to better outcomes for individuals experiencing early psychosis.

What evidence suggests that this behavioral intervention is effective for early psychosis?

Research has shown that certain treatments can help people with schizophrenia and similar disorders, often improving both medical and personal well-being. Early treatment of symptoms can reduce the likelihood of recurrence and enhance other outcomes. Specifically, treatments that include behavioral therapy can help manage symptoms and lower the risk of violent behavior. This trial will test the adapted behavioral intervention, which might help individuals with early psychosis manage their symptoms more effectively. ^{2 3 4 6 7}

Who Is on the Research Team?

Paul S Appelbaum, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for young adults aged 16 to 30 who are receiving treatment for early psychosis at OnTrackNY clinics and can participate in research interviews. They must have a diagnosis within the schizophrenia spectrum, excluding affective psychoses, and be fluent in English.

Inclusion Criteria

I am aged 16-30 and have been diagnosed with a type of nonaffective psychosis.

I am willing to do interviews after each study visit.

I am receiving treatment for my first episode of psychosis at an OnTrackNY clinic.

Exclusion Criteria

I am not fluent in English.

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week behavioral intervention to reduce violent behavior

12 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adapted Behavioral Intervention

Trial Overview The study tests an adapted behavioral intervention designed to reduce violent behavior in individuals with early-stage nonaffective psychotic disorders such as schizophrenia.

How Is the Trial Designed?

Group I: behavioral intervention Experimental Treatment 1 Intervention

This will involve conducting a 12-week open pilot trial (up to n=16 dyads of EIS clinicians-EIS participants) to test the feasibility and acceptability of the adapted Psychological Interventions for Coping with Anger and Schizophrenia: a study of outcomes (PICASSO) intervention in the OnTrackNY setting.

Adapted Behavioral Intervention is already approved in United States for the following indications:

Approved in United States as Adapted Behavioral Intervention for:

• Early psychosis with violent behavior

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Users in both Brazil and Chile found the task-shifting approach of the CTI-TS program to be beneficial, appreciating the personalized support it provided, but expressed a desire for longer intervention durations to maintain benefits.

The study highlighted significant contextual differences, such as stigma and community violence, that affected engagement with the program, suggesting that adaptations to interventions must consider local social factors for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a pilot community-based psychosocial intervention for patients with psychoses in Chile and Brazil: a comparative analysis of users' perspectives. Dev, S., Kankan, T., Blasco, D., et al.[2023]

In a study involving 801 patients with schizophrenia, the implementation of patient-reported outcomes significantly increased the likelihood of using weight management services, making patients 2.3 times more likely to engage with these services compared to control sites.

Patients at implementation sites had a final weight that was 5.9 kg lighter than those at control sites, indicating that the intervention may help improve weight management outcomes without affecting the weight gain liability of prescribed medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Patient-Reported Outcomes to Improve the Quality of Care for Weight of Patients with Schizophrenia. Young, AS., Cohen, AN., Hamilton, AB., et al.[2020]

The study examined the fidelity of clinicians to the Individual Resiliency Training (IRT) protocol within the NAVIGATE program for first-episode psychosis, revealing a two-factor structure in the fidelity scale used to assess adherence.

Significant correlations were found between clinicians' years of education and their fidelity ratings, suggesting that more educated clinicians may adhere better to the IRT protocol, which could enhance therapeutic outcomes for individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factor structure of therapist fidelity to individual resiliency training in the Recovery After an Initial Schizophrenia Episode Early Treatment Program. Browne, J., Edwards, AN., Penn, DL., et al.[2019]

A 25-session cognitive-behavioral therapy program for early psychosis showed significant improvements in psychotic symptoms among 20 patients, with effects maintained at a 6-month follow-up.

The program had a high acceptance rate of 75% and an 84% compliance rate, indicating that the treatment dosage and structure were effective in engaging participants, including adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy in early psychosis: an open study in a clinical setting]. Marois, MJ., Gingras, N., Provencher, MD., et al.[2018]

In a study involving 177 participants with first-episode psychosis, those receiving Cognitive Behavioural Therapy (CBT) alongside standard treatment (TAU) showed significantly better improvements in functioning and symptom reduction compared to those receiving TAU alone.

The CBT+TAU group not only experienced a greater decline in depressive and psychotic symptoms but also demonstrated better treatment adherence and increased levels of brain-derived neurotrophic factor, suggesting enhanced neurobiological effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicentre, Randomised, Controlled Trial of a Combined Clinical Treatment for First-Episode Psychosis. González-Ortega, I., Vega, P., Echeburúa, E., et al.[2021]

A modified version of Cognitive Adaptation Training (CAT) was tested with 23 participants, showing significant improvements in adaptive functioning, psychiatric symptoms, and goal attainment after 4 months of intervention and 5 months of case management support.

The study suggests that a shorter, supported version of CAT can maintain its positive effects on individuals with schizophrenia, indicating that ongoing case management can help sustain treatment benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing a modification of cognitive adaptation training: streamlining the model for broader implementation. Kidd, SA., Herman, Y., Barbic, S., et al.[2018]

An 8-week Internet-based intervention for psychosis showed a significant reduction in psychotic symptoms compared to a wait-list control, indicating its effectiveness as an additional treatment option.

Participants reported high satisfaction with the intervention (89%), and it was found to be safe, with only 4.9% experiencing adverse events, suggesting it could be a feasible option for wider implementation in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based self-help for psychosis: Findings from a randomized controlled trial. Westermann, S., Rüegg, N., Lüdtke, T., et al.[2021]

An intensive implementation support strategy significantly increased fidelity to evidence-based practices (EBPs) in treating psychosis over 18 months, with a mean difference in fidelity score change of 0.86 compared to control sites.

The most notable improvements were seen in illness management and recovery practices, indicating that certain EBPs may benefit more from intensive support strategies than others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Intensive Implementation Support on Fidelity for Four Evidence-Based Psychosis Treatments: A Cluster Randomized Trial. Ruud, T., Drake, RE., Šaltytė Benth, J., et al.[2022]

Cognitive behavioural therapy, family interventions, vocational interventions, and behavioral weight management show considerable evidence of effectiveness in treating early psychosis, although most studies have focused on individuals with established schizophrenia.

There is a need for more research specifically targeting first-episode populations to confirm the efficacy of these interventions and support their routine inclusion in treatment plans for early psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial and psychological interventions in early psychosis: essential elements for recovery. Killackey, E.[2014]

Early intervention for psychosis is now a standard practice, focusing on identifying young individuals in the pre-psychotic phase who are at high risk for developing psychosis.

Cognitive behavioral therapy (CBT) has been explored as a promising treatment for these individuals, with early studies indicating its potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals at high risk of developing psychosis. Addington, J., Mancuso, E.[2018]

Home-based interventions for psychosis, such as Early Intervention Services and crisis resolution teams, have been shown to improve treatment adherence and enhance patients' quality of life, autonomy, and social skills.

These interventions also help reduce hospital admissions and address family and social conflicts, making them effective options for both first-episode and resistant psychosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domiciliary intervention in psychosis: a systematic review. Gomis, O., Palma, C., Farriols, N.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10990032/

Evidence-based psychosocial interventions in schizophrenia Several different psychosocial interventions for people living with SSD have shown consistent evidence of effectiveness in different clinically and personally ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2559918/

Early intervention in psychosis: concepts, evidence and ... The rise of the early intervention paradigm in psychotic disorders represents a maturing of the therapeutic approach in psychiatry.

3. withpower.com withpower.com/trial/phase-disease-3-2023-ae8c6

Behavioral Therapy for Early Psychosis · Info for Participants Trial Overview The study tests an adapted behavioral intervention designed to reduce violent behavior in individuals with early-stage nonaffective psychotic ...

4. psychiatrictimes.com psychiatrictimes.com/view/early-psychosis-intervention-new-research-identifies-critical-components

Early Psychosis Intervention: New Research Identifies ... EPI programs with low caseloads and clozapine access significantly reduce relapse rates and improve secondary outcomes in early psychosis ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/10/6/e034280

Early Psychosis Intervention-Spreading Evidence-based ... The primary outcome is fidelity to the EPI model as measured using the First Episode Psychosis Services—Fidelity Scale. Four hundred participants in the EPI ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8792869/

Early Intervention in Psychosis services: A systematic review ... Early intervention in psychosis (EIP) is associated with positive effects on clinical and functional status at 5-year follow-up in FEP [6], although there are ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05756855

Study Details | NCT05756855 | Young Adults With Violent ... ... evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis. ... Behavioral : adapted behavioral intervention.