Behavioral Therapy for Early Psychosis

Recruiting in Palo Alto (17 mi)

Overseen by Stephanie Rolin, MD, MPH

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Columbia University

Disqualifiers: Unable to consent, Not fluent English

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a program that helps people with early psychosis learn new ways to manage their emotions and actions to reduce violent behavior.

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 data supports the effectiveness of the treatment Adapted Behavioral Intervention for early psychosis?

Research shows that cognitive-behavioral therapy for psychosis (CBTp) can be effective for persistent symptoms, especially when introduced during a stable phase of early psychosis. Additionally, cognitive adaptation training (CAT), a similar behavioral intervention, has shown improvements in functioning and symptoms in people with schizophrenia, suggesting potential benefits for early psychosis as well. ^{1 2 3 4 5}

Is behavioral therapy for early psychosis safe for humans?

Research on cognitive-behavioral therapy (CBT) for psychosis, which is similar to behavioral therapy, suggests it is generally safe for humans. An Internet-based CBT program for psychosis was found to be feasible and safe compared to usual care. ^{1 2 6 7 8}

How is the Adapted Behavioral Intervention treatment for early psychosis different from other treatments?

Adapted Behavioral Intervention for early psychosis is unique because it focuses on behavioral therapy tailored to the individual's needs, potentially during a stable phase rather than an acute phase, which may improve long-term outcomes. This approach contrasts with traditional treatments that often involve medication or are introduced during acute episodes. ^{2 3 9 10 11}

Research Team

Stephanie Rolin, MD, MPH

Principal Investigator

Columbia University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Adapted Behavioral Intervention (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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Testing a modification of cognitive adaptation training: streamlining the model for broader implementation. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy in early psychosis: an open study in a clinical setting]. [2018]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Implementing Patient-Reported Outcomes to Improve the Quality of Care for Weight of Patients with Schizophrenia. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The Effect of Intensive Implementation Support on Fidelity for Four Evidence-Based Psychosis Treatments: A Cluster Randomized Trial. [2022]

6. Australia 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. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Internet-based self-help for psychosis: Findings from a randomized controlled trial. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Multicentre, Randomised, Controlled Trial of a Combined Clinical Treatment for First-Episode Psychosis. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

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

10. Spain pubmed.ncbi.nlm.nih.gov

Domiciliary intervention in psychosis: a systematic review. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals at high risk of developing psychosis. [2018]