Narrative Enhancement and Cognitive Therapy for First Episode Psychosis

(NECT-YA Trial)

Overseen By Bethany Leonhardt, Psy.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: John Jay College of Criminal Justice, City University of New York

Disqualifiers: Substance use, Mood disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 20 sessions

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Narrative Enhancement and Cognitive Therapy for First Episode Psychosis combined with Coordinated Specialty Care?

Research shows that multi-element psychosocial interventions, which include therapies like cognitive behavioral therapy and family intervention, can improve symptoms and overall functioning in people with first-episode psychosis. These findings suggest that combining Narrative Enhancement and Cognitive Therapy with Coordinated Specialty Care could be effective in improving outcomes for these patients. ^{1 2 3 4 5}

Is Narrative Enhancement and Cognitive Therapy for First Episode Psychosis safe for humans?

The available research does not provide specific safety data for Narrative Enhancement and Cognitive Therapy for First Episode Psychosis, but similar cognitive therapies have been used safely in treating psychosis and schizophrenia, focusing on improving symptoms and quality of life. ^{6 7 8 9 10}

How is the treatment Narrative Enhancement and Cognitive Therapy for First Episode Psychosis different from other treatments?

Narrative Enhancement and Cognitive Therapy (NECT) is unique because it combines storytelling and cognitive therapy to help young adults with first-episode psychosis understand and reshape their personal narratives, which can improve self-esteem and recovery. This approach is integrated into Coordinated Specialty Care, which focuses on personalized, comprehensive support including therapy, education, and skills training to promote recovery and quality of life. ^{3 10 11 12 13}

What is the purpose of this trial?

The overall purpose of the proposed exploratory intervention development application, is to conduct research that will inform the adaptation and preliminary testing of NECT modified for youth (aged 15-24) with first episode psychosis (FEP), targeting self-concept and illness conceptions to increase treatment engagement. The specific aims of the project are to: 1) adapt NECT to be responsive to the needs and preferences of youth with FEP, and 2) Assess the feasibility, acceptability and preliminary effectiveness of the modified intervention (NECT-YA) combined with coordinated specialty care (CSC) services, compared to CSC services alone, in a small (n = 40) RCT.

Eligibility Criteria

This trial is for young people aged 15-24 who are experiencing their first episode of psychosis within the last five years, without a primary substance use or mood disorder causing symptoms. Participants should have moderate to high self-stigma and must speak English well enough for assessments and group participation.

Inclusion Criteria

I am aged 15-24, started experiencing psychosis in the last 5 years, and don't primarily use substances or have a mood disorder.

Meets criteria for moderate (defined as a mean score of 1-1.5 on the 0-3 scale of the Internalized Stigma of Mental lllness Scale [ISMI]) or elevated (defined as a mean score of 1.5-3 on the 0-3 scale of the ISMI) self-stigma

Is able to provide informed consent to participate

Exclusion Criteria

Does not meet any of the above inclusion criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NECT-YA combined with Coordinated Specialty Care or Coordinated Specialty Care alone

20 sessions

Sessions may be individual or via telehealth

Follow-up

Participants are monitored for service engagement, therapeutic alliance, and other outcomes

4 weeks

Treatment Details

Interventions

• Combined with Coordinated Specialty Care
• Coordinated Specialty Care
• Narrative Enhancement and Cognitive Therapy- Young Adult

Trial Overview The study is testing an adapted version of Narrative Enhancement and Cognitive Therapy (NECT) designed for young adults with first episode psychosis, combined with Coordinated Specialty Care (CSC). It compares this combination treatment's effectiveness against CSC alone in a small randomized controlled trial.

Participant Groups

Group I: Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care Experimental Treatment 2 Interventions

NECT is a structured, 20-session group-based treatment called that combines psychoeducation, cognitive restructuring, and elements of narrative psychotherapy. NECT-YA will be modified to meet the needs of people who have experienced an FEP and may have fewer sessions or be provided in individual format or via telehealth for this study. NECT-YA will be offered to participants who are also receiving treatment within Coordinated Specialty Care programs for First Episode Psychosis.

Group II: Coordinated Specialty Care Active Control 1 Intervention

Coordinated Specialty Care is an evidence-based treatment for FEP that includes multiple treatment components. The FEP programs in at the recruiting site follow the Coordinated Specialty Care model.

Who Is Running the Clinical Trial?

John Jay College of Criminal Justice, City University of New York

Lead Sponsor

Trials

3

Recruited

310+

Indiana University School of Medicine

Collaborator

Trials

194

Recruited

181,000+

Findings from Research

A machine-learning prediction tool was developed to forecast education and work outcomes for individuals aged 16 to 30 with first-episode psychosis, showing strong predictive accuracy with AUCs ranging from 0.68 to 0.88 for one-year trajectories.

While the tool effectively predicts education/work status, it struggled with forecasting psychiatric hospitalizations beyond three months, indicating a need for further development in this area before clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction Tool for Individual Outcome Trajectories Across the Next Year in First-Episode Psychosis in Coordinated Specialty Care. Basaraba, CN., Scodes, JM., Dambreville, R., et al.[2023]

A cognitive health toolkit was developed and implemented in 18 OnTrackNY teams, involving 933 participants, to assess and address cognitive strengths and weaknesses in individuals with first-episode psychosis.

Preliminary results showed that 43.9% of new admissions received cognitive assessments, leading to the identification of cognitive health needs in over half of participants, which facilitated targeted services like psychoeducation and skills training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toolkit for assessing and addressing cognitive health in early psychosis: Evaluation of feasibility and utility in a coordinated specialty care setting. Saperstein, AM., Medalia, A., Malinovsky, I., et al.[2023]

A survey of 53 clinicians from the OnTrackNY program revealed a strong belief in the importance of addressing cognitive health during the early phase of psychosis, with most clinicians recognizing a significant link between cognitive impairment and community functioning.

88% of clinicians expressed a high likelihood of adopting new cognitive health tools if provided, indicating a readiness to integrate compensatory approaches into their practices, but highlighting the need for systematic training to effectively implement these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing cognitive health in coordinated specialty care for early psychosis: Real-world perspectives. Saperstein, AM., Medalia, A., Bello, I., et al.[2023]

Cognitive-behavioral therapy (CBT) has been shown to effectively reduce positive symptoms of schizophrenia, such as hallucinations, and can also help prevent relapses, as supported by several studies and a meta-analysis.

Despite its proven efficacy, CBT is rarely implemented in routine clinical settings for schizophrenia patients, highlighting a gap in treatment delivery that could improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychotherapy of positive symptoms in the treatment of patients with schizophrenia psychosis]. Wiedemann, G., Klingberg, S.[2019]

Cognitive enhancement therapy (CET) for first-episode schizophrenia effectively combines supportive therapy with social skills and cognitive training, aiming to improve cognitive and negative symptoms in a motivational format.

The therapy emphasizes a strong therapeutic alliance, allowing clinicians to use techniques like errorless learning and positive reinforcement, making it adaptable for both group and individual treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive enhancement therapy: a therapeutic treatment strategy for first-episode schizophrenia patients. Miller, R., Mason, SE.[2019]

Coordinated specialty care (CSC) is an evidence-based approach for treating individuals experiencing their first episode of psychosis, focusing on therapies that support both the client and their family.

The CSC model emphasizes building a therapeutic alliance and includes education and skills training to enhance recovery, improve quality of life, and help clients achieve their personal goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Psychosocial Treatment for Individuals with Early Psychosis. Wright, A., Browne, J., Mueser, KT., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

A statewide evaluation system for early psychosis. [2019]

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

Prediction Tool for Individual Outcome Trajectories Across the Next Year in First-Episode Psychosis in Coordinated Specialty Care. [2023]

3. Australia pubmed.ncbi.nlm.nih.gov

Toolkit for assessing and addressing cognitive health in early psychosis: Evaluation of feasibility and utility in a coordinated specialty care setting. [2023]

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

Psychosocial interventions for people with a first episode psychosis: between tradition and innovation. [2023]

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

Feasibility and Effectiveness of a Multi-Element Psychosocial Intervention for First-Episode Psychosis: Results From the Cluster-Randomized Controlled GET UP PIANO Trial in a Catchment Area of 10 Million Inhabitants. [2019]

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

Efficacy and safety of pharmacological and psychological interventions for the treatment of psychosis and schizophrenia in children, adolescents and young adults: a systematic review and meta-analysis. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Addressing cognitive health in coordinated specialty care for early psychosis: Real-world perspectives. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Integrated treatment of first episode psychosis with online training (e-learning): study protocol for a randomised controlled trial. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

[Psychotherapy of positive symptoms in the treatment of patients with schizophrenia psychosis]. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Cognitively-oriented psychotherapy for early psychosis (COPE). Preliminary results. [2018]

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

Cognitive enhancement therapy: a therapeutic treatment strategy for first-episode schizophrenia patients. [2019]

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

Evidence-Based Psychosocial Treatment for Individuals with Early Psychosis. [2021]

13. Australia pubmed.ncbi.nlm.nih.gov

Assessing clinicians' management of first episode schizophrenia using clinical case vignettes. [2019]