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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help young people experiencing their first episode of psychosis. It tests whether a modified therapy called NECT-YA (Narrative Enhancement and Cognitive Therapy for Young Adults), combined with Coordinated Specialty Care (CSC), can improve self-concept and treatment engagement compared to CSC alone. The trial is open to individuals aged 15-24 who have experienced psychotic symptoms within the last five years and do not primarily have a substance use or mood disorder. Participants should also experience some level of self-stigma and be able to communicate in English for group activities.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future treatments for young adults experiencing 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. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this therapy is safe for youth with first episode psychosis?

Research has shown that Narrative Enhancement and Cognitive Therapy (NECT) is generally safe for treating individuals with serious mental illnesses. NECT involves learning about mental health, altering negative thought patterns, and sharing personal stories. Although specific safety data for NECT in individuals experiencing their first episode of psychosis is lacking, similar therapies have been well-tolerated in other contexts.

As a type of talk therapy, NECT does not carry the same risks as medication. Participants usually find these sessions safe and beneficial. While exploring personal stories may present some emotional challenges, these are typically manageable with therapist support. Studies on NECT have not reported any significant negative effects.

For questions or concerns, consulting a healthcare provider can help determine if joining a trial is a suitable choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Narrative Enhancement and Cognitive Therapy for young adults because it blends psychoeducation, cognitive restructuring, and narrative psychotherapy in a unique way. Unlike traditional treatments that might focus solely on medication or basic talk therapy, this approach helps individuals reshape their personal stories and beliefs about themselves, which can be crucial in recovering from First Episode Psychosis (FEP). Additionally, this therapy is adaptable—it can be delivered in fewer sessions, one-on-one, or even via telehealth, making it more accessible and tailored to individual needs.

What evidence suggests that this trial's treatments could be effective for first episode psychosis?

Research has shown that Narrative Enhancement and Cognitive Therapy (NECT), which participants in this trial may receive, can help treat first episode psychosis. Studies have found that NECT improves self-esteem, quality of life, and hope, while reducing feelings of self-stigma. These improvements are crucial for young people experiencing their first episode of psychosis. NECT is generally well-tolerated, making it a promising option for enhancing mental health in this group. Overall, NECT could support recovery and encourage participation in treatment. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3954406/

Narrative Enhancement and Cognitive Therapy (NECT) ... The NECT treatment group showed significant (p < .05) reductions in self-stigma and increases in self-esteem, quality of life, and Hope-Agency scores.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24114797/

Narrative enhancement and cognitive therapy (NECT ... The current study aims to examine the effectiveness of NECT. A quasi-experimental design. Design: Baseline and follow-up data were collected and outcomes were ...

3. withpower.com withpower.com/trial/phase-psychotic-disorders-9-2022-d6396

Narrative Enhancement and Cognitive Therapy for First ... ... Narrative Enhancement and Cognitive Therapy- Young Adult will have tolerable side effects & efficacy for patients with First Episode Psychosis and Young People.

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05067-1

Narrative enhancement and cognitive therapy (NECT) to ... NECT is a promising intervention for reducing self-stigma and improving recovery-related outcomes in SMI. If shown to be effective in this trial ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/15/2/e096222

Narrative enhancement and cognitive therapy for self ... Secondary outcomes include acceptability and the intervention's impact on self-stigma, wellness, symptomatology, treatment-seeking attitudes and other related ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6971141/

The Adaptation and Feasibility of Narrative Enhancement and ... The aim of this study is to adapt and feasibility test the narrative component of Narrative Enhancement and Cognitive Therapy (NECT) for ...

7. researchgate.net researchgate.net/publication/257648372_Narrative_Enhancement_and_Cognitive_Therapy_NECT_Effectiveness_A_Quasi-Experimental_Study

Narrative Enhancement and Cognitive Therapy (NECT ... The current study aims to examine the effectiveness of NECT. A quasi-experimental design. Baseline and follow-up data were collected and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2589537020301656

Clinicians' views of treatment types for first episode ... Clinicians consistently valued AP as the primary treatment for FEP, with CBT and/or FI seen as helpful secondary treatment options.