Resilience Training for High Risk of Psychosis

Overseen By Daphne J Holt, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Psychotropic medications

Disqualifiers: Active symptoms, Substance use, Chronic illness, others

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

Compensation: Varies

Number of Visits: 10

Duration: 4 weeks

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Resilience Training can assist college students at higher risk of developing serious mental health issues. The program spans four weeks, teaching skills such as mindfulness and self-compassion. Another group will engage in Life Skills Training, which focuses on practical skills like financial literacy and health. The trial is designed for first or second-year college students who have experienced some psychotic episodes. Participants should not currently receive psychological treatment or use certain medications. As an unphased trial, this study provides a unique opportunity for students to acquire valuable skills that could enhance their mental well-being.

Will I have to stop taking my current medications?

The trial requires that participants are not currently using psychotropic medications (drugs that affect mood, perception, or behavior) other than stimulants. If you are taking such medications, you would need to stop before joining the trial.

What prior data suggests that Resilience Training is safe for college students at high risk of psychosis?

Research shows that Resilience Training is generally easy for people to handle. Studies on resilience examine how certain protective factors help individuals manage risks, such as developing serious mental health issues. This training teaches skills like mindfulness (paying attention to the present moment), self-compassion (being kind to oneself), and mentalization (understanding one's own and others' thoughts and feelings). These skills are not known to cause harm.

Similar programs have reported no major negative effects. Participants often find these skills useful for managing stress and improving mental well-being. Although hard data is limited, the nature of the training suggests it is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Resilience Training (RT) for individuals at high risk of psychosis because it takes a fresh approach by focusing on mental skills like mindfulness, self-compassion, and mentalization. Unlike traditional treatments that often rely on medication or cognitive therapy, RT empowers individuals through a 4-week program of interactive sessions designed to build personal resilience. This method aims to enhance mental well-being by teaching participants to better manage their thoughts and emotions, potentially offering a proactive way to reduce the risk of psychosis.

What evidence suggests that Resilience Training could be effective for reducing the risk of serious mental illness?

Research shows that Resilience Training (RT), a treatment in this trial, can help reduce mental health symptoms. Studies have found that RT, which includes mindfulness and self-compassion exercises, improves resilience and reduces symptoms of mental health issues. Participants in RT programs reported lasting improvements in their mental well-being, even after the training ended. This trial will compare RT with Life Skills Training (LST), another treatment arm, to determine their effectiveness in helping college students at risk for serious mental health problems by strengthening their mental resilience. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for college students who may be at high risk of developing serious mental illnesses, such as psychosis or mood and anxiety disorders. Participants should not yet have a diagnosed severe mental illness but might experience early signs like unusual thoughts.

Inclusion Criteria

Enrolled as a first or second year student (i.e., freshman or sophomore) in an undergraduate program at the college or university where the intervention takes place

Students who endorse some psychotic experiences (Peter's et al. Delusion Inventory (PDI) score > 3)

Exclusion Criteria

Inability to provide informed consent

Current self-reported Diagnostic Statistical Manual 5 (DSM-5) diagnosis with active symptoms (such as active psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) determined by clinical interview with participant, or self-report of a psychiatric diagnosis that necessitates close monitoring or individual therapy and/or inpatient or partial hospitalization

Current enrollment in psychological or behavioral health treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week program of weekly 90-minute sessions, either Resilience Training or Life Skills Training

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular assessments at 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Resilience Training

Trial Overview The study tests Resilience Training (RT) against Life Skills Training (LST) to see which better prevents the progression to serious mental illness in young adults showing early warning signs.

How Is the Trial Designed?

Group I: Resilience Training (RT) Experimental Treatment 1 Intervention

RT is a 4-week program of weekly 90-minute sessions in which participants are taught the following skills: mindfulness, self-compassion and mentalization.

Group II: Life Skills Training (LST) Active Control 1 Intervention

LST is a 4-week program of weekly 90-minute sessions, in which participants are provided information about helpful life skills, including financial literacy, health, physical and internet safety.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

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]

The targeted case identification intervention significantly increased referrals to the clinical high-risk unit for first-episode psychosis, with a notable rise in eligible cases (P = 0.01 and P = 0.03, respectively).

The majority of referrals came from the first-episode psychosis service, indicating that integrated outreach strategies can effectively enhance the identification of individuals at high risk for psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an integrated outreach intervention targeting multiple stages of early psychosis improve the identification of individuals at clinical high risk? McIlwaine, SV., Jordan, G., Pruessner, M., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9433469/

Efficacy of a transdiagnostic, prevention-focused program ... Conclusions. RT is a brief, group-based intervention associated with improved resilience and reduced symptoms of psychopathology, with sustained effects on PEs, ...

2. academic.oup.com academic.oup.com/schizophreniabulletin/advance-article/doi/10.1093/schbul/sbaf072/8164311

Candidate Targets for Resilience Training to Reduce ... Resilience Training (RT) is a 4-session, group-based behavioral intervention, focusing on mindfulness-based skills, that leads to reductions in psychopathology.

3. cnl.psy.msu.edu cnl.psy.msu.edu/wp-content/uploads/2023/07/Thakkar-et-al.-2023.pdf

Moving from risk to resilience in psychosis research However, there is substantial variability in psychological and functional outcomes for those at risk for psychosis, even among individuals at high risk.

4. withpower.com withpower.com/trial/phase-anxiety-disorders-1-2025-8a192

Resilience Training for High Risk of Psychosis This is a randomized controlled trial testing the efficacy of Resilience Training in college students with elevated transdiagnostic risk for developing a ...

5. nature.com nature.com/articles/s41386-025-02261-6

Synergistic pathways to psychosis A resilience-based approach helps conceptualize how some individuals experience variable outcomes despite exposure to risk factors. This not ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39488001/

Protective Factors Predict Resilient Outcomes in Clinical High ... The primary focus of CHR research has been the risk and prediction of psychosis, while less is known about protective factors.

7. mdpi.com mdpi.com/2076-328X/14/10/898

A Systematic Review of Resilience in At-Risk Youth for ... This systematic review aimed to assess how resilience factors might buffer the adverse effects of risk factors on the development of psychosis among youth, ...