192 Participants Needed

Resilience Training for High Risk of Psychosis

DJ
Overseen ByDaphne J Holt, MD, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Resilience Training for high risk of psychosis?

Research suggests that individualized resiliency training, when integrated with cognitive-behavioral therapy, can enhance treatment for early psychosis by combining unique aspects of both approaches. This integration may improve therapeutic outcomes by offering a more comprehensive treatment model.12345

How is Resilience Training different from other treatments for high risk of psychosis?

Resilience Training is unique because it focuses on building psychological and social resilience, helping individuals cope with stress and potentially prevent the onset of psychosis. Unlike traditional treatments that may focus on medication or symptom management, this approach emphasizes personal growth and adaptation to stressors.12678

What is the purpose of this trial?

This is a randomized controlled trial testing the efficacy of Resilience Training in college students with elevated transdiagnostic risk for developing a serious mental illness.

Eligibility Criteria

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
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Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Resilience Training (RT)Experimental Treatment1 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 Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Findings from Research

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.
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.
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]

References

Factor structure of therapist fidelity to individual resiliency training in the Recovery After an Initial Schizophrenia Episode Early Treatment Program. [2019]
Does an integrated outreach intervention targeting multiple stages of early psychosis improve the identification of individuals at clinical high risk? [2019]
Brief report describing the integration of two psychotherapy evidence-based practices within coordinated specialty care services for early psychosis. [2021]
Effects of a recovery-oriented cognitive therapy training program on inpatient staff attitudes and incidents of seclusion and restraint. [2021]
Early intervention in first episode psychosis: hope for a better future. [2009]
Psychosis-like experiences and resilience: A systematic and critical review of the literature. [2023]
A naturalistic study on the relationship among resilient factors, psychiatric symptoms, and psychosocial functioning in a sample of residential patients with psychosis. [2022]
Reducing symptoms of trauma among carers of people with psychosis: pilot study examining the impact of writing about caregiving experiences. [2022]
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