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

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.

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. 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]

2. Australia 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? [2019]

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

Brief report describing the integration of two psychotherapy evidence-based practices within coordinated specialty care services for early psychosis. [2021]

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

Effects of a recovery-oriented cognitive therapy training program on inpatient staff attitudes and incidents of seclusion and restraint. [2021]

5. Serbia pubmed.ncbi.nlm.nih.gov

Early intervention in first episode psychosis: hope for a better future. [2009]

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

Psychosis-like experiences and resilience: A systematic and critical review of the literature. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

A naturalistic study on the relationship among resilient factors, psychiatric symptoms, and psychosocial functioning in a sample of residential patients with psychosis. [2022]

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

Reducing symptoms of trauma among carers of people with psychosis: pilot study examining the impact of writing about caregiving experiences. [2022]