Just Do You for Psychosis

Overseen By Phil Tibbo

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Non-psychotic disorders, Age, Intellectual disability

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

Compensation: Varies

Number of Visits: 4

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve young adults' engagement and recovery in early intervention services for psychosis by addressing negative past healthcare experiences. Participants will receive two psychotherapy sessions, called "Just Do You," which focus on overcoming barriers like self-stigma and negative beliefs about healthcare. The study compares outcomes between those with and without prior negative healthcare experiences to determine if the intervention is more effective for certain groups. This trial may suit young adults diagnosed with a psychotic disorder within the last five years who have been in early intervention services for 3 to 12 months. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research aimed at enhancing mental health care.

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 consult with the trial coordinators or your healthcare provider for guidance.

What prior data suggests that the Just Do You intervention is safe for young adults with early psychosis?

Research shows that the "Just Do You" program aims to help young adults with negative healthcare experiences engage more effectively in early treatment for psychosis. Although specific safety data from past studies is unavailable, this type of program involves talk therapy, which is generally safe and well-tolerated. The program employs methods like cognitive-behavioral therapy (CBT) and motivational interviewing, common techniques that typically lack physical side effects.

In this trial, healthcare professionals and peer support workers lead short sessions to address issues like self-stigma and negative healthcare experiences. Similar programs have been safely used in other contexts, suggesting safety for participants. However, as with any treatment, participants should monitor their feelings and discuss any concerns with the healthcare team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

"Just Do You" is unique because it combines cognitive behavioral therapy (CBT) and motivational interviewing to specifically address engagement barriers in young adults with psychosis. Unlike standard treatments like antipsychotics and general CBT, this approach directly targets issues like self-stigma and negative perceptions of healthcare, aiming to improve patients' willingness to participate in their treatment. Researchers are excited about this treatment's potential to foster a more personalized and empowering therapeutic experience, which could lead to better outcomes by enhancing engagement and self-efficacy in managing psychosis.

What evidence suggests that the "Just Do You" intervention might be effective for improving engagement and recovery in young adults with early psychosis?

Research has shown that the "Just Do You" program, provided to participants in the Engagement Intervention Group of this trial, might help young adults connect better with early treatment services for psychosis. A recent study in the USA found that this short program improved patient involvement and recovery by addressing obstacles like negative past healthcare experiences. It uses methods from cognitive behavioral therapy (CBT) and motivational interviewing to address issues such as self-doubt and negative thoughts about healthcare. Early results from that study indicated that participants in the program were more engaged and had better outcomes than those who did not participate. This approach appears promising for improving treatment experiences and recovery in young adults dealing with early psychosis. ^{6 7 8 9 10}

Who Is on the Research Team?

Phil Tibbo, MD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

This trial is for young adults experiencing psychosis who are part of the Nova Scotia Early Psychosis Program. It's especially aimed at those with negative prior healthcare experiences. Participants should be willing to attend two psychotherapy/psychoeducation sessions.

Inclusion Criteria

I started treatment in early intervention services less than a year ago.

I have been diagnosed with a psychotic disorder like schizophrenia.

I was diagnosed within the last 5 years.

Exclusion Criteria

I do not fall within the required age range for the trial.

My primary diagnosis is not related to a psychotic disorder.

I have an intellectual disability with an IQ below 70.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Engagement Intervention

Participants receive a brief 2-module engagement focused psychotherapeutic orientation co-delivered by a mental health clinician and a peer support worker.

4 weeks

2 sessions (in-person or virtual)

Follow-up

Participants are monitored for improvements in engagement and recovery, with assessments at multiple intervals.

4 months

Assessments at 2 weeks, 4 weeks, and 4 months

Long-term Monitoring

Monitoring of administrative health outcomes such as missed appointments and emergency visits.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Just Do You

Trial Overview The 'Just Do You' intervention, consisting of two sessions co-led by a clinician and peer support worker, is being tested to see if it improves engagement and recovery in early intervention services for psychosis.

How Is the Trial Designed?

Group I: Engagement Intervention Group (experimental) Experimental Treatment 1 Intervention

As described in further detail in the study description: In addition to regular early intervention treatment for psychosis, participants in this group will receive a brief 2-module engagement focused psychotherapeutic orientation co-delivered by a mental health clinician and a peer support worker. This intervention will involve integration of principles of CBT and motivational interviewing in order to target previously identified affective and cognitive barriers to young adults' engagement in treatment. Treatment targets include: self-stigma, negative perceptions/beliefs towards healthcare, negative past experiences with psychiatric services, recover, and external vs internal locus of control. Participants will be guided through a standard therapeutic protocol adapted from the original Munson et al. (2022), trial targeting these barriers over 2 90-120 minute sessions delivered 1 month apart.

Group II: Treatment as Usual Group (control) Active Control 1 Intervention

As described in further detail in the study description, control participants will receive the usual treatment provided at our early intervention for psychosis clinic. Treatment as usual includes psychiatric monitoring of lowest effective dose pharmaceutical treatment (e.g., antipsychotics), and various psychosocial interventions including CBT for psychosis when indicated, occupational therapy, family education and support sessions, and support for client's educational or vocational goals. Those in the engagement intervention group (experimental) will also receive this treatment in addition to the experimental engagement intervention.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Queen Elizabeth II Health Sciences Centre

Collaborator

Trials

26

Recruited

14,200+

Published Research Related to This Trial

In a study of 708 patients with chronic psychotic illness over 2 years, reductions in various symptoms (positive, negative, depressive, and manic) were linked to improvements in social disability and independent living.

Specifically, reducing negative symptoms was associated with less hospital time and better quality of life, indicating that targeting multiple symptom dimensions in treatment could lead to broader benefits for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To what extent does symptomatic improvement result in better outcome in psychotic illness? UK700 Group. van Os, J., Gilvarry, C., Bale, R., et al.[2019]

In a study of 8580 individuals aged 16-74, 5.5% reported experiencing psychotic symptoms, indicating that these symptoms may exist on a continuum rather than as a strict category.

Factors such as cannabis and alcohol dependence, victimization, recent stressful life events, and lower intellectual ability were found to be independently associated with these self-reported psychotic symptoms, highlighting important demographic and clinical correlates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and correlates of self-reported psychotic symptoms in the British population. Johns, LC., Cannon, M., Singleton, N., et al.[2022]

In a study involving 801 patients with schizophrenia, the implementation of patient-reported outcomes significantly increased the likelihood of using weight management services, making patients 2.3 times more likely to engage with these services compared to control sites.

Patients at implementation sites had a final weight that was 5.9 kg lighter than those at control sites, indicating that the intervention may help improve weight management outcomes without affecting the weight gain liability of prescribed medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Patient-Reported Outcomes to Improve the Quality of Care for Weight of Patients with Schizophrenia. Young, AS., Cohen, AN., Hamilton, AB., et al.[2020]

In a study involving 280 young adults with first-episode psychosis, the intensive 'OPUS' treatment did not significantly improve quality of life compared to standard treatment over a two-year period.

Quality of life was found to correlate more strongly with factors like affective balance and self-esteem rather than the type of treatment received, indicating that these personal factors may play a crucial role in the patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The quality of life among first-episode psychotic patients in the OPUS trial. Thorup, A., Petersen, L., Jeppesen, P., et al.[2016]

In a study of 77 first episode psychosis patients, men exhibited greater impairment in premorbid functioning compared to women, but there were no significant clinical differences between genders.

Patients with a shorter duration of untreated psychosis (DUP) of less than 28 weeks had better premorbid functioning than those with a longer DUP, suggesting that poor premorbid functioning may lead to delays in treatment and longer DUP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Premorbid functioning by gender and its relationship with duration of untreated psychosis in first psychotic episode]. Fresán, A., Apiquian, R., Ulloa, RE., et al.[2018]

New antipsychotic medications offer hope for improved outcomes in individuals with schizophrenia, focusing on recovery rather than just maintenance of symptoms.

The article presents a framework for understanding the diverse outcomes of long-term psychosis treatment, which can help in creating more effective treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an outcomes-oriented approach for the treatment of schizophrenia. Lehman, AF.[2019]

A survey of 293 mental health practitioners revealed that 69% endorsed the use of antipsychotic medications for treating attenuated psychosis syndrome, indicating a tendency to approach it similarly to full-threshold psychosis.

Family support and involvement were also recognized as important interventions, with 58% and 49% of practitioners endorsing these approaches, highlighting the role of family in the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining treatment as usual for attenuated psychosis syndrome: a survey of community practitioners. Jacobs, E., Kline, E., Schiffman, J.[2021]

Familial history of severe mental illness, along with developmental factors and cognitive deficits, significantly increases the risk of developing psychosis in adolescents and young adults, highlighting the need for early family-centered assessments and interventions.

Intervention trials indicate that patients in the prodromal phase of psychosis, who exhibit early symptoms like anxiety and social decline, can benefit from treatment that may prevent or delay the onset of full-blown psychosis, though more extensive studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection and intervention of psychosis. A review. Salokangas, RK., McGlashan, TH.[2008]

A new condition called 'instrumental psychosis' has been identified, where patients deliberately create symptoms similar to those of real psychosis, often stemming from a history of previous psychotic disorders.

A 'pseudopsychosis inventory' rating scale was developed to help identify this condition, showing good reliability in a study of 15 patients, and suggesting that instrumental psychosis may be present in about 4.4% of patients with putative psychotic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Instrumental psychosis: the Good Soldier Svejk syndrome. Tyrer, P., Babidge, N., Emmanuel, J., et al.[2020]

The study highlights that while patient-reported outcomes (PROs) like treatment satisfaction and quality of life are important, the current measures used for patients with psychosis lack methodological quality and show significant overlap in concepts.

To improve the use of PROs in mental health services, the authors recommend developing distinct, concise measures that are clinically relevant and have strong psychometric properties, while also suggesting that future research should focus on enhancing their validity and precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring patient-reported outcomes in psychosis: conceptual and methodological review. Reininghaus, U., Priebe, S.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8042707/

Early Youth Engagement in psychosis (EYE-2) study: trial Investing in recovery: making the business case for effective interventions for people with schizophrenia and psychosis. 2014. [Google ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10955207/

a systematic review and component network meta-analysis Psychosis and schizophrenia in adults: treatment and management. ... Family intervention for schizophrenia. Cochrane Database Syst Rev ...

3. cambridge.org cambridge.org/core/journals/the-british-journal-of-psychiatry/article/early-youth-engagement-eye2-intervention-in-firstepisode-psychosis-services-pragmatic-cluster-randomised-controlled-trial-and-costeffectiveness-evaluation/219DF7BEE22343C1DF4AA1FC03C91EB5

The Early Youth Engagement (EYE-2) intervention in first- ... Relationship between duration of untreated psychosis and outcome in first-episode schizophrenia: a critical review and meta analysis. Am J ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03919760

Study Details | NCT03919760 | Early Psychosis Intervention Individual inclusion criteria: Age range of 14-35 years;; any DSM-diagnosis that can manifest as early psychosis (schizophrenia, schizoaffective disorder, ...

5. nature.com nature.com/articles/s41537-022-00300-5

Disengagement from early psychosis intervention services While evidence suggests that young people with psychosis can achieve superior outcomes ... Telehealth interventions for schizophrenia-spectrum ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1489880/

The recognition and optimal management of early psychosis An optimistic attitude to treatment and recovery in schizophrenia and psychosis generally should be strongly communicated (27). If this offer of intervention is ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S016517812400310X

Effects of Actissist, a digital health intervention for early ... Eligible participants were adults with schizophrenia-spectrum psychosis within five years of first episode onset meeting a criterion level of positive symptoms ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0920996423004681

Predictors of relapse and engagement in care one year ... The present study aims to address the dearth of US-based studies investigating outcomes after CSC through a retrospective analysis of an early psychosis program ...

9. grants.nih.gov grants.nih.gov/grants/guide/rfa-files/RFA-MH-24-105.html

Expired RFA-MH-24-105: Early Psychosis Intervention ... Scientific hubs must partner with 5 or more early psychosis intervention programs that offer CSC, practice measurement-based care (i.e., ...

10. thelancet.com thelancet.com/journals/lanpsy/article/PIIS2215-0366(22)00103-1/fulltext

a feasibility cluster randomised controlled trial in Scotland ... A Cochrane review (2013) focused on the effectiveness of interventions targeting recognition and management of early warning signs of relapse in schizophrenia.