40 Participants Needed

Just Do You for Psychosis

BS
PT
Overseen ByPhil Tibbo
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Nova Scotia Health Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Negative experiences with healthcare prior to referral to early intervention services for psychosis (EIS) have been linked to poor engagement and clinical outcomes. Recent research indicates that young adults who come to EIS services thru emergency departments, urgent care, or inpatient services have significantly greater rates of future use of these services as well as more negative perceptions of EIS and diminished engagement in treatment compared to young adults referred to EIS by other pathways. These findings suggest a need for additional support to be provided to EIS patients, especially those with prior negative healthcare experiences, to maximize treatment engagement and outcomes. A recent USA-based trial of a brief intervention addressing barriers to disengagement (Just Do You), including prior negative healthcare experiences, showed promise in improving engagement and recovery. This project seeks to adapt and evaluate the Just Do You intervention to a young adult early psychosis population in Nova Scotia. The investigators aim to recruit young adults from the Nova Scotia Early Psychosis Program to engage in 2 psychotherapy/psychoeducation sessions co-led by a clinician and peer support worker. Following the intervention, the investigators will measure improvements in participants' engagement and recovery to determine the effectiveness of the program. Outcomes between participants with negative prior healthcare experiences and those without will be compared to assess differential impact of the intervention for high-risk sub-groups. This project has the potential to improve patients' engagement in EIS care and enhance recovery outcomes for young adults.

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 data supports the effectiveness of the treatment Just Do You for psychosis?

The research highlights the importance of patient-reported outcomes and specialized team-based treatments in improving care for psychosis, suggesting that approaches focusing on patient engagement and comprehensive care can enhance quality of life and treatment outcomes.12345

How is the 'Just Do You' treatment for psychosis different from other treatments?

The 'Just Do You' treatment for psychosis may focus on early detection and intervention, particularly in individuals with familial risk or early symptoms, which can help prevent or delay the onset of full psychosis. This approach is unique as it emphasizes monitoring and preventive interventions during the prodromal phase (early stage before full symptoms develop), unlike standard treatments that often address symptoms after they fully manifest.678910

Research Team

PT

Phil Tibbo, MD

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

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

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

Treatment Details

Interventions

  • Just Do You
Trial OverviewThe '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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Engagement Intervention Group (experimental)Experimental Treatment1 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 Control1 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.

Find a Clinic Near You

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+

Findings from Research

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

References

To what extent does symptomatic improvement result in better outcome in psychotic illness? UK700 Group. [2019]
Developing an outcomes-oriented approach for the treatment of schizophrenia. [2019]
Implementing Patient-Reported Outcomes to Improve the Quality of Care for Weight of Patients with Schizophrenia. [2020]
Measuring patient-reported outcomes in psychosis: conceptual and methodological review. [2022]
The quality of life among first-episode psychotic patients in the OPUS trial. [2016]
Early detection and intervention of psychosis. A review. [2008]
Defining treatment as usual for attenuated psychosis syndrome: a survey of community practitioners. [2021]
Prevalence and correlates of self-reported psychotic symptoms in the British population. [2022]
Instrumental psychosis: the Good Soldier Svejk syndrome. [2020]
[Premorbid functioning by gender and its relationship with duration of untreated psychosis in first psychotic episode]. [2018]