Family Education for Psychosis

Recruiting at 3 trial locations

Overseen By Melanie Robles, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Not proficient in English

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

113 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help families support young adults dealing with psychosis by providing valuable education and skills. It focuses on reducing family stress and helping young adults remain stable in their communities. Participants will attend sessions on understanding psychosis, managing stress, and improving communication. This approach, called Supporting Patients by Family Education in Psychotic Illness Group, empowers families. Families of young adults treated for psychosis in an Edmonton psychiatric unit within the last year may be a good fit for this trial. As an unphased trial, it offers families the chance to gain unique insights and skills to better support their loved ones.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this psychoeducation intervention is safe for family carers?

Research has shown that family psychoeducation has safely and effectively supported people with schizophrenia for over 40 years. Studies indicate that this method can reduce relapse rates by 50-60% compared to standard care, suggesting it is well-tolerated and beneficial for patients. This trial's psychoeducation program aims to help families of young adults with psychosis. It seeks to lessen family stress and improve the stability of those with the condition in their community. Reports have not indicated any negative effects from the family psychoeducation method, making it a promising and safe choice for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Psychoeducation Intervention for psychosis because it focuses on empowering families with knowledge and skills, which is different from traditional medication-based treatments. This approach includes psychoeducation on the family's journey and the biopsychosocial aspects of psychosis, offering a holistic understanding of the condition. Additionally, it incorporates Acceptance and Commitment Therapy for Caregivers and LEAP communication training, helping families support their loved ones more effectively. By enhancing family support, it aims to improve patient outcomes in a way that current treatments, which often focus solely on medication, do not.

What evidence suggests that this psychoeducation intervention is effective for supporting family carers of young adults with psychosis?

Research shows that family psychoeducation, provided to participants in this trial, can greatly assist families of young adults with psychosis. Studies have found that these programs reduce family stress and enhance the well-being of individuals with psychosis. A review of multiple studies found that family-based programs outperform standard care for both caregivers and their relatives with psychosis. These programs impart valuable skills and knowledge, leading to improved communication and coping strategies. Overall, evidence suggests that family psychoeducation is a promising method to support families dealing with psychosis. ^{1 2 3 5 6}

Who Is on the Research Team?

Melanie Robles, md

Principal Investigator

University of Alberta

Adam Abba-Aji, MD

Principal Investigator

Alberta Health services

Are You a Good Fit for This Trial?

This trial is for family carers of young adults aged 17-27 with psychosis in Edmonton who have been admitted to or discharged from specific psychiatric units within the last year. It's not suitable for those not proficient in English or if the young adult hasn't had recent unit admission/discharge.

Inclusion Criteria

I am between 17 and 27 years old.

A young adult who has been admitted to or discharged from a specific psychiatric unit in Edmonton for psychosis within the last 12 months.

Exclusion Criteria

I am not fluent in English.

You have not been admitted to or discharged from a specific type of mental health unit in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Family carers participate in psychoeducation modules over 9 weeks, focusing on skills and knowledge to support young adults with psychosis.

9 weeks

9 sessions (in-person)

Follow-up

Participants are monitored for long-term effectiveness of the intervention, including service utilization and functional indexes.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Supporting Patients by Family Education in Psychotic Illness Group

Trial Overview The study tests a psychoeducation program aimed at teaching family carers how to support young adults with psychosis. The intervention includes nine expert-reviewed modules delivered over nine weeks, focusing on skill and knowledge enhancement.

How Is the Trial Designed?

Group I: Family Psychoeducation Intervention Arm Experimental Treatment 1 Intervention

These participants will receive the psychoeducation intervention and outcome measures will be taken from them and their young adult service user. The intervention includes psychoeducation on stages of a family's journey, the biopsychosocial basis of psychosis, and skills for coping (Acceptance and Commitment Therapy for Caregivers) and communicating (LEAP).

Supporting Patients by Family Education in Psychotic Illness Group is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Family Psychoeducation for:

• Schizophrenia
• Psychotic Disorders

Approved in United States as Family Psychoeducation for:

• Schizophrenia
• Psychotic Disorders

Approved in Canada as Family Psychoeducation for:

• Schizophrenia
• Psychotic Disorders

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Families Supporting Adults with Mental Illness-Alberta

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

Family psychoeducation has evolved over 40 years into a highly effective treatment for schizophrenia, reducing relapse rates by 50-60% compared to standard treatment, based on over 100 outcome studies.

The approach focuses on engaging family members as partners in care, enhancing social functioning and well-being, and has shown promising results in early intervention for first episode and prodromal psychosis, leading to significant improvements in functioning and prevention of psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Interventions for Schizophrenia and the Psychoses: A Review. McFarlane, WR.[2022]

A psychoeducational family intervention following a first episode of psychosis helps both patients and their families develop insight and acceptance of the illness, which is crucial for recognizing the need for support.

Participants reported improved communication skills and problem-solving abilities, as well as increased independence for patients, highlighting the intervention's effectiveness in fostering better family dynamics and personal responsibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participants' perceived benefits of family intervention following a first episode of psychosis: a qualitative study. Nilsen, L., Frich, JC., Friis, S., et al.[2016]

A one-year psychoeducational intervention for families of patients with schizophrenia, involving 48 professionals and 55 families across six European countries, led to significant improvements in patients' symptoms and social functioning.

The intervention also positively impacted relatives by reducing their burden and enhancing their coping strategies and social resources, despite initial organizational challenges faced by the professionals delivering the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a psychoeducational intervention for families of patients with schizophrenia: preliminary results of a study funded by the European Commission. Magliano, L., Fiorillo, A., Fadden, G., et al.[2023]

An eight-session psychoeducational program for patients with schizophrenia and their relatives significantly increased knowledge about the condition and improved satisfaction with relatives' involvement, as measured by the Verona Service Satisfaction Scale.

However, the program did not significantly impact key outcomes such as relapse rates, compliance, or overall psychosocial functioning, indicating that while education is beneficial, it may not be enough to address all aspects of schizophrenia management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and relative education in community psychiatry: a randomized controlled trial regarding its effectiveness. Merinder, LB., Viuff, AG., Laugesen, HD., et al.[2019]

A multiple family group education program significantly enhanced families' knowledge and understanding of mental illness and treatment for clients experiencing their first episode of psychosis.

The evaluation highlights the effectiveness of these educational groups and underscores the important role of community mental health nurses in delivering family interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple family group interventions in first episode psychosis: Enhancing knowledge and understanding. Mullen, A., Murray, L., Happell, B.[2019]

The online multifamily group program for relatives of individuals with schizophrenia showed high participation rates and satisfaction among participants, with most attending over half of the sessions.

While the intervention did not significantly impact the clinical status of individuals with schizophrenia or reduce relatives' distress, there was a trend towards fewer hospitalizations in the online group, suggesting potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A proof of concept trial of an online psychoeducational program for relatives of both veterans and civilians living with schizophrenia. Glynn, SM., Randolph, ET., Garrick, T., et al.[2022]

The family psychoeducation group program significantly improved the functioning of both families and patients with schizophrenia over a 12-month period, as shown in a controlled trial with 84 family members.

Participants in the psychoeducation group experienced reduced burden of care and fewer rehospitalizations compared to those receiving standard care, highlighting the program's effectiveness in supporting families and enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A family psychoeducation group program for chinese people with schizophrenia in Hong Kong. Chien, WT., Wong, KF.[2017]

Family-focused therapy for individuals at clinical high risk for psychosis (FFT-CHR) was delivered with high fidelity by newly trained clinicians, with 90% of treatment sessions rated above acceptable thresholds.

FFT-CHR emphasized communication and problem-solving skills more than enhanced care, suggesting it may be a more effective psychosocial intervention for preventing psychosis in youth and young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-focused therapy for individuals at clinical high risk for psychosis: treatment fidelity within a multisite randomized trial. Marvin, SE., Miklowitz, DJ., O'Brien, MP., et al.[2021]

Psychoeducation for families of individuals experiencing first-episode psychosis is effective in preventing relapse and promoting recovery, while also helping families feel less isolated and more informed.

Inpatient staff play a crucial role in providing immediate support and information to families during the acute phase of the illness, which is essential alongside community-based psychoeducation programs later on.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervening Early with Family Members during First-Episode Psychosis: An Evaluation of Mental Health Nursing Psychoeducation within an Inpatient Unit. Petrakis, M., Laxton, S.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10603450/

Supporting patients by family education in psychotic illness The primary goal is to study the effect of a psychoeducation intervention for family carers supporting young adults with psychosis on family burden and ...

2. bmjopen.bmj.com bmjopen.bmj.com/content/13/10/e072881

Supporting patients by family education in psychotic illness The primary goal is to study the effect of a psychoeducation intervention for family carers supporting young adults with psychosis on family burden and ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37879701/

Supporting patients by family education in psychotic illness The primary goal is to study the effect of a psychoeducation intervention for family carers supporting young adults with psychosis on family burden and ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05500001/supporting-patients-by-family-education-in-psychotic-illness-a-prospective-cohort-study

Supporting Patients by Family Education in Psychotic Illness The primary study goal is to implement a psychoeducation intervention for family carers supporting young adults with psychosis to reduce family burden.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0920996425000064

Systematic review and meta-analysis of family-based ... Family interventions for early psychosis benefit both family carers and their relatives diagnosed with psychosis when compared with usual care.

6. withpower.com withpower.com/trial/phase-mental-disorders-8-2022-8cfb2

Family Education for Psychosis Family psychoeducation has evolved over 40 years into a highly effective treatment for schizophrenia, reducing relapse rates by 50-60% compared to standard ...