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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: A lack of education, resources, and support for family carers of young adults with psychotic illnesses leaves them ill-equipped to support their loved one. Although family support groups exist, few groups offer evidence-based, skills-focused, psychoeducation taught by certified professionals and provided on a public-health level. By equipping families with skills and knowledge, public healthcare harnesses a powerful ally to maintain community stabilization. Aims: The primary study goal is to implement a psychoeducation intervention for family carers supporting young adults with psychosis to reduce family burden and foster community stabilization of service users. Methods: A longitudinal pre-post design will be used to assess the long-term effectiveness of the psychoeducation intervention for family carers supporting a young adult with psychosis on service utilization and functional indexes. Nine expert-reviewed, and family peer-informed psychoeducation modules are administered in 2-hour sessions over 9 weeks to family carers. Conclusion: Presenting the novel approach of an expert-reviewed, peer-informed psychoeducation intervention for family carers, with a focus on knowledge and skill development, the researchers contribute to literature and best practice in patient and family-centered care.

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 data supports the effectiveness of the treatment Supporting Patients by Family Education in Psychotic Illness Group?

Research shows that family psychoeducation, a key part of this treatment, can significantly improve symptoms and social functioning in patients with schizophrenia, and reduce the burden on their families. Studies also indicate that such interventions can reduce relapse rates by 50-60% and enhance family knowledge and understanding, which helps in recovery and preventing further episodes. ^{1 2 3 4 5}

Is family education for psychosis safe for participants?

Family education for psychosis, also known as family psychoeducation or family intervention, has been used safely for many years to help people with conditions like schizophrenia and bipolar disorder. It focuses on providing information and support to families, and there are no reports of it causing harm to participants. ^{2 5 6 7 8}

How is the Family Education for Psychosis treatment different from other treatments for psychosis?

Family Education for Psychosis is unique because it involves educating families to support recovery and prevent relapse in individuals experiencing psychosis. This approach focuses on improving the family's understanding and coping skills, making them active partners in the treatment process, which is different from traditional treatments that primarily focus on the individual alone. ^{2 3 4 7 9}

Research Team

Melanie Robles, md

Principal Investigator

University of Alberta

Adam Abba-Aji, MD

Principal Investigator

Alberta Health services

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Italy 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. [2023]

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

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

3. Germany pubmed.ncbi.nlm.nih.gov

Patient and relative education in community psychiatry: a randomized controlled trial regarding its effectiveness. [2019]

4. Australia pubmed.ncbi.nlm.nih.gov

Multiple family group interventions in first episode psychosis: Enhancing knowledge and understanding. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

Participants' perceived benefits of family intervention following a first episode of psychosis: a qualitative study. [2016]

6. Australia pubmed.ncbi.nlm.nih.gov

Family-focused therapy for individuals at clinical high risk for psychosis: treatment fidelity within a multisite randomized trial. [2021]

7. United States 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. [2019]

8. United States 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. [2022]

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

A family psychoeducation group program for chinese people with schizophrenia in Hong Kong. [2017]