Psychotic Disorders Clinical Trial
Official title:
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 1, 2025 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years to 27 Years |
Eligibility | Inclusion Criteria: - Young adult service user is aged 17-27 at time of recruitment - Young adult service user has had an admission or discharge from an Alberta Health Services or Covenant Health psychiatric unit for psychosis in the Edmonton Zone within previous 12-months Exclusion Criteria: - Not proficient in English - Young adult service user has NOT had an admission or discharge from an Alberta Health Services or Covenant Health psychiatric unit for psychosis in the Edmonton Zone within previous 12-months |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Hospital Edmonton | Edmonton | Alberta |
Canada | Grey Nuns Community Hospital | Edmonton | Alberta |
Canada | Royal Alexandra Hospital | Edmonton | Alberta |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Alberta Health services, Families Supporting Adults with Mental Illness-Alberta |
Canada,
Alberta Health Services. (2018). Patient and Family Centered Care Resource Kit: How to Improve the Patient Experience. Quality and Healthcare Improvement, Engagement and Patient Experience Department.
Amador X. (2020).I Am Not Sick, I Don't Need Help! How To Help Someone Accept Treatment. New York: Vida Press
American Psychological Association [APA]. (2011). Family Interventions. Retrieved on August 9, 2022 from https://www.apa.org/pi/about/publications/caregivers/practice-settings/intervention/family
Day K, Starbuck R, Petrakis M. Family group interventions in an early psychosis program: A re-evaluation of practice after 10 years of service delivery. Int J Soc Psychiatry. 2017 Aug;63(5):433-438. doi: 10.1177/0020764017710301. Epub 2017 May 24. — View Citation
Day, K., & Petrakis, M. (2017). Family interventions in early psychosis service delivery: A systematized review. Social Work in Mental Health, 15(6): 632-650. doi:10.1080/15332985.2016.1271381
Early Psychosis Guidelines Writing Group and EPPIC National Support Program (2016). Australian Clinical Guidelines for Early Psychosis, 2nd edition update, Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne.
Ewertzon M, Hanson E. Support Interventions for Family Members of Adults with Mental Illness: A Narrative Literature Review. Issues Ment Health Nurs. 2019 Sep;40(9):768-780. doi: 10.1080/01612840.2019.1591547. Epub 2019 May 30. — View Citation
Hayes, S.C., Strosahl, K.D., & Wilson, K.G. (1999)Acceptance and commitment therapy: An experiential approach to behavior change. Guilford Press.
Jolley S, Johns LC, O'Donoghue E, Oliver J, Khondoker M, Byrne M, Butler L, De Rosa C, Leal D, McGovern J, Rasiukeviciute B, Sim F, Morris E. Group acceptance and commitment therapy for patients and caregivers in psychosis services: Feasibility of training and a preliminary randomized controlled evaluation. Br J Clin Psychol. 2020 Nov;59(4):524-551. doi: 10.1111/bjc.12265. Epub 2020 Sep 17. — View Citation
Kreyenbuhl J, Buchanan RW, Dickerson FB, Dixon LB; Schizophrenia Patient Outcomes Research Team (PORT). The Schizophrenia Patient Outcomes Research Team (PORT): updated treatment recommendations 2009. Schizophr Bull. 2010 Jan;36(1):94-103. doi: 10.1093/schbul/sbp130. Epub 2009 Dec 2. — View Citation
MacCourt, P. (2013). Family Caregivers Advisory Committee, Mental Health Commission of Canada. National Guidelines for a Comprehensive Service System to Support Family Caregivers of Adults with Mental Health Problems and Illnesses. Calgary, AB: Mental Health Commission of Canada. Retrieved from: http://www.mentalhealthcommission.ca
McFarlane WR, Dixon L, Lukens E, Lucksted A. Family psychoeducation and schizophrenia: a review of the literature. J Marital Fam Ther. 2003 Apr;29(2):223-45. doi: 10.1111/j.1752-0606.2003.tb01202.x. — View Citation
Poon, A.W.C., Curtis, J., Howard, A., Ward, P.B., & Lappin, J.M. (2019). Health of Carers of Young People with Early Psychosis: A Biopsychosocial Approach. Australian Social Work, 72(3): 260-273, DOI: 10.1080/0312407X.2018.1530269
Rachamim L, Nacasch N, Sinay I. Complicated Grief, Depression, Health and Attachment Style in First Degree Relatives of Individuals with a Chronic Psychotic Disorders. Community Ment Health J. 2022 Apr;58(3):526-535. doi: 10.1007/s10597-021-00848-z. Epub 2021 Jun 16. — View Citation
Rosas-Santiago, F.J., Genchi, J.J., Heredia, I.S., & Zamora, V.E.R. (2022). Psychoeducation and group acceptance and commitment therapy as psychological support strategies for informal caregivers of patients with a first psychotic episode: An experimental study. Psychosis: Psychological, Social and Integrative Approaches.[Preprint]. doi:10.1080/17522439.2022.2061041.
World Health Organization. (2013). Mental health action plan 2013-2020. World Health Organization Library Cataloguing-in-Publication Data. https://www.who.int/publications/i/item/9789241506021
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Family Burden Interview Schedule | assesses overall burden of the family related to supporting a loved one with addiction and mental health concerns, including the following domains: financial, routines and activities, leisure, relationships, physical health, mental health | Baseline-Day 0 (Pre-intervention) | |
Primary | Family Burden Interview Schedule | assesses overall burden of the family related to supporting a loved one with addiction and mental health concerns, including the following domains: financial, routines and activities, leisure, relationships, physical health, mental health | 9-Week Follow-Up (Post-Intervention) | |
Primary | Family Burden Interview Schedule | assesses overall burden of the family related to supporting a loved one with addiction and mental health concerns, including the following domains: financial, routines and activities, leisure, relationships, physical health, mental health | 6-Month Follow-Up (Post-Intervention) | |
Primary | Family Burden Interview Schedule | assesses overall burden of the family related to supporting a loved one with addiction and mental health concerns, including the following domains: financial, routines and activities, leisure, relationships, physical health, mental health | 24-Month Follow-Up (Post-Intervention) | |
Primary | Positive and Negative Symptom Schedule | assesses overall symptom severity of service users, including 7 positive symptoms (e.g., hallucinations, grandiosity, etc.), 7 negative symptoms (e.g., blunted affect, emotional withdrawal) and general symptoms (e.g., anxiety, lack of judgement/insight, poor impulse control) | Baseline-Day 0 (Pre-intervention) | |
Primary | Positive and Negative Symptom Schedule | assesses overall symptom severity of service users, including 7 positive symptoms (e.g., hallucinations, grandiosity, etc.), 7 negative symptoms (e.g., blunted affect, emotional withdrawal) and general symptoms (e.g., anxiety, lack of judgement/insight, poor impulse control) | 9-Week Follow-Up (Post-Intervention) | |
Primary | Positive and Negative Symptom Schedule | assesses overall symptom severity of service users, including 7 positive symptoms (e.g., hallucinations, grandiosity, etc.), 7 negative symptoms (e.g., blunted affect, emotional withdrawal) and general symptoms (e.g., anxiety, lack of judgement/insight, poor impulse control) | 6-Month Follow-Up (Post-Intervention) | |
Primary | Positive and Negative Symptom Schedule | assesses overall symptom severity of service users, including 7 positive symptoms (e.g., hallucinations, grandiosity, etc.), 7 negative symptoms (e.g., blunted affect, emotional withdrawal) and general symptoms (e.g., anxiety, lack of judgement/insight, poor impulse control) | 24-Month Follow-Up (Post-Intervention) | |
Primary | Manchester Short Assessment of Quality of Life | assessing service user quality of life on a scale of 1 (couldn't be worse) to 7 (couldn't be better) and "yes/no" for select items. | Baseline-Day 0 (Pre-intervention) | |
Primary | Manchester Short Assessment of Quality of Life | assessing service user quality of life on a scale of 1 (couldn't be worse) to 7 (couldn't be better) and "yes/no" for select items. | 9-Week Follow-Up (Post-Intervention) | |
Primary | Manchester Short Assessment of Quality of Life | assessing service user quality of life on a scale of 1 (couldn't be worse) to 7 (couldn't be better) and "yes/no" for select items. | 6-Month Follow-Up (Post-Intervention) | |
Primary | Manchester Short Assessment of Quality of Life | assessing service user quality of life on a scale of 1 (couldn't be worse) to 7 (couldn't be better) and "yes/no" for select items. | 24-Month Follow-Up (Post-Intervention) | |
Secondary | Inpatient Readmission Rate | Readmission rate for mental health diagnosis within 30 days of an inpatient discharge | 12-24 months post-intervention | |
Secondary | Inpatient Readmission Rate | Readmission rate for mental health diagnosis within 30 days of an inpatient discharge | 12-months pre-intervention | |
Secondary | Inpatient Readmission Rate | Readmission rate for mental health diagnosis within 30 days of an inpatient discharge | 12-months post-intervention | |
Secondary | Inpatient Admission Frequency | Frequency of hospital admissions for mental health diagnosis | 12-months pre-intervention | |
Secondary | Inpatient Admission Frequency | Frequency of hospital admissions for mental health diagnosis | 12-months post-intervention | |
Secondary | Inpatient Admission Frequency | Frequency of hospital admissions for mental health diagnosis | 12-24 months post-intervention | |
Secondary | Emergency Department Visit Frequency | Frequency of emergency departments visits within 30 days of last emergency presentation | 12-months pre-intervention | |
Secondary | Emergency Department Visit Frequency | Frequency of emergency departments visits within 30 days of last emergency presentation | 12-months post-intervention | |
Secondary | Emergency Department Visit Frequency | Frequency of emergency departments visits within 30 days of last emergency presentation | 12-24 months post-intervention | |
Secondary | Community Appointment Frequency | Appointment frequency for community-based services | 12-months pre-intervention | |
Secondary | Community Appointment Frequency | Appointment frequency for community-based services | 12-months post-intervention | |
Secondary | Community Appointment Frequency | Appointment frequency for community-based services | 12-24 months post-intervention | |
Secondary | Crisis Service Frequency | Frequency of crisis calls and visits | 12-months pre-intervention | |
Secondary | Crisis Service Frequency | Frequency of crisis calls and visits | 12-months post-intervention | |
Secondary | Crisis Service Frequency | Frequency of crisis calls and visits | 12-24 months post-intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Terminated |
NCT03230097 -
This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year
|
Phase 2 | |
Completed |
NCT03497663 -
VIA Family - Family Based Early Intervention Versus Treatment as Usual
|
N/A | |
Active, not recruiting |
NCT05726617 -
Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders
|
N/A | |
Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
Recruiting |
NCT02874573 -
Tocilizumab in Schizophrenia
|
Phase 1 | |
Completed |
NCT02906553 -
The Role of Nitric Oxide in Cognition in Schizophrenia
|
N/A | |
Terminated |
NCT02584114 -
Brain Effects of Memory Training in Early Psychosis
|
N/A | |
Terminated |
NCT02841956 -
Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement
|
N/A | |
Completed |
NCT01981356 -
Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis
|
Phase 0 | |
Withdrawn |
NCT02213887 -
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
|
Phase 4 | |
Recruiting |
NCT02009969 -
Serial Comparisons of Abdominal and Neurological MRI Scans
|
N/A | |
Recruiting |
NCT02848469 -
Irish Omega-3 Study
|
Phase 2 | |
Completed |
NCT02648321 -
Motivational Intervention for Physical Activity in Psychosis
|
N/A | |
Enrolling by invitation |
NCT00762866 -
Psychiatric Genotype/Phenotype Project Repository
|
||
Completed |
NCT00484302 -
Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis
|
N/A | |
Completed |
NCT00130923 -
Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
|
Phase 4 | |
Completed |
NCT00455234 -
Rapid Tranquillization Trial: TREC-India II
|
Phase 3 | |
Completed |
NCT00844922 -
Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)
|
Phase 2 | |
Completed |
NCT00253240 -
Diabetes Screening, Risk Management and Disease Management in a High-Risk Mental Health Population
|