Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study

NCT05500001 | Recruiting

• 1 other identifier: Pro00110691
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Psychotic Disorders; Family Members; Anosognosia; Paranoia

Keywords

Young Adult; Psychosis; Family Psychoeducation; Family Burden; Acceptance and Commitment Therapy; LEAP

Outcome Measures

Primary Outcomes (12)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (15)

• Inpatient Readmission Rate

  12-24 months post-intervention

• Inpatient Readmission Rate

  12-months pre-intervention

• Inpatient Readmission Rate

  12-months post-intervention

• Inpatient Admission Frequency

  12-months pre-intervention

• Inpatient Admission Frequency

  12-months post-intervention

Study Arms (1)

Family Psychoeducation Intervention Arm

EXPERIMENTAL

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).

Behavioral: Supporting Patients by Family Education in Psychotic Illness Group

Interventions

Supporting Patients by Family Education in Psychotic Illness Group BEHAVIORAL

Psychoeducation for families supporting young adults with psychosis.

Family Psychoeducation Intervention Arm

Eligibility Criteria

• Age: 17 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator
• Families Supporting Adults with Mental Illness-Alberta: collaborator

Study Sites (4)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

RECRUITING

Alberta Hospital Edmonton

Edmonton, Alberta, T5J 2J7, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X8, Canada

RECRUITING

Related Publications (17)

• 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.

  BACKGROUND

• Amador X. (2020).I Am Not Sick, I Don't Need Help! How To Help Someone Accept Treatment. New York: Vida Press

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 28537124 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31145025 BACKGROUND

• Hayes, S.C., Strosahl, K.D., & Wilson, K.G. (1999)Acceptance and commitment therapy: An experiential approach to behavior change. Guilford Press.

  BACKGROUND

• 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.

  PMID: 32944971 BACKGROUND

• 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.

  PMID: 19955388 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 12728780 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 34132930 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• Zentner KE, Shettell K, Abba-Aji A, Robles M. Supporting patients by family education in psychotic illness: a longitudinal pre-post study protocol. BMJ Open. 2023 Oct 24;13(10):e072881. doi: 10.1136/bmjopen-2023-072881.

  PMID: 37879701 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Agnosia; Paranoid Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melanie Robles, md

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Adam Abba-Aji, MD

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Robles, MD

CONTACT

(780) 983-9773; maduples@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A longitudinal pre-post study design will be used. A non-equivalent comparison group will be available for some measures.

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 12, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available to requesting individuals/organizations through the corresponding author for a timeframe appropriate to the requesting party\'s needs.
• Access Criteria: The purpose and timeframe of the requesting individuals/organizations dataset access will be reviewed on a case by case basis by the research team and is subject to approval by Alberta Health Services based on data sharing policies.

Locations

CA (4)