Evaluation of a Brief Intervention to Improve Engagement in Early Intervention Services for Psychosis

NCT06410508 | Recruiting DMC

• 1 other identifier: 62437
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Engagement, Patient; Psychotic Disorders; Psychiatric Hospitalization

Keywords

early phase psychosis

Outcome Measures

Primary Outcomes (3)

• Yatchmenoff Client Engagement Scale - Modified

  Participants' self-reported engagement in treatment is measured using a modified version of the Yatchmenoff Client Engagement Scale. Initially designed to assess engagement in child protective services, but previously modified and used in the initial Just Do You trial, modification of this scale will involve for this study slight changes to wording of questions to different care setting. This 19-item measure assesses respondents' perceptions of treatment and engagement in it across 4 dimensions using a 5-point likert scale with responses ranging from 1 - Strongly Disagree to 5 - Strongly Agree: Receptivity (Range: 4 - 20, with higher scores indicating increased receptivity to treatment) Buy-in (Range: 8 - 40, with higher scores indicating increased buy-in to treatment), Working relationship (Range: 4 - 20, with higher scores indicating perceptions of a stronger working relationship), and Trust (Range: 3 - 15, with higher scores indicating increased trust in care providers).

  Administered at baseline (T0), 2 weeks follow up, 4 weeks follow-up and at end of study follow up at 4 months.

• Recovery Assessment Scale - Revised (RAS-R)

  Participants' recovery is measured using the 24-item revised version of the Recovery Assessment Scale (RAS-R). The RAS is a self-report assessment of individuals' recovery, previously determined to be valid for use with those experiencing serious mental illness. The RAS-R assesses respondents' perceptions of personal recovery in 5 domains: Personal confidence and hope, Willingness to ask for help, Goal and success orientation, Reliance on others, and No domination by symptoms. Responses are scored using a 5-point likert scale with responses ranging from 1 - Strongly Disagree to 5 - Strongly Agree. Total scores range from 24 - 120 with higher values indicating respondents' perceptions of more improved recovery.

  Administered at baseline (T0), 2-weeks follow up, 4 weeks follow-up and at end of study follow up at 4 months.

• 9-item Internalized Stigma of Mental Illness Inventory (ISMI-9)

  Participants' internalized stigma will be measured using the abbreviated 9-item Internalized Stigma of Mental Illness Inventory (ISMI-9). The ISMI-9 is an abbreviated version of the original 29 item ISMI, that aims to assess degree of internalized/self stigma in those experiencing mental illness. Each item of the scale is measured on a 4-point Likert scale (1 - strongly disagree to 4 - strongly agree). Total are then divided by 9 to obtain an average score for internalized stigma with higher scores indicating greater degrees of internalized stigma for respondents (Range: 1 - 4). The 29-item version of this scale has been widely used in studies of stigma in early psychosis samples, but the abbreviated version will be used for this study to reduce burden of involvement on study participants. The 9-item version has been previously demonstrated to have adequate psychometric properties.

  Administered at baseline (T0) and at end of study follow up at 4 months.

Secondary Outcomes (7)

• Positive and Negative Syndrome Scale 6-item abbreviated version (PANSS-6)

  Administered at baseline (T0) and at end of study follow up at 4 months.

• Clinical Global Impression (CGI-I & CGI-S)

  Administered at baseline (T0) and at end of study follow up at 4 months.

• Social and Occupational Functioning Assessment Scale (SOFAS)

  Administered at baseline (T0) and at end of study follow up at 4 months.

• Abbreviated Scale to Assess Unawareness in Mental Disorder (SUMD)

  Administered at baseline (T0) and at end of study follow up at 4 months.

• WHO Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) - FC

  Administered at baseline (T0) and at end of study follow up at 4 months.

Other Outcomes (2)

• Quantitative Engagement: Rate of Missed Appointments

  Number/rate of missed appointments will begin being measured 3-month's prior to involvement in the study and end 6-months following initial engagement in the study.

• Rate of Emergency Department Visits & Hospital Admissions

  Number/rate of missed appointments will begin being measured 3-month's prior to involvement in the study and end 6-months following initial engagement in the study.

Study Arms (2)

Engagement Intervention Group (experimental)

EXPERIMENTAL

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.

Other: Just Do You

Treatment as Usual Group (control)

NO 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.

Interventions

Just Do You OTHER

As described in further detail previously, the experimental intervention is a brief psychotherapeutic intervention informed by principles of CBT and motivational interviewing that is co-delivered by a mental health clinician and peer support worker. This intervention will be a version of the initial intervention delivered in the "Just Do You" trial by Munson et al.(2022), adapted for increased suitability with our clinical population.

Also known as: Engagement Focused Psychotherapeutic Orientation

Engagement Intervention Group (experimental)

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Within first 3-12 months of treatment in early intervention services.
• Diagnosis of a psychotic disorder using the DSM-5 criteria for schizophrenia spectrum and other psychotic disorders (e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, unspecified schizophrenia spectrum and other psychotic disorder, etc.)
• Diagnosis within past 5 years.

You may not qualify if:

• Primary diagnosis that is not a psychotic disorder.
• Outside of age limits.
• Intellectual Disability (IQ \< 70)

Sponsors & Collaborators

• Queen Elizabeth II Health Sciences Centre: collaborator
• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Early Psychosis Program (NSEPP)

Halifax, Nova Scotia, B3H 2E2, Canada

RECRUITING

Related Publications (41)

• Bertolote J, McGorry P. Early intervention and recovery for young people with early psychosis: consensus statement. Br J Psychiatry Suppl. 2005 Aug;48:s116-9. doi: 10.1192/bjp.187.48.s116.

  PMID: 16055800 BACKGROUND

• Addington J, Van Mastrigt S, Hutchinson J, Addington D. Pathways to care: help seeking behaviour in first episode psychosis. Acta Psychiatr Scand. 2002 Nov;106(5):358-64. doi: 10.1034/j.1600-0447.2002.02004.x.

  PMID: 12366470 BACKGROUND

• Weiss A, Steadman S, Mercier HD, Hansel TC, Chaudhry S, Clark I. Pathways to Care: How Help-Seeking Behaviors Relate to Duration of Untreated Psychosis and Treatment Engagement. Psychiatr Q. 2022 Jun;93(2):473-482. doi: 10.1007/s11126-021-09960-5. Epub 2021 Oct 20.

  PMID: 34669120 BACKGROUND

• Jones N, Gius BK, Shields M, Collings S, Rosen C, Munson M. Investigating the impact of involuntary psychiatric hospitalization on youth and young adult trust and help-seeking in pathways to care. Soc Psychiatry Psychiatr Epidemiol. 2021 Nov;56(11):2017-2027. doi: 10.1007/s00127-021-02048-2. Epub 2021 Mar 9.

  PMID: 33751175 BACKGROUND

• Anderson KK, Fuhrer R, Schmitz N, Malla AK. Determinants of negative pathways to care and their impact on service disengagement in first-episode psychosis. Soc Psychiatry Psychiatr Epidemiol. 2013 Jan;48(1):125-36. doi: 10.1007/s00127-012-0571-0. Epub 2012 Sep 14.

  PMID: 22976337 BACKGROUND

• Rodrigues R, Anderson KK. The traumatic experience of first-episode psychosis: A systematic review and meta-analysis. Schizophr Res. 2017 Nov;189:27-36. doi: 10.1016/j.schres.2017.01.045. Epub 2017 Feb 14.

  PMID: 28214175 BACKGROUND

• MacDonald K, Fainman-Adelman N, Anderson KK, Iyer SN. Pathways to mental health services for young people: a systematic review. Soc Psychiatry Psychiatr Epidemiol. 2018 Oct;53(10):1005-1038. doi: 10.1007/s00127-018-1578-y. Epub 2018 Aug 22.

  PMID: 30136192 BACKGROUND

• Seed T, Fox JR, Berry K. The experience of involuntary detention in acute psychiatric care. A review and synthesis of qualitative studies. Int J Nurs Stud. 2016 Sep;61:82-94. doi: 10.1016/j.ijnurstu.2016.05.014. Epub 2016 Jun 4.

  PMID: 27314181 BACKGROUND

• Silva B, Bachelard M, Amoussou JR, Martinez D, Bonalumi C, Bonsack C, Golay P, Morandi S. Feeling coerced during voluntary and involuntary psychiatric hospitalisation: A review and meta-aggregation of qualitative studies. Heliyon. 2023 Feb 2;9(2):e13420. doi: 10.1016/j.heliyon.2023.e13420. eCollection 2023 Feb.

  PMID: 36820044 BACKGROUND

• Priebe S, Katsakou C, Amos T, Leese M, Morriss R, Rose D, Wykes T, Yeeles K. Patients' views and readmissions 1 year after involuntary hospitalisation. Br J Psychiatry. 2009 Jan;194(1):49-54. doi: 10.1192/bjp.bp.108.052266.

  PMID: 19118325 BACKGROUND

• Priebe S, Katsakou C, Glockner M, Dembinskas A, Fiorillo A, Karastergiou A, Kiejna A, Kjellin L, Nawka P, Onchev G, Raboch J, Schuetzwohl M, Solomon Z, Torres-Gonzalez F, Wang D, Kallert T. Patients' views of involuntary hospital admission after 1 and 3 months: prospective study in 11 European countries. Br J Psychiatry. 2010 Mar;196(3):179-85. doi: 10.1192/bjp.bp.109.068916.

  PMID: 20194537 BACKGROUND

• Mueser KT, Lu W, Rosenberg SD, Wolfe R. The trauma of psychosis: posttraumatic stress disorder and recent onset psychosis. Schizophr Res. 2010 Feb;116(2-3):217-27. doi: 10.1016/j.schres.2009.10.025. Epub 2009 Nov 24.

  PMID: 19939633 BACKGROUND

• Minsky SK, Lu W, Silverstein SM, Gara M, Gottlieb JD, Mueser KT. Service Use and Self-Reported Symptoms Among Persons With Positive PTSD Screens and Serious Mental Illness. Psychiatr Serv. 2015 Aug 1;66(8):845-50. doi: 10.1176/appi.ps.201400192. Epub 2015 Apr 15.

  PMID: 25873024 BACKGROUND

• Senger B, Pencer A, Crocker CE, Simon P, Taylor B, Tibbo PG. The role of referral pathway to early intervention services for psychosis on 2-year inpatient and emergency service use. J Psychiatr Res. 2024 Apr;172:340-344. doi: 10.1016/j.jpsychires.2024.02.035. Epub 2024 Feb 28.

  PMID: 38442449 BACKGROUND

• Dixon LB, Holoshitz Y, Nossel I. Treatment engagement of individuals experiencing mental illness: review and update. World Psychiatry. 2016 Feb;15(1):13-20. doi: 10.1002/wps.20306.

  PMID: 26833597 BACKGROUND

• Macbeth A, Gumley A, Schwannauer M, Fisher R. Service engagement in first episode psychosis: clinical and premorbid correlates. J Nerv Ment Dis. 2013 May;201(5):359-64. doi: 10.1097/NMD.0b013e31828e0e19.

  PMID: 23588222 BACKGROUND

• Munson MR, Jaccard JJ, Scott LD Jr, Narendorf SC, Moore KL, Jenefsky N, Cole A, Davis M, Gilmer T, Shimizu R, Pleines K, Cooper K, Rodwin AH, Hylek L, Amaro A. Engagement intervention versus treatment as usual for young adults with serious mental illness: a randomized pilot trial. Pilot Feasibility Stud. 2020 Jul 23;6:107. doi: 10.1186/s40814-020-00650-w. eCollection 2020.

  PMID: 32714561 BACKGROUND

• Munson MR, Jaccard J, Moore KL, Rodwin AH, Shimizu R, Cole AR, Scott LD Jr, Narendorf SC, Davis M, Gilmer T, Stanhope V. Impact of a brief intervention to improve engagement in a recovery program for young adults with serious mental illness. Schizophr Res. 2022 Dec;250:104-111. doi: 10.1016/j.schres.2022.11.008. Epub 2022 Nov 15.

  PMID: 36399899 BACKGROUND

• Abelson J, Li K, Wilson G, Shields K, Schneider C, Boesveld S. Supporting quality public and patient engagement in health system organizations: development and usability testing of the Public and Patient Engagement Evaluation Tool. Health Expect. 2016 Aug;19(4):817-27. doi: 10.1111/hex.12378. Epub 2015 Jun 25.

  PMID: 26113295 BACKGROUND

• Kontopantelis E, Doran T, Springate DA, Buchan I, Reeves D. Regression based quasi-experimental approach when randomisation is not an option: interrupted time series analysis. BMJ. 2015 Jun 9;350:h2750. doi: 10.1136/bmj.h2750.

  PMID: 26058820 BACKGROUND

• Street LL, Luoma JB. Control groups in psychosocial intervention research: ethical and methodological issues. Ethics Behav. 2002;12(1):1-30. doi: 10.1207/S15327019EB1201_1.

  PMID: 12171079 BACKGROUND

• Statistics Canada. 2019. "The Canadian Index of Multiple Deprivation". Statistics Canada Catalogue no. 45-20-0001.

  BACKGROUND

• Matheson FI, Dunn JR, Smith KL, Moineddin R, Glazier RH. Development of the Canadian Marginalization Index: a new tool for the study of inequality. Can J Public Health. 2012 Apr 30;103(8 Suppl 2):S12-6. doi: 10.1007/BF03403823.

  PMID: 23618065 BACKGROUND

• D. K. Yatchmenoff, "Measuring client engagement from the client's perspective in nonvoluntary child protective services," Res. Soc. Work Pract., vol. 15, no. 2, pp. 84-96, 2005.

  BACKGROUND

• Corrigan PW, Salzer M, Ralph RO, Sangster Y, Keck L. Examining the factor structure of the recovery assessment scale. Schizophr Bull. 2004;30(4):1035-41. doi: 10.1093/oxfordjournals.schbul.a007118.

  PMID: 15957202 BACKGROUND

• Salzer MS, Brusilovskiy E. Advancing recovery science: reliability and validity properties of the Recovery Assessment Scale. Psychiatr Serv. 2014 Apr 1;65(4):442-53. doi: 10.1176/appi.ps.201300089.

  PMID: 24487405 BACKGROUND

• Kaplan K, Salzer MS, Brusilovskiy E. Community participation as a predictor of recovery-oriented outcomes among emerging and mature adults with mental illnesses. Psychiatr Rehabil J. 2012 Winter;35(3):219-29. doi: 10.2975/35.3.2012.219.229.

  PMID: 22246120 BACKGROUND

• Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

  PMID: 3616518 BACKGROUND

• W. Guy, "Clinical Global Impression," in Assessment manual for psychopharmacology, Rockville, MD: US Department of Health, Education, and Welfare, 1976.

  BACKGROUND

• Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand. 2000 Apr;101(4):323-9.

  PMID: 10782554 BACKGROUND

• Amador XF, Strauss DH, Yale SA, Flaum MM, Endicott J, Gorman JM. Assessment of insight in psychosis. Am J Psychiatry. 1993 Jun;150(6):873-9. doi: 10.1176/ajp.150.6.873.

  PMID: 8494061 BACKGROUND

• Michel P, Baumstarck K, Auquier P, Amador X, Dumas R, Fernandez J, Lancon C, Boyer L. Psychometric properties of the abbreviated version of the Scale to Assess Unawareness in Mental Disorder in schizophrenia. BMC Psychiatry. 2013 Sep 22;13:229. doi: 10.1186/1471-244X-13-229.

  PMID: 24053640 BACKGROUND

• WHO ASSIST Working Group. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183-94. doi: 10.1046/j.1360-0443.2002.00185.x.

  PMID: 12199834 BACKGROUND

• McRee B, Babor TF, Lynch ML, Vendetti JA. Reliability and Validity of a Two-Question Version of the World Health Organization's Alcohol, Smoking and Substance Involvement Screening Test: The ASSIST-FC. J Stud Alcohol Drugs. 2018 Jul;79(4):649-657.

  PMID: 30079882 BACKGROUND

• Carr S, Hardy A, Fornells-Ambrojo M. The Trauma and Life Events (TALE) checklist: development of a tool for improving routine screening in people with psychosis. Eur J Psychotraumatol. 2018 Sep 11;9(1):1512265. doi: 10.1080/20008198.2018.1512265. eCollection 2018.

  PMID: 30220986 BACKGROUND

• Hammer, J. H., & Toland, M. D. (2017). Internal structure and reliability of the Internalized Stigma of Mental Illness Scale (ISMI-29) and Brief Versions (ISMI-10, ISMI-9) among Americans with depression. Stigma and Health, 2(3), 159.

  BACKGROUND

• Boyd JE, Adler EP, Otilingam PG, Peters T. Internalized Stigma of Mental Illness (ISMI) scale: a multinational review. Compr Psychiatry. 2014 Jan;55(1):221-31. doi: 10.1016/j.comppsych.2013.06.005. Epub 2013 Sep 21.

  PMID: 24060237 BACKGROUND

• West BT. Analyzing longitudinal data with the linear mixed models procedure in SPSS. Eval Health Prof. 2009 Sep;32(3):207-28. doi: 10.1177/0163278709338554. Epub 2009 Aug 13.

  PMID: 19679634 BACKGROUND

• Liu S, Rovine MJ, Molenaar PC. Selecting a linear mixed model for longitudinal data: repeated measures analysis of variance, covariance pattern model, and growth curve approaches. Psychol Methods. 2012 Mar;17(1):15-30. doi: 10.1037/a0026971. Epub 2012 Jan 16.

  PMID: 22251268 BACKGROUND

• Weaver CG, Ravani P, Oliver MJ, Austin PC, Quinn RR. Analyzing hospitalization data: potential limitations of Poisson regression. Nephrol Dial Transplant. 2015 Aug;30(8):1244-9. doi: 10.1093/ndt/gfv071. Epub 2015 Mar 25.

  PMID: 25813274 BACKGROUND

• Becker-Blease KA, Freyd JJ. Research participants telling the truth about their lives: the ethics of asking and not asking about abuse. Am Psychol. 2006 Apr;61(3):218-26. doi: 10.1037/0003-066X.61.3.218.

  PMID: 16594838 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Patient Participation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Phil Tibbo, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brannon Senger

CONTACT

2892318986; sengerbrt@gmail.com

Phil Tibbo

CONTACT

9024731678; phil.tibbo@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Participants will not be randomized to study conditions due to recruitment difficulties and ethical concerns related to randomizing participants to a condition that has previously been demonstrated to be efficacious. Instead, participants wanting to engage in the intervention will be included in the active treatment arm and those wishing to recieve treatment as usual will be included as controls. See description of study protocol above for more detailed explanation of interventional study design.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 13, 2024
• Study Start: September 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following study completion and result publication in roughly Spring 2027
• Access Criteria: Available upon request with information to contact provided in published manuscript.

Locations

CA (1)