Evaluation of a Brief Intervention to Improve Engagement and Recovery for At-risk Youth Enrolled in Early Intervention Services for Psychosis .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- 9-item Internalized Stigma of Mental Illness Inventory (ISMI-9)
研究概览
简要总结
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.
详细描述
Background and rationale
For young adults experiencing early phase psychosis, interactions with health services during initial help seeking are believed to be crucial in framing future attitudes towards healthcare and engagement in subsequent treatment. Young adults experiencing psychosis often encounter significant adversity during initial help-seeking. Delays to accessing suitable early intervention treatment are common, and most young adults are referred to early intervention services for psychosis (EIS) via emergency and inpatient services while experiencing acute psychosis. These referral experiences can involve law enforcement and involuntary hospitalization which are highly distressing for young adults, especially in the context of first contact with services.
In general psychiatric samples (i.e., across diagnostic groups, ages and phases of illness), prior involuntary hospitalization is associated with negative views towards subsequent treatment with views of treatment as punitive and coercive rather than therapeutic, and feelings of betrayal towards healthcare. In addition, in young adults experiencing early phase psychosis with prior hospitalization, the prevalence of PTSD diagnosis is twice that of individuals without prior hospitalization with research attributing this increased prevalence to adversity specific to individuals' prior experiences of healthcare. Individuals experiencing early phase psychosis with comorbid PTSD, often display diminished recovery and engagement in treatment. While these outcomes alone are undesirable, less is known about the relationship to between adverse experiences with healthcare and future engagement in EIS.
Recent research at the Nova Scotia Early Psychosis Program (NSEPP), has shown a relationship between referral source to EIS and subsequent health care utilization: when controlling for symptom severity and functioning, participants referred to NSEPP from urgent services (emergency, inpatient and urgent care), compared to those referred from GPs, had a greater than 3-fold use of emergency and inpatient services 2 years following their acceptance to the NSEPP. A related qualitative study further linked service users' help-seeking and referral experiences to their perceptions towards EIS and engagement in treatment; participants with previous experiences of inpatient hospitalization especially those experiencing involuntary hospitalization or interactions with law enforcement, described increased adversity during healthcare interactions, as well as diminished trust towards treatment providers, confidence in the benefits of treatment, and engagement in treatment. Furthermore, participants often cited past negative experiences with healthcare as explanations for these outcomes. These results taken together suggest that many young adults referred to EIS, especially those referred from urgent services, are at risk for negative clinical outcomes including relapse which may be influenced by intermediate outcomes such as negative perceptions of EIS and decreased engagement in treatment. As engagement in treatment is associated with improved symptomatic and functional outcomes, this available research highlights the need for additional support to be provided to new patients in EIS in order to address potential negative perceptions towards healthcare and strengthen engagement in treatment which may predict long term clinical outcomes.
A recent trial of a brief engagement intervention called Just Do You, showed promise in addressing barriers to engagement and recovery for young adults with serious mental illness (SMI) and may be useful at the NSEPP. This manualized intervention aimed to strengthen engagement in treatment by facilitating the processing of prior negative experiences with healthcare, empowering participants to take leadership in recovery, thus increasing participants "buy-in" towards treatment. Additionally, the Just Do You intervention was initially designed to be 2 sessions in length. While more intensive psychotherapeutic interventions may provide additional benefit, these are often more resource intensive and associated with increased difficulty with recruitment and maintaining participant engagement. Considering these challenges, a briefer intervention focused on bolstering engagement may be more feasible and cost-effective for a wider population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Primary diagnosis that is not a psychotic disorder.
- •Outside of age limits.
- •Intellectual Disability (IQ < 70)
研究组 & 干预措施
Engagement Intervention Group (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.
干预措施: Just Do You (Other)
Treatment as Usual Group (control)
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.
结局指标
主要结局
9-item Internalized Stigma of Mental Illness Inventory (ISMI-9)
时间窗: Administered at baseline (T0) and at end of study follow up at 4 months.
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.
Yatchmenoff Client Engagement Scale - Modified
时间窗: Administered at baseline (T0), 2 weeks follow up, 4 weeks follow-up and at end of study follow up at 4 months.
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).
Recovery Assessment Scale - Revised (RAS-R)
时间窗: Administered at baseline (T0), 2-weeks follow up, 4 weeks follow-up and at end of study follow up at 4 months.
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.
次要结局
- 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.)
- Social and Occupational Functioning Assessment Scale (SOFAS)(Administered at baseline (T0) and at end of study follow up at 4 months.)
- The Trauma and Life Events (TALE) checklist(Administered at baseline (T0))
- Clinical Global Impression (CGI-I & CGI-S)(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.)
- Demographic Questionnaire(Administered at baseline (T0))
研究者
Phil Tibbo
Physician
Nova Scotia Health Authority