A Remote Electronically Delivered Integrated Care Pathway for Adolescents With Major Depressive Disorder: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 3
- 主要终点
- Number of Psychiatry Appointments
研究概览
简要总结
This is a one-armed observational study and feasibility trial of a remote electronically-delivered integrated care pathway for the treatment of adolescents. Eligible participants are between the ages of 13 and 18, inclusive, who have a primary diagnosis of major depressive disorder. Outcomes of interest are recruitment rates and participation in pathway components, including: appointments, measure-completion and use of electronically-delivered cognitive behavioural therapy.
详细描述
Introduction
Depression is common and debilitating in the adolescent age range. Geography or other logistical barriers may prevent youth from accessing care. Progress in the treatment of youth that uses their tendencies to engage in electronically mediated contacts (e.g., text, online videos, and livestream video chat) can strategically address depressive disorders to overcome these barriers.
Methods: The Principal Investigator will conduct a pilot single-arm trial to assess the feasibility of a 16-week remote electronically delivered integrated care pathway (ICP) for the treatment of adolescents (age 13-18) with major depressive disorder. CBT components being delivered has been tested in the age 18-30 with depression. The ICP includes: tele-psychiatry appointments, online measurement-based care, internet-based cognitive behavioural therapy combined with mindfulness training, and text-based health coaching. Eligible subjects will be recruited from Child, Youth and Family services at the Centre for Addiction and Mental Health. The Principal Investigator aims to recruit 12 participants.
Outcomes: Feasibility outcomes are of the primary interest; namely, recruitment rates, proportion of psychiatry appointments attended, proportion of self-report measures completed, proportion of online CBT videos viewed, number of text-exchanges between youth and health coaches, physical activity levels and qualitative feedback from youth about their experiences. Primary clinical outcomes will be described via self-reported depressive symptoms using the Mood and Feelings Questionnaire. Secondary outcomes include self-reported anxiety (anxiety-related subscales of the Revised Children's Anxiety and Depression Scale) and function (Youth Columbia Impairment Scale). The Principal Investigator will also measure self-injurious thoughts and behaviours using the Columbia Suicide Severity Rating Scale.
Discussion: If results confirm hypotheses that youth can be feasibly treated with a remote electronically delivered ICP, further efficacy testing may be performed to assess this as a viable option for service delivery that reduces barriers to care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •13-18 years old at baseline
- •Mood and Feelings Questionnaire - Childhood, long version (MFQ) score of ≥22
- •Diagnosis of Major Depressive Disorder by impression from the referring psychiatrist and confirmed using the KSADS
- •Internet access at home
- •Access to a smartphone for personal and private use, with an associated standard data plan (ie. greater than or equal to 500 MB/month)
- •Able to speak and read English fluently
排除标准
- •Individuals that arecurrently receiving structured psychotherapy
- •Clinically significant suicidal ideation that is defined as 'imminent intent' or attempted suicide in the past 6 months
- •Co-morbid diagnosis of borderline personality disorder (as assessed by the Childhood Interview for Borderline Personality Disorder) (Zanarini, 2003), schizophrenia, bipolar disorder, moderate-to-severe eating disorder, obsessive compulsive disorder and/or severe alcohol/substance use disorder in the past 3 months
- •Youth with known or clinically suspected intellectual disability or autism spectrum disorder
- •Youth who are not able to provide informed consent for any other reason
研究组 & 干预措施
Remote Electronically Delivered Integrated Care Pathway (ICP)
The remote electronically-delivered ICP (also known as eCARIBOU) will consist of psychiatry appointments through telemedicine every 4 weeks over 16 weeks, where the youth is at home. Prior to these appointments, measures (i.e., Mood and Feelings Questionnaire - MFQ) will be sent to the youth to be completed. Change in measure scores will be reviewed collaboratively between the psychiatrist and the youth to assist in making treatment decisions. The medication algorithm in the in-person ICP will be used to guide these decisions. The psychiatrist will also administer the Columbia Suicide Severity Rating Scale (C-SSRS) at each telepsychiatry appointment to monitor risk. Concurrently, youth will be offered internet-based Cognitive Behavioural Therapy (iCBT) and health-coaching via text.
干预措施: eCARIBOU (Other)
结局指标
主要结局
Number of Psychiatry Appointments
时间窗: 16 weeks
Proportion of scheduled psychiatry appointments attended (number attended divided by 4 for each participant)
Number of iCBT Content Viewed
时间窗: 16 weeks
Proportion of online CBT videos viewed per participant (number viewed divided by 54)
Youth's Experience with eCARIBOU
时间窗: 16 weeks
Qualitative Interview feedback from youth pertaining to the intervention - including ease of use, content relevance, level of engagement with the intervention
Recruitment
时间窗: 6 months
Time it takes to recruit 12 participants to the study
Fitbit Usage
时间窗: 16 weeks
Number of days the fitbit is worn and the percentage of data collected
ICP Deviations
时间窗: 16 weeks
Frequency of deviations from the pathway and any documented reasons for deviations
Psychiatric Management
时间窗: 16 weeks
Number of events involving of self-harm behaviour/suicidal ideation that required acute psychiatric management (where the study psychiatrist needs to communicate with the youth and/or family members outside of regular appointments every 4 weeks).
Number of Health Coach Text Messages
时间窗: 16 weeks
Number of text messages the participant sent to the health coach (count data)
次要结局
未报告次要终点
研究者
Darren Courtney
Clinician Scientist with the Cundill Centre for Child and Youth Depression and a Staff Psychiatrist in the Youth Addictions and Concurrent Disorders Service
Centre for Addiction and Mental Health