A Validation Study of a Mobile Phone Digit Symbol Substitution Test Application for Cognition in Adults With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Validation of the mobile DSST application
研究概览
简要总结
Objectives The primary objective of this study is to determine the convergent validity of the mobile DSST application with the pencil and paper version of the DSST.
Design and Outcomes This study will be performed by the Brain and Cognition Discovery Foundation (BCDF). The BCDF is an organization based in Toronto, Ontario, Canada led by Dr. Roger S. McIntyre. Membership of the BCDF has developed and validated rating scales and metrics for adults with mood disorders for over 10 years. A member of the BCDF provides diagnoses and treatment for adults (age 18-65) with mood disorders and provides clinical care to the largest catchment area in Canada. The BCDF conducts clinical research according to the International Conference on Harmonization, Declaration of Helsinki, and Good Clinical Practice (GCP) guidelines. The study will be approved by the community Research Ethics Board.
Thirty adults (18-65) with DSM-5 MDD will be enrolled at the BCDF Toronto, Ontario. All subjects will have their diagnosis ascertained clinically and confirmed by Mini International Neuropsychiatric Interview Version 5.0 (M.I.N.I.).
At baseline, data will be collected from all participants and will include demographics, comorbidities, medication history and concurrent medications. All subjects will be assessed symptomatically with the Montgomery and Asberg Depression Rating Scale (MADRS) as well as the Hamilton Anxiety Rating Scale (HAM-A), Snaith Hamilton Pleasure Scale (SHAPS) for anhedonia, as well as the paper and pencil version of the DSST at baseline and end of study (Day 7).
The DSST has been normed on the sex, age and gender. These norms will be used as reference. All subjects will complete the pencil and paper version of the DSST and complete the mobile app-based version of the DSST.
Sample Size and Population This is a small validation study of 30 subjects. Subjects diagnosed with major depressive disorder will be eligible for participation in this study.
详细描述
Primary Objective The primary objective of this study is to determine the convergent validity of the mobile DSST application with the pencil version of the DSST.
Secondary Objectives To determine whether a correlation exists between the digitalized DSST performance and depression symptoms severity.
To determine patient satisfaction with the digitalized version of the DSST as measured by a satisfaction Likert scale.
Background Health-related information and communication technology solutions that utilize mobile phones, known as mobile health applications (apps), have the potential to expand health interventions beyond face-to-face contacts of traditional healthcare. For the healthcare provider, mobile apps can offer low cost and easily scalable interventions to monitor and improve services to patient populations that are difficult to retain in treatment, potentially leading to more sensitive measurement of cognition, mood and may promote better health. Uptake of health-related mobile apps has increased in recent years as technology barriers such as access, knowledge, and product usability have improved, reducing obstacles for 'digitally excluded' subpopulations (e.g., poor, rural, and older). Consensus exists that the availability of a mobile phone application-based cognitive measure would be more user friendly, aligned with busy office practice and would be more likely to be adopted by end users. Patients with depression and their treating provider may benefit from the use of a mobile health app to assist in disease self-management. This validation study will assess the convergent validity of the mobile DSST application with the pencil version of the DSST. Correlations between performance on app-based version of the DSST and paper-based version of DSST will be measured.
Study Rationale MDD is a serious public health concern worldwide with ample documentation demonstrating that MDD is one of the leading contributors to the global burden of disease and is currently the leading cause of disability worldwide. Moreover, the economic burden of MDD is estimated to total $210.5 billion with approximately 50% of the cost being attributable to impairment in role function (e.g., workplace performance: presenteeism, absenteeism, and short-/long-term disability). Accumulating evidence suggests that the treatment and resolution of mood symptoms among individuals with MDD is insufficient in facilitating full functional recovery among individuals affected by MDD wherein a highly reproduced observation is that impairments in cognitive function remain persistent, pervasive, and progressive during the "remitted" state. The foregoing portrait of MDD as a multidimensional syndrome associated with cognitive impairment and differential functional implications, provides the impetus for evaluating the disparate domains commonly affected in this clinical population using valid and reliable measures/assessments capable of providing actionable information in the treatment and management of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is able and willing to provide informed consent.
- •The participant is male or female 18-65 years of age and owns a smart phone.
- •The participant has received a current diagnosis of a major depressive episode (MDE) as part of MDD as per DSM-5 criteria.
- •The participant's current MDE is confirmed by the M.I.N.I.
- •The participant is an outpatient of a psychiatric setting.
- •The participant has a MADRS score ≥ 20 at screening and baseline.
- •At least one prior MDE formally diagnosed by a healthcare provider or validated by previous treatment (e.g., guideline-informed pharmacotherapy and/or manual-based psychotherapy).
排除标准
- •Current alcohol and/or substance use disorder as confirmed by the M.I.N.I.
- •Presence of comorbid psychiatric disorder other than MDD that is a focus of clinical concern as confirmed by the M.I.N.I.
- •Medications approved and/or employed off-label for cognitive dysfunction (e.g., psychostimulants).
- •Any medication for a general medical disorder that, in the opinion of the investigator, may affect cognitive function.
- •Use of benzodiazepines within 12 hours of cognitive assessments.
- •Consumption of alcohol within 8 hours of cognitive assessments.
- •Inconsistent use or abuse of marijuana.
- •Physical, cognitive, or language impairments sufficient to adversely affect data derived from cognitive assessments.
- •Diagnosed reading disability or dyslexia.
- •Clinically significant learning disorder by history.
- •Electroconvulsive therapy (ECT) in the last 6 months.
- •History of moderate or severe head trauma (e.g., loss of consciousness for >1 hour), other neurological disorders, or unstable systemic medical diseases that in the opinion of the investigator are likely to affect the central nervous system.
- •Pregnant and/or breastfeeding.
- •Received investigational agents as part of a separate study within 30 days of the screening visit.
- •Actively suicidal/presence of suicidal ideation or evaluated as being a suicide risk (as per clinical judgment using the Columbia-Suicide Severity Rating Scale).
- •Currently receiving treatment with Monoamine Oxidase Inhibitors anti-depressants, antibiotics such as linezolid, or intravenous methylene blue.
- •Previous hypersensitivity reaction to vortioxetine or any components of the formulation.
- •Clinical worsening symptoms of depression and suicide risk based on investigator judgement.
- •History of or current diagnosis of Serotonin syndrome.
- •History of or current Abnormal bleeding.
- •Previous history or current symptoms of mania/hypomania.
- •Angle closure glaucoma.
- •Hyponatremia.
- •Moderate hepatic impairment.
- •History of seizures and epilepsy.
研究组 & 干预措施
Pen and Paper vs. Mobile Digit Symbol Substitution Test
This validation study will assess the convergent validity of the mobile DSST application with the pencil version of the DSST. Correlations between performance on app-based version of the DSST and paper-based version of DSST will be measured.
干预措施: Pen and Paper Digit Symbol Substitution Test (DSST) (Other)
Pen and Paper vs. Mobile Digit Symbol Substitution Test
This validation study will assess the convergent validity of the mobile DSST application with the pencil version of the DSST. Correlations between performance on app-based version of the DSST and paper-based version of DSST will be measured.
干预措施: Electronic Digit Symbol Substitution Test (DSST)- (a.k.a. Codebreaker) (Other)
结局指标
主要结局
Validation of the mobile DSST application
时间窗: 1 week
The primary objective of this study is to determine the convergent validity of the mobile DSST application with the pencil version of the DSST. Correlation between performance on the digitalized DSST and the pencil and paper version will be conducted. In light of the small sample size and this being a feasibility pilot study, we will be looking at descriptive statistics of demographics, depression severity and cognition performance. An interim analysis will be completed after the first 15 subjects complete the study.
次要结局
- Montgomery and Asberg Depression Rating Scale (MADRS)(1 week)
- Snaith Hamilton Pleasure Scale (SHAPS )(1 week)
- Hamilton Anxiety Rating Scale (HAM-A)(1 week)
研究者
Dr. Roger S. McIntyre
Chairman and Executive Director
Brain and Cognition Discovery Foundation