Naturalistic Pilot Study Comparing the Feasibility of Applying a Student Senior Isolation Prevention Partnership vs. Problem-solving Therapy vs. Waitlist Control in Patients Suffering From Late-life Depression During the COVID-19 Pandemic: A Randomized Controlled Trial

Lawson Health Research Institute2 个研究点分布在 1 个国家开始时间: 2021年8月9日最近更新: 2022年4月18日

适应症

试验速览

阶段: 1 期
状态: 撤回
发起方: Lawson Health Research Institute
试验地点: 2
主要终点: Completeness of data entry

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The COVID-19 pandemic and continued lockdown measures have led to social isolation that is likely disproportionately affecting community-dwelling seniors. This social isolation of seniors is expected to cause detrimental health effects especially in those who have an ongoing or new onset late life depressive episode. The COVID-19 pandemic has also made accessing formal psychotherapy services increasingly difficult due to an increased demand for these services and a limited number of trained professionals available to deliver these interventions. We plan to conduct an open label, pilot, randomized controlled trial (RCT), comparing a virtually delivered (telephone) student led mental health supportive initiative, Student Senior Isolation Prevention Partnership (SSIPP) (n=15) compared to a telephone delivered standard psychotherapy intervention, problem-solving therapy (PST) (n=15) versus a wait list control (n=15) in community-dwelling seniors suffering from late life depression. Participants in this study will be blinded to the hypothesis, while those performing data analysis will be blinded to treatment allocation. Both SSIPP and PST will be delivered via telephone as a weekly session for 12-weeks. Feasibility measures of recruitment, retention and costs will be collected as primary outcome measures. Self-rated measures of depression, anxiety, isolation and resilience will comprise secondary exploratory outcomes. We anticipate that it will be feasible to conduct an RCT of these telephone interventions, SSIPP and PST, in socially isolated community-dwelling seniors. Data from this study will be critical to plan a subsequent confirmatory large-scale RCT. It could be that telephone delivered medical student led supportive intervention, SSIPP and/or a telephone delivered psychotherapy initiative, PST, can be feasibly applied in the current pandemic to a high-risk population, isolated seniors suffering from depression.

详细描述

BACKGROUND

The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for the current coronavirus disease 2019 (COVID-19) outbreak, has led to strict social distancing and social isolation recommendations from the World Health Organization (1). As the elderly are most susceptible to critical illness and fatality due to infection with SARS-CoV-2, they have also been subjected to the most stringent social isolation guidelines in Canada as an attempt to prevent death in this population (1,2). While these public health measures are necessary to prevent the spread of SARS-CoV-2 among our vulnerable geriatric populations and to protect our over-burdened healthcare systems, social isolation has had a detrimental impact on the mental health of this population and has been deemed a mental health crisis (1,3).

The aim of this study is to assess the feasibility of delivering SSIPP in London, Canada, as compared to an active control, PST, as well as a wait list control. Such a study would also allow to collect effect size estimates on the efficacy of SSIPP on self-rated depression, anxiety, isolation and resilience among community-dwelling seniors. As SSIPP is more accessible and more readily available than PST, we aim to determine if SSIPP is as effective as the structured psychotherapy intervention PST at achieving these outcomes. Data from this study will help inform the design of a future large, multi-center RCT.

OBJECTIVES

Objective 1: To determine if it is feasible to conduct an RCT of telephone SSIPP in comparison to PST delivered to community-dwelling seniors during the current constraints imposed by COVID-19 and the need for telephone delivery of these services.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

盲法说明

All study participants will be blinded to the study hypotheses to prevent expectation bias.

入排标准

年龄范围: 65 Years 至 —（Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Community-dwelling senior 65 years of age or older.
•Meeting criteria of suffering from an episode of major depression, mild to moderate, as assessed by an experienced psychiatrist (DSM 296.21, 296.22, 296.31, 296.32), with the following applicable specifiers including anxious distress, mixed features, melancholic features, atypical features and seasonal pattern
•Willing to receive services via telephone.
•Have sufficient hearing to converse via telephone.
•Have an adequate understanding of written and spoken English.
•Answer yes to the question "do you perceive that you are either lonely or isolated?"

排除标准

•Pre-existing dementia or other neurodegenerative disorder as confirmed by a Montreal Cognitive Assessment (MoCA) score, telephone version, 17 or below
•History of schizophrenia
•History of bipolar disorder
•History of substance use disorder
•History of personality disorder as per previous clinical documentation
•History of suicide attempts or threats as per previous clinical documentation or endorsement of any of the questions from item 2-6 of the Columbia- Suicide Severity Rating Scale.