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临床试验/NCT04747873
NCT04747873已完成不适用

Investigating the Effectiveness of Incorporating a Stepped Care Approach Into Electronically-delivered CBT for Depression

Dr. Nazanin Alavi2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2021年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
79
试验地点
2
主要终点
Change in quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire)

研究概览

简要总结

This randomized trial intervention will provide e-CBT for MDD through the Online Psychotherapy Tool (OPTT), a secure, cloud-based, digital mental health platform. Participants (age: 18-65 years) will be offered an e-CBT program tailored to MDD over 12 weeks to address their depressive symptoms. Participants will complete pre-designed modules and homework assignments while receiving personalized feedback and asynchronous interaction with a therapist through the platform. The content of the e-CBT modules is designed to mirror in-person standard CBT for MDD. There will be 12 weekly sessions that include approximately 30 slides each along with interactive content, delivered through OPTT. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be evaluated. Both groups will receive the 12-week e-CBT program with one group receiving the standard program. In the second arm, a stepped care approach can be implemented if deemed necessary by the care provider. This decision will be made if the participant has not shown improvement. Questionnaire data along with physiological data will be used to determine the decision.

详细描述

Participants Participants (n = 110; 55 e-CBT participants, 55 e-CBT + stepped care participants) aged 18-65 years will be recruited at Queen's University from outpatient psychiatry clinic at both Kingston Health Sciences Centre sites (Hotel Dieu Hospital and Kingston General Hospital) as well as Providence Care hospital, family doctors, physicians, clinicians, and self-referrals in Kingston, Ontario, Canada. Once informed consent is provided, participants will be evaluated by a psychiatrist on the research team through secure video appointment to make or confirm a diagnosis of Major Depressive Disorder (MDD) using the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).

The inclusion criteria for the study include the following: at least 18 years of age at the start of the study, diagnosed with major depressive disorder according to DSM-5 by an attending psychiatrist on the research team, competence to consent to participate, ability to speak and read English, and consistent and reliable access to the internet. Exclusion criteria include active psychosis, acute mania, severe alcohol or substance use disorder, and/or active suicidal or homicidal ideation. If a participant is receiving another form of psychotherapy, they will also be excluded from the study, to avoid any confounding effect on the efficacy of this e-CBT program. If eligible for the study, participants will choose between the e-CBT program (n = 55) or the in-person CBT offered individually through this program at Hotel Dieu Hospital (n = 55).

During the informed consent process, it is explained to all participants that this program is not a crisis resource and that they will not have access to their therapist at all times. In the case of an emergency, participants are directed to the proper resources (e.g., emergency department, crisis lines, etc.) and this event will be reported to the principal investigator of the study.

Online Module Content Both e-CBT modules and in-person CBT sessions are designed to instill constructive and balanced coping strategies in participants. During the program, we focus on essential thinking and behavioural skills to help the patients become more engaged in day-to-day activities. The focus of the sessions is placed on the connection between thoughts, behaviours, emotions, physical reactions, and the environment. We work on evaluating negative beliefs and thought processes and their relationship with depression. Our goal is to adjust the negative thinking so that participants can think about and adapt to the things that are happening to them. This allows them to adjust the way they behave and think about their problems in a way that is not as negative and replaces those thoughts and behaviours with potentially more realistic and productive ones.

e-CBT Procedures The e-CBT care plan consists of 12 weekly sessions of approximately 30 slides and interactive content, delivered through OPTT. The e-CBT module content mirrors in-person standard CBT content, including different weekly topics, general information, skill overviews, and homework. Participants are instructed to go through the content and complete homework at the end of the session which helps them practice skills they learned through that session. Homework is submitted through OPTT and reviewed by the therapist assigned to the participant, who will provide personalized feedback within three days of submission. Therapists have access to pre-designed session-specific feedback templates to use as a basic structure to write their feedback. By doing so, the time needed to respond to each patient is reduced and therefore the number of patients each therapist can handle increases. At the same time, by using a structured format in responding to patients, a more standardized quality of care can be assured. The general structure of the feedback template is as follows: -validating the participant's time and effort, -reviewing the event they have used in their homework, -summarizing the previous module's content, and -discussing the participant's homework submission and how they could improve it. In addition to these points, the feedback will have an emphasis on specific content from the participant's submission, reassuring them that their therapist is reading and understanding their challenges. All feedback submissions are finished with a personalized signature from the therapist, helping to develop a rapport between the therapist and the participant. On average, developing this feedback takes a therapist 15-20 minutes per patient. In addition to the weekly feedback, participants have the option to message their therapist through the platform throughout the week regarding any questions or concerns they may have. All technical issues are handled directly through OPTT's technical support team.

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
Single (Participant)

盲法说明

Participants will not be told if they are in a stepped care approach or not. They will all be participating in the same e-CBT modules.

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

入选标准

  • 18-65 years at the start of the study
  • Diagnosis of major depressive disorder according to DSM-5 criteria
  • Competence to consent and participate
  • Ability to speak and read English
  • Consistent and reliable access to the internet

排除标准

  • Active psychosis
  • Acute mania
  • Severe alcohol or substance use disorder
  • Active suicidal or homicidal ideation
  • Currently receiving another form of psychotherapy

结局指标

主要结局

Change in quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire)

时间窗: Week 1, 6, 12

Clinical standardized symptom questionnaire. Scale of 1-5, 1 being the worst.

Change in symptoms (Quick Inventory of Depressive Symptoms)

时间窗: Week 1

Clinical standardized symptom questionnaire. Scale of 0-3, 3 being the worst.

Change in symptoms (Participant Health Questionnaire - 9 Item)

时间窗: Week 3, 6, 9, 12

Clinical standardized symptom questionnaire. Scale of 0-3, 3 being the worst.

次要结局

未报告次要终点

研究者

发起方
Dr. Nazanin Alavi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Nazanin Alavi

Principal Investigator, Assistant Professor

Queen's University

研究点 (2)

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