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临床试验/NCT04754438
NCT04754438已完成不适用

Comparing the Efficacy of an Electronically Delivered Cognitive Behavioural Therapy Program to a Mental Health Coaching Program for Generalized Anxiety Disorder

Dr. Nazanin Alavi2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2021年4月1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
96
试验地点
2
主要终点
Change in symptoms (Generalized Anxiety Disorder - 7 Item)

研究概览

简要总结

This study will compare the efficacy of an electronically-delivered cognitive behavioural therapy (e-CBT) program versus a mental health coaching program to treat generalized anxiety disorder (GAD). This randomized trial intervention will provide the e-CBT and mental health coaching for GAD through a secure, online platform. Participants will be between the ages of 18 and 65 years with a confirmed diagnosis of GAD according to the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5). Participants will either be offered an e-CBT program tailored to GAD or an online mental health coaching program over 12 weeks to address their anxiety symptoms. e-CBT participants will complete pre-designed modules and homework assignments while receiving personalized feedback and asynchronous interaction with a therapist through the platform. Participants in the coaching group will be contacted weekly through the online platform's chat feature. Therapists will ask the participants a series of pre-designed questions that revolve around a different theme each week to prompt conversation. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be compared to the coaching group. These questionnaires will be completed at baseline, week 6, week 12, and at a 6-month follow-up. Questionnaires include the State-Trait Anxiety Inventory (STAI), the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF), the Generalized Anxiety Disorder - 7 Item (GAD-7), and the Depression Anxiety Stress Scale - 42 Item (DASS-42).

详细描述

This randomized trial intervention will provide e-CBT for GAD through the Online Psychotherapy Tool (OPTT), a secure, cloud-based, digital mental health platform. Participants (age: 18-65 years) will be randomly assigned to either an e-CBT program tailored to GAD or a mental health coaching program over 12 weeks to address their anxiety symptoms. In the e-CBT group, 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 GAD. 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. In the mental health coaching group, participants will have weekly interaction with a therapist through the chat function in OPTT where the coach will check in on the participant and touch on a specific subject each week.

Participants (n = 110; 50 e-CBT participants, 50 coaching) aged 18-65 years will be recruited at Queen's University from outpatient psychiatry clinics at both Kingston Health Sciences Centre sites (Hotel Dieu Hospital and Kingston General Hospital). Additional recruitment will occur from 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 appointments to make or confirm a diagnosis of a generalized anxiety disorder (GAD) using the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).

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.

Both e-CBT modules and in-person CBT sessions are designed to instill constructive and balanced coping strategies in participants. During the program, the focus will be 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. The goal is to change how patients evaluate 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.

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. 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.

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

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

  • Between the ages of 18-65 years of age at the start of the study
  • Diagnosis of GAD according to DSM-5 by attending psychiatrist on research team
  • Competence to consent to 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
  • Receiving another form of psychotherapy

结局指标

主要结局

Change in symptoms (Generalized Anxiety Disorder - 7 Item)

时间窗: Week 0, week 6, week 12, 6-month follow-up

Clinically validated symptom questionnaire. Scale of 0-3, 3 being the worst.

Change in symptoms (Depression Anxiety Scale - 42 Item)

时间窗: Week 0, week 6, week 12, 6-month follow-up

Clinically validated symptom questionnaire. Scale of 0-3, 3 being the worst.

Change in symptoms (State-Trait Anxiety Inventory)

时间窗: Week 0, week 6, week 12, 6-month follow-up

Clinically validated symptom questionnaire. Scale of 0-4, 4 being the worst.

Change in symptoms (Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form)

时间窗: Week 0, week 6, week 12, 6-month follow-up

Clinically validated symptom questionnaire. Scale of 0-5, 5 being the best.

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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