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临床试验/NCT03984786
NCT03984786已完成不适用

Internet-delivered Cognitive Behaviour Therapy for Alcohol Misuse: A Factorial Trial Examining the Effects of Assessment Interview and Guidance

University of Regina2 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2019年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
312
试验地点
2
主要终点
Drinks preceding week as measured by Timeline Followback (TLFB)

研究概览

简要总结

Internet-delivered cognitive behaviour therapy (ICBT) shows considerable promise as a convenient treatment for alcohol misuse. ICBT may differ in whether the user works alone (self-guided) or along with an individual who guides treatment (e.g., therapist/health educator). Guided ICBT involves completing online lessons over several weeks coupled with support from a guide in the form of emails, online messages and/or brief telephone calls. Self-guided ICBT allows users to complete lessons by themselves without any contact with a guide. In some studies, guided-ICBT has shown greater reductions in alcohol consumption than self-guided ICBT. Further, some research on alcohol treatment shows that assessment in itself may have an effect on alcohol consumption, a phenomenon referred to in the literature as "assessment reactivity". It is believed that verbalizing one's drinking problems to another person might lead to greater realization of the problem extent and severity, which in turn can lead to initiation of the change process. Experimental studies have shown that extended and frequent assessments lead to greater alcohol reductions compared to brief and infrequent assessments.

Although ICBT for alcohol misuse is an attractive treatment option, it is not often available to clients as part of routine care. The Online Therapy Unit at the University of Regina is currently exploring extending services to include guided ICBT for alcohol misuse. The Unit has been providing treatment in ICBT for depression and anxiety as well as various health conditions since 2010 and has offered treatment to ~4200 individuals. The purpose of this study is to evaluate ICBT for individuals with alcohol misuse within the routine online clinic, and to investigate ways to optimize future modes of delivery. Of specific interest in this study, is how outcomes vary depending on whether or not weekly guidance from a health educator is available and whether or not an initial extended assessment telephone call is included or not compared to a briefer screening telephone call. Of interest will also be if the extended assessment leads to greater alcohol reductions and higher motivation pre-treatment.

详细描述

Alcohol misuse refers to alcohol consumption that causes harm to the drinker, others, and/or greater society. Internet-delivered cognitive behaviour therapy (ICBT) shows considerable promise as a convenient treatment for alcohol misuse. The overall goal of ICBT for alcohol misuse is typically behavioural change measured in terms of reduction of drinks consumed, as opposed to abstinence. The design of these interventions may differ in whether the user works alone (self-guided) or along with an individual who guides treatment (e.g., therapist/health educator). Guided ICBT involves completing online lessons over several weeks coupled with support from a guide in the form of emails, online messages or brief telephone calls. Self-guided ICBT allows users to complete lessons by themselves without any contact with a guide. In some studies, guided-ICBT has shown greater reductions in alcohol consumption than self-guided ICBT. Further, some research on alcohol treatment shows that assessment in itself may have an effect on alcohol consumption, a phenomenon referred to in the literature as "assessment reactivity". It is believed that verbalizing one's drinking problems to another person might lead to greater realization of the problem extent and severity, which in turn can lead to initiation of the change process. Experimental studies have shown that extended and frequent assessments lead to greater alcohol reductions compared to brief and infrequent assessments.

Although ICBT for alcohol misuse is an attractive treatment option, it is not often available to clients as part of routine care. The Online Therapy Unit at the University of Regina is currently exploring extending services to include guided ICBT for alcohol misuse. The Unit has been providing treatment in ICBT for depression and anxiety as well as various health conditions since 2010 and has offered treatment to ~4200 individuals. The purpose of this study is to evaluate ICBT for individuals with alcohol misuse, and to investigate ways to optimize future modes of delivery. Of specific interest in this study, is how outcomes vary depending on whether or not weekly guidance from a health educator is available and whether or not an initial extended assessment telephone call is included or not compared to a briefer screening telephone call.

Clients will be recruited online, through use of Google Ads and/or Facebook ads. Clients may also learn of the course from providers/organizations who will be informed of the study through posters, emails, and phone calls. All interested clients will be directed to the study website (www.onlinetherapyuser.ca) to complete an online screening questionnaire. As part of this questionnaire, they will be presented with a consent form explaining the screening protocol. After consent is given, clients will be assessed for eligibility using an online screening questionnaire. The online screening questionnaire captures demographic information (e.g., sex, ethnicity, location), contact details (e.g., telephone number, email address), information about alcohol, depression and other mental health issues, and background information needed to deliver therapy (e.g., medical history, mental health history, symptoms).

Once clients have been assessed for eligibility through the online screening questionnaire, they will be asked to book a telephone interview with unit staff. During the telephone screening interview, clients will be asked a series of follow-up questions to the online screening questionnaire to ensure eligibility as per exclusion criteria. Clients who meet any of the exclusion criteria during the online telephone screening interview will be referred to more appropriate mental health services. Clients who are excluded in the screening questionnaire by reporting a low score on either TLFB or AUDIT, or a high score on PHQ-9, will be informed about relevant treatment options and will be offered unguided ICBT with no assessment interview. Clients who are included in the study, will be randomized by the interviewer, while the client is still on the phone, to one of four conditions. The two factors in the trial are:

Factor 1: Guidance (yes or no)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Participants will be blinded to randomization, i.e. will not know which groups they can be randomized to. Health educators providing guidance to participants will be blinded to whether the client has been randomized to "Assessment Interview" factor (condition 1) or "No assessment interview (condition 3). All outcomes are collected online, so there is no need to blind any outcomes assessor.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Timeline Followback (TLFB; preceding week alcohol consumption) > 13 drinks
  • Alcohol Use Disorders Identification Test (AUDIT) > 7

排除标准

  • Severe depression (measured by scoring > 23 on PHQ-9)
  • Suicidal ideation (measured by scoring > 2 to question 9 of PHQ-9)
  • Severe mental health or medical conditions
  • Severe drug use problems (measured by scoring > 24 on Drug Use Disorders Identification Test [DUDIT] or clinical assessment)
  • Low motivation to do, or concerns regarding, online treatment
  • Ongoing or impending significant mental health treatment
  • Not residing in Canada for the duration of treatment
  • Lack of or inconsistent access to a computer and internet at home or private place for the duration of treatment

结局指标

主要结局

Drinks preceding week as measured by Timeline Followback (TLFB)

时间窗: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment

Change in preceding week alcohol consumption in terms of the total number of standard drinks consumed on each day during the previous 7 days.

Heavy drinking days preceding week as measured by Timeline Followback (TLFB).

时间窗: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment

Change in preceding week alcohol consumption in terms of the total number of heavy drinking days during the previous 7 days.

次要结局

  • Alcohol Use Disorders Identification Test (AUDIT).(Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment)
  • Brief Situational Confidence Questionnaire (BSCQ).(Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment)
  • Generalized Anxiety Disorder 7-item (GAD-7)(Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment)
  • Treatment Credibility and Expectancy Scale(4 weeks (mid-treatment))
  • Readiness to Change Questionnaire Treatment Version (RCQ-TV)(Screening (Pre-treatment))
  • Penn Alcohol Craving Scale(Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment)
  • Evaluation and Negative Effects Questionnaire(8 weeks (post-treatment))
  • Patient Health Questionnaire (PHQ-9)(Screening (Pre-treatment), 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment)
  • Sheehan Disability Scale(Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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