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临床试验/NCT03684434
NCT03684434已完成不适用

Development and Evaluation of a Brief Online Motivational Interviewing Intervention for Enhancing Engagement in Internet-delivered Cognitive Behaviour Therapy

University of Regina2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2018年9月27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
480
试验地点
2
主要终点
Change in motivation levels

研究概览

简要总结

Anxiety and depression are prevalent and disabling conditions. Although cognitive behaviour therapy (CBT) has been shown to significantly reduce symptoms of anxiety and depression, access to the service is limited. Internet-delivered cognitive behaviour therapy (ICBT) represents a novel approach to overcoming access barriers and involves delivering therapeutic content to manage symptoms via structured online lessons. The Online Therapy Unit has been studying the efficacy of ICBT for anxiety and depression and found that ~75% of clients complete treatment and demonstrate large improvement in symptoms. However, recent research suggests that younger clients and clients with higher baseline distress are more likely to dropout of ICBT. While it remains unclear why these clients are more susceptible to attrition, it is plausible that they are experiencing a greater degree ambivalence to change and, thus, terminate treatment as a result. Motivational interviewing (MI) aims to help facilitate clients' intrinsic motivation to change by resolving ambivalence. MI has been integrated into CBT for anxiety to overcome similar concerns of poor treatment retention. Evidence suggests that the integration of MI and CBT further enhances response and completion rates. In the context of online therapy, however, the efficacy of MI remains unclear. In the current trial, the investigators aimed to assess a recently developed online MI pre-treatment (i.e., the Planning for Change lesson). A total of 480 clients (original aim for sample size was 300) applying to transdiagnostic ICBT in routine care were randomly assigned to receive the MI pre-treatment or no pre-treatment (i.e., a waiting period) prior to participating in ICBT (i.e., the Wellbeing Course). The investigators sought to examine: how ICBT with MI compared to standardized ICBT in terms of symptom change, rates of reliable improvement, intervention usage (e.g., number of lessons completed), frequency of motivational language in the first two emails to therapist, and motivation levels. It was hypothesized that there would be a small but significant effect of MI on these variables. Additionally, the investigators aimed to explore if age and severity of baseline distress moderate the effect between MI and ICBT outcomes. Younger clients and clients with higher baseline distress are more likely to drop out of ICBT and, thus, it was further hypothesized that online MI will have a greater impact on these groups.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • is 18 years of age or older
  • is a resident of Saskatchewan, Canada
  • is experiencing at least mild to moderate symptoms of anxiety and/or depression
  • has not been hospitalized within the last year for mental health and/or suicide risk concerns
  • is not seeking regular face-to-face therapy for anxiety and/or depression
  • has access to a secure computer and the Internet
  • is comfortable using technology
  • is available to work through treatment each week
  • is willing to provide a medical contact as emergency contact

排除标准

  • is younger than 18 years of age
  • is not a resident of Saskatchewan, Canada
  • is experiencing no symptoms of anxiety and/or depression
  • has been hospitalized within the last year for mental health and/or suicide risk concerns
  • has unmanaged problems with alcohol, drugs, psychosis, or mania
  • is seeking regular face-to-face therapy for anxiety and/or depression
  • does not have access to a secure computer and the Internet
  • is not comfortable using technology
  • is not available to work through treatment each week
  • is not willing to provide a medical contact as an emergency contact

结局指标

主要结局

Change in motivation levels

时间窗: Baseline and week 1

Change Questionnaire - 3 Item: Items are summed into a total score. Total score ranges from 0 to 30, with higher scores representing greater self-reported levels of motivation.

Change in depression symptoms

时间窗: Baseline, weeks 2, 3, 5, 6, 8, 10, 13, 25, and 53

Patient Health Questionnaire - 9 Item: Items are summed into a total score. Total score ranges from 0 to 27, with higher scores representing more severe self-reported levels of depression.

Client engagement in online therapy (i.e., the Wellbeing Course)

时间窗: week 10

Measured by: Number of lessons completed, number of lesson logins, number of days of access, number of emails sent to therapist, number of phone calls with therapist, number of emails from therapist to client

Client feedback questions

时间窗: week 1 (following completion of the Planning for Change lesson)

Administered to only those participants assigned to the Online MI plus ICBT group: A series of rating and open-ended questions developed by the investigators designed to ascertain clients' perceptions of the Planning for Change lesson. Questions are designed to provide both quantitative and qualitative information, and do not include total scores.

Change in anxiety symptoms

时间窗: Baseline, weeks 2, 3, 5, 6, 8, 10, 13, 25, and 53

Generalize Anxiety Disorder - 7 Item: Items are summed into a total score. Total score ranges from 0 to 21, with higher scores representing more severe self-reported levels of anxiety.

Change in motivation to engage in treatment

时间窗: Monday of week 1 and Sunday of week 1

Two questions developed by Titov et al. (2010) to measure motivation to engage in ICBT: Both questions are rated on a 1 to 9 scale, with higher scores representing greater self-reported motivation levels. Questions will be independently assessed and, thus, there will be no total score.

次要结局

  • Change in social anxiety symptoms(Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because SIAS was mistakenly not administered at baseline)
  • NOTE ABOUT SECONDARY MEASURES(weeks 1 to 53)
  • Change in treatment credibility(Baseline and week 10)
  • Therapeutic alliance(week 10)
  • Change in social phobia symptoms(Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because SPS was mistakenly not administered at baseline)
  • Change in quality of life symptoms(Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because EQ-5D-5L was mistakenly not administered at baseline)
  • Psychological Distress(Baseline, weeks 2, 10, 13, 25, and 53 **K10 outcomes were only collected for half the sample during baseline due to the measure accidentally not being included at the start of recruitment. As such, distress was measured using the PHQ-9 and GAD-7 instead.)
  • Changes in treatment costs(Baseline, week 13, 25, and 53 **Only used to assess for group differences at baseline**)
  • Change in panic symptoms(Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because PDSS was mistakenly not administered at baseline)
  • Change in disability(Baseline, weeks 2, 10, 13, 25, and 53)
  • Change in post-traumatic symptoms(Baseline, weeks 13, 25, and 53)
  • Satisfaction with Wellbeing Program assessed by the Internet-CBT Treatment Satisfaction Measure(week 10)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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