Enhancing Therapist-Guided Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety With Additional Content
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 494
- 试验地点
- 3
- 主要终点
- UCLA Loneliness Scale 3-item (UCLA-3)
研究概览
简要总结
This study evaluates the effectiveness of additional content on loneliness offered alongside the Wellbeing Course - an internet-delivered cognitive behavioral therapy (ICBT) intervention for symptoms of depression and anxiety- in improving treatment outcomes for individuals with elevated scores on loneliness seeking treatment for depression and anxiety at a routine care online therapy clinic (the Online Therapy Unit). In this partially randomized control trial, the investigators aim to contribute to the literature by examining whether providing additional content on loneliness alongside the Wellbeing Course enhances engagement, satisfaction, and treatment outcomes among clients experiencing frequent loneliness compared to those completing only the Wellbeing Course. Over 8 weeks, participants will review course materials (with the addition of the loneliness content for those assigned to the loneliness content condition) online and complete questionnaires assessing changes in various outcomes over time.
详细描述
Depression and anxiety are prevalent mental health conditions that are frequently under-treated. To improve timely and effective psychological treatment, Internet-delivered Cognitive Behaviour Therapy (ICBT) has been developed as a scalable treatment option. ICBT delivers evidence-based therapeutic content via structured online lessons over the course of several months, teaching the same skills as face-to-face cognitive behaviour therapy. In routine practice, ICBT is typically accompanied by brief therapist guidance offered via secure messaging and/or phone calls.
In Saskatchewan, the Online Therapy Unit (OTU) offers ICBT as part of routine care for a range of mental health concerns. The flagship program is the Wellbeing Course, a transdiagnostic ICBT program targeting symptoms of depression and anxiety. Research shows this course is associated with substantial significant improvements in depression and anxiety that are maintained over time. Nevertheless, not all clients engage with or respond equally to treatment. Consequently, there is a need to explore enhancements to ICBT that may improve outcomes for clients receiving care in naturalistic settings.
Emerging research shows a strong association between depression, anxiety and loneliness. Consistent with these findings, OTU recently found that approximately 76% of past OTU clients who enrolled in the Wellbeing Course reported experiencing frequent loneliness. Notably, ICBT was found to reduce loneliness in addition to alleviating symptoms of depression and anxiety.
Previous studies have found that many OTU clients engage with supplementary resources provided alongside the Wellbeing Course to tailor the program to their individual needs. However, no research to date has examined whether individuals experiencing frequent loneliness derive added benefit from receiving targeted content addressing loneliness in the context of ICBT for depression and anxiety.
The present trial aims to address this gap by evaluating whether offering additional loneliness content alongside the Wellbeing Course leads to greater engagement, satisfaction and improved treatment outcomes among clients with frequent loneliness compared to those who complete the Wellbeing Course alone.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Saskatchewan resident,
- •Aged 18 years or older,
- •Self-reported difficulty with depression and/or anxiety,
- •Access to a computer (or other appropriate device) and the Internet,
- •Willingness to learn information and skills to self-manage mental health difficulties, and
- •Total score on UCLA-3 is greater than 5 at screening
排除标准
- •Current severe medical or psychiatric condition that requires immediate treatment (e.g. current mania or psychosis, actively suicidal or unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment);
- •Unable to read and understand English (All content is provided in English and staff is English speaking)
结局指标
主要结局
UCLA Loneliness Scale 3-item (UCLA-3)
时间窗: Baseline (Screening), weeks 4, 8 and 20 from enrollment
Measures loneliness. 3 items are measured on a 3-point Likert scale ranging from 1-3. Scores are summed into a total score ranging from 3 to 9, with higher scores indicating higher levels of perceived loneliness.
Patient Health Questionnaire - 9 (PHQ-9)
时间窗: Baseline (Screening), weeks 1-8 and 20 from enrollment
Tracking the change in depression symptoms. 9 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed with total scores ranging from 0 to 27. Higher scores are associated with higher depression severity.
Generalized Anxiety Disorder - 7 (GAD-7)
时间窗: Baseline (Screening), weeks 1-8 and 20 from enrollment
Tracking the change in anxiety symptoms. 7 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.
次要结局
- Treatment Credibility and Expectancy Questionnaire (CEQ)(Baseline (Screening) and week 4)
- Things You Do - 15 (TYD-15)(Baseline (Screening), weeks 4, 8, and 20 from enrollment)
- Lubben Social Network Scale - 6 items (LSNS-6)(Baseline (Screening), weeks 8 and 20 from enrollment)
- Brief Social Support Scale (BS-6)(Baseline (Screening) weeks 8 and 20 from enrollment)
- Mini Social Phobia Inventory (Mini SPIN)(Baseline (Screening), weeks 8 and 20 from enrollment)
- Work and Social Adjustment Scale (WSAS)(Baseline (Screening), weeks 8 and 20 from enrollment)
- Treatment Satisfaction Questionnaire(Week 8)
- Loneliness Content Satisfaction(Week 8)
- Things You Do - 15 (TYD-15)(Baseline (Screening), weeks 4, 8, and 20 from enrollment)
- Lubben Social Network Scale - 6 items (LSNS-6)(Baseline (Screening), weeks 8 and 20 from enrollment)
- Brief Social Support Scale (BS-6)(Baseline (Screening) weeks 8 and 20 from enrollment)
- Mini Social Phobia Inventory (Mini SPIN)(Baseline (Screening), weeks 8 and 20 from enrollment)
- Work and Social Adjustment Scale (WSAS)(Baseline (Screening), weeks 8 and 20 from enrollment)
- Treatment Credibility and Expectancy Questionnaire (CEQ)(Baseline (Screening) and week 4)
- Treatment Satisfaction Questionnaire(Week 8)
- Loneliness Content Satisfaction(Week 8)