Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy for Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Generalized Anxiety Disorder 7-item (GAD-7)
研究概览
简要总结
Depression and anxiety are common and prevalent conditions that are frequently under treated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered Cognitive Behaviour Therapy (ICBT) has emerged. ICBT involves delivering therapeutic content to manage depression and or anxiety via structured online lessons. This is often combined with brief therapist guidance, for example once per week for 8 weeks via secure messaging or phone calls. Although outcomes of ICBT are very impressive, there is room for improvement in terms of completion rates and outcomes. Feedback from patients suggest that some patients would prefer longer term support or follow-up care.
In this two-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) and being offered a booster session at 16 weeks after treatment enrollment (yes vs no). Follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. Primary outcomes are reduced anxiety and depression. Secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use.
详细描述
Past research of ICBT offered in routine care has found that patients and therapists often recommend "personalizing" the delivery of ICBT, for example, by increasing the length of time therapist support is available or offering booster sessions after treatment has ended. To date, in terms of ICBT, there has been limited research on the impact of extending support after treatment materials have been delivered or offering a booster session.
In this trial, the investigators will examine if the efficacy of ICBT is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) or by being offered a booster session at 16 weeks after treatment enrollment (yes vs no). Follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. Primary outcomes are reduced anxiety and depression. Secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use. The impact of these factors on intervention usage (e.g., completion rates, log-ins, emails sent) and treatment satisfaction will also be examined.
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
- 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
- 否
入选标准
- •18 years or older
- •Endorse symptoms of anxiety or depression
- •Resident of Saskatchewan
- •Access to a computer and the Internet
排除标准
- •Have a severe psychiatric illness (e.g. psychosis)
- •Assessed as being at high risk of suicide
- •Report severe problems with alcohol or drugs
- •Report severe cognitive impairment
研究组 & 干预措施
Extended Contact
Clients in the Extended Contact condition will be asked at the 6 week mark if they like they can extend their treatment and receive up to 12 weeks of support. They will be informed that this may be helpful if they feel they have fallen behind in reviewing of the materials, if they would like to receive support while they work on supplementary resources or if they would like extended support while they work on core lessons. If they would like additional support, participants will answer questions presented on the website about their desire for this additional support what they would like to focus on during this time. Those clients who indicate that they would like this extended support will automatically have their therapists check-in with them for up to 12 weeks. Those that do not request the additional support will end treatment as planned at the end of 8 weeks.
干预措施: Internet-delivered cognitive behaviour therapy (Behavioral)
8 Week ICBT no Booster
In the standard condition, clients will receive 8 weeks of therapist support. They will not be given the option to extend their treatment and support to 12 weeks. The booster course will not be offered in this condition.
干预措施: Internet-delivered cognitive behaviour therapy (Behavioral)
Extended Contact with Booster
Clients in the Extended Contact condition will receive an email at the 6 week mark letting them know that they if they like they can extend their treatment and receive up to 12 weeks of support. At week 6, clients will answer questions on the website about whether they would like this additional support or not and what they would like to focus on during this time. Clients who indicate they would like this extended support will automatically have their therapists check-in with them for up to 12 weeks.
They will also be told that at 16 weeks they will have access to a booster session (online materials that go over core skills such as thought challenging, deep breathing, behavioural activation, and graded exposure). At 16 weeks, they will be sent an email reminder to log in for the booster course. The therapist will send a supportive email to the client offering to assist with any challenges the client reports in the check-in questionnaire by email or phone call over the next 2 weeks.
干预措施: Internet-delivered cognitive behaviour therapy (Behavioral)
8 week ICBT with Booster
Clients in the booster condition will be told that at 16 weeks they will have access to a booster session (online materials that go over core skills such as thought challenging, deep breathing, behavioural activation, and graded exposure). At 16 weeks, they will be sent an email reminder to log in for the booster course. The therapist will send a supportive email to the client offering to assist with any challenges the client reports in the check-in questionnaire by email or phone call over the next 2 weeks.
干预措施: Internet-delivered cognitive behaviour therapy (Behavioral)
结局指标
主要结局
Generalized Anxiety Disorder 7-item (GAD-7)
时间窗: Baseline (Screening), weeks 1-12 and 16 and 26 week from enrollment
Change in anxiety symptoms. 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.
Patient Health Questionnaire 9-item (PHQ-9)
时间窗: Baseline (Screening), weeks 1-12, 16 and 26 week from enrollment
Change in depression symptoms. 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.
次要结局
- Sheehan Disability Scale (SDS)(Baseline (Screening), week 8, 16 and 26 week from enrollment)
- Life Events Checklist for DSM-5 (LEC-5)(Baseline (Screening))
- PTSD Checklist for DSM-5 (PCL-5)(Baseline (Screening), week 8, 16 and 26 week from enrollment)
- Social Interaction Anxiety Scale (6 items)(Baseline (Screening), week 8, 16 and 26 week from enrollment)
- Quality of Life (EQ-ED-5L)(Baseline (Screening), week 8, 16 and 26 week from enrollment)
- Panic Disorder Severity Scale Self-report(Baseline (Screening), week 8, 16 and 26 week from enrollment)
- Social Phobia Scale-Short form (6 items)(Baseline (Screening), week 8, 16 and 26 week from enrollment)
- Mental Health Service Use, Medication, and Employment(Baseline (Screening) and Week 26 week from enrollment)
- Treatment Satisfaction(Week 8, 16 and 26 week from enrollment)
- Insomnia Severity Index (ISI)(Baseline)