Therapeutics Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy for Depression and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 631
- 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 often go untreated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered cognitive behavioural therapy (ICBT) has emerged. ICBT involves delivering therapeutic content via structured online lessons. This is often combined with therapist guidance, such as once per week contact via secure messaging or phone calls over several months. Over the past several years, the investigators have been studying the efficacy of ICBT for symptoms of depression and anxiety and found ~70% of patient's fully complete treatment and demonstrate large improvement in symptoms. Although outcomes of ICBT are very impressive, there is some room for improvement in terms of completion rates and outcomes.
In this three-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT in routine practice is moderated by amount of contact (once versus twice a week), inclusion of homework reflection questionnaire (yes vs no) and location of therapist (specialized unit vs community mental health clinic). Follow-up measures will be carried out at 3, 6 and 12 months after randomization. Primary outcomes are reduced anxiety and depression. Secondary outcomes include psychological distress, panic, social anxiety, trauma, health anxiety, quality of life, disability, intervention usage (e.g., completion rates, log-ins, emails sent), satisfaction, therapeutic alliance, and costs (e.g., health care utilization).
详细描述
Based on past research of ICBT in routine care, patients and therapists have expressed an interest in "personalizing" the delivery of ICBT, for example, by increasing the amount of therapist support available (from once a week to twice a week) to reflect the unique needs and preferences of the patients. Patients also express an interest in personalizing "therapy messages". One current barrier to offering more personalized messages, however, is that patients do not consistently provide information on their use of new treatment strategies, as well as strengths and challenges of using strategies. As a result, therapists find it difficult to personalize their messages. One method of overcoming this difficulty is to systematically ask patients to reflect on their use of treatment strategies (e.g., monitoring thoughts, challenging thoughts, controlled breathing, pleasant activities, and exposure) through questionnaires rather than relying on patients to provide this information in emails. Another factor that could moderate ICBT efficacy is therapist location. Some therapists who provide ICBT work in a specialized unit where there is primary focus on ICBT and daily attention to following ICBT guidelines. Other therapists deliver ICBT from community mental health clinics where the primary focus of the setting is on face-to-face care and there is lower familiarity with ICBT. It is possible that ICBT may be more effectively delivered in a setting where the primary focus is on ICBT.
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
- Single (Participant)
盲法说明
Participants are told about the nature of their treatment but not about the exact nature of all the conditions.
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
Community Mental Health Clinic
In this arm, clients will be assigned to therapists working in a community mental health clinic in Saskatchewan where the focus of the setting is primarily on face-to-face treatment and ICBT makes up a small component of the workload in the clinic.
干预措施: Internet-delivered cognitive behaviour therapy (Behavioral)
Once a week therapist contact
In once a week treatment, therapists will email their clients once a week on a pre-determined day.
干预措施: Internet-delivered cognitive behaviour therapy (Behavioral)
Reflection Questionnaire
In the reflection questionnaire, patients will be asked to complete the following questions five times during the treatment period (beginning lesson 2-5 and then at the point they complete post-questionnaires):
- How much of the lesson were you able to review?
- How much effort were you able to put into the lesson?
- How difficult was the lesson?
- Please share any difficulties you had with the lesson.
- How understandable was the lesson?
- How helpful did you find the lesson?
- Please describe an example of what you learned.
- To what extent have you continued to use strategies from previous lessons
- If applicable, please provide an example of what you are working on from previous lessons
- Please indicate which Additional Resources you reviewed this week.
- If applicable, please share any skills you are working on from the Additional Resources.
干预措施: Internet-delivered cognitive behaviour therapy (Behavioral)
Specialized Internet Therapy Clinic
In this arm, clients will be assigned to therapists working in a specialized internet therapy clinic where the therapists only deliver ICBT.
干预措施: Internet-delivered cognitive behaviour therapy (Behavioral)
Twice a week therapist contact
In twice a week treatment, therapists will email their clients twice a week on pre-determined days.
干预措施: Internet-delivered cognitive behaviour therapy (Behavioral)
No Reflection Questionnaire
In this arm, no reflection questions will be asked of clients receiving ICBT.
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, weeks 2, 4, 5, 7, 8, and 3-, 6-, and 12-month follow-up
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, weeks 2, 4, 5, 7, 8 and 3-, 6-, and 12-month follow-up
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
- PTSD Check List 5(Baseline, week 8 and 3-, 6-, and 12-month follow-up)
- Treatment Engagement(Week 8)
- Social Interaction Anxiety Scale (6 items) and Social Phobia Scale-Short form (6 items)(Time Frame: Baseline, Week 8, 3-, 6-, and 12-month follow-up)
- Sheehan Disability Scale 3-item(Baseline, week 8, and 3-, 6-, and 12-month follow-up)
- Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada(Baseline and 3-, 6-, and 12-month follow-up)
- Short Health Anxiety Inventory-14(Baseline, week 8 and 3-, 6-, and 12-month follow-up)
- Quality of life questionnaire (EQ-ED-5L)(Baseline, week 8, and 3-, 6-, and 12-month follow-up)
- Treatment Credibility Questionnaire(Baseline, week 8, and 3-month follow-up)
- Working Alliance Inventory Short-Form(Baseline, week 8, and 3-, 6-, and 12-month follow-up)
- Panic Disorder Severity Scale Self-report(Time Frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up)
- Kessler Psychological Distress(Baseline, week 8, and 3-, 6-, and 12-month follow-up)
- Treatment Satisfaction and Negative Effects Questionnaires(Week 8)