A 12-week Randomized Waitlist-Controlled Trial of Mindbeacon Therapist Assisted Internet Delivered CBT for Depression
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- IAPT Definition of "Recovery" (Change between baseline and 3 month follow-up)
研究概览
简要总结
Utilization of therapist Assisted internet-delivered cognitive behavioural therapy (TAiCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT) and the Ontario Structured Psychotherapy Program (SPP), is a potential solution for addressing the treatment gap in mental health. Investigators propose to investigate the effectiveness of Beacon TAiCBT for Depression to demonstrate the potential value of TAiCBT in a stepped care model. Investigators propose to conduct a 12-week pragmatic randomized controlled trial with a 1:1 (iCBT intervention: waiting-list) allocation, for participants referred to the Anxiety and Mood, Prompt Anxiety and Mood, and Trauma Programs at Ontario Shores Centre for Mental Health Sciences and on a waiting-list to receive clinical service.
The primary outcome measures will be the Improving Access to Psychological Therapies (IAPT) definitions of Recovery, Reliable Improvement, and Reliable Recovery which are derived using the PHQ-9 and GAD-7 . The PHQ-9 (Depression), GAD-7 (anxiety) and WSAS (functional impairment) will be used as secondary outcome measures for all participants.
Over the course of the study, 200 participants will be randomized (iCBT, 100; waiting-list, 100). Statistical analyses will include intention-to-treat analyses to test the interaction effects for the primary outcome measures at discharge/12-weeks and 3, and 12 months post-treatment.
It is predicted that participants in the treatment condition will show significantly reduced symptoms of depression related to the waitlist control. It is predicted that this will be maintained through follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Minimum age of 18 years
- •Meets Diagnostic Assessment Research Tool (DART) screening criteria for a primary diagnosis of depression and reports being at least moderately depressed according to the PHQ-9
- •Sufficient language proficiency to understand the treatment materials written at grade 10 reading level
- •Understands what TAiCBT and is open and interested to participating in a study using this treatment modality
- •Is able to reliably access the internet, and has basic computer skills to navigate the internet using a web browser
- •Willing to participate in a waitlist-control study and be followed for 12 months
排除标准
- •Suicidal intent or clinically significant suicidal ideation
- •Clinically significant self-harm
- •Active psychotic illness
- •Currently participating in psychological treatment for depression and/or receiving evidence-based treatment (other than medication) for depression
- •Clinically significant alcohol and/or other substance use including prescription and over the counter medication that would likely interfere with treatment
- •Current or previous diagnosis of Borderline Personality Disorder
- •Does not meet DART criteria for a primary diagnosis of depression
- •Change in psychotropic medication within 3 weeks of treatment baseline
结局指标
主要结局
IAPT Definition of "Recovery" (Change between baseline and 3 month follow-up)
时间窗: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
The IAPT criteria for 'Recovery' are met when patients move from 'caseness' at the beginning of the intervention (e.g., scoring \>9 on the PHQ-9 or \>7 on the GAD-7) to 'non-caseness' at the end of treatment (thus scoring below the cut-off)
IAPT Definition of "Recovery" (Change between baseline and 12 month follow-up)
时间窗: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
The IAPT criteria for 'Recovery' are met when patients move from 'caseness' at the beginning of the intervention (e.g., scoring \>9 on the PHQ-9 or \>7 on the GAD-7) to 'non-caseness' at the end of treatment (thus scoring below the cut-off)
IAPT definition of "Reliable recovery" (Change between Baseline and Post-treatment)
时间窗: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and post-treatment (week 12 of treatment)
Reliable recovery is defined as when the patient meets the criteria for both recovery and reliable improvement as defined above. Thus, a patient who moves from caseness to non-caseness, and also shows a 'reliable' (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) decrease in their symptom scores, is said to have a reliable recovery
IAPT Definition of "Recovery" (Change between Baseline and Post-treatment)
时间窗: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and "post-treatment" which is week 12 of treatment)
The IAPT criteria for 'Recovery' are met when patients move from 'caseness' at the beginning of the intervention (e.g., scoring \>9 on the PHQ-9 or \>7 on the GAD-7) to 'non-caseness' at the end of treatment (thus scoring below the cut-off)
IAPT Definition of "Reliable improvement" (Change between baseline, and 3 month follow-up)
时间窗: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
Reliable improvement is defined as when the patient has a 'reliable' decrease in their PHQ-9 / GAD-7 (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) score upon completion of their course of treatment
IAPT Definition of "Reliable improvement" (Change between baseline and 12 month follow-up)
时间窗: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Reliable improvement is defined as when the patient has a 'reliable' decrease in their PHQ-9 / GAD-7 (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) score upon completion of their course of treatment
IAPT definition of "Reliable recovery" (Change between baseline and 12 month follow-up)
时间窗: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Reliable recovery is defined as when the patient meets the criteria for both recovery and reliable improvement as defined above. Thus, a patient who moves from caseness to non-caseness, and also shows a 'reliable' (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) decrease in their symptom scores, is said to have a reliable recovery
IAPT Definition of "Reliable improvement" (Change between Baseline and Post-treatment)
时间窗: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and "post-treatment" which is week 12 of treatment)
Reliable improvement is defined as when the patient has a 'reliable' decrease in their PHQ-9 / GAD-7 (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) score upon completion of their course of treatment
IAPT definition of "Reliable recovery" (Change between baseline and 3 month follow-up)
时间窗: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
Reliable recovery is defined as when the patient meets the criteria for both recovery and reliable improvement as defined above. Thus, a patient who moves from caseness to non-caseness, and also shows a 'reliable' (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) decrease in their symptom scores, is said to have a reliable recovery
次要结局
- Patient Health Questionnaire 9 (PHQ-9) - (Change between baseline and post-treatment)(Administered at baseline (initial screening) and post-treatment (week 12 of treatment))
- Patient Health Questionnaire 9 (PHQ-9) - (Change between baseline and 3 month follow-up)(Administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment))
- Patient Health Questionnaire 9 (PHQ-9) - (Change between baseline and 12 month follow-up)(Administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment))
- Generalized Anxiety Disorder 7 (GAD-7) - (Change between baseline and 3 month follow-up)(Administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment))
- Generalized Anxiety Disorder 7 (GAD-7) - (Change between baseline and 12 month follow-up)(Administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment))
- Work and Social Adjustment Scale (WSAS) - (Change between Baseline and Post-treatment)(Administered at baseline (initial screening) and post-treatment (week 12 of treatment))
- Work and Social Adjustment Scale (WSAS) - (Change between baseline and 3 month follow-up)(Administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment))
- Work and Social Adjustment Scale (WSAS) - (Change between baseline and 12 month follow-up)(Administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment))
- Generalized Anxiety Disorder 7 (GAD-7) - (Change between baseline and post-treatment)(Administered at baseline (initial screening) and post-treatment (week 12 of treatment))