Examining The Acceptability and Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy for Symptoms of Postpartum Anxiety and Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in postpartum depression
研究概览
简要总结
In the proposed study, the investigators will examine the efficacy of transdiagnostic, Internet-delivered cognitive behaviour therapy (ICBT) in the treatment of postpartum anxiety and depression. Half of participants will receive the treatment immediately, and half of the participants will be assigned to a treatment-as-usual control condition. Participants assigned to the control condition will be offered the treatment after a 12-week waiting period, although data from this portion will not be included in the current study. All participants will complete questionnaires prior to the start of the treatment, following treatment (or corresponding 8-week waiting period), at 1-months follow-up (or corresponding 12-week waiting period), and at 6-months follow-up (in those assigned to the treatment condition). Further, those who receive the treatment will complete questionnaires on a weekly basis. The primary outcome measures include anxiety and depression. As part of the battery of questionnaires administered after the completion of the program, participants will be asked to rate the program content, the overall service, and their satisfaction with the program.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •have given birth and have a child under one year of age
- •score of 10 or above on EPDS or a score of 9 or above on the GAD-7
- •be a resident of Saskatchewan
- •have access to a secure computer and the Internet, and be comfortable using technology
- •be available to work through treatment each week
- •be willing to provide a medical contact as an emergency contact
排除标准
- •younger than 18 years
- •not female
- •have not given birth to a child less than one year of age
- •are experiencing minimal to no symptoms of anxiety and/or depression
- •are not a resident of Saskatchewan
- •have been hospitalized within the last year for mental health and/or suicide risk concerns;
- •have unmanaged problems with alcohol, drugs, psychosis or mania, or are at increased suicide risk (specific plans and intent reflected by the Suicide Behaviors Questionnaire-Revised)
- •started a new psychotropic medication within the past month
- •do not have access to a secure computer and the Internet or is not comfortable using technology
- •are not available to work through treatment each week
- •are not willing to provide a medical contact as an emergency contact
结局指标
主要结局
Change in postpartum depression
时间窗: Baseline, weeks 1-9, 13, and 37
Measured by the Edinburgh Postnatal Depression Scale (EPDS). 10 items are summed into a total score ranging from 0 to 30, with higher scores indicating more severe depression.
Change in anxiety
时间窗: Baseline, weeks 1-9, 13, and 37
Measured by the Generalized Anxiety Disorder Scale 7-Item (GAD-7). 7 items 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
- Service utilization(Weeks 9, 13, and 37)
- Change in depression(Baseline, weeks 1-9, 13, and 37)
- Change in depression, anxiety, stress(Baseline, 8 weeks, 1 month, and 6 months)
- Mother-infant bonding(Baseline, weeks 9, 13, and 37)
- Relationship satisfaction(Baseline, weeks 9, 13, and 37)
- Treatment credibility(Baseline and week 9)
- Therapeutic alliance(9 weeks following baseline)
- Treatment satisfaction(9 weeks following baseline)
- Adverse effects(9 weeks following baseline)