A Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients in an Outpatient Hospital Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 主要终点
- Change in Patient Health Questionnaire-9 (PHQ9)
研究概览
简要总结
This study aims to explore the efficacy and acceptability of a clinician-guided internet-based Cognitive Behavioural Therapy (iCBT) programme for patients with depression, in Singapore.
详细描述
All outpatients, from the Institute of Mental Health, Singapore, who are diagnosed with a primary diagosis of mild to moderate depression and were referred to the Psychology Department for therapy were invited to take part in this research. Participants were randomised into two groups: iCBT Intervention Group and Delayed Waitlist-Control Group. The four-week iCBT programme comprised of three face to face 30-minute sessions with a clinician and six online modules).The treatment group is hypothesised to exhibit pre-post improvements in depressive symptoms, compared to the control group.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 to 65 years old
- •Not currently seeing a therapist for any form of invidual or group therapy
- •Diagnosed with a primary diagnosis of depression by IMH psychiatrist
- •A total score of above 9 on the Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001), indicating at least mild symptoms
- •If using medication for depression then on a stable dose for at least 1 month,
- •Provides informed consent
- •Able to read and speak at least Primary 6 level English
- •Adequate IT skills to operate iCBT programme
排除标准
- •Severe depression (i.e. score = 23 on PHQ-9)
- •Strong suicidal ideation (i.e. score > 2 on Question 9 of the PHQ-9)
- •Current active suicidal intention or plan
- •Presenting problem is not depression
- •Does not meet the minimum English language requirements stated above
- •Participants who are concurrently attending other forms of group/individual psychotherapy
研究组 & 干预措施
Delayed Wait-list control
The delayed wait-list control did not receive any therapy interventions for 4 weeks from the pre-treatment assessment and from the fifth week onwards, they received the same intervention as the iCBT experimental group.
Internet-delivered Cognitive Behavioural Therapy (iCBT)
The iCBT programme comprised of 6 online modules, delivered over 4 weeks, with 3 face-to-face sessions provided by a clinician.The face-to-face sessions were conducted at week 1, 3 and 4. The objectives of the face-to-face sessions was for participants to discuss with the clinician about the application of the content of the modules and the active therapeutic interventions were all found in the online modules.
干预措施: Internet-delivered Cognitive Behavioural Therapy (Behavioral)
结局指标
主要结局
Change in Patient Health Questionnaire-9 (PHQ9)
时间窗: week 1, week 3, week 4 and 3-month follow-up
The PHQ-9 is a nine-item self-report measure of symptoms and severity of major depressive disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV; American Psychiatric Association, 2000) criteria for Major Depressive Disorder. Scores on each item range from 0 (not at all) to 3 (nearly every day). An overall cut-off score of 10 or greater has been found to be sensitive to a DSM-IV diagnosis of depression (Kroenke, Spitzer, Williams, amp; Löwe, 2010). The PHQ9 has an internal reliability of 0.86- 0.89, sensitivity of 88% and specificity of 88% for the clinical cut-off of 10. Test-retest reliability of 0.84, and moderately correlated(r=0.58) with the SF-20 mental health scale. (Kronke et al.,2001).
次要结局
- Change in Generalised Anxiety Disorder-7 (GAD-7)(week 1, week 3, week 4 and 3-month follow-up)
- Change in Work and Social Adjustment Scale (WSAS)(week 1, week 3, week 4 and 3-month follow-up)