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临床试验/CTRI/2020/03/023693
CTRI/2020/03/023693已完成不适用

Blended internet-based and face-to-face intervention for treatment of depression

Sindhuja Sudarshan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Severity of depressive symptoms,

研究概览

简要总结

The study aims to examine the feasibility, acceptability and effectiveness of a blended intervention which combines internet-based self-help with face-to-face sessions in the treatment of mild-to-moderate depression.  A single group pre post follow up study design will be employed where participants will receive the blended intervention (n=60).  The primary outcome measures will be severity of depression as assessed on Beck Depression Inventory (BDI) and functioning assessed on Work and Social Adjustment Scale (WSAS) at baseline, post assessment at 8 weeks and 3 month follow up. The secondary outcomes will be self-esteem and psychological recovery assessed at baseline, post assessment at 8 weeks and 3 month follow up.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.A primary diagnosis of mild to moderate depression and/or dysthymia as per ICD-10 as determined through Mini International Neuropsychiatric Interview (MINI, Sheehan et al., 1998) 2.Score of 14 and above on Beck Depression Inventory(BDI II; Beck,Street & Brown; 1996) 3.Minimum education upto class X 4.Ability to read, write and comprehend English 5.Access to and comfort in using internet 6.Individuals in whom the anti-depressant dose has not been changed by over 25 percent over the past four weeks if on medication.

排除标准

  • 1.Diagnoses of Psychosis, Bipolar Affective Disorder, Severe Depression with/without psychotic symptoms, cluster B personality disorders, organic disorders 2.Individuals whose current problems predominantly indicate the need for current engagement in marital or family therapy as clinically adjudged 3.Current suicidality assessed as moderate or severe on MINI 4.Patients who are currently undergoing psychotherapy or who have undergone psychotherapy in the last 6 months in the form of more than 3 structured psychotherapy sessions.

结局指标

主要结局

Severity of depressive symptoms,

时间窗: Baseline, post assessment at 8 weeks, 3 month follow up

Functioning

时间窗: Baseline, post assessment at 8 weeks, 3 month follow up

次要结局

  • Self-esteem(Baseline, post assessment at 8 weeks, 3 month follow up)
  • Psychological recovery(Baseline, post assessment at 8 weeks, 3 month follow up)

研究者

发起方
Sindhuja Sudarshan
申办方类型
Other [self]

研究点 (1)

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