ISRCTN10761003进行中（未招募）Unknown
Cognitive therapy for depression in tuberculosis treatment, protocol for a multi-centre pragmatic parallel arm randomized control trial with an internal pilot
ational Institute for Health and Care Research0 个研究点目标入组 560 人开始时间: 2023年11月27日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 560
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38889941/ (added 19/06/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 20/02/2024:
- •1. Adults aged between 18 and 70 years
- •2. Are Pakistani or Afghan nationals (with refugee status as per their registration in the National Database and Registration Authority of Pakistan)
- •3. Started on ATT within 1 month of diagnosis for pulmonary and extrapulmonary TB or MDR-TB and diagnosis of TB following the standard diagnostic procedure of the TB program (http://ntp.gov.pk/ntp-old/uploads/National_Guidelines_for_TB_Revised_2019.pdf). The researchers will include both pulmonary and extra-pulmonary TB forms
- •4. Meeting the criteria for depression (score of 10 or above on PHQ-9)
- •5. Score above 16 on WHODAS, questionnaire for functional impairments (WHO Disability Assessment Schedule 2.0; WHODAS)
- •Previous inclusion criteria:
- •1. Adults aged 18 years and above
- •2. Are Pakistani or Afghan nationals (with refugee status as per their registration in the National Database and Registration Authority of Pakistan)
- •3. Started on ATT within 1 month of diagnosis for pulmonary and extrapulmonary TB or MDR-TB and diagnosis of TB following the standard diagnostic procedure of the TB program (http://ntp.gov.pk/ntp-old/uploads/National_Guidelines_for_TB_Revised_2019.pdf). The researchers will include both pulmonary and extra-pulmonary TB forms
- •4. Meeting the criteria for depression (score of 10 or above on PHQ-9)
- •5. Score above 16 on WHODAS, questionnaire for functional impairments (WHO Disability Assessment Schedule 2.0; WHODAS)
排除标准
- •1. Meeting ICD-10 criteria for current or lifetime bipolar disorder, other forms of severe mental illness, have evidence of learning disability or severe substance abuse (except nicotine dependence)
- •2. Receiving any treatment for depression (psychotherapy or antidepressants over the last 6 months
- •3. Are currently suicidal, as defined in the mhGAP Intervention Guide, or made a suicidal attempt within the past 2 years
- •4. Have TB directly affecting the CNS, are severely ill and suffer from complications of TB such as pleural effusion or in severe pain that prevents them from taking part in the study in view of treating physicians
- •5. Are living in the same household as another participant of the study to prevent the risk of contamination between the intervention and control group
- •6. Are pregnant or breastfeeding
研究者
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