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Cognitive therapy for depression in tuberculosis treatment

Not Applicable
Conditions
Depression in tuberculosis treatment
Mental and Behavioural Disorders
Registration Number
ISRCTN10761003
Lead Sponsor
ational Institute for Health and Care Research
Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38889941/ (added 19/06/2024)

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
560
Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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