Depression in tuberculosis treatment Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomly allocated to one of the study arms in a 1:1 ratio (via random permuted blocks stratified by patients' nationality and type of TB (i.e. TB or MDR-TB). Randomization and al
Sponsors
National Institute for Health and Care Research
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 19/11/2024: Based on the findings from the pilot trial, the eligibility criteria for the definitive trial have been updated as follows: 1. Adults aged 18 – 70 years old 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 and diagnosis of TB following the standard diagnostic procedure of the TB programme (http://ntp.gov.pk/ntp-old/uploads/National_Guidelines_for_TB_Revised_2019.pdf ). We will include both pulmonary and extra-pulmonary TB forms. 4. Started on ATT within 3-6 months of diagnosis for Multi-Drug Resistance TB. 5. Meeting the criteria for depression (score of 10 or above on PHQ-9); The PHQ-9 is a nine-item instrument measuring the presence and severity of depression during the past 2 weeks (Kroenke and Spitzer, 2002). The PHQ-9 questions are derived from the 16-item version. Participants rate their responses on a four-point Likert scale ranging from “not at all” to “nearly every day”. The PHQ-9 total severity score ranges from 0 to 27. 6. Score above 16 on WHODAS, questionnaire for functional impairments (WHO Disability Assessment Schedule 2.0; WHODAS) (Üstün et al., 2010). _____ Previous 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
Exclusion criteria: Current exclusion criteria as of 19/11/2024: 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. Pregnant or breast-feeding mothers will not be excluded in the definitive trial. _____ Previous 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 25/01/2024: Acceptability and feasibility outcomes of the inbuilt pilot which determines the progression criteria will include: 1. Recruitment rate, measured by the number of patients recruited at baseline 2. Retention rates in therapy, are measured by the percentage of participants completing at least four sessions. This will be measured at week 8 post-randomization. 3. Completion rates for the trial follow-up, measured by the percentage of participants who are followed up and complete the 24-week post-randomization follow-up assessment. Progression criteria: The results from the pilot study will be presented to the Trial Steering Committee and the funders. The researchers will proceed to the main trial without major modification if: 1. Sample size of 40-80 participants recruited within the 3-month time frame. 2. If 40-70% of the patients complete at least four therapy sessions 3. And if 40-75% of the participants complete the follow-up assessments at week 8 and week 24 post-randomization If any major modification is required to the intervention design or delivery, the researchers will recommend that the internal pilot is changed to an external pilot with afresh recruitment to the main trial based on the substantial re-design. Other acceptability and feasibility outcomes of the inbuilt pilot will include: 4. The degree of completion of screening at routine TB treatment visits, indicated by at least a 65% compliance rate, measured at baseline. 5. Compliance in completing the outcome measures for mental health, indicated by at least a 65% compliance rate. This will be measured at baseline, week 8, and week 32 post-randomization. 6. The willingness of TB health workers: the number of TBHWs approached, completing a training program in both arms. This will be measured at baseline, week 8, and week 32 post-randomization. 7. The acceptability of trial procedures: adherence to trial procedures and completion of the assessments. Thi | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 25/01/2024: 1. Cost-effectiveness measured using the Service Receipt Inventory (SRI) at baseline, week 8, and week 32 post-randomisation 2. Severity of anxiety symptoms assessed using the Generalized Anxiety Disorder scale (GAD-7) at baseline, week 8, and week 32 post-randomization 3. Caregivers’ burden assessed by Zarit Burden interview at baseline, week 8, week 32 post-randomization 4. Perceived stigma assessed using the Internalized Stigma of Mental Illness scale at baseline, week 8, week 32 post-randomisation 5. Quality-adjusted life years (QALY) and general health status measured using the EuroQoL EQ5D at baseline, week 8, and week 32 post-randomization 6. Traumatic stress symptoms will be measured using the Harvard Trauma Questionnaire (HTQ) at baseline, week 8, and week 32 post-randomization 7. Functional impairment measured using WHODAS at baseline, week 8, and week 32 post-randomization 8. Clinical outcomes will be assessed using measures developed and successfully incorporated in routine TB programme recording tools at 24 weeks post-randomization 10. Acceptability of trial procedures measured by the adherence to trial procedures and completion of the assessments at baseline, 8 weeks, 24 weeks, and 32 weeks post-randomization 11. Implementation outcomes for appropriateness measured using the Intervention Appropriate Measure (IAM) scale at week 32 post-randomization 12. Implementation outcomes for feasibility and acceptability will be measured using the Applied Mental Health Research Group (AMHR) feasibility Scale at week 32 post-randomization 13. Intervention Fidelity, measured using an independent ratter using a checklist and The Cognitive Therapy Scale (CTS-R), at week 8 & week 32 post-randomization 14. Penetration and sustainability of the intervention will be measured using the acceptance of Mental Health Measures in Routine TB Health outcomes at week 32 post-randomization Previous secondary outcome measures: 1. | — |
Countries
Pakistan
Contacts
Public ContactSaeed Farooq
Outcome results
None listed